How and why do patients with Type 1 diabetes sustain their use of flexible intensive insulin therapy? A qualitative longitudinal investigation of patients' self-management practices following attendance at a Dose Adjustment for Normal Eating (DAFNE) course. Explaining engagement in self-monitoring among participants of the DESMOND Self-monitoring Trial: a qualitative interview study. Does self monitoring of blood glucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol Structured, intensive education maximising engagement, motivation and long-term change for children and young people with diabetes: a cluster randomised controlled trial with integral process and economic evaluation - the CASCADE study. A nurse‐led interdisciplinary approach to promote self‐management of type 2 diabetes: a process evaluation of post‐intervention experiences Implementation and evaluation of a decision support system for type II diabetes.
BACKGROUND Conventional insulin therapy requires patients with Type 1 diabetes to adhere to rigid dietary and insulin injection practice s. Recent trends towards flexible intensive insulin therapy enable patients to match insulin to dietary intake and lifestyle ; however , little work has examined patients ' experiences of incorporating these practice s into real-life context s. This qualitative longitudinal study explored patients ' experiences of using flexible intensive insulin therapy to help inform the development of effective long-term support . METHODS Semi-structured interviews were conducted with 30 adult patients with Type 1 diabetes following participation in a structured education programme on using flexible intensive insulin therapy , and 6 and 12 months post-course .  Longitudinal data analysis used an inductive , thematic approach . RESULTS Patients consistently reported feeling committed to and wanting to sustain flexible intensive insulin therapy .  This regimen was seen as a logical and effective method of self-management , as patients experienced improved blood glucose readings and /or reported feeling better . Implementing and sustaining flexible intensive insulin therapy was enhanced when patients had stable routines , with more challenges reported by those working irregular hours and during weekends/holidays . Some patients re-crafted their lives to make this approach work for them ; for instance , by creating dietary routines or adjusting dietary choices . CONCLUSIONS Clinical data have shown that flexible intensive insulin therapy can lead to improvement in glycaemic control . This study , drawing on patients ' perspectives , provides further endorsement for flexible intensive insulin therapy by demonstrating patients ' liking of , and their motivation to sustain , this approach over time . To help patients implement and sustain flexible intensive insulin therapy , follow-up support should encourage them to identify routines to better integrate this regimen into their lives BACKGROUND The Diabetes Education and Self-Management for Ongoing and Newly Diagnosed ( DESMOND ) Self-monitoring Trial reported that people with newly diagnosed type 2 diabetes attending community-based structured education and r and omized to self-monitoring of blood glucose ( SMBG ) or urine monitoring  had comparable improvements in biomedical outcomes , but differences in satisfaction with , and continued use of monitoring method , well-being and perceived threat from diabetes . OBJECTIVES To explore experiences of SMBG and urine monitoring following structured education . We specifically addressed the perceived usefulness of each monitoring method and the associated well-being . METHODS Qualitative semi-structured interviews with 18 adults with newly diagnosed type 2 diabetes participating in the DESMOND Self-monitoring Trial ( SMBG , N=10 ; urine monitoring , N=8)~12 months into the trial . Analysis was informed by the constant comparative approach . RESULTS Interviewees reported SMBG as accurate , convenient and useful . Declining use was explained by having established a pattern of managing blood glucose with less frequent monitoring or lack of feedback or encouragement from health care professionals . Many initially positive views of urine monitoring progressively changed due to perceived inaccuracy , leading some to switch to SMBG . Perceiving diabetes as less serious was attributable to lack of symptoms , treatment with diet alone and -in the urine-monitoring group-consistently negative readings . Urine monitoring also provided less visible evidence of diabetes and of the effect of behaviour on glucose . CONCLUSIONS The findings highlight the importance for professionals of considering patients ' preferences when using self-monitoring technologies , including how these change over time , when supporting the self-care behaviours of people with type 2 diabetes Background The benefit of self-monitoring of blood glucose ( SMBG ) in people with type 2 diabetes on diet or oral agents other than sulphonylureas  remains uncertain . Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results . A recent systematic review concluded that SMBG was not cost-effective . However , what was unclear was whether a cheaper method of self-monitoring ( such as urine glucose monitoring ) could produce comparable benefit and patient acceptability for less cost . Methods / Design The DESMOND SMBG trial is comparing two monitoring strategies ( blood glucose monitoring and urine testing ) over 18 months when incorporated into a comprehensive self-management structured education programme . It is a multi-site cluster r and omised controlled trial , conducted across 8 sites ( 7 primary care trusts ) in Engl and , UK involving individuals with newly diagnosed Type 2 diabetes . The trial has 80 % power to demonstrate equivalence in mean HbA1c ( the primary end-point ) at 18 months of within ± 0.5 % assuming 20 % drop out and 20 % non-consent . Secondary end-points include blood pressure , lipids , body weight and psychosocial measures as well as a qualitative sub- study . Practice s were r and omised to one of two arms : participants attend a  DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose . The programme is delivered by accredited educators who received specific training about equipoise . Biomedical data are collected and psychosocial scales completed at baseline , and 6 , 12 , and 18 months post programme . Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring . Discussion The DESMOND SMBG trial is design ed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes . Strengths include a setting in primary care , a cluster design , a health economic analysis , a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub- study .Trial registration IS RCT N : IS RCT N95696668 BACKGROUND Type 1 diabetes ( T1D ) in children and young people is increasing worldwide with a particular increase in children under the age of 5 years . Fewer than one in six children and young people achieve glycosylated fraction of haemoglobin ( HbA1c ) values in the range identified as providing best future outcomes . There is an urgent need for clinic-based pragmatic , feasible and effective interventions that improve both glycaemic control and quality of life ( QoL ) . The intervention offers both structured education , to ensure young people know what they need to know , and a delivery model design ed to motivate self-management . OBJECTIVE To assess the feasibility of providing a clinic-based structured educational group programme incorporating psychological approaches to improve long-term glycaemic control , QoL and psychosocial functioning in a diverse range of young people . DESIGN The study was a pragmatic , cluster r and omised control trial with integral process and economic evaluation . SETTING Twenty-eight paediatric diabetes services across London , south-east Engl and and the Midl and s. R AND OMISATION Minimised by clinic size , age ( paediatric or adolescent ) and specialisation ( district general hospital clinic or teaching hospital/tertiary clinic ) . ALLOCATION Half of the sites were r and omised to the intervention arm and half to the control arm . Allocation was concealed until after clinics had consented and the first participant was recruited . Where possible , families were blind to allocation until recruitment finished . PARTICIPANTS Forty-three health-care practitioners ( 14 teams ) were trained in the intervention . The study recruited 362 children aged 8 - 16 years , diagnosed with T1D for > 12 months , with a mean 12-month HbA1c level of ≥ 8.5 % . INTERVENTION Two 1-day workshops taught intervention delivery . A detailed manual and re sources were provided . The intervention consists of four group education sessions led by a paediatric diabetes specialist nurse with another team member . OUTCOMES The primary outcome was glycaemic control , assessed at the individual level using venous HbA1c values , measured at baseline , 12 and 24 months . Secondary outcomes were directly and indirectly related to diabetes management , including hypoglycaemic episodes , hospital admissions , diabetes regimen , knowledge , skills and responsibility for diabetes management , intervention compliance , clinic utilisation , emotional and behavioural adjustment , and general and diabetes-specific QoL. PROCESS EVALUATION Question naires , semistructured interviews , informal discussion following observation sessions , fieldwork notes and case note review were used to collect qualitative and quantitative data from key stakeholder groups at specific time points in the trial . STATISTICAL ANALYSES Primary and secondary analyses were intention-to-treat comparisons of outcomes at 12 and 24 months , using analysis of covariance with a r and om effect for clinic . Prespecified subgroup analyses based on age , gender , initial HbA1c value and socioeconomic status were estimated from models that included an interaction term . The economic analysis compared long-term costs and predicted quality -adjusted life-years ( QALYs ) . RESULTS The intervention did not improve HbA1c at 12 months [ intervention effect 0.11 ; 95 % confidence interval ( CI ) -0.28 to 0.50 ; p = 0.584 ] or 24 months ( intervention effect 0.03 ; 95 % CI -0.36 to 0.41 ; p = 0.891 ) . A total of 298/362 patients ( 82.3 % ) provided blood sample s at 12-month follow-up , and 284/362 ( 78.5 % ) provided blood sample s at 24-month follow-up . Follow-up question naires were completed by 307 patients ( 85.3 % ) at 12 months and by 295 patients ( 81.5 % ) at 24 months . Intervention group parents at 12 months ( 95 % CI 0.74 ; 0.03 to 1.52 ) and young people at 24 months ( 0.85 ; 95 % CI 0.03 to 1.61 ) had higher scores on the diabetes family responsibility question naire . Young people reported reduced happiness with body weight at 12 months ( -0.56 ; 95 % CI -1.03 to -0.06 ) . Only 68 % of groups were run . Of the 180 families recruited , 96 ( 53 % ) attended at least one module . Reasons for low uptake included difficulties organising groups , and work and school commitments . Young people with higher HbA1c levels were less likely to attend . Parents and young people who attended groups described improved family relationships , improved knowledge and underst and ing , greater confidence and increased motivation to manage diabetes . Twenty-four months after the intervention , nearly half of the young people reported that the groups had made them want to try harder and that they had carried on trying . A high- quality , complex , pragmatic trial of structured education can be delivered alongside st and ard care in NHS diabetes clinics . Health-care providers benefited from behaviour change skill training and can deliver pragmatic aspects of a National Institute for Health and Care Excellence (NICE)-compliant structured education programme after relatively brief training . The process evaluation provides insight into aspects of the model , and highlights strengths and aspects that may have contributed to the failure to influence primary and secondary outcomes . Current NHS practice dominates CASCADE ( Child and Adolescent Structured Competencies Approach to Diabetes Education ) in that it achieves the same number of QALYs at a lower cost . The mean cost of providing the intervention was £ 5098 per site or £ 683 per child . Members of paediatric diabetes services trained to deliver the CASCADE structured education package using behaviour change techniques did not improve glycaemic control in patients compared with control subjects 1 and 2 years after the intervention . The training workshops for practitioners were well evaluated ; however , more intensive training was needed . The intervention cost £ 683 per patient but was not cost-effective because it did not improve metabolic control . CONCLUSIONS A high- quality , complex , pragmatic trial of structured education can be successfully conducted alongside st and ard care in NHS diabetes clinics . Pragmatic components of a NICE-compliant structured education programme can be successfully delivered following a relatively brief 2-day training while paediatric health-care professionals benefit from training in behaviour change skills . The study provides invaluable information on barriers and opportunities regarding future , similar interventions . A low dropout rate and good attendance for the subgroup that attended the intervention suggests there might be improved uptake if offered to young people with lower HbA1c . Testing whether this approach can be more successful with a robust ongoing supervisory element should be a target of further research . TRIAL REGISTRATION Current Controlled Trials IS RCT N52537669 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 18 , No. 20 . See the NIHR Journals Library website for further project information RATIONALE , AIMS AND OBJECTIVES Self-management of type 2 diabetes through diet , exercise and for many medications , are vital in achieving and maintaining glycaemic control in type 2 diabetes . A number of interventions have been design ed to improve self-management , but the outcomes of these are rarely explored from a qualitative angle and even fewer through a process evaluation . METHOD A process evaluation was conducted using a qualitative design with participants r and omized to an intervention . Seventy-three people living with type 2 diabetes and hyperglycaemia for a minimum of 1 year , r and omized to one of two interventions ( n = 34 to an education intervention and n = 39 to an education and acceptance and commitment therapy intervention )  completed stage one of the process evaluation , immediately following the intervention through written feedback guided by open-ended questions . A purposive sample of 27 participants completed semi-structured interviews at 3 and 6 months post intervention . Interview data were transcribed and data analysed using a thematic analysis . RESULTS The majority of participants described an increase in knowledge around diabetes self-management and an increased sense of personal responsibility . Participants also described changes in self-management activities and reflected on the challenges in instigating and maintaining change to improve diabetes management . CONCLUSION The complexities of implementing change in daily life to improve glycaemic control indicate the need for ongoing support post intervention , which may increase and maintain the effectiveness of the intervention A decision support system for the management of  oral hypoglycaemic therapy  in type II diabetes was evaluated . The ruleset contained therein forms the basis of a prototype computer programme , but in order to assess the robustness of the individual rules , it was decided it was necessary to use a paper-based form of the ruleset . A nurse with no previous experience of managing type II diabetes was trained to use the system and then undertook the exclusive management of half of all new type II diabetics , from a district population of 300,000 , over a 16-month period . General practice s within this area were divided into two groups , study and control , matching for size , geographical area and st and ards of existing diabetes care . Patients ( n = 102 ) from the study group practice s were then assigned to her care . Those patients ( n = 116 ) in the control group of practice s were treated according to their normal procedures . The decision support system for oral hypoglycaemic therapy was based on the following criteria : the current type of treatment ( six levels ) ; current glycaemic control ( HbA1 and FBS)-whether improving , steady or worsening ; and weight-%IBW , whether rising , steady or falling . Each of these parameters was carefully defined on the basis of established practice and clinical experience . Patients after initial education were seen at their usual clinic by the nurse only , on a monthly basis , until satisfactory glycaemic control was established and thereafter review ed 3 monthly . She was also responsible for ensuring the organisation of Diabetes Annual Review procedures . The medical records of the control group patients were examined at the end of the study and data on glycaemic control and Annual Review s extracted . In the study group 98 % patients achieved HbA1 levels within the normal range and all patients had full annual review s performed . The control practice s achieved much poorer degrees of metabolic control ( P < 0.01 ) and completed fewer annual review s. The study group did not demonstrate a significantly increased frequency of clinical hypoglycaemia consequent upon better blood sugar control . No exceptions to the ruleset , as initially defined , were detected . In conclusion , this decision support system was successful at achieving st and ards of diabetes control and care equal to or better than conventional structures of diabetes care . Implementation of such a system , on a simple computer platform , could greatly assist and possibly improve diabetes management in general practice
This model outlines the challenges participants encounter in maintaining diabetes self-management practice s after attending structured education , and describes how participants try to address these barriers by adapting , simplifying or personalising the self-management approaches they have learned .
Conclusions This meta-ethnography highlights how providing skills training using structured education to people with type 1 diabetes does not necessarily result in participants adopting and sustaining recommended changes in behaviour .
Background People with type 1 diabetes who attend structured education training in self-management using flexible intensive therapy achieve improved blood glucose control and experience fewer episodes of severe hypoglycaemia .
However , many struggle to sustain these improvements over time .
To inform the design of more effective follow-up support we undertook a review of qualitative studies which have identified factors that influence and inform participants ’ self-management behaviours after attending structured education  and their need for support to sustain improvements in glycaemic control .