Effectiveness of continuous glucose monitoring during diabetic pregnancy (GlucoMOMS trial); a randomised controlled trial Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial Calibration of a subcutaneous amperometric glucose sensor. Part 1. Effect of measurement uncertainties on the determination of sensor sensitivity and background current. CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol The pregnancies of women with Type 2 diabetes: poor outcomes but opportunities for improvement. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. What we can really expect from telemedicine in intensive diabetes treatment: results from 3-year study on type 1 pregnant diabetic women. The Effect of Real-Time Continuous Glucose Monitoring in Pregnant Women With Diabetes Peri-Conceptional A1C and Risk of Serious Adverse Pregnancy Outcome in 933 Women With Type 1 Diabetes Preterm delivery in women with pregestational diabetes mellitus or chronic hypertension relative to women with uncomplicated pregnancies. The National institute of Child health and Human Development Maternal- Fetal Medicine Units Network. Telemedicine in the treatment of diabetic pregnancy. Pre-Conception Management of Insulin- Dependent Diabetes: Improvement of Pregnancy Outcome Incidence of spontaneous abortion among normal women and insulin-dependent diabetic women whose pregnancies were identified within 21 days of conception. Patient-reported outcomes for an integrated real-time continuous glucose monitoring/insulin pump system. The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial MANAGEMENT OF THE PREGNANT DIABETIC: HOME OR HOSPITAL, WITH OR WITHOUT GLUCOSE METERS? Self-monitoring of blood glucose by diabetic women during the third trimester of pregnancy. Preprandial versus postprandial blood glucose monitoring in type 1 diabetic pregnancy: a randomized controlled clinical trial. Efficacy of home glucose monitoring in diabetic pregnancy. Is there a difference in pregnancy and glycemic outcome in patients with type 1 diabetes on insulin pump with constant or intermittent glucose monitoring? A pilot study. Managing Preexisting Diabetes for Pregnancy Real-time continuous glucose monitoring during labour and delivery in women with Type 1 diabetes - observations from a randomized controlled trial.
Background Hyperglycemia in pregnancy is associated with poor perinatal outcome . Even if pregnant women with diabetes are monitored according to current guidelines , they do much worse than their normoglycaemic counterparts , marked by increased risks of pre-eclampsia , macrosomia , and caesarean section amongst others . Continuous Glucose Monitoring ( CGM ) is a new method providing detailed information on daily fluctuations , used to optimize glucose control . Whether this tool improves pregnancy outcome remains unclear . In the present protocol , we aim to assess the effect of CGM use in diabetic pregnancies on pregnancy outcome . Methods / design The GlucoMOMS trial is a multicenter open label r and omized clinical trial with a decision and cost-effectiveness study alongside . Pregnant women aged 18 and over with either diabetes mellitus type 1 or 2 on insulin therapy or with gestational diabetes requiring insulin therapy before 30 weeks of gestation will be asked to participate . Consenting women will be r and omly allocated to either usual care or complementary CGM . All women will determine their glycaemic control by self-monitoring of blood glucose levels and HbA1c . In addition , women allocated to CGM will use it for 5–7 days every six weeks . Based on their CGM profiles they receive dietary advice and insulin therapy adjustments if necessary . The primary outcome measure is rate of macrosomia , defined as a birth weight above the 90th centile . Secondary outcome measures will be birth weight , composite neonatal morbidity , maternal outcome and costs . The analyses will be according to the intention to treat principle . Discussion With this trial we aim at clarifying whether the CGM improves pregnancy outcome when used during diabetic pregnancies . Trial registration Nederl and s Trial Register : Objective To evaluate the effectiveness of continuous glucose monitoring during pregnancy on maternal glycaemic control , infant birth weight , and risk of macrosomia  in women with type 1 and type 2 diabetes . Design Prospect i ve , open label r and omised controlled trial . Setting Two secondary care multidisciplinary obstetric clinics for diabetes in the United Kingdom . Participants 71 women with type 1 diabetes ( n=46 ) or type 2 diabetes ( n=25 ) allocated to antenatal care plus continuous glucose monitoring  ( n=38 ) or to st and ard antenatal care  ( n=33 ) . Intervention Continuous glucose monitoring was used as an educational tool to inform shared decision making and future therapeutic changes at intervals of 4 - 6 weeks during pregnancy . All other aspects of antenatal care were equal between the groups . Main outcome measures The primary outcome was maternal glycaemic control during the second and third trimesters from measurements of HbA1c levels every four weeks . Secondary outcomes were birth weight and risk of macrosomia using birthweight st and ard deviation scores and customised birthweight centiles . Statistical analyses were done on an intention to treat basis . Results Women r and omised to continuous glucose monitoring had lower mean HbA1c levels from 32 to 36 weeks ’ gestation compared with women r and omised to st and ard antenatal care : 5.8 % ( SD 0.6 ) v 6.4 % ( SD 0.7 ) . Compared with infants of mothers in the control arm those of mothers in the intervention arm had decreased mean birthweight st and ard deviation scores ( 0.9 v 1.6 ; effect size 0.7 SD , 95 % confidence interval 0.0 to 1.3 ) , decreased median customised birthweight centiles ( 69 % v 93 % ) , and a reduced risk of macrosomia ( odds ratio 0.36 , 95 % confidence interval 0.13 to 0.98 ) . Conclusion Continuous glucose monitoring during pregnancy is associated with improved glycaemic control in the third trimester , lower birth weight , and reduced risk of macrosomia . Trial registration Current Controlled Trials IS RCT N84461581 The calibration of a continuous glucose monitoring system , i.e. the transformation of the signal I(t ) generated by the glucose sensor at time ( t ) into an estimation of glucose concentration G(t ) , represents a key issue . The two-point calibration procedure consists of the determination of a sensor sensitivity S and of a background current I(o ) by plotting two values of the sensor signal versus the concomitant blood glucose concentrations . The estimation of G(t ) is subsequently given by G(t ) = ( I(t)-I(o))/S. A glucose sensor was implanted in the subcutaneous tissue of nine type 1 diabetic patients during 3 ( n = 2 ) and 7 days ( n = 7 ) . For each individual trial , S and I(o ) were determined by taking into account the values of two sets of sensor output and blood glucose concentration distant by at least 1 h , the procedure being repeated for each consecutive set of values . S and I(o ) were found to be negatively correlated , the value of I(o ) being sometimes negative . Theoretical analysis demonstrates that this phenomenon can be explained by the effect of measurement uncertainties on the determination of capillary glucose concentration and of sensor output Background Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes . For most women , optimal glycemic control is challenging to achieve and maintain . The aim of this study is to determine whether the use of real-time continuous glucose monitoring ( RT-CGM ) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy . Methods / design A multi-center , open label , r and omized , controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % ( 53 to ≤ 86 mmol/mol ) or are in early pregnancy ( < 13 weeks 6 days ) with an HbA1c of 6.5 % to ≤10.0 % ( 48 to ≤ 86 mmol/mol ) . Participants will be r and omized to either RT-CGM alongside conventional intermittent home glucose monitoring ( HGM ) , or HGM alone .  Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase . To be eligible for r and omization , a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight ( 11 pm-7 am ) of CGM glucose values are required . Those meeting these criteria are r and omized to RT- CGM or HGM . A total of 324 women will be recruited ( 110 planning pregnancy , 214 pregnant ) . This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinical ly relevant 0.5 % difference between groups at 90 % power with 5 % significance . R and omization will stratify for type of insulin treatment ( pump or multiple daily injections ) and baseline HbA1c . Analyses will be performed according to intention to treat . The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy , and from baseline to 34 weeks gestation during pregnancy . Secondary outcomes include maternal hypoglycemia , CGM time in , above and below target ( 3.5–7.8 mmol/l ) , glucose variability measures , maternal and neonatal outcomes . Discussion This will be the first international multicenter r and omized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes . Trial registration Clinical Trials.gov Identifier : NCT01788527 Registration Date : December 19 , 2012 AIM To compare the outcomes of Type 1 and Type 2 diabetic pregnancies and identify risk factors for poor outcome of Type 2 pregnancies METHODS The data from all ( 389 Type 1 and 146 Type 2 ) pre-gestational diabetic pregnancies from 10 UK hospitals were collected prospect ively . RESULTS The Type 2 mothers were less likely to have documented  pre-pregnancy counselling  ( 28.7 vs. 40.5 % ; P<0.05 ) or be taking folic acid at conception ( 21.9 vs. 36.4 % ; P<0.001 ) than Type 1 mothers . The percentage of pregnancies having a serious adverse outcome was higher in Type 2 patients ( 16.4 vs. 6.4 % ; P=0.002 ) . Congenital abnormalities ( 12.3 % in Type 2 vs. 4.4 % in Type 1 ; P=0.002 ) accounted for most of this difference . The HbA1c of the Type 2 patients was similar to that of the Type 1 with mean first trimester HbA1c of 7.22 and 7.35 % , respectively ( P=0.5 ) . Treatment with oral hypoglycaemic agents [ odds ratio ( OR ) , 1.8 ; 95 % confidence interval ( CI ) , 1.0 - 3.3 ; P=0.04 ] , body mass index ( OR , 1.09 ; 95 % CI , 1.01 - 1.18 ; P=0.02 ) and  folic acid supplementation  ( OR , 0.3 ; 95 % CI , 0.09 - 1.0 ; P=0.04 ) were all independently associated with congenital malformation . CONCLUSION Type 2 diabetic pregnancies are characterized by poor pre-pregnancy planning , inadequate folic acid supplementation and treatment with oral hypoglycaemic agents , all of which may contribute to the serious adverse outcomes affecting one in six Type 2 diabetic pregnancies . These remediable aspects of the pre-pregnancy care of women with Type 2 diabetes provide opportunities for improving the outcome towards that of women with Type 1 diabetes BACKGROUND The fetuses of women with gestational diabetes mellitus are at risk for macrosomia and its attendant complications . The best method of achieving euglycemia in these women and reducing morbidity in their infants is not known . We compared the efficacy of postpr and ial and prepr and ial monitoring in achieving glycemic control in women with gestational diabetes . METHODS We studied 66 women with gestational diabetes mellitus who required insulin therapy at 30 weeks of gestation or earlier . The women were r and omly assigned to have their diabetes managed according to the results of prepr and ial monitoring or postpr and ial monitoring ( one hour after meals ) of blood glucose concentrations . Both groups were also monitored with  fasting blood glucose measurements . The goal of insulin therapy was a prepr and ial value of 60 to 105 mg per deciliter ( 3.3 to 5.9 mmol per liter ) or a postpr and ial value of less than 140 mg per deciliter ( 7.8 mmol per liter ) . Obstetrical data and information on neonatal outcomes were collected . RESULTS The prepregnancy weight , weight gain during pregnancy , gestational age at the diagnosis of diabetes and at delivery , degree of compliance with therapy , and degree of achievement of target blood glucose concentrations were similar in the two groups . The mean ( + /- SD ) change in the glycosylated hemoglobin value was greater in the group in which postpr and ial measurements were used ( -3.0 + /- 2.2 percent vs. 0.6 + /- 1.6 percent , P < 0.001 ) and the infants ' birth weight was lower ( 3469 + /- 668 vs. 3848 + /- 434 g , P = 0.01 ) . Similarly , the infants born to the women in the postpr and ial-monitoring group had a lower rate of neonatal hypoglycemia ( 3 percent vs. 21 percent , P = 0.05 ) , were less often large for gestational age ( 12 percent vs. 42 percent , P = 0.01 ) and were less often delivered by cesarean section because of cephalopelvic disproportion ( 12 percent vs. 36 percent , P = 0.04 ) than those in the prepr and ial-monitoring group . CONCLUSIONS Adjustment of insulin therapy in women with gestational diabetes according to the results of postpr and ial , rather than prepr and ial , blood glucose values improves glycemic control and decreases the risk of neonatal hypoglycemia , macrosomia , and cesarean delivery Existing st and ards of the management of the diabetic patients are not efficient enough , and further improvement is needed . The major objective of this paper is to present and discuss the therapeutic effectiveness of an intensive care telematic system design ed and applied for intensive treatment of pregnant type 1 diabetic women . The developed system operates automatically , every night transferring all the data recorded during the day in the patient 's glucometer memory to a central clinical unit . In order to assess the efficiency of the design ed and developed system , a 3-year r and omized prospect i ve clinical trial was conducted , using the study group and the control group , each consisting of 15 pregnant type 1 diabetic women . All patients were treated by the same diabetologist . In the presented analysis , two indices calculated weekly were used for the assessment of glycemic control : MBG represents mean blood glucose level , and the universal J-index is sensitive to the glycemic level and glycemic variations . The most important results from the study concern : ( a ) better glycemic control in the study group in comparison with the control group during the course of treatment , as assessed by the average differences of the MBG and J indices calculated weekly ( n = 24 ) ( deltaMBG = -3.2 + /- 4.3 mg/dL , p = 0.0016 , deltaJ = -1.4 + /- 2.3 , p = 0.0065 ) ; ( b ) much more similar results in glycemic control among members of the study group compared to each other , than among members of the control group compared to each other , as indicated by significantly lower variations of the applied glycemic control indices ( SDMBG : 11.9 vs. 18.7 mg/dL , p = 0.0498 ; SDJ : 6.5 vs. 10.9 , p = 0.0318 ) ; ( c ) the observed tendency of a better glycemic control for patients with a lower level of intelligence ( IQ < 100 ) supported by the telematic system in comparison with all other assessed groups of patients . The last result was not statistically significant ( p > 0.05 ) . This telematic intensive care system improved the effectiveness of diabetes treatment during pregnancy . It also allows the diabetologist 's strategy to be much more precise than if it were conducted without telematic support . This telematic system is inexpensive and simple in use OBJECTIVE To assess whether intermittent real-time continuous glucose monitoring ( CGM ) improves glycemic control and pregnancy outcome in unselected women with pregestational diabetes . RESEARCH DESIGN AND METHODS A total of 123 women with type 1 diabetes and 31 women with type 2 diabetes were r and omized to use real-time CGM for 6 days at 8 , 12 , 21 , 27 , and 33 weeks in addition to routine care , including self-monitored plasma glucose seven times daily , or routine care only . To optimize glycemic control , real-time CGM readings were evaluated by a diabetes caregiver . HbA1c , self-monitored plasma glucose , severe hypoglycemia , and pregnancy outcomes were recorded , with large-for-gestational-age infants as the primary outcome . RESULTS Women assigned to real-time CGM ( n = 79 ) had baseline HbA1c similar to that of women in the control arm ( n = 75 ) ( median 6.6 [ range 5.3–10.0 ] vs. 6.8 % [ 5.3–10.7 ] ; P = 0.67 ) ( 49 [ 34–86 ] vs. 51 mmol/mol [ 34–93 ] ) . Forty-nine ( 64 % ) women used real-time CGM per protocol . At 33 weeks , HbA1c ( 6.1 [ 5.1–7.8 ] vs. 6.1 % [ 4.8–8.2 ] ; P = 0.39 ) ( 43 [ 32–62 ] vs. 43 mmol/mol [ 29–66 ] ) and self-monitored plasma glucose ( 6.2 [ 4.7–7.9 ] vs. 6.2 mmol/L [ 4.9–7.9 ] ; P = 0.64 ) were comparable regardless of real-time CGM use , and a similar fraction of women had experienced severe hypoglycemia ( 16 vs. 16 % ; P = 0.91 ) . The prevalence of large-for-gestational-age infants ( 45 vs. 34 % ; P = 0.19 ) and other perinatal outcomes were comparable between the arms . CONCLUSIONS In this r and omized trial , intermittent use of real-time CGM in pregnancy , in addition to self-monitored plasma glucose seven times daily , did not improve glycemic control or pregnancy outcome in women with pregestational diabetes OBJECTIVE To study the association between peri-conceptional A1C and serious adverse pregnancy outcome ( congenital malformations and perinatal mortality ) . RESEARCH DESIGN AND METHODS Prospect i ve data were collected in 933 singleton pregnancies complicated by type 1 diabetes . RESULTS The risk of serious adverse outcome at different A1C levels was compared with the background population . The risk was significantly higher when peri-conceptional A1C exceeded 6.9 % , and the risk tended to increase gradually with increasing A1C . Women with A1C exceeding 10.4 % had a very high risk of 16 % . Congenital malformation rate increased significantly at A1C above 10.4 % , whereas perinatal mortality was increased even at A1C below 6.9 % . CONCLUSIONS These results support recent guidelines of preconceptional A1C levels < 7 % in women with type 1 diabetes OBJECTIVE The purpose of this study was to compare the rates of indicated and spontaneous preterm delivery among women with chronic hypertension or pregestational diabetes mellitus with the rates among healthy women . STUDY DESIGN This was a secondary analysis of data from healthy women with singleton gestations enrolled in a prospect i ve observational study for prediction of preterm delivery ( control group , n = 2738 ) , women with pregestational diabetes mellitus requiring insulin therapy ( n = 461 ) , and women with chronic hypertension ( n = 761 ) . The two latter groups were enrolled in a r and omized multicenter trial for prevention of preeclampsia . The main outcome measures were rates of preterm delivery , either spontaneous ( preterm labor or rupture of membranes ) or indicated ( for maternal or fetal reasons ) , and neonatal outcomes . RESULTS The overall rates of preterm delivery were significantly higher among women with diabetes mellitus ( 38 % ) and hypertension ( 33.1 % ) than among control women ( 13.9 % ) . Rates were also significantly higher for delivery at < 35 weeks ' gestation . Women with diabetes mellitus had significantly higher rates of both indicated preterm delivery ( 21.9 % vs 3.4 % ; odds ratio , 8.1 ; 95 % confidence interval , 6.0 - 10.9 ) and spontaneous preterm delivery ( 16.1 % vs 10.5 % ; odds ratio , 1.6 ; 95 % confidence interval , 1.2 - 2.2 ) than did women in the control group . In addition , they had significantly higher rates of both indicated preterm delivery ( odds ratio , 4.8 ; 95 % confidence interval , 3.0 - 7.5 ) and spontaneous preterm delivery ( odds ratio , 2.1 ; 95 % confidence interval , 1.4 - 3.0 ) at < 35 weeks ' gestation than did control women . Compared with control women those with chronic hypertension had higher rates of indicated preterm delivery at both < 37 weeks ' gestation ( 21.9 % vs 3.4 % ; odds ratio , 8.1 ; 95 % confidence interval , 6.2 - 10.6 ) and at < 35 weeks ' gestation ( 12.1 % vs 1.6 % ; odds ratio , 8.2 ; 95 % confidence interval , 5.7 - 11.9 ) , but there were no differences in rates of spontaneous preterm delivery . CONCLUSION The increased rate of preterm delivery among women with chronic hypertension relative to control women was primarily an increase in indicated preterm delivery , whereas the rates of both spontaneous and indicated preterm delivery were increased among women with pregestational diabetes mellitus Good diabetic control requires that treatment be continuously adapted to the patient behavior . We investigated whether the use of telemedicine could present an advantage to the management of the diabetic woman during pregnancy . A system completely automatic ( DIANET system ) was used . Twenty IDDM women participated in the study : 10 treated by telemedicine and 10 by conventional system , at times " entry " ( 9.5 weeks ) , " basal " ( 9.5 - 16.8 weeks ) , " 1st month " of investigation , and " end " ( near delivery ) . All women used intensified protocol s of insulin administration . The treatment with DIANET vs conventional showed a better metabolic control as estimated by profile of blood glucose absolute values ( at time " end " : values significantly lower before breakfast : 87 + /- 6 vs 104 + /- 4 mg , lunch : 85 + /- 5 vs 104 + /- 4 mg , and after dinner : 102 + /- 5 vs 124 + /- 6 mg ) . These results were associated with higher insulin doses in the DIANET vs conventional treatment , and a significant reduction of hypoglycemic reaction in both group . Our results suggest that telemedicine-DIANET is a practical way of providing specialist care in the pregnancy area Poor glycemic control in early pregnancy in insulindependent diabetes is associated with an increased risk for spontaneous abortions and congenital malformations . Strict glycemic control from the initial stages of embryogenesis is one of the major goals of management in these pregnancies . We hypothesized that insulin-dependent diabetic patients attending a pre-conception program  would have improved glycemic control compared with insulin-dependent diabetic patients who enrolled after conception and would have better pregnancy outcome , with fewer spontaneous abortions and fewer major malformations .  Ninety-nine pregnant insulin-dependent diabetic patients were recruited before reaching 9 weeks ' gestation and were followed prospect ively throughout pregnancy . Twenty-eight had attended a pre-conception clinic to optimize glycemic control ( study group ) and 71 had enrolled after conception ( control group ) .  Early glycemic control was significantly better in the study group : Glycohemoglobin values at the first prenatal visit and at 9 and 14 weeks ' gestation were significantly lower than in the control group . The rate of spontaneous abortion was significantly lower in the study group ( 7 % ) than in the controls ( 24 % ) . There was one major malformation in the control group and none in the study group . We conclude that patients with insulin-dependent diabetes attending a preconception program have a decreased rate of early pregnancy loss compared with those receiving prenatal care early in pregnancy . ( Obstet Gynecol 77:846 , 1991 Whether pregnant women with insulin-dependent diabetes mellitus have an increased risk of spontaneous abortion is controversial . To address this question , we enrolled 386 women with insulin-dependent diabetes and 432 women without diabetes before or within 21 days after conception and followed both groups prospect ively . Sixty-two diabetic women ( 16.1 percent ) and 70 control women ( 16.2 percent ) had pregnancy losses ( odds ratio , 0.99 ; 95 percent confidence interval , 0.67 to 1.46 ) . After adjustment for known risk factors for spontaneous abortion , the rate was still not significantly higher in the diabetic group ( odds ratio , 0.91 ; 95 percent confidence interval , 0.59 to 1.40 ) . Nonetheless , among the diabetic women , most of whom had good metabolic control , those who had spontaneous abortions had higher fasting and postpr and ial glucose levels in the first trimester than those whose pregnancies continued to delivery ( P = 0.01 for fasting glucose levels and P = 0.005 for postpr and ial levels ) . In the small subgroup of diabetic women with poor control , who had elevated values for glycosylated hemoglobin in the first trimester , each increase of 1 SD above the normal range was associated with an increase of 3.1 percent in the rate of pregnancy loss ( 95 percent confidence interval , 0.6 to 5.6 ) . We conclude that diabetic women with good metabolic control are no more likely than nondiabetic women to lose a pregnancy , but that diabetic women with elevated blood glucose and glycosylated hemoglobin levels in the first trimester have a significantly increased risk of having a spontaneous abortion BACKGROUND A 16-week , two-site study evaluated outcomes for a new device ( the Paradigm 722 System , Medtronic MiniMed , Northridge , CA ) that combines a " smart " continuous subcutaneous insulin infusion ( CSII ) pump with real-time ( RT ) continuous glucose monitoring ( CGM ) and CareLinktrade mark data management software ( DMS ) . METHODS CSII-naive adults with type 1 diabetes in suboptimal control ( mean glycosylated hemoglobin [ A1C ] = 8.6 % ) were r and omized to the control arm , consisting of multiple daily injections ( MDI ) and self-monitoring of blood glucose ( SMBG ) , or the study arm ( CSII with RT-CGM as an adjunct to SMBG ) . Participants ( n = 28 ) completed the vali date d Insulin Delivery System Rating Question naire ( IDSRQ ) and the parallel Blood Glucose ( BG ) Monitoring System Rating Question naire ( BGMSRQ ) at study start and end . Participants in the study arm ( n = 14 ) also completed newly developed User Acceptance Question naires ( UAQs ) for CSII , RT-CGM , and DMS at study end . RESULTS A1C reduction from study start to end was significant ( P < 0.05 ) in both arms ( -1.7 % for study arm;-1.0 % for control arm ) ; there was no significant change in weight in either arm . The IDSRQ showed significantly ( P < 0.05 ) greater benefit for the study arm in convenience , acceptability of BG monitoring requirements , BG control efficacy , diabetes worries , and interpersonal hassles , as well as higher overall satisfaction/preference . The BGMSRQ showed significantly ( P < 0.05 ) greater benefit for the study arm in the BG monitoring system 's ability to help manage glycemic control and less interest in changing to another BG monitoring system . The Study Arm UAQs showed positive ratings of system features . CONCLUSIONS Several patient-reported outcomes were significantly more positive in the study arm than the control arm ; none was significantly more positive in the control arm . The features of the integrated RT-CGM/CSII system were frequently used and highly rated by participants , with high user satisfaction OBJECTIVE The objective of the Hyperglycemia and Adverse Pregnancy Outcome ( HAPO ) Study is to clarify unanswered questions on associations of maternal glycemia , less severe than overt diabetes mellitus , with risks of adverse pregnancy outcome . This report describes the background and design of the HAPO Study . METHODS HAPO is a 5-year investigator-initiated prospect i ve observational study that will recruit approximately 25000 pregnant women in 10 countries . HAPO utilizes a Central Laboratory for measurement of key metabolic variables , a Clinical Coordinating Center , a Data Coordinating Center , and an independent Data Monitoring Committee . Glucose tolerance is assessed by a 75 g 2-h OGTT at 24 - 32 weeks ' gestation . Results are unblinded to the woman and her caregivers if : fasting plasma glucose > 5.8 mmol/l , 2-h plasma glucose > 11.1 mmol/l or any plasma glucose < 2.5 mmol/l . R and om plasma glucose measurement is performed at 34 - 37 weeks or if symptoms suggest hyperglycemia ; results are unblinded for values > or = 8.9 mmol/l . Sociodemographic and health history data are collected via question naire and medical record abstract ion . Maternal blood is obtained for measurement of serum C-peptide and hemoglobin A1c ( HbA(1C ) ) , cord blood for serum C-peptide and plasma glucose , and a capillary specimen is taken between 1 and 2 h following delivery for neonatal plasma glucose . Neonatal anthropometrics are obtained , and follow-up data are collected at 4 - 6 weeks post-delivery . The primary outcomes to be assessed in relation to maternal glycemia are cesarean delivery , increased fetal size ( macrosomia/LGA/obesity ) , neonatal morbidity ( hypoglycemia ) , and fetal hyperinsulinism Summary Background Pregnant women with type 1 diabetes are a high-risk population who are recommended to strive for optimal glucose control , but neonatal outcomes attributed to maternal hyperglycaemia remain suboptimal . Our aim was to examine the effectiveness of  continuous glucose monitoring ( CGM )  on maternal glucose control and obstetric and neonatal health outcomes . Methods In this multicentre , open-label , r and omised controlled trial , we recruited women aged 18–40 years with type 1 diabetes for a minimum of 12 months who were receiving intensive insulin therapy . Participants were pregnant ( ≤13 weeks and 6 days ' gestation ) or planning pregnancy from 31 hospitals in Canada , Engl and , Scotl and , Spain , Italy , Irel and , and the USA . We ran two trials in parallel for pregnant participants and for participants planning pregnancy . In both trials , participants were r and omly assigned to either CGM in addition to capillary glucose monitoring or capillary glucose monitoring alone . R and omisation was stratified by insulin delivery ( pump or injections ) and baseline glycated haemoglobin ( HbA1c ) . The primary outcome was change in HbA1c from r and omisation to 34 weeks ' gestation in pregnant women and to 24 weeks or conception in women planning pregnancy , and was assessed in all r and omised participants with baseline assessment s. Secondary outcomes included obstetric and neonatal health outcomes , assessed with all available data without imputation . This trial is registered with Clinical Trials.gov , number NCT01788527 . Findings Between March 25 , 2013 , and March 22 , 2016 , we r and omly assigned 325 women ( 215 pregnant , 110 planning pregnancy ) to capillary glucose monitoring with CGM ( 108 pregnant and 53 planning pregnancy ) or without ( 107 pregnant and 57 planning pregnancy ) . We found a small difference in HbA1c in pregnant women using CGM ( mean difference −0·19 % ; 95 % CI −0·34 to −0·03 ; p=0·0207 ) . Pregnant CGM users spent more time in target ( 68 % vs 61 % ; p=0·0034 ) and less time hyperglycaemic ( 27 % vs 32 % ; p=0·0279 ) than did pregnant control participants , with comparable severe hypoglycaemia episodes ( 18 CGM and 21 control ) and time spent hypoglycaemic ( 3 % vs 4 % ; p=0·10 ) . Neonatal health outcomes were significantly improved , with lower incidence of large for gestational age ( odds ratio 0·51 , 95 % CI 0·28 to 0·90 ; p=0·0210 ) , fewer neonatal intensive care admissions lasting more than 24 h ( 0·48 ; 0·26 to 0·86 ; p=0·0157 ) , fewer incidences of neonatal hypoglycaemia ( 0·45 ; 0·22 to 0·89 ; p=0·0250 ) , and 1-day shorter length of hospital stay ( p=0·0091 ) . We found no apparent benefit of CGM in women planning pregnancy . Adverse events occurred in 51 ( 48 % ) of CGM participants and 43 ( 40 % ) of control participants in the pregnancy trial , and in 12 ( 27 % ) of CGM participants and 21 ( 37 % ) of control participants in the planning pregnancy trial . Serious adverse events occurred in 13 ( 6 % ) participants in the pregnancy trial ( eight [ 7 % ] CGM , five [ 5 % ] control ) and in three ( 3 % ) participants in the planning pregnancy trial ( two [ 4 % ] CGM and one [ 2 % ] control ) . The most common adverse events were skin reactions occurring in 49 ( 48 % ) of 103 CGM participants and eight ( 8 % ) of 104 control participants during pregnancy and in 23 ( 44 % ) of 52 CGM participants and five ( 9 % ) of 57 control participants in the planning pregnancy trial . The most common serious adverse events were gastrointestinal ( nausea and vomiting in four participants during pregnancy and three participants planning pregnancy ) . Interpretation Use of CGM during pregnancy in patients with type 1 diabetes is associated with improved neonatal outcomes , which are likely to be attributed to reduced exposure to maternal hyperglycaemia . CGM should be offered to all pregnant women with type 1 diabetes using intensive insulin therapy . This study is the first to indicate potential for improvements in non-glycaemic health outcomes from CGM use . Funding Juvenile Diabetes Research Foundation , Canadian Clinical Trials Network , and National Institute for Health Research Thirteen pregnant insulin-dependent diabetic patients were allocated to blood-glucose self-monitoring ( meter ) or conventionally treated ( non-meter ) groups at 30 - -31 weeks . A day-profile of blood-glucose and intermediary metabolite levels was obtained 2 weeks later at home and after routine admission to hospital at 35 - -36 weeks . Metabolic profiles were also obtained in eight normal pregnant women of equivalent gestational ages admitted to hospital for study . The mean blood-glucose and metabolite concentrations in both the meter and non-meter groups were similar to those obtained in the non-diabetic pregnant women ( mean diurnal blood-glucose 4.6 + /- 1.1 mmol/l , meter group ; 5.3 + /- 1.5 non-meter group ; 4.8 + /- 0.8 controls ) . The diabetic control achieved at home was not improved by the use of a meter or admission to hospital ( mean glucose at home 5.0 + /- 1.3 and 6.3 + /- 1.6 mmol/l in hospital ) . Both the use of a meter and admission to hospital may be valuable in some patients . Neither , however , is essential for the good control of blood-glucose in all pregnant diabetics The clinical value of self-monitoring blood glucose in diabetic pregnancy at  home was compared with hospital care in the thirty-second to thirty-sixth week of pregnancy in a prospect i ve r and omized study including 100 pregnancies in 97 patients ( White 's class B , 38 ; C , 25 ; D , 28 ; and F , 9 ) of which 54 were in the home group and 46 in the hospital group . The duration of pregnancy was not significantly different in two treatment groups , with a median duration of 266.0 days in the home group and 266.5 days in the hospital group . The mean blood glucose values during the study period were 5.9 mmol/L in the home group and 6.0 mmol/L in the hospital group , thus there were no significant group differences . There were no significant group differences in pregnancy complications ; however , 10 of 54 ( 19 % ) had to interrupt home-monitoring because of pregnancy complications . The perinatal morbidity was not significantly different in the two treatment groups , with the following percentages of complications in the combined series : 4 % idiopathic respiratory distress syndrome , 7 % transient tachypnea , 2 % symptomatic hypoglycemia , 16 % hyperbilirubinemia , 22 % feeding problems , and 10 % erythrocytosis OBJECTIVE This study was undertaken to compare prepr and ial and postpr and ial capillary glucose monitoring in pregnant women with type 1 diabetes . STUDY DESIGN Sixty-one women with type 1 diabetes were r and omly assigned at 16 weeks ' gestation to prepr and ial or postpr and ial blood glucose monitoring using memory-based glucose reflectance meters throughout pregnancy . Serial measurements of hemoglobin A1c and fructosamine were obtained throughout pregnancy . Insulin , glucose , and insulin-like growth factor-I ( IGF-I ) were measured in cord blood at delivery . Neonatal anthropometric measures were performed within 72 hours of delivery RESULTS Maternal age , parity , age of onset of diabetes , number of prior miscarriages , smoking status , social class , weight gain in pregnancy , and compliance with therapy were similar in the two groups . The postpr and ial monitoring group had a significantly reduced incidence of preeclampsia ( 3 % vs 21 % , P<.048 ) , a greater success in achieving glycemic control targets ( 55 % vs 30 % , P<.001 ) and a smaller neonatal triceps skinfold thickness ( 4.5+/-0.9 vs 5.1+/-1.3 , P=.05 ) . CONCLUSION Postpr and ial capillary blood glucose monitoring in type 1 diabetic pregnancy may significantly reduce the incidence of preeclampsia and neonatal triceps skinfold thickness compared with prepr and ial monitoring A r and omized , prospect i ve study was performed to evaluate the efficacy of daily home glucose monitoring on the outcome of pregnancies in women with insulin-dependent diabetes mellitus .  Home glucose monitoring was compared with a weekly venipuncture protocol . No differences were observed between groups in clinical features ( age , parity , White 's classification ) or representative delivery outcomes ( method of delivery , weeks ' gestation , or weight at birth ) . No statistically significant differences were observed between the groups in several aspects of perinatal morbidity . However , home glucose monitoring was associated with fewer readmissions for diabetic control ( p = 0.05 ) , fewer days in the hospital ( p less than 0.01 ) , and decreased total patient expense ( p less than 0.05 ) BACKGROUND The aim of the study is to describe glycemic and insulin outcomes by trimester and maternal and fetal outcome in patients with type 1 diabetes using an insulin pump with constant or intermittent continuous glucose monitoring ( CGM ) . METHODS Twenty-five women with type 1 diabetes with newly diagnosed pregnancy were treated with insulin pump therapy ( Medtronic 722 , Medtronic Minimed , Northridge , CA ) for at least 1 year . Insulin pump and CGM ( Medtronic Paradigm Real-Time ) were implemented at least 3 months before conception . Patients were r and omized in two groups : constant CGM group , 12 patients on insulin pump with glucose sensor , 24 h/day ; and intermittent CGM group , 13 patients on insulin pump with intermittent glucose sensor , 14 days/month . The following parameters were analyzed : glycosylated hemoglobin ( HbA1c ) , mean blood glucose , insulin requirement ( in IU/kg/day ) , weight gain , severe hypoglycemic events , diabetic ketoacidosis , macrosomia , cesarean section , and neonatal hypoglycemia . RESULTS Both groups achieved good glucose control during their pregnancies ( P<0.05 ) : 6.78±1.3 % and 6.92±0.9 % at the beginning of the study compared with 6.14±0.9 % ( constant CGM group ) and 6.23±0.6 % ( intermittent CGM group ) at the end of the study ( last HbA1c before delivery ) . There was no significant decrease of HbA1c between the two groups . The constant CGM group had a significantly lower A1c in the first trimester compared with the intermittent CGM group . Maternal and fetal outcome did not show a significant difference between the two groups . CONCLUSIONS Insulin pump therapy together with constant or intermittent CGM can improve diabetes control and pregnancy outcome in type 1 diabetes . The quality of the glucose profile at conception was the important factor for pregnancy outcome This document presents consensus panel recommendations for the medical care of pregnant women with preexisting diabetes , including type 1 and type 2 diabetes . The intent is to help clinicians deal with the broad spectrum of problems that arise in management of diabetes before and during pregnancy , and to prepare diabetic women for treatment that may reduce complications in the years after pregnancy . A thorough discussion of the evidence supporting the recommendations is presented in the book , Management of Preexisting Diabetes and Pregnancy , authored by the consensus panel and published by the American Diabetes Association ( ADA ) in 2008 ( 1 ) . A consensus statement on obstetrical and postpartum management will appear separately . The recommendations are diagnostic and therapeutic actions that are known or believed to favorably affect maternal and perinatal outcomes in pregnancies complicated by diabetes . The grading system adapted by the ADA was used to clarify and codify the evidence that forms the basis for the recommendations ( 2 ) . Unfortunately there is a paucity of r and omized controlled trials ( RCTs ) of the different aspects of management of diabetes and pregnancy . Therefore our recommendations are often based on trials conducted in nonpregnant diabetic women or nondiabetic pregnant women , as well as on peer- review ed experience before and during pregnancy in women with preexisting diabetes ( 3–4 ) . We also review ed and adapted existing diabetes and pregnancy guidelines ( 5–10 ) and guidelines on diabetes complications and comorbidities ( 2,3,11–14 ) . # # # A. Organization of preconception and pregnancy care # # # # AIMS To explore whether real-time continuous glucose monitoring during labour and delivery supplementary to hourly self-monitored plasma glucose in women with Type 1 diabetes reduces the prevalence of neonatal hypoglycaemia . METHODS Women with Type 1 diabetes participating in a r and omized controlled trial on the effect of real-time continuous glucose monitoring in pregnancy were included in this study . Twenty-seven of 60 ( 45 % ) women in the intervention arm used real-time continuous glucose monitoring during labour and delivery , supplementary to hourly self-monitored plasma glucose . Real-time continuous glucose monitoring glucose data  covering the last 8 h prior to delivery were retrospectively evaluated , and maternal hypo- and hyperglycaemia were defined as glucose values ≤ 3.9 mmol/l and > 7.0 mmol/l , respectively . Women in the control arm ( n = 59 ) solely used  self-monitored plasma glucose . Neonatal hypoglycaemia was defined as a 2-h plasma glucose < 2.5 mmol/l . RESULTS In infants of women using real-time continuous glucose monitoring during labour and delivery , 10 ( 37 % ) developed neonatal hypoglycaemia vs. 27 ( 46 % ) infants in the control arm ( P = 0.45 ) . Among 10 infants with and 17 infants without neonatal hypoglycaemia within the real-time continuous glucose monitoring arm , median maternal self-monitored plasma glucose was 6.2 ( range 4.2 - 7.8 ) vs. 5.6 ( 3.3 - 8.5 ) mmol/l ( P = 0.26 ) during labour and delivery , with maternal hyperglycaemia present in 17 ( 0 - 94 ) vs. 4 (0 - 46)% of the time ( P = 0.02 ) , and birthweight was 4040 ( 3102 - 4322 ) vs. 3500 ( 1829 - 4320 ) g ( P = 0.04 ) . Maternal hypoglycaemia up to delivery was relatively rare . CONCLUSIONS The prevalence of neonatal hypoglycaemia was comparable between infants of women using real-time continuous glucose monitoring supplementary to self-monitored plasma glucose during labour and delivery and infants of women solely using self-monitored plasma glucose
BACKGROUND Self-monitoring of blood glucose ( SMBG ) is recommended as a key component of the management plan for diabetes therapy during pregnancy .
No existing systematic review s consider the benefits /effectiveness of various techniques of blood glucose monitoring on maternal and infant outcomes among pregnant women with pre-existing diabetes .
The effectiveness of the various monitoring techniques is unclear .
OBJECTIVES To compare techniques of blood glucose monitoring and their impact on maternal and infant outcomes among pregnant women with pre-existing diabetes .