The National Institute of Child Health and Human Development Maternal-Fetal Medicine Unit Network Randomized Clinical Trial in Progress Metformin should be considered in the treatment of gestational diabetes: a prospective randomised study The Impact of Self-Monitoring of Blood Olucose on Self-Efficacy and Pregnancy Outcomes in Women With Diet-Controlled Gestational Diabetes Indication and results of insulin therapy for gestational diabetes mellitus Is treatment needed for mild impairment of glucose tolerance in pregnancy? A randomized controlled trial. Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus Mild gestational diabetes in pregnancy and the adipoinsular axis in babies born to mothers in the ACHOIS randomised controlled trial A randomized controlled trial of strict glycemic control and tertiary level obstetric care versus routine obstetric care in the management of gestational diabetes: a pilot study. Supervised home-based exercise may attenuate the decline of glucose tolerance in obese pregnant women. Toward universal criteria for gestational diabetes: relationships between seventy-five and one hundred gram glucose loads and between capillary and venous glucose concentrations. Glycemia and Its Relationship to Outcomes in the Metformin in Gestational Diabetes Trial Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. Can a Low–Glycemic Index Diet Reduce the Need for Insulin in Gestational Diabetes Mellitus? 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A randomised controlled trial of dietary energy restriction in the management of obese women with gestational diabetes Metformin Compared With Glyburide in Gestational Diabetes: A Randomized Controlled Trial Impact of gestational diabetes mellitus nutrition practice guidelines implemented by registered dietitians on pregnancy outcomes. [Treating women with gestational impaired glucose tolerance reduces adverse outcome of pregnancy]. The Potential Diabetic and Her Treatment in Pregnancy Exercise in Gestational Diabetes: An Optional Therapeutic Approach? Medical Treatment of the Gestational Diabetic Exercise fails to improve postprandial glycemic excursion in women with gestational diabetes. Treatment of women with an abnormal glucose challenge test (but a normal oral glucose tolerance test) decreases the prevalence of macrosomia. 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It is recognized that women with gestational diabetes mellitus ( GDM ) who have significantly elevated fasting blood glucose levels are at increased risk for fetal macrosomia and perinatal morbidity if treatment is not provided ( 1,2 ) . The association of milder forms of GDM with perinatal morbidity and mortality remains unclear , primarily because the condition is often confounded with other risk factors such as maternal obesity , age , and parity . Screening for GDM is recommended for most pregnant women , yet it is unknown whether there is a benefit to the identification and treatment of mild carbohydrate intolerance during pregnancy ( 3,4 ) . The present report is an up date of our previous description of a current ongoing r and omized treatment trial for mild GDM ( 5 ) . A r and omized clinical trial of women with mild GDM ( fasting glucose < 95 mg/dl ) is being undertaken that compares perinatal outcomes in those receiving diet therapy and insulin as required versus those r and omized to no specific treatment . This study aims to clarify whether there is utility in identifying and treating women with a normal fasting glucose level who meet st and ard criteria for GDM . We plan to compare perinatal outcomes in women who have been r and omized to diet and /or insulin therapy with women who have been r and omized to no specific treatment . A r and omized treatment trial of mild GDM will clarify whether identification and treatment of mild GDM reduce perinatal morbidity . This information will assist in determining appropriate thresholds for the treatment of GDM . Overall , with broader identification and aggressive treatment , perinatal mortality rates associated with GDM appear to be similar to the nondiabetic population ( 1 ) . Several analyses of 20 years ago did document an increased stillbirth rate for GDM pregnancies that would qualify as preexisting diabetes according to World Health Organization criteria ( 6–9 ) . Below this threshold , the extent to Please cite this paper as : Ijäs H , Vääräsmäki M , Morin‐Papunen L , Keravuo R , Ebeling T , Saarela T , Raudaskoski T. Metformin should be considered in the treatment of gestational diabetes : a prospect i ve r and omised study . BJOG 2011;118:880–885 PURPOSE The purpose of this study was to examine the effects of self-monitoring of blood glucose ( SMBG ) on feelings of self-efficacy , dietary compliance , and pregnancy outcomes in women with diet-controlled gestational diabetes mellitus ( GDM ) . METHODS Fifty-eight women with GDM and a fasting blood glucose level < 95 mg/dL were r and omly assigned to 2 groups . The experimental group measured their blood glucose levels 4 times daily using a reflectance meter with memory . Metabolic status  was assessed in the control group by periodic monitoring at prenatal visits . Otherwise the management protocol was identical for both groups . The Diabetes Empowerment Scale was completed at study entry and at 37 weeks gestation to assess feelings of self-efficacy .  Dietary compliance was assessed at each visit . RESULTS Both groups of women achieved excellent glucose control ; only 1 woman in each group required insulin therapy . There were no significant differences with regard to feelings of self-efficacy , dietary compliance , birth weight , gestational age at delivery , Apgar scores , and neonatal complications . Rates of macrosomia , delivery by cesarean section , and occurrence of birth trauma were similar . CONCLUSIONS SMBG appears to have little effect on maternal feelings of self-efficacy , dietary compliance , or pregnancy outcomes in women with diet-controlled GDM The aim of this study was to determine whether amniotic fluid insulin concentration ( AFI ) is a better parameter than mean maternal blood glucose values ( MBG ) for deciding about insulin therapy in patients with gestational diabetes . MBG 's were calculated on the base of 9 blood glucose levels during a 24 hour period after one week of diet therapy . In a prospect i ve trial between 1987 and 1989 in Karlsburg , 123 gestational diabetic patients were r and omized into two groups . Treatment was either based on the concentration of AFI or MBG levels . In a second series in Berlin , 103 patients were offered amniocentesis . 81 patients agreed and 22 refused . Treatment was then analogous to that in Karlsburg . In both groups of the r and omized population , strict metabolic control was achieved . There was no difference regarding pregnancy complications . Earlier labor induction and higher cesarean section rates were seen in the non-invasive group ( p < 0.05 ) . The incidence of diabetic fetopathy and neonatal hypoglycemia was significantly lower in the invasive group ( p < 0.01 ) , even though the metabolic control parameters did not differ between the two groups . The results in Berlin correspond to these findings . In conclusion , AFI enables the recognition of any hyperinsulinism reaction to the maternal metabolic situation . We recommend the additional measurement of the AFI concentration between 28 and 36 weeks as the direct fetal parameter for deciding about insulin treatment The study was design ed to identify those pregnant women who are diagnosed as having gestational diabetes by National Diabetes Data Group ( NDDG ) criteria , but normal glucose tolerance ( NGT ) or impaired glucose tolerance ( IGT ) by the World Health Organization ( WHO ) criteria , and to test whether treatment changed the perinatal outcome in those with NGT and IGT . The 216 women with an abnormal 100 g oral glucose tolerance test ( OGTT ) using NDDG criteria were subjected to a 75 g OGTT . Using the WHO criteria , 111 women ( 51 % ) had NGT , 98 ( 45 % ) had IGT and 7 ( 3 % ) had frank diabetes mellitus . Those with NGT and IGT were r and omized into control and treatment groups . The perinatal outcome in these two groups was comparable whether the NGT and IGT groups were analysed together or separately except , that in those who were treated for IGT , smaller babies were born one week earlier than in the control group ( 3407 g vs 3110 g , P less than 0.01 ) . This suggests that the WHO criteria can safely replace the 100 g OGTT with substantial savings in manpower , money and patients ' time Aim The efficacy and safety of insulin aspart ( IAsp ) , a rapid-acting human insulin analogue , were compared with regular human insulin ( HI ) as the bolus component of basal-bolus therapy for subjects with gestational diabetes mellitus ( GDM ) . Methods In a r and omized , parallel-group , open-labelled trial , 27 women with GDM ( age 30.7 ± 6.3 years , HbA1c < 7 % ) were r and omized to receive IAsp ( 5 min before meal ) or HI ( 30 min before meal ) . The trial period extended from diagnosis of GDM ( 18–28 weeks ) to 6 weeks postpartum . Results Both treatment groups maintained good overall glycaemic control during the study ( beginning and end of study HbA1c≤ 6 % ) . During the meal test , mean glucose at week 6 ( IAsp 4.2 ± 0.57 mmol/l , HI 4.8 ± 0.86 mmol/l ) was slightly lower than at week 0 ( IAsp 4.9 ± 0.59 mmol/l , HI 5.1 ± 0.36 mmol/l ) . However , change from baseline values for average glucose ( IAsp –1.09 ± 0.54 mmol/l , HI –0.54 ± 0.74 mmol/l ; P = 0.003 ) and C-peptide ( IAsp –0.50 ± 0.67 nmol/l , HI –0.30 ± 0.70 nmol/l ; P = 0.027 ) were significantly lower after IAsp treatment than HI treatment . No major hypoglycaemic events were reported during the study . Cross-reacting insulin antibody binding increased slightly from baseline in both treatments groups ( end of study : IAsp 2.1 ± 5.4 % , HI 6.4 ± 13.9 % ) , whereas antibodies specific to IAsp or HI remained relatively low ( < 1 % binding ) . Conclusion IAsp was more effective than HI in decreasing postpr and ial glucose concentrations . Duration of IAsp injection 5 min before a meal rather than 30 min prior to meals offers a more convenient therapy for subjects with GDM . Overall safety and effectiveness of IAsp were comparable to HI in pregnant women with GDM . Diabet . Med . 24 , 1129–1135 ( 2007 Background Mild gestational diabetes is a common complication of pregnancy , affecting up to 9 % of pregnant women . Treatment of mild GDM is known to reduce adverse perinatal outcomes such as macrosomia and associated birth injuries , such as shoulder dystocia , bone fractures and nerve palsies . This study aim ed to compare the plasma glucose concentrations and serum insulin , leptin and adiponectin in cord blood of babies of women ( a ) without gestational diabetes mellitus ( GDM ) , ( b ) with mild GDM under routine care , or ( c ) mild GDM with treatment . Methods 95 women with mild GDM on oral glucose tolerance testing ( OGTT ) at one tertiary level maternity hospital who had been recruited to the ACHOIS trial at one of the collaborating hospitals and r and omised to either Treatment ( n = 46 ) or Routine Care ( n = 49 ) and Control women with a normal OGTT ( n = 133 ) were included in the study . Women with mild GDM ( treatment or routine care group ) and OGTT normal women received routine pregnancy care . In addition , women with treated mild GDM received dietary advice , blood glucose monitoring and insulin if necessary . The primary outcome measures were cord blood concentrations of glucose , insulin , adiponectin and leptin . Results Cord plasma glucose was higher in women receiving routine care compared with control , but was normalized by treatment for mild GDM ( p = 0.01 ) . Cord serum insulin and insulin to glucose ratio were similar between the three groups . Leptin concentration in cord serum was lower in GDM treated women compared with routine care ( p = 0.02 ) and not different to control ( p = 0.11 ) . Adiponectin was lower in both mild GDM groups compared with control ( Treatment p = 0.02 and Routine Care p = 0.07 ) , while the adiponectin to leptin ratio was lower for women receiving routine care compared with treatment ( p = 0.08 ) and control ( p = 0.05 ) . Conclusion Treatment of women with mild GDM using diet , blood glucose monitoring and insulin if necessary , influences the altered fetal adipoinsular axis characteristic of mild GDM in pregnancy OBJECTIVES The purpose of this study was to determine whether strict maternal glycemic control for the treatment of gestational diabetes lessened the risk of fetal macrosomia , birth trauma , neonatal hypoglycemia , and operative delivery . The aim of the pilot study was to prepare for a multicenter trial by assessing patient acceptance of the study , by determining realistic accrual rates , and by detecting any major adverse outcomes in the control group that received routine obstetric care . STUDY DESIGN The study was a prospect i ve r and omized controlled trial comparing fetal-neonatal and maternal outcomes in 300 women with gestational diabetes . Women r and omized to the treatment arm were managed by strict glycemic control and tertiary level obstetric care , and women in the control arm received routine obstetric care . RESULTS Three hundred women with gestational diabetes mellitus were studied . There was no difference in maternal age , weight , or length of gestation between groups . The treatment mean birth weight was 3437 + /- 575 gm compared with 3544 + /- 601 gm in the control group , a difference of 107 gm ( not significant ) . Macrosomia rates were similar . There was no birth trauma in either group . The frequency of neonatal hypoglycemia and other metabolic complications was the same . The mode of delivery also showed similar patterns . The treatment group had significantly lower prepr and ial and postpr and ial glucose levels by 32 weeks ' gestation , which continued to term . CONCLUSION This pilot study suggests that intensive treatment of gestational diabetes mellitus may have little effect on birth weight , birth trauma , operative delivery , or neonatal metabolic disorders . It has demonstrated the safety of proceeding to a multicenter trial of sufficient sample size to confirm these findings AIM The significant deterioration of insulin sensitivity and glucose tolerance during pregnancy can have serious health implication s for both the pregnant woman and her baby . Although it is well established that regular exercise benefits insulin sensitivity in the nonpregnant population , the effect on glucose tolerance in obese pregnant women is not known . The purpose of this study was to investigate the effect of a supervised 10-week , home-based , exercise programme , beginning at week 18 of gestation , on glucose tolerance and aerobic fitness in previously sedentary obese women . METHODS Twelve sedentary obese women were r and omized into an exercise ( EX ; n=6 ) or control ( CON ; n=6 ) group at 18 weeks of gestation . Those r and omized to EX engaged in 10 weeks of supervised home-based exercise ( three sessions a week of stationary cycling ) , while those in the CON group maintained their usual daily activity . Their glucose and insulin responses to an oral glucose tolerance test ( OGTT ) , as well as their aerobic fitness , were assessed both pre- and postintervention . RESULTS Reduced glucose tolerance in the CON , but not EX , group was indicated by a tendency postintervention towards higher blood glucose levels at 1h of the OGTT ( P=0.072 ) . Furthermore , at 2h of the postintervention OGTT , blood glucose tended to remain elevated from baseline in the CON ( P=0.077 ) . There was also a trend towards increased fitness in the EX ( P=0.064 ) , but not the CON group . CONCLUSION Regular aerobic exercise begun during pregnancy may have favourable effects on glucose tolerance and fitness in obese women , and warrants further investigation in a larger sample population OBJECTIVES Replacement of the two-step , 100 gm , 3-hour National Diabetes Data Group procedure by the one-step , 75 gm , 2-hour World Health Organization oral glucose tolerance test has been hindered by a paucity of data comparing the two tests during pregnancy . The current series compared 100 gm and 75 gm glucose loads and glucose measurements in venous plasma or capillary blood . STUDY DESIGN After a 75 gm oral glucose tolerance test  30 gestational diabetics and 30 metabolically healthy pregnant women were r and omly assigned to a second 75 or 100 gm test within 3+/-1.3 ( mean+/-SD ) days . Glucose levels at both tests was measured in capillary blood and venous plasma , as were insulin and C peptide . RESULTS In controls 1-hour maternal glucose levels ( 112 vs 128 mg/dl ) and 2-hour levels ( 104 vs 113 mg/dl ) differed significantly after a 75 or 100 gm load ( paired t test ) . In gestational diabetes mellitus , however , there was no difference ( 176 vs 178 mg/dl ) but a low insulin/glucose quotient at 1 hour . Only 2-hour levels differed significantly ( 133 vs 149 mg/dl ) . In controls glucose measurement in capillary blood and venous plasma differed significantly at 1 hour ( 126 vs 115 mg/dl ) and 2 hours ( 111 vs 104 mg/dl ) independently of the glucose load . In gestational diabetes mellitus , however , glucose measurement in capillary blood and venous plasma differed neither in 1-hour levels ( 179 vs 174 mg/dl ) nor in 2-hour levels ( 142 vs 139 mg/dl ) . CONCLUSION In metabolically healthy women both different loading and different blood fractions lead to statistically different blood glucose levels at 1 and 2 hours . In gestational diabetes mellitus , however , 1-hour glucose levels do not differ after a 75 or 100 gm load or after glucose measurement in capillary blood or venous plasma . This is due to elevated insulin resistance shown by a low insulin/glucose quotient at 1 hour . For comparison of tests in gestational diabetes mellitus only , 2-hour values must be adjusted by 16 mg/dl after different loading OBJECTIVE To determine how glucose control in women with GDM treated with metformin and /or insulin  influenced  pregnancy outcomes . RESEARCH DESIGN AND METHODS Women r and omly assigned to metformin or insulin treatment in the Metformin in Gestational Diabetes ( MiG ) trial had baseline glucose tolerance test ( OGTT ) results and A1C documented , together with all capillary glucose measurements during treatment . In the 724 women who had glucose data for analysis , tertiles of baseline glucose values and A1C and of mean capillary glucose values during treatment were calculated . The relationships between maternal factors , glucose values , and outcomes ( including a composite of neonatal complications , preeclampsia , and large-for-gestational-age [ LGA ] and small-for-gestational-age infants ) were examined with bivariable and multivariate models . RESULTS Baseline OGTT did not predict outcomes , but A1C predicted LGA infants ( P = 0.003 ) . During treatment , fasting capillary glucose predicted neonatal complications ( P < 0.001 ) and postpr and ial glucose predicted preeclampsia ( P = 0.016 ) and LGA infants ( P = 0.001 ) . Obesity did not influence outcomes , and there was no interaction between glycemic control , r and omized treatment , or maternal BMI in predicting outcomes . The lowest risk of complications was seen when fasting capillary glucose was < 4.9 mmol/l ( mean ± SD 4.6 ± 0.3 mmol/l ) compared with 4.9–5.3 mmol/l or higher and when 2-h postpr and ial glucose was 5.9–6.4 mmol/l ( 6.2 ± 0.2 mmol/l ) or lower . CONCLUSIONS Glucose control in women with gestational diabetes mellitus treated with metformin and /or insulin is strongly related to outcomes . Obesity is not related to outcomes in this group . Targets for fasting and postpr and ial capillary glucose may need to be lower than currently recommended BACKGROUND We conducted a r and omized clinical trial to determine whether treatment of women with gestational diabetes mellitus reduced the risk of perinatal complications . METHODS We r and omly assigned women between 24 and 34 weeks ' gestation who had gestational diabetes to receive dietary advice , blood glucose monitoring , and insulin therapy as needed ( the intervention group ) or routine care . Primary outcomes included serious perinatal complications ( defined as death , shoulder dystocia , bone fracture , and nerve palsy ) , admission to the neonatal nursery , jaundice requiring phototherapy , induction of labor , cesarean birth , and maternal anxiety , depression , and health status . RESULTS The rate of serious perinatal complications was significantly lower among the infants of the 490 women in the intervention group than among the infants of the 510 women in the routine-care group ( 1 percent vs. 4 percent ; relative risk adjusted for maternal age , race or ethnic group , and parity , 0.33 ; 95 percent confidence interval , 0.14 to 0.75 ; P=0.01 ) . However , more infants of women in the intervention group were admitted to the neonatal nursery ( 71 percent vs. 61 percent ; adjusted relative risk , 1.13 ; 95 percent confidence interval , 1.03 to 1.23 ; P=0.01 ) . Women in the intervention group had a higher rate of induction of labor than the women in the routine-care group ( 39 percent vs. 29 percent ; adjusted relative risk , 1.36 ; 95 percent confidence interval , 1.15 to 1.62 ; P<0.001 ) , although the rates of cesarean delivery were similar ( 31 percent and 32 percent , respectively ; adjusted relative risk , 0.97 ; 95 percent confidence interval , 0.81 to 1.16 ; P=0.73 ) . At three months post partum , data on the women 's mood and quality of life , available for 573 women , revealed lower rates of depression and higher scores , consistent with improved health status , in the intervention group . CONCLUSIONS Treatment of gestational diabetes reduces serious perinatal morbidity and may also improve the woman 's health-related quality of life OBJECTIVE A low – glycemic index diet is effective as a treatment for individuals with diabetes and has been shown to improve pregnancy outcomes when used from the first trimester . A low – glycemic index diet is commonly advised as treatment for women with gestational diabetes mellitus ( GDM ) . However , the efficacy of this advice and associated pregnancy outcomes have not been systematic ally examined . The purpose of this study was to determine whether prescribing a low – glycemic index diet for women with GDM could reduce the number of women requiring insulin without compromise of pregnancy outcomes . RESEARCH DESIGN AND METHODS All women with GDM seen over a 12-month period were considered for inclusion in the study . Women ( n = 63 ) were r and omly assigned to receive either a low – glycemic index diet or a conventional high-fiber ( and higher glycemic index ) diet . RESULTS Of the 31 women r and omly assigned to a low – glycemic index diet , 9 ( 29 % ) required insulin . Of the women r and omly assigned to a higher – glycemic index diet , a significantly higher proportion , 19 of 32 ( 59 % ) , met the criteria to commence insulin treatment ( P = 0.023 ) . However , 9 of these 19 women were able to avoid insulin use by changing to a low – glycemic index diet . Key obstetric and fetal outcomes were not significantly different . CONCLUSIONS Using a low – glycemic index diet for women with GDM effectively halved the number needing to use insulin , with no compromise of obstetric or fetal outcomes OBJECTIVE To compare glycemic control and neonatal outcomes in women with gestational diabetes mellitus ( GDM ) treated with metformin vs. insulin . STUDY DESIGN Women with GDM not controlled with diet and exercise were r and omized to metformin ( n = 32 ) or insulin ( n = 31 ) . The levels of glycemic control as well as maternal/neonatal complications were evaluated . RESULTS The mean ( + /- SD ) fasting and 2-hour postpr and ial blood glucose did not differ statistically between the 2 treatment groups . No patient failed metformin and required insulin . The majority ( 27/32 ) were easily controlled on the initial dosage ( 500 mg twice a day ) . Gestational age at entry and delivery ( p = 0.077 , 0.412 ) were similar . The difference in the rate of cesarean delivery was not statistically significant between the 2 groups ( p = 0.102 ) . Neonatal statistics were also not different between the metformin and insulin groups : birth weight , Apgar score at 5 minutes , respiratory distress syndrome , hyperbilirubinemia , neonatal hypoglycemia and neonatal intensive care unit admission ( p = 0.144 - 0.373 ) . CONCLUSION Based on these preliminary data , metformin appears to be an effective alternative to insulin in the treatment of GDM Background Recommended best practice is that economic evaluation of health care interventions should be integral with r and omised clinical trials . We performed a cost-consequence analysis of treating women with mild gestational diabetes mellitus by dietary advice , blood glucose monitoring and insulin therapy as needed compared with routine pregnancy care , using patient-level data from a multi-centre r and omised clinical trial . Methods Women with a singleton pregnancy who had mild gestational diabetes diagnosed by an oral glucose-tolerance test between 24 and 34 weeks ' gestation and their infants were included . Clinical outcomes and outpatient costs derived from all women and infants in the trial . Inpatient costs derived from women and infants attending the hospital contributing the largest number of enrolments ( 26.1 % ) , and charges to women and their families derived from a sub sample of participants from that hospital ( in 2002 Australian dollars ) . Occasions of service and health outcomes were adjusted for maternal age , ethnicity and parity . Analysis of variance was used with bootstrapping to confirm results . Primary clinical outcomes were serious perinatal complications ; admission to neonatal nursery ; jaundice requiring phototherapy ; induction of labour and caesarean delivery . Economic outcome measures were outpatient and inpatient costs , and charges to women and their families . Results For every 100 women with a singleton pregnancy and positive oral glucose tolerance test who were offered treatment for mild gestational diabetes mellitus in addition to routine obstetric care , $ 53,985 additional direct costs were incurred at the obstetric hospital , $ 6,521 additional charges were incurred by women and their families , 9.7 additional women experienced induction of labour , and 8.6 more babies were admitted to a neonatal nursery . However , 2.2 fewer babies experienced serious perinatal complication and 1.0 fewer babies experienced perinatal death . The incremental cost per additional serious perinatal complication prevented was $ 27,503 , per perinatal death prevented was $ 60,506 and per discounted life-year gained was $ 2,988 . Conclusion It is likely that the general public in high-income countries such as Australia would find reductions in perinatal mortality and in serious perinatal complications sufficient to justify additional health service and personal monetary charges . Over the whole lifespan , the incremental cost per extra life-year gained is highly favourable . Trial Registration Australian Clinical Trials Registry This study discusses two main questions : the direct medical costs and the clinical effectiveness of the hospital treatment with insulin of pregnant women with gestational diabetes ( GD ) . A prospect i ve study that includes 50 women with GD is performed . The pregnant women are divided into 2 groups : Group I ( n=30 ) — pregnant women treated only with a diet ; and Group II ( n=20 ) — pregnant women treated with diet and insulin . We found that the metabolite compensation degree is improved after the applied treatment with insulin . The coefficient cost/effectiveness is 6954 lv./100 women . The analysis decision tree confirms in a very convenient way the fact that insulin treatment is a clinical ly more effective and financially more profitable strategy OBJECTIVE We sought to investigate the association between glyburide dose , degree of severity in  gestational diabetes mellitus ( GDM ) ,  level of glycemic control , and  pregnancy outcome in insulin- and glyburide-treated patients . STUDY DESIGN In a secondary analysis of our previous r and omized study , 404 women were analyzed . The association among glyburide dose , severity of GDM , and selected maternal and neonatal factors was evaluated . Severity levels of GDM were stratified by fasting plasma glucose ( FPG ) from the oral glucose tolerance test ( OGTT ) . Infants with birth weight at or above the 90th percentile were considered large-for-gestational age ( LGA ) . Macrosomia was defined as birth weight > or = 4000 g. Well-controlled was defined as mean blood glucose < or = 95 mg/dL. The association between glyburide- and insulin-treated patients by severity of GDM and neonatal outcome was evaluated . RESULTS The dose received for the glyburide-treated patients was 2.5 mg-32 % ; 5 mg-23 % ; 10 mg-17 % ; 15 mg-8 % ; and 20 mg-20 % . Patients were grouped into low ( < or = 10 mg ) and high ( > 10 mg ) daily dose of glyburide . A comparison between severity of the disease ( fasting plasma glucose categories ) and highest dose of glyburide revealed a significant difference between the low-95 FPG and the other severity categories ( P = .02 ) . Of patients in the well-controlled glycemic group , only 6 % required the high dose of glyburide ( > 10 mg ) . In patients with poor glycemic control ( mean blood glucose > 95 mg/dL ) , 38 % received the high dose of glyburide ( P = .0001 ) . Comparison between the high glyburide ( > 10 mg ) and the low glyburide dosages ( < or = 10 mg ) revealed that the rate of macrosomia was 16 % vs 5 % and LGA 22 % vs 8 % , ( P = .01 ) , respectively . No significant difference was found in composite outcome , metabolic complications , and Ponderal Index between the 2 dose groups . Stratification by disease severity revealed a significantly lower rate of LGA for both the glyburide- and insulin-treated subjects . No significant difference was found between metabolic , respiratory , and neonatal intensive care unit ( NICU ) for patients within each fasting plasma glucose severity category . CONCLUSION Glyburide and insulin are equally efficient for treatment of GDM in all levels of disease severity . Achieving the established level of glycemic control , not the mode of pharmacologic therapy , is the key to improving the outcome in GDM OBJECTIVE To compare management based on maternal glycemic criteria with management based on relaxed glycemic criteria and fetal abdominal circumference ( AC ) measurements in order to select patients for insulin treatment of gestational diabetes mellitus ( GDM ) with fasting hyperglycemia . RESEARCH DESIGN AND METHODS In a pilot study , 98 women with fasting plasma glucose ( FPG ) concentrations of 105 - 120 mg/dl were r and omized . The st and ard group received insulin treatment . The experimental group received insulin if the AC , measured monthly , was > or = 70th percentile and /or if any venous FPG measurement was > 120 mg/dl . Power was projected to detect a 250-g difference in birth weights . RESULTS Gestational ages , maternal glycemia , and AC percentiles were similar at r and omization . After initiation of protocol , venous FPG ( P = 0.003 ) and capillary blood glucose levels ( P = 0.049 ) were significantly lower in the st and ard group . Birth weights ( 3,271 + /- 458 vs. 3,369 + /- 461 g ) , frequencies of birth weights > 90th percentile ( 6.3 vs 8.3 % ) , and neonatal morbidity ( 25 vs. 25 % ) did not differ significantly between the st and ard and experimental groups , respectively . The cesarean delivery rate was significantly lower ( 14.6 vs. 33.3 % , P = 0.03 ) in the st and ard group ; this difference was not explained by birth weights . In the experimental group , infants of women who did not receive insulin had lower birth weights than infants of mothers treated with insulin ( 3,180 + /- 425 vs. 3,482 + /- 451 g , P = 0.03 ) . CONCLUSIONS In women with GDM and fasting hyperglycemia , glucose plus fetal AC measurements identified pregnancies at low risk for macrosomia and result ed in the avoidance of insulin therapy in 38 % of patients without increasing rates of neonatal morbidity BACKGROUND Metformin is a logical treatment for women with gestational diabetes mellitus , but r and omized trials to assess the efficacy and safety of its use for this condition are lacking . METHODS We r and omly assigned 751 women with gestational diabetes mellitus at 20 to 33 weeks of gestation to open treatment with metformin ( with supplemental insulin if required ) or insulin . The primary outcome was a composite of neonatal hypoglycemia , respiratory distress , need for phototherapy , birth trauma , 5-minute Apgar score less than 7 , or prematurity . The trial was design ed to rule out a 33 % increase ( from 30 % to 40 % ) in this composite outcome in infants of women treated with metformin as compared with those treated with insulin . Secondary outcomes included neonatal anthropometric measurements , maternal glycemic control , maternal hypertensive complications , postpartum glucose tolerance , and acceptability of treatment . RESULTS Of the 363 women assigned to metformin  , 92.6 % continued to receive metformin until delivery and 46.3 % received supplemental insulin . The rate of the primary composite outcome was 32.0 % in the group assigned to metformin and 32.2 % in the insulin group ( relative risk , 0.99 [ corrected ] ; 95 % confidence interval , 0.80 [ corrected ] to 1.23 [ corrected ] ) . More women in the metformin group than in the insulin group stated that they would choose to receive their assigned treatment again ( 76.6 % vs. 27.2 % , P<0.001 ) . The rates of other secondary outcomes did not differ significantly between the groups . There were no serious adverse events associated with the use of metformin . CONCLUSIONS In women with gestational diabetes mellitus , metformin ( alone or with supplemental insulin ) is not associated with increased perinatal complications as compared with insulin . The women preferred metformin to insulin treatment . ( Australian New Zeal and Clinical Trials Registry number , 12605000311651 . ) OBJECTIVE This study examines the effects of circuit-type resistance training on the need for insulin in women with gestational diabetes mellitus . STUDY DESIGN Thirty-two patients with gestational diabetes mellitus were r and omly assigned either to a group that was treated with diet alone or to a group that was treated with diet plus resistance exercise . RESULTS The number of women whose condition required insulin therapy was the same , regardless of treatment . However , a subgroup analysis that examined only overweight women ( prepregnant body mass index , > 25 kg/m(2 ) ) showed a lower incidence of insulin use in the diet-plus-exercise group ( P<.05 ) . Women in the diet-plus-exercise group were prescribed less insulin ( P<.05 ) and showed a longer delay from diagnosis to the initiation of insulin therapy ( P<.05 ) , compared with the diet-alone group . CONCLUSION Resistance exercise training may help to avoid insulin therapy for overweight women with gestational diabetes mellitus The Metformin in Gestational Diabetes ( MiG ) trial is a prospect i ve r and omized multicenter trial in women with gestational diabetes mellitus ( GDM ) that is testing the hypothesis that metformin treatment , compared with insulin , is associated with similar perinatal outcomes , improved markers of insulin sensitivity in the mother and baby , and improved treatment acceptability . Women with GDM who are at 20–33 weeks ’ gestation in a singleton pregnancy and meet entry criteria are r and omized to insulin or metformin  treatment . The primary outcome is a composite of neonatal morbidity , with 750 recruits required . The trial finished recruiting in October 2006 . Interim data on 200 women ( and subsequently 550 women ) have been review ed by the data safety monitoring committee , which has reported that the trial should answer the hypotheses and no protocol changes are required . Data from 457 women show recruits are a mean age of 33.3 ± 5.3 years ; BMI of 32.1 ± 7.8 kg/m2 ; and ethnicity 47.2 % European/Caucasian , 25.7 % Polynesian , and 24.3 % Indian/Asian .  The mean fasting glucose at recruitment is 5.3 ± 1.1 mmol/l and A1C is 5.7 ± 0.8 % . Long-term follow-up of children started at age 2 years , with assessment s of body composition , neurodevelopment , diet , and activity levels . The MiG trial will address the efficacy and detailed safety of metformin compared with insulin in women with GDM . Long-term follow-up of offspring will examine whether treatment influences later health ( Australasian Clinical Trials Registry number 12605000311651 ) . GDM is diagnosed in over 4 % of pregnant women ( 1,2 ) . The prevalence is increasing as the pregnancy population becomes older and fatter . Women with GDM have increased rates of pregnancy complications and risks of later type 2 diabetes ( 1,2 ) . The offspring of women with GDM also have increased risks of perinatal complications and long-term risks of obesity and type 2 diabetes ( 1– OBJECTIVE Gestational diabetes mellitus ( GDM ) may cause obesity in the offspring . The objective was to assess the effect of treatment for mild GDM on the BMI of 4- to 5-year-old children . RESEARCH DESIGN AND METHODS Participants were 199 mothers who participated in a r and omized controlled trial of the treatment of mild GDM during pregnancy and their children . Trained nurses measured the height and weight of the children at preschool visits in a state-wide surveillance program in the state of South Australia . The main outcome measure was age- and sex-specific BMI Z score based on st and ards of the International Obesity Task Force . RESULTS At birth , prevalence of macrosomia ( birth weight ≥4,000 g ) was 5.3 % among the 94 children whose mothers were in the intervention group , and 21.9 % among the 105 children in the routine care control group . At 4- to 5-years-old , mean ( SD ) BMI Z score was 0.49 ( 1.20 ) in intervention children and 0.41 ( 1.40 ) among controls . The difference between treatment groups was 0.08 ( 95 % CI −0.29 to 0.44 ) , an estimate minimally changed by adjustment for maternal race , parity , age , and socio-economic index ( 0.08 [ −0.29 to 0.45 ] ) . Evaluating BMI ≥85th percentile rather than continuous BMI Z score gave similarly null results . CONCLUSIONS Although treatment of GDM substantially reduced macrosomia at birth , it did not result in a change in BMI at age 4- to 5-years-old One hundred eight gestational diabetics were r and omized to receive either diet alone or diet plus insulin ( 20 units NPH and 10 units regular ) for glycemic control . Blood glucose levels were evaluated weekly in a high-risk clinic where medical and nutritional support and counseling were provided . Among 68 women successfully treated for a minimum of 6 weeks , the mean birth weight , macrosomia rate , and ponderal index were reduced significantly in the insulin- treated group . Insulin  reduced birth weights significantly in women with a delivery weight of 200 lb or more ( 4060 ± 342 versus 3397 ± 640 g ) and in those with a delivery weight less than 200 lb ( 3324 ± 448 versus 3047 ± 394 g ) . No patient with good glucose control and a maternal delivery weight under 200 lb had a newborn over 4000 g. Patients failing glycemic control were at greatest risk ( 30 % ) for fetal overgrowth whether initially receiving insulin or not . Maternal obesity or failure to achieve glycemic control should alert the clinician to a substantially increased risk of macrosomia We studied the impact of a training program on glucose tolerance in gestational diabetes mellitus . Women with gestational diabetes mellitus ( N = 19 ) were r and omized into either group I , a 6-week diet alone group ( 24 to 30 kcal/kg/24 hours ; 20 % protein , 40 % carbohydrate , 40 % fat ) , or group II , which followed the same diet plus exercise ( 20 minutes three times a week for 6 weeks ) . An arm ergometer was used to maintain heart rate in the training range . Glycemic response was monitored by glycosylated hemoglobin , a 50 gm oral glucose challenge with a fasting and 1-hour plasma glucose , and blood glucose self-monitoring , fasting and 1 hour  after meals .  Week 1 glycemic parameters were the same for both groups . Week 6 data ( mean + /- SD ) were as follows : group I glycosylated hemoglobin , 4.7 % + 0.2 % versus group II , 4.2 % + /- 0.2 % ; p less than 0.001 . The group I glucose challenge fasting value was 87.6 + /- 6.2 versus 70.1 + /- 6.6 mg/dl , p less than 0.001 for group II . The group I 1-hour plasma glucose challenge result was 187.5 + /- 12.9 mg/dl versus 105.9 + /- 18.9 mg/dl for group II , p less than 0.001 . The glycemic levels diverged between the groups at week 4 . We conclude that arm ergometer training is feasible in women with gestational diabetes mellitus and results in lower glycosylated hemoglobin , fasting , and 1-hour plasma glucose concentrations than diet alone . Arm ergometer training may provide a useful treatment option for women with gestational diabetes mellitus and may obviate insulin treatment OBJECTIVE To assess blood glucose control and neonatal outcomes when women with gestational diabetes mellitus ( GDM ) were treated with metformin or glyburide . METHODS When an appropriate diet was insufficient to control their blood glucose levels , women with GDM were r and omized to a glyburide or a metformin treatment group . If the maximum dose was reached , the assessed drug was replaced by insulin . The primary outcome measures analyzed were maternal glucose levels during pregnancy , birth weight , and neonatal glucose levels . RESULTS The only significant difference in outcome between the 2 treatment drugs was that maternal weight gain during pregnancy was less in the metformin ( n=40 ) than in the glyburide group ( n=32 ) ( 10.3 kg vs 7.6 kg ; P=0.02 ) . No differences were found in treatment failure , mean level of fasting or postpr and ial plasma glucose , rate of participants with glycated hemoglobin , birth weight , rate of large-for-gestational-age newborns , or newborns with hypoglycemia . CONCLUSION The treatment of GDM with metformin or glyburide was found to be equivalent for both women and newborns A r and omised prospect i ve study of treatment with dietary restriction alone or insulin therapy with dietary advice was performed in 15 women with glucose intolerance diagnosed early in the third trimester of pregnancy . Twenty-four hour profiles of plasma glucose and 3-hydroxybutyrate were performed before and four weeks after commencing treatment . The effect on neonatal outcome was assessed . The case history of one of the patients in the study was sent to British physicians with a special interest in diabetes to obtain their opinion about the appropriate initial treatment of women with gestational diabetes The goal of this study was to determine whether the type of fat plays a role in the glucose response to a meal , independent of the carbohydrate content . Ten gestational diabetic women ( gestational weeks 29 - 34 ) who were well controlled on diet alone were r and omized as to the order in which they would eat a meal , after overnight fast , containing saturated fat ( SF ) or monounsaturated fat ( MUFA ) . Blood was drawn at 0 , 60 , 120 , and 180 min for plasma glucose , insulin , lipid profile ( triglycerides , total cholesterol , HDL-cholesterol , LDL-cholesterol , VLDL-cholesterol ) and free fatty acids . After 2 weeks , each patient received the other type of meal . The test meal was composed of 20 % of the total daily caloric needs based on ideal body weight . The area under the curve showed a significantly lower glucose concentration for SF meal ( p = 0.001 ) . Serum insulin concentrations followed the glucose response with the peak at the 60-min time point and a significantly lower concentration at the 180-min time point in the SF than in the MUFA group . The present study demonstrated that the addition of SF to the meal result ed in lower postpr and ial glucose and insulin than when the meal contained MUFA . Thus , SF may be useful in controlling postpr and ial glucose OBJECTIVE We tested the hypothesis that intensified management of gestational diabetes mellitus on the basis of stringent glycemic control , verified glucose data , and adherence to an established criterion for insulin initiation results in near normoglycemia control and reduction of adverse outcomes . STUDY DESIGN A prospect i ve , population -based study compared the effect on perinatal outcome of conventional  ( n = 1316 )  and intensified  ( n = 1145 )  management . Group assignment was based on availability of memory-based reflectance meters at entry to the program . A contemporaneous r and omized control group ( nondiabetic , n = 4922 ) was selected . RESULTS The diabetic groups were comparable in demographic characteristics and in factors associated with higher risk for adverse pregnancy outcome , such as  previous macrosomia , previous gestational diabetes mellitus , and family history of diabetes . The control group was younger , less obese , and had a lower rate of previous macrosomia .  The intensified management group had rates of macrosomia , cesarean section , metabolic complications , shoulder dystocia , stillbirth , neonatal intensive care unit days , and respiratory complications lower than those in the conventional management group and comparable to those of the nondiabetic controls . Other maternal complication rates , such as for preeclampsia , chronic hypertension , and infection , were similar for the three groups . Mean blood glucose levels were a good predictor of perinatal outcome . Gestational age at delivery , previous history of macrosomia , and overall mean blood glucose levels were the only significant predictors of birth weight percentile in both diabetic groups ( logistic regression ) . CONCLUSION The intensified management approach is significantly associated with enhanced perinatal outcome . This management strategy clarifies the relationship between glycemic control and neonatal outcome OBJECTIVES In order to prevent abnormalities of fetal growth still characterizing pregnancies complicated by Gestational Diabetes ( GDM ) , in the present study we evaluated a therapeutic strategy for GDM based on ultrasound ( US ) measurement of fetal insulin-sensitive tissues . METHODS All GDM women diagnosed before 28th week immediately started diet and self-monitoring of blood glucose ;  after 2 weeks they were r and omized to conventional ( C ) or modified ( M ) management . In C the glycemic target ( GT ) was fixed at 90 fasting/120 post-pr and ial mg/dl ; in M GT varied , according to US measurement of the Abdominal Circumference ( AC ) centile performed every 2 weeks : 80/100 if AC > or = 75th , 100/140 if AC<75th . Therapy was tailored to mean fasting ( FG ) and postpr and ial glycemia ( PPG ) . RESULTS Globally , 229 women completed the study , 78 in C , 151 in M.  Use of insulin  was 16.7 % in C , 30.4 % in M ( total groups ) , significantly more frequent in M than in C ( 59.7 % vs 15.4 % ) when considering only women with AC > or = 75th c. Mean metabolic data were similar in the 2 groups , but in M a tightly-optimized subgroup , result ing from the lowering of GT due to AC > or = 75th , coexisted with a less-controlled one , whose higher GT was justified by AC<75th . Pregnancy outcome was better in M , with lower ( p<0.05 * ) rate of LGA * ( 7.9 % vs 17.9 % ) , SGA ( 6.0 % vs 9.0 % ) and Macrosomia * ( 3.3 % vs 11.5 % ) . CONCLUSIONS Our data show the value of a flexible US-based approach to the treatment of GDM . This model does not necessarily involve a generalized aggressive treatment , allowing to concentrate therapeutical efforts on a small subgroup of women showing indirect US evidence of fetal hyperinsulinization . Such a selective approach allowed to obtain a near-normalization of fetal growth , with clear advantages on global pregnancy outcome OBJECTIVE We hypothesized that body composition would be similar among neonates of women with gestational diabetes ( GDM ) treated with glyburide or insulin . STUDY DESIGN Women with GDM requiring medical therapy were r and omized to insulin or glyburide . The primary outcome was percent neonatal fat mass measured by total body electrical conductivity . Secondary outcomes included anthropometrics , glycemic control , and biomarkers . Statistical analysis included Student t test , chi(2 ) , and regression modeling . RESULTS Eighty-two neonates underwent postnatal measurements . Baseline factors were not different by group . Neonatal percent fat mass did not differ between treatment groups ( 11.2 + /- 4.2 vs 12.8 + /- 5.7 ) . Fat mass , body mass index , ponderal index , skinfold sum , and arm fat area were not different when analyzed by intent to treat or actual treatment group . Cord concentrations of biomarkers were also similar . CONCLUSION There was no difference in neonatal adiposity in infants of women treated for GDM with glyburide or insulin In this study we sought to test the hypothesis that treatment of women with one abnormal oral glucose tolerance test value will result in reduction of adverse outcome .  One hundred twenty-six women with one abnormal oral glucose tolerance test value and 146 women in the control group ( normal oral glucose tolerance test values ) participated in a prospect i ve study during the third trimester of pregnancy . The subjects with one abnormal test result were r and omized into treated ( group 1 ) and untreated groups ( group II ) . Group 1 subjects were treated with a strict diabetic protocol to maintain tight glycemic control by means of diet and insulin therapy . Group 2 subjects tested their capillary blood glucose for a baseline period . The study revealed that the level of glycemic control was similar before initiation of therapy ( mean capillary blood glucose 118 + /- 14 vs. 119 + /- 15 mg/dl , p = NS ) for groups 1 and 2 , respectively . There was a significant difference in mean capillary blood glucose ( 95 + /- 10 vs. 119 + /- 15 mg/dl , p less than 0.0001 ) , prepr and ial , and postpr and ial determinations between the treated and untreated groups . The overall incidence of neonatal metabolic complications ( 4 % vs. 14 % , p less than 0.05 ) and large infants ( 6 % vs. 24 % , p less than 0.03 ) was significantly lower in the treated group . Comparison between the control ( normal oral glucose tolerance test ) and the untreated groups showed a significantly higher incidence of large infants and metabolic complications . No difference was found between the normal and treated groups . Thus we conclude that treatment of individuals with one abnormal oral glucose tolerance test value will result in significant reduction in adverse outcome in pregnancy Objective To assess the usefulness of a breakfast test in determining which women with gestational diabetes do not need self-monitoring of  blood glucose levels ( home monitoring ) . Methods a 1-hour post-st and ardized breakfast blood glucose below 7.8 mmol/L ( 140 mg/dL ) was measured in 227 women and at or above 7.8 mmol/L in 115 . Within each group , women were r and omized to home monitoring with a meter or to clinic follow-up . Target glucose values were 5.3 mmol/L ( 95 mg/dL ) fasting , 5.6 mmol/L ( 101 mg/dL ) before meals , and 7.8 mmol/L ( 140 mg/dL ) 1 hour postpr and ial . Up to these thresholds women on clinic follow-up were transferred to home monitoring . Insulin therapy was started on the same thresholds in women r and omized or transferred to home monitoring .  Large ofr gestational age ( LGA ) newborns  represented the main outcome , with the transfer rate to home monitoring and need of insulin therapy the secondary ones . Results The LGA delivery rate was not significantly different in the two follow-up groups in women with a breakfast result below 7.8 mmol/L ( 9.8 versus 4.3 % ) but was higher in the clinic follow-up among women with a breakfast result at or above 7.8 mmol/L ( 13.3 % versus 30.9 % ; P < .05 ) . Fewer women with a breakfast result below 7.8 mmol/L were transferred to home monitoring ( 2.6 versus 52.7 % ; P < .001 ) or started on insulin therapy ( 3.6 versus 25.2 % ; P < .001 ) . The breakfast test cutoff of 7.8 mmol/L predicted insulin need with a sensitivity of 91.0 % and a specificity of 72.0 % . Conclusion A breakfast test is useful in identifying a low-risk population in which clinic follow-up may be used safely OBJECTIVE The objective of the study was to compare premixed insulin aspart 30 ( BIAsp 30 ) vs premixed human insulin 30 ( BHI 30 ) on efficacy , safety , fetal and perinatal outcomes in pregnancies associated with gestational diabetes mellitus [ GDM ] . This was the first r and omized study to use pre mixed insulin analogue [ BIAsp ] in GDM . METHODS The study population consisted of 76 GDM women assigned to BIAsp 30 ( group A ) and an equal number to BHI 30 ( group B ) . RESULTS There was no statistically significant difference between the age , BMI , gestational weeks and glycemic level at entry between the group A and group B women ( p > 0.05 ) . There was no statistical difference between the two groups in glycemic control or insulin dose ( p > 0.05 ) before confinement . The frequency of birth weight of new born above 90 percentile was 6.8 % in Group 1 and 9.2 % in Group 2 . The proportion of macrosomia was higher in Group 2 when compared to Group 1 , however the difference was not statistically significant ( P = 0.819 ) . CONCLUSION BIAsp was safe during pregnancy and pregnant women found it convenient due to meal time dosing . Fetal outcome using BIAsp was also comparable with BHI 30 A 16-yr prospect i ve study of 615 gestational diabetic subjects , half of whom were r and omly assigned to insulin therapy during pregnancy , is evaluated to report on the potential reduction in subsequent diabetes due to insulin therapy . No such difference in incidence rates was observed between the two groups . In the subsets of women managed with insulin who bore a baby of large birthweight or who had a family history of diabetes , subsequent decompensated diabetes was found to be significantly reduced . Both life table and multivariate analyses to adjust for the effects of age , weight , level of blood glucose at selection , duration of follow-up , and other potentially confounding covariables confirmed this conclusion . The finding suggests the possibility of long-term preventive benefits from insulin treatment in high risk subsets of women with gestational diabetes RATIONALE , AIMS AND OBJECTIVE To investigate whether the introduction of a programme of optimising drug treatment , intensive education and self-monitoring of patients diagnosed with gestational diabetes mellitus ( GDM ) at an early stage ( < 20 gestational weeks ) , will improve management outcomes as determined by objective measures of patient knowledge about diabetes , glycaemia control , maternal/neonatal complications , and health-related quality of life . METHODS The study was a r and omized , controlled , longitudinal , prospect i ve clinical trial performed at Al-Ain Hospital , Al-Ain , United Arab Emirates . Over an 18-month period , patients diagnosed with GDM were recruited and were r and omly assigned to either an intervention or a control group , in a ratio of 3:2 . Intervention patients received a structured pharmaceutical care service ( including education and introduction of intensive self-monitoring ) while control patients received traditional services . Patients were followed up from time of recruitment until 6 months postnatally at scheduled outpatient clinics . A range of clinical and humanistic outcome measures , including maternal and neonatal complications , were used to assess the impact of the intervention . RESULTS A total of 165 patients ( 99 intervention , 66 control ) completed the study . The intervention patients exhibited a range of benefits from the provision of the programme when compared with control group patients . Statistically significant ( P < 0.05 ) improvements were shown in the intervention group for knowledge of diabetes , health-related quality of life ( as determined by the SF36 ) , control of plasma glucose and HbA(1c ) , maternal complications [ e.g. decreased incidence of pre-eclampsia ( 5.1 % vs. 16.7 % ) , eclampsia ( 1.0 % vs. 7.6 % ) , episodes of severe hyperglycaemia ( 3.0 % vs. 19.7 % ) and need for Caesarean section ( 7.1 % vs. 18.2 % ) ] , and neonatal complications [ e.g. decreased incidence of neonatal hypoglycaemia ( 2.0 % vs. 10.6 % ) , respiratory distress at birth ( 4.0 % vs. 15.2 % ) , hyperbilirubinaemia ( 1.0 % vs. 12.1 % ) and large for gestational age ( 9.0 % vs. 22.7 % ) ] . CONCLUSION The research provides clear evidence that provision of pharmaceutical care adds value to the management of GDM as exemplified by improved maternal and neonatal outcomes Objective To determine whether a study of a less intensive form of management for impaired glucose tolerance in pregnancy is feasible and whether women would accept r and omisation OBJECTIVE To eluci date the glycemic response and antibody formation in gestational diabetic women treated with insulin injected by a needle or a jet . The American Diabetes Association 's position statement on jet injectors raised the concern that “ insulin could be denatured as a result of forceful injection through a tiny port , which could lead to an increase in antibody formation ” ( Diabetes Care11:600 , 1988 ) . However , the pharmacokinetics of jet-injected insulin suggest that it might be useful in controlling postpr and ial glucose levels . METHODS We r and omized 20 women with gestational diabetes mellitus ( < 34 wk gestation ) who required insulin to receive either jet-injected or needle-injected human NPH and regular insulin .  Variables of interest were evaluated at the start of therapy , weekly until delivery , and 6-wk postpartum that included : 1 ) insulin antibodies in the mother and her infant , 2 ) HbA1c , 3 ) insulin dose , 4 ) fasting and postpr and ial glucose levels , and 5 ) subject acceptance and preference . RESULTS Of the 10 women in the needle group , 6 developed significant insulin antibodies compared with 1 of 10 in the jet group ( P < 0.001 ) . HbA1c and insulin doses were the same in both groups . During the test meal , glucose levels in the jet group were significantly lower ( P < 0.01 ) , yet none of the women in the jet group experienced blood glucose 70 mg/dl ( 3.89 mM ) at 3–4 h after the meal , compared with 5 in the needle group ( P < 0.001 ) . Jet injection was associated with less variability ( P < 0.001 ) in postpr and ial glucose values but slightly greater variability ( P < 0.05 ) in fasting glucose .  Jet-injected insulin was more readily accepted by subjects than needle injections . CONCLUSIONS Jet injection is associated with a diminished antibody response and postpr and ial variability compared with needle-injected insulin . Thus , this warrants consideration as a therapeutic option for women with gestational diabetes mellitus and may also be applicable to nonpregnant , insulin-requiring diabetic patients Abstract Women with gestational diabetes mellitus ( GDM ) have a greater risk of developing type 2 diabetes mellitus ( DM ) and heart disease than pregnant women without GDM . Advice given during the GDM pregnancy provides an opportunity to develop protective dietary patterns for the long-term management of this risk . Dietary guidelines for the prevention and management of type 2 DM support the inclusion of unsaturated fats , but food advice needs to target this outcome . The aim of this study was to compare the  dietary intakes  of women with GDM given general low-fat advice ( control group )  to women with GDM given the same advice with additional targets for food sources of unsaturated fats ( intervention group ) . After approximately 6 weeks , the intervention group reported more ideal dietary fatty acid intakes than the control group , with polyunsaturated : saturated fat ratios of 1:1 and 0.4:1 , respectively ( P < .001 ) , assessed using repeated measures analysis of variance . These results confirm the need to include food sources of unsaturated fats in advice strategies to assure optimal protective eating habits in this at-risk group AIM The objectives of this pilot study were to determine the feasibility and effect on glycaemic control of a low-glycaemic-index ( GI ) diet in women with gestational diabetes or impaired glucose tolerance of pregnancy . METHODS participants , recruited from the Diabetes-in-Pregnancy Clinic of an inner-city teaching hospital serving a predominantly non-Caucasian population , were r and omized to a low-GI ( n=23 ) or control ( n=24 ) diet and followed from 28 weeks gestation until delivery .  Self-monitored-blood-glucose ( SMBG ) , maternal and infant weight were collected from medical charts .  Dietary intakes were assessed using diet records and question naires . RESULTS diet GI on control ( 58 , 95 % CI : 56,60 ) was significantly higher than on low-GI ( 49 , 95 % CI : 47,51 ; p=0.001 ) . Glycaemic control improved on both diets , but more postpr and ial glucose values were within target on low-GI ( 58.4 % of n=1891 ) than control ( 48.7 % of n=1834 ; p<0.001 ) . SMBG post-breakfast was directly related to pre-pregnancy BMI in the control , but not the low-GI group ( BMI * diet interaction ; p=0.021 ) . Participants accepted the study foods and were willing to consume them post-intervention . CONCLUSIONS a low-GI diet was feasible and acceptable in this sample and facilitated control of postpr and ial glucose . A larger study is needed to determine the effect of a low-GI diet on maternal and infant outcomes Summary : A r and omised controlled trial was design ed to determine the effect of moderate 30 % maternal dietary energy restriction on the requirement for maternal insulin therapy  and the incidence of macrosomia in gestational diabetes .  Although the control group restricted their intake to a level similar to that of the intervention group ( 6845 kiloJoules ( kJ ) versus 6579 kJ ) , the result ing cohort could not identify any adverse effect of energy restriction in pregnancy . Energy restriction did not alter the frequency of insulin therapy ( 17.5 % in the intervention group and 16.9 % in the control group ) . Mean birth weight  ( 3461 g in the intervention group and 3267 g in the control group ) was not affected . There was a trend in the intervention group towards later gestational age at commencement of insulin therapy ( 33 weeks versus 31 weeks ) and lower maximum daily insulin dose ( 23 units versus 60 units ) which did not reach statistical significance . Energy restriction did not cause an increase in ketonemia OBJECTIVE : To compare the efficacy of metformin with glyburide for glycemic control in gestational diabetes . METHODS : Patients with gestational diabetes who did not achieve glycemic control on diet were r and omly assigned to metformin ( n=75 ) or glyburide ( n=74 ) as single agents . The primary outcome was glycemic control . Secondary outcomes were drug failure rate and neonatal and obstetric complications . RESULTS : In the patients who achieved adequate glycemic control , the mean fasting and 2-hour postpr and ial blood glucose levels were not statistically different between the two groups . However , 26 patients in the metformin group ( 34.7 % ) and 12 patients in the glyburide group ( 16.2 % ) did not achieve adequate glycemic control and required insulin therapy ( P=.01 ) . CONCLUSION : In this study , the failure rate of metformin was 2.1 times higher than the failure rate of glyburide when used in the management of gestational diabetes ( 95 % confidence interval 1.2–3.9 ) . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00965991 . LEVEL OF EVIDENCE : Nutrition practice guidelines were developed for gestational diabetes mellitus by registered dietitians from the Diabetes Care and Education and the Women 's Health and Reproductive Nutrition dietetic practice groups . To vali date the guidelines , a clinical trial was design ed with clinic sites r and omly assigned to either nutrition practice guidelines care ( 12 sites ) or usual nutrition care ( 13 sites ) , with diabetes , obstetric , and other clinic types represented in both groups . Volunteer dietitians served as study coordinators and recruited women diagnosed with gestational diabetes mellitus . The nutrition practice guidelines define medical nutrition therapy ( MNT ) for gestational diabetes and emphasize three areas -definition of MNT clinical goals with indexes to modify or advance MNT and criteria to start insulin ; use of self-monitoring tools ; and provision of three nutrition visits . Usual care sites provided prenatal nutrition care according to usual practice . The effect of nutrition care ( sites following the nutrition care guidelines ) and type of clinic site on changes in glycated hemoglobin and infant birth weight , adjusted for other covariates , were evaluated using linear regression . Differences in insulin use and other infant outcomes between treatment groups were evaluated using logistic regression . Generalized estimating equations were used to accommo date nonindependence within r and omized clusters of patients within clinic sites . Data from 215 women indicated less  insulin use at diabetes clinic sites in the nutrition practice guidelines groups and improved glycated hemoglobin control during the treatment period in diabetes clinics compared with obstetric or other clinics . A higher proportion of women in the usual care group had glycated hemoglobin levels that exceeded 6 % at follow-up compared with women in the nutrition practice guidelines group ( 13.6 % vs 8.1 % ) , although not statistically significant ( P=0.26 ) . A significant clinic type and treatment group effect was found for birth weight . Nutrition practice guidelines for gestational diabetes mellitus reflected nutrition care already being provided by registered dietitians in diabetes clinics prior to this study because outcomes at these clinics were not impacted . Use of the guidelines by dietitians at obstetric and other clinics tended to improve outcomes at these sites OBJECTIVE To study the treatment of women with gestational impared glucose tolerance ( GIGT ) in relation to outcome of fetus and newborns . METHODS 98 women with GIGT were r and omized into untreated ( 37 mothers ) and treated groups ( 61 mothers ) that included diet control and insulin therapy . The perinatal outcomes were compared in the two groups . RESULTS The incidence of macrosomia ( P < 0.01 ) and fetal distress ( P < 0.05 ) was found to be significantly higher in the untreated group when compared with the treated group . The prevalence of neonatal metabolic complications in the untreated group was higher than that of the treated group as well . CONCLUSION Treatment of women with GIGT will reduce adverse outcome in pregnancy The purpose of this study was to examine pregnancy outcome in women with abnormal oral glucose tolerance tests , in relation to treatment with diet and insulin . Glucose tolerance tests , done because of well-known historical risk factors , were considered abnormal if two or more readings exceeded the following : fasting , 110 ; 1 hour , 170 ; 2 hours , 120 ; and 3 hours , 110 ( all in mg/100 mL , measured as total reducing substances in whole venous blood ) . Those with positive tests were divided r and omly into a “ positive-control ” group ( n 308 ) that received  st and ard prenatal care or a “ positive-treated ” group ( n 307 ) that received dietary instructions ( 30 kcal/kg ideal body weight , 40 % as carbohydrate , and 1.5–2 g protein/kg body weight ) and insulin ( initial dose 10 U per day of intermediate-acting insulin , adjusted subsequently as directed by blood and urine studies ) , beginning at usually about 32 weeks . A third group ( n 328 ) , termed “ negative controls , ” had exhibited normal glucose tolerance testing . The three groups were similar , except that those with abnormal glucose tolerance tended to be older and heavier , as expected . With respect to outcome , infants with birth weights exceeding 9 lb were three times as frequent in positive-control subjects as in either positive-treated subjects or negative controls ( 13.1 % , 4.3 % , and 3.7 % , respectively ) . Perinatal deaths ( 28 weeks ’ gestation through 14 days after birth ) were similar in the two positive groups ( 4.9 % in control and 4.3 % in treated ) and significantly higher than in negative controls ( 1.9 % ) , with the increase involving both fetal and neonatal components . The conclusions were 1 ) abnormal glucose tolerance during pregnancy leads to larger infants and higher perinatal mortality and 2 ) treatment with diet and insulin ameliorates the former but not the latter . This study concerned what O’Sullivan called potential diabetes and others at the time termed latent or chemical diabetes or prediabetes , but what today we refer to as gestational diabetes . Acceptance of it as a pathologic entity was far from unanimous in 1966 . O’Sullivan resolved the controversy with this large , well- design ed , and well-analyzed clinical trial . The immediate influence was two-fold . In the first place , it settled the existing disagreement as to whether or not impaired glucose tolerance adversely influences pregnancy outcome ; large infants occurred three times as frequently and perinatal deaths were more than doubled in women with abnormal carbohydrate metabolism . Second , the findings of the intervention trial indicated clearly that treatment of gestational diabetes with diet and insulin in late gestation normalizes birth weight ( although it did not seem to influence perinatal mortality ) , a finding confirmed a number of times by subsequent investigators . Incidentally , the frequencies of both fetal and neonatal deaths may seem high , but it needs to be remembered that this experience ante date d the advent of modern fetal surveillance and neonatal intensive care . John B. O’Sullivan , a pioneer in clinical research in gestational diabetes , was an internist . He defined st and ards for the oral glucose tolerance test in pregnancy that , though modified slightly by subsequent investigators , are basically those in use today . Born in 1926 , he received his medical education in his native Irel and before immigrating to the United States in 1955 . After further training in internal medicine at the Lahey Clinic , he took a faculty position at the Boston University School of Medicine , where he did his original work on early diabetes as medical director of the Prenatal Metabolism Clinic at Boston City Hospital and chief of medicine at St. Margaret ’s Hospital . In addition to his position as Associate Professor at Boston University , he also served on the faculties of the Harvard and Yale medical schools . Later he was director of employee health for the Liberty Mutual Insurance Company . He died of cancer in August 2001 Forty-one patients with gestational diabetes requiring insulin were enrolled in a r and omized study to investigate the efficacy of an exercise program in normalizing glucose tolerance . Seventeen of 21 patients completed the exercise program while maintaining normoglycemia and obviating  insulin therapy . Maternal and neonatal complications did not differ between the study and control groups . The type of program described appears to be safe and can serve as a model for exercise prescription for pregnant diabetic women to attain improved glucose tolerance The outcome of pregnancy  in control and treated gestational diabetics was not significantly different . The decreased loss rate among the insulin- and diet-treated gestational diabetics , however , did become significant when the data were reanalyzed with consideration of two important influencing variables . The high-risk group of gestational diabetics aged 25 years and older who received  insulin therapy  before the 32nd week of gestation had fewer fetal losses . Documentation of the critical role played by both maternal age and the gestational age at which insulin therapy is commenced now makes the institution of a conclusive prospect i ve study feasible . The adequately established hypothesis that insulin management of gestational diabetics favorably affects the outcome of their pregnancies can then be finally resolved The effect of an acute period of moderate intensity exercise on maternal glycemic excursion following a mixed nutrient meal was studied . Five normal ( NL ) and six gestational diabetic ( GDM ) subjects were enrolled . A r and omized crossover design was used to compare fasting glucose and insulin levels , peak glucose and insulin levels and incremental area of the glycemic and insulin curves following a mixed nutrient meal with or without an exercise stress that took place 14 h earlier . Exercise consisted of upright stationary cycling for 30 min at a heart rate consistent with 60 % VO2max . The clinical characteristics of normal and gestational diabetic subjects were comparable . Mean values ( + /-SEM ) with , versus without , exercise for fasting glucose ( NL : 78.9 + /- 2.6 vs. 80.0 + /- 2.6 mg/dl ; GDM : 86.4 + /- 2.0 vs. 82.1 + /- 3.5 mg/ dl ) , peak glucose ( NL : 132.3 + /- 10.4 vs. 139.1 + /- 15.6 mg/dl ; GDM : 165.8 + /- 5.5 vs. 160.3 + /- 7.8 mg/dl ) , the area under the glycemic curve ( NL : 5758 + /- 1038 vs. 6393 + /- 1281 mg/dl.min ; GDM : 8,178 + /- 890 vs. 8,331 + /- 563 mg/dl.min ) did not differ . Similarly , plasma insulin levels did not differ between protocol s for either group of subjects . Exercise has been proposed as a treatment to reduce glycemia in gestational diabetes . Results from this study indicate a single bout of exercise did not blunt the glycemic response observed following a mixed nutrient meal Infant macrosomia is a serious medical concern . Pregnant women who do not meet the specific diagnosis for gestational diabetes may still have glucose-mediated macrosomia . In Santa Barbara County all pregnant women are screened for gestational diabetes at 24 - 28 weeks with a 50-g , 1-hr glucose challenge test ( GCT ) . All patients who fail this test are placed on a st and ard euglycemic diet ( 40 % carbohydrate , 20 % protein , 40 % fat ) and perform home glucose monitoring of fasting and postpr and ial glucose levels . The objective of this study was to examine the effectiveness of this treatment program in decreasing infant macrosomia , maternal and infant morbidity , maternal complications , and operative delivery . We studied 103 women who had a positive GCT , but a negative 100-g , 3-hr oral glucose tolerance test ( OGTT ) . The women were r and omly assigned to either experimental or control groups with experimental women receiving dietary counseling and home glucose monitoring instruction ( HBGM ) . HBGM diaries were review ed weekly by clinic nurses . All women had hemoglobin A1c ( HbA1c ) tests at 28 and 32 weeks . Maternal and fetal charts were review ed to determine delivery type and complications , indications for cesarean section ( C-section ) , and infant gestational age , gender , Apgar scores , birth weight , morbidities , and congenital anomalies . Of the 103 women , 5 women required insulin treatment , 1 woman had an abortion , and 14 women were indeterminate regarding compliance or were control women who received diet counseling and HBGM . The results are based on 83 women--48 control and 35 experimental . There were no significant differences between the groups for age , parity , or weight at 28 - 30 weeks or 37 weeks to delivery , or HbA1c at 28 weeks . HbA1c was significantly higher in control women at 32 weeks . Birth weight expressed in grams or as a percentile specific for gender , ethnicity , and gestational age was significantly higher in control infants . Birth weight was significantly correlated with maternal intake weight , weight at 28 - 30 weeks , and weight at delivery and with HbA1c at 32 weeks ' gestation . There were no significant differences between groups for maternal complications . Groups were significantly different for mode of delivery with experimental women having more induced vaginal deliveries but fewer repeat C-sections than control women . Groups were not different for primary C-sections . Women who fail the GCT , but not the OGTT and thus do not receive the diagnosis of GDM are still at risk for delivering a macrosomic infant and operative delivery . Our program of treatment for all women who fail the GCT improves outcome by reducing infant birth weight and the number of cesarean sections Major problems with gestational diabetes ( GDM ) have been the high frequency of fetal macrosomia , and perinatal complications , especially among mothers needing  insulin  in addition to diet therapy ( 1 ) . Both long-acting insulin ( LAI ) and shortacting insulin ( SAI ) are used , the former to reduce the basal glucose level and the latter to control postpr and ial glucose peaks after meals . Despite many improvements , insulin therapy has not solved the above-mentioned problems . We compared the effects of SAI and LAI on perinatal outcome in insulin-requiring GDM . We hypothesized that SAI therapy and postpr and ial glucose monitoring would lead to better glycemic control than LAI and therefore reduce fetal macrosomia . After obtaining approval by the Ethics Committee of the Helsinki University Central Hospital , department of Obstetrics and Gynecology and given information to all study participants , we included 23 consecutive women with insulin-requiring GDM in a prospect i ve r and omized trial . A 2-hr oral glucose tolerance test ( OGTT ) with 75 g of glucose was performed at 24–28weeks of gestation in women Two-hundred and two pregnant women with impaired glucose tolerance were r and omized to treatment with diet or diet and insulin by stratified selection . Self-monitoring of blood glucose was performed six times a day , 3 days/wk . Dietary treatment was considered inappropriate if fasting and postpr and ial blood glucose values exceeded 7 and 9 mmol/L , respectively , in which case insulin therapy was instituted . Insulin doses were adjusted according to blood glucose values , aim ing at fasting and postpr and ial values below 5 and 6.5 mmol/L , respectively . There were no perinatal deaths . The two treatment regimens disclosed no differences regarding achieved degree of maternal blood glucose control , hemoglobin A1c at delivery , obstetric or neonatal complications , infant 's size at birth including skinfold thickness , or C-peptide concentration in cord serum . Routine treatment of pregnant women with mild carbohydrate intolerance with insulin seems unnecessary . However , 15 patients ( 14 % ) in the diet group needed insulin to achieve acceptable blood glucose control , underlining the importance of monitoring blood glucose to detect those who are at risk of developing overt diabetes Seventy-two patient with gestational diabetes were r and omly treated with insulin ( 20 units NPH and 10 units regular ) and diabetic diet , diet alone , or neither . Of the 27 patients treated with insulin and diet , 2 ( 7 % ) had babies weighing more than 8 1/2 pounds . Of the 11 patients treated with diet alone , 4 ( 36.4 % ) had babies weighing more than 8 1/2 pounds . Of the 34 patients treated with neither diet nor insulin , 17 ( 50 % ) had babies weighing more than 8 1/2 pounds . These data support the hypothesis that treatment of the gestational diabetic with insulin will reduce the incidence of fetal macrosomia OBJECTIVE To assess the short-term efficacy of insulin aspart in comparison with regular human insulin in women with gestational diabetes mellitus ( GDM ) during st and ardized meal tests . RESEARCH DESIGN AND METHODS The study included 15 women with GDM who had inadequate diabetes control with diet alone . On 3 consecutive days , breakfast meal tests were performed-the first with no exogenous insulin and the other two after the injection of either regular insulin or insulin aspart . RESULTS The peak insulin concentration was higher and the peak glucose and C-peptide concentrations were lower with both insulin preparations than with no exogenous insulin .  Glucose areas under the curve above baseline were significantly lower with insulin aspart ( 180-min area , 7.1 mg . h. dl(-1 ) ; P = 0.018 ) , but not with regular insulin ( 30.2 mg . h. dl(-1 ) ; P = 0.997 ) , than with no insulin ( 29.4 mg . h. dl(-1 ) ) . CONCLUSIONS This study demonstrates that effective postpr and ial glycemic control in women with GDM who required insulin was brought about by insulin aspart through higher insulin peak and lower dem and on endogenous insulin secretion OBJECTIVE To examine the effects of a Parish Nurse Intervention Program ( PNIP ) on maternal health behaviors , glycemic control , and neonatal outcomes among Mexican American women with gestational diabetes . DESIGN A r and omized controlled trial comparing care as usual ( CAU ) with a supplementary 1-hour education session for diabetes education reinforcement by a Parish Nurse . SETTING An outpatient treatment clinic for gestational diabetes within a 250-bed tertiary care , non-profit hospital with a Parish Nurse partnership . PARTICIPANTS One hundred Mexican American women were included in the study with r and omization into Parish Nurse Intervention Program ( n=49 ) and care as usual ( n=51 ) groups . MAIN OUTCOME MEASURES The Health Promoting Lifestyle Profile II ( HPLP II ) and two measures of glycemic control pre- and post-intervention , as well as newborn size , and days of maternal and neonatal hospitalization . RESULTS Outcomes indicate significantly improved Health Promoting Lifestyle Profile II scores in the Parish Nurse Intervention Program group post-intervention compared with the Care As Usual group . No significant differences between groups regarding glycemic control , macrosomia , or days of maternal or neonatal hospitalization were found . CONCLUSIONS A Parish Nurse Intervention Program for pregnant women of Mexican descent with gestational diabetes is effective in leading to improved self-reported health promoting behaviors In pregnancies complicated by diabetes , foetal lung maturation depends on a good control of maternal blood glucose values . In poorly controlled maternal diabetes , foetal hyperinsulinaemia may cause a delay in pulmonary maturation . There was no single case of respiratory distress syndrome ( RDS ) in 112 pregnant class B-F diabetic patients that we treated with high doses of insulin . Furthermore , in a controlled r and omized trial of diet versus insulin treatment in class A diabetes we found no differences in perinatal mortality in patients with adequate metabolic control . In pregnancies complicated by Rh isoimmunization , determination of phosphatidylglycerol in amniotic fluid is a more reliable marker of foetal lung maturity than is the lecithin/sphingomyelin ratio . The marked decrease in perinatal mortality due to Rh incompatibility observed in recent years depends on several factors including administration of corticosteroids to the mother to prevent RDS , irrespective of whether amniotic fluid parameters indicate foetal lung maturity BACKGROUND Women with gestational diabetes mellitus are rarely treated with a sulfonylurea drug , because of concern about teratogenicity and neonatal hypoglycemia . There is little information about the efficacy of these drugs in this group of women . METHODS We studied 404 women with singleton pregnancies and gestational diabetes that required treatment . The women were r and omly assigned between 11 and 33 weeks of gestation to receive glyburide or insulin according to an intensified treatment protocol . The primary end point was achievement of the desired level of glycemic control . Secondary end points included maternal and neonatal complications . RESULTS The mean ( + /-SD ) pretreatment blood glucose concentration as measured at home for one week was 114+/-19 mg per deciliter ( 6.4+/-1.1 mmol per liter ) in the glyburide group and 116+/-22 mg per deciliter ( 6.5+/-1.2 mmol per liter ) in the insulin group ( P=0.33 ) . The mean concentrations during treatment were 105+/-16 mg per deciliter ( 5.9+/-0.9 mmol per liter ) in the glyburide group and 105+/-18 mg per deciliter ( 5.9+/-1.0 mmol per liter ) in the insulin group ( P=0.99 ) . Eight women in the glyburide group ( 4 percent ) required insulin therapy . There were no significant differences between the glyburide and insulin groups in the percentage of infants who were large for gestational age ( 12 percent and 13 percent , respectively ) ; who had macrosomia , defined as a birth weight of 4000 g or more ( 7 percent and 4 percent ) ; who had lung complications ( 8 percent and 6 percent ) ; who had hypoglycemia ( 9 percent and 6 percent ) ; who were admitted to a neonatal intensive care unit ( 6 percent and 7 percent ) ; or who had fetal anomalies ( 2 percent and 2 percent ) . The cord-serum insulin concentrations were similar in the two groups , and glyburide was not detected in the cord serum of any infant in the glyburide group . CONCLUSIONS In women with gestational diabetes , glyburide is a clinical ly effective alternative to insulin therapy INTRODUCTION Nutrition therapy is an integral part of the management of gestational diabetes mellitus ( GDM ) . Most women with GDM are treated by nutritional management alone . The goal of our study was to compare low and high carbohydrate diets in their effectiveness , safety and tolerability in women with GDM . MATERIAL AND METHODS The study group consisted of 30 Caucasian women newly diagnosed with GDM , with a mean age of 28.7 + /- 3.7 years and pregnancy duration of 29.2 + /- 5.4 weeks . The patients were r and omised into two groups : those on a low and those on a high carbohydrate diet ( 45 % vs. 65 % respectively of energy supply coming from carbohydrates ) . The presence of urine ketones was controlled every day . After two weeks daily glucose profiles and compliance with the recommended diets were analysed . RESULTS Glucose concentration before implementation of the diet regimen did not differ between groups . No changes in fasting blood glucose were noticed in the group that had followed a low carbohydrate diet , although a significant decrease in glucose concentration was observed after breakfast ( 102 + /- 16 vs. 94 + /- 11 mg/dl ) , lunch ( 105 + /- 12 vs. 99 + /- 9 mg/dl ) and dinner ( 112 + /- 16 vs. 103 + /- 13 mg/dl ) ( p < 0.05 ) . In the high carbohydrate diet group fasting and after-breakfast glucose concentration did not change . A significant decrease in glycaemia was noticed after lunch ( 106 + /- 15 vs. 96 + /- 7 mg/dl ) and dinner ( 107 + /- 12 vs. 97 + /- 7 mg/dl ) ( p < 0.05 ) . Ketonuria was not observed in either group . Obstetrical outcomes did not differ between groups . CONCLUSIONS Both high and low carbohydrate diets are effective and safe . A diet with carbohydrate limitation should be recommended to women who experience the highest glycaemia levels after breakfast Objective : A planned study is described which will determine whether a benefit exists for the treatment of mild carbohydrate intolerance during pregnancy . Methods : A r and omized clinical trial of women with mild gestational diabetes will compare perinatal outcomes in those receiving diet therapy and insulin as required versus those r and omized to no specific treatment . Results : The primary outcome of this study will be a composite of neonatal morbidity in the treatment and control groups . Conclusions : A r and omized treatment trial of mild gestational diabetes mellitus will clarify whether identification and treatment of mild gestational diabetes mellitus reduces perinatal morbidity . This information will aid in selecting appropriate thresholds for the treatment of gestational diabetes mellitus BACKGROUND It is uncertain whether treatment of mild gestational diabetes mellitus improves pregnancy outcomes . METHODS Women who were in the 24th to 31st week of gestation and who met the criteria for mild gestational diabetes mellitus ( i.e. , an abnormal result on an oral glucose-tolerance test but a fasting glucose level below 95 mg per deciliter [ 5.3 mmol per liter ] ) were r and omly assigned to usual prenatal care ( control group ) or dietary intervention , self-monitoring of blood glucose , and insulin therapy , if necessary ( treatment group ) . The primary outcome was a composite of stillbirth or perinatal death and neonatal complications , including hyperbilirubinemia , hypoglycemia , hyperinsulinemia , and birth trauma . RESULTS A total of 958 women were r and omly assigned to a study group--485 to the treatment group and 473 to the control group . We observed no significant difference between groups in the frequency of the composite outcome ( 32.4 % and 37.0 % in the treatment and control groups , respectively ; P=0.14 ) . There were no perinatal deaths . However , there were significant reductions with treatment as compared with usual care in several prespecified secondary outcomes , including mean birth weight ( 3302 vs. 3408 g ) , neonatal fat mass ( 427 vs. 464 g ) , the frequency of large-for-gestational-age infants ( 7.1 % vs. 14.5 % ) , birth weight greater than 4000 g ( 5.9 % vs. 14.3 % ) , shoulder dystocia ( 1.5 % vs. 4.0 % ) , and cesarean delivery ( 26.9 % vs. 33.8 % ) . Treatment of gestational diabetes mellitus , as compared with usual care , was also associated with reduced rates of preeclampsia and gestational hypertension ( combined rates for the two conditions , 8.6 % vs. 13.6 % ; P=0.01 ) . CONCLUSIONS Although treatment of mild gestational diabetes mellitus did not significantly reduce the frequency of a composite outcome that included stillbirth or perinatal death and several neonatal complications , it did reduce the risks of fetal overgrowth , shoulder dystocia , cesarean delivery , and hypertensive disorders . ( Clinical Trials.gov number , NCT00069576 .
BACKGROUND Gestational diabetes ( GDM ) affects 3 % to 6 % of all pregnancies .
Women are often intensively managed with increased obstetric monitoring , dietary regulation , and insulin .
However , there has been no sound evidence base to support intensive treatment .
The key issue for clinicians and consumers is whether treatment of GDM improves perinatal outcome .
OBJECTIVES To compare the effect of alternative treatment policies for GDM on both maternal and infant outcomes .