title: 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. A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial. Flexible eating and flexible insulin dosing in patients with diabetes: Results of an intensive self-management course. Improved Biomedical and Psychological Outcomes 1 Year After Structured Education in Flexible Insulin Therapy for People With Type 1 Diabetes Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial Intensified insulin therapy and the risk of severe hypoglycaemia
abstract: 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 Insulin is generally administered to people with type 1 diabetes mellitus ( T1DM ) using multiple daily injections ( MDIs ) , but can also be delivered using infusion pumps . In the UK , pumps are recommended for patients with the greatest need and adult use is less than in comparable countries . Previous trials have been small , of short duration and have failed to control for training in insulin adjustment . OBJECTIVE To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM , with both groups receiving equivalent structured training in flexible insulin therapy . DESIGN Pragmatic , multicentre , open-label , parallel-group cluster r and omised controlled trial , including economic and psychosocial evaluations . After participants were assigned a group training course , courses were r and omly allocated in pairs to either pump or MDI . SETTING Eight secondary care diabetes centres in the UK . PARTICIPANTS Adults with T1DM for > 12 months , willing to undertake intensive insulin therapy , with no preference for pump or MDI , or a clinical indication for pumps . INTERVENTIONS Pump or MDI structured training in flexible insulin therapy , followed up for 2 years . MDI participants used insulin analogues . Pump participants used a Medtronic Paradigm ® VeoTM ( Medtronic , Watford , UK ) with insulin aspart ( NovoRapid , Novo Nordisk , Gatwick , UK ) . MAIN OUTCOME MEASURES Primary outcome - change in glycated haemoglobin ( HbA1c ) at 2 years in participants whose baseline HbA1c was ≥ 7.5 % ( 58 mmol/mol ) . Key secondary outcome - proportion of participants with HbA1c ≤ 7.5 % at 2 years . Other outcomes at 6 , 12 and 24 months - moderate and severe hypoglycaemia ; insulin dose ; body weight ; proteinuria ; diabetic ketoacidosis ; quality of life ( QoL ) ; fear of hypoglycaemia ; treatment satisfaction ; emotional well-being ; qualitative interviews with participants and staff ( 2 weeks ) , and participants ( 6 months ) ; and ICERs in trial and modelled estimates of cost-effectiveness . RESULTS We r and omised 46 courses comprising 317 participants : 267 attended a Dose Adjustment For Normal Eating course ( 132 pump ; 135 MDI ) ; 260 were included in the intention-to-treat analysis , of which 235 ( 119 pump ; 116 MDI ) had baseline HbA1c of ≥ 7.5 % . HbA1c and severe hypoglycaemia improved in both groups . The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI . The mean difference ( MD ) in HbA1c change at 2 years , at which the baseline HbA1c was ≥ 7.5 % , was -0.24 % [ 95 % confidence interval ( CI ) -0.53 % to 0.05 % ] in favour of the pump ( p = 0.098 ) . The per- protocol analysis showed a MD in change of -0.36 % ( 95 % CI -0.64 % to -0.07 % ) favouring pumps ( p = 0.015 ) . Pumps were not cost-effective in the base case and all of the sensitivity analyses . The pump group had greater improvement in diabetes-specific QoL diet restrictions , daily hassle plus treatment satisfaction , statistically significant at 12 and 24 months and supported by qualitative interviews . LIMITATION Blinding of pump therapy was not possible , although an objective primary outcome was used . CONCLUSION Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM . RESEARCH PRIORITY To underst and why few patients achieve a HbA1c of < 7.5 % , particularly as glycaemic control is worse in the UK than in other European countries . TRIAL REGISTRATION Current Controlled Trials IS RCT N61215213 . FUNDING This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 21 , No. 20 . See the NIHR Journals Library website for further project information AIMS To evaluate the outcomes of an established programme to teach patients to match their insulin dose to their carbohydrate intake . RESEARCH DESIGN AND METHODS A prospect i ve observational study in Australia ( Newcastle , NSW ) of 137 consecutive patients with type 1 ( n=82 ) or type 2 diabetes ( n=55 ) over two successive years . Four educational principles were used to teach intensive insulin management and diabetes self-care skills including : carbohydrate counting and insulin dose adjustment , exercise , appropriate treatment of hypoglycaemia and hyperglycaemia , managing sickness , problem solving , communication with health professionals , goal setting , and the importance of support . Outcomes included changes at 4 and 12 months in HbA1c , self-efficacy measured by a diabetes empowerment scale ( DES ) , diabetes specific quality of life ( ADDQoL ) , and problem solving . Both intention to treat and efficacy analyses were performed . RESULTS Diabetes-related quality of life and diabetes problem solving skills improved significantly . Excluding 16 people who failed to adopt intensive insulin management and 24 who started with an HbA1c less than 7 % , intention to treat analysis showed the average HbA1c fell from 8.7 % initially to 8.1 % at 12 months and the number of people with an HbA1c of less than 8 % rose from 67 ( 48.9 % ) before the program to 86 ( 62.8 % ) afterwards . CONCLUSIONS An intensive diabetes self-management program led to improvements in HbA1c , empowerment , and quality of life that were largely sustained at 1 year . This is all the more remarkable given that the intervention was once only , entailed no long-term follow-up , and took place in normal clinical operations OBJECTIVE DAFNE ( Dose Adjustment For Normal Eating ) , a structured education program in flexible insulin therapy , has been widely adopted in the U.K. after validation in a r and omized trial . To determine benefits in routine practice , we collected biomedical and psychological data from all participants attending during a 12-month period . RESEARCH DESIGN AND METHODS HbA1c , weight , self-reported hypoglycemia awareness , severe hypoglycemia frequency , PAID ( Problem Areas In Diabetes ) , HADS ( Hospital Anxiety and Depression Scale ) , and EuroQol Group 5-Dimension Self-Report  Question naire scores were recorded prior to DAFNE and after 1 year . RESULTS Complete baseline and follow-up HbA1c data were available for 639 ( 54.9 % ) of 1,163 attendees . HbA1c fell from 8.51 ± 1.41 ( mean ± SD ) to 8.24 ± 1.29 % ( difference 0.27 [ 95 % CI 0.16–0.38 ] ; P < 0.001 ) , with a greater mean fall of 0.44 % from baseline HbA1c > 8.5 % . Severe hypoglycemia rate fell from 1.7 ± 8.5 to 0.6 ± 3.7 episodes per person per year ( 1.1 [ 0.7–1.4 ] ) and hypoglycemia recognition improved in 43 % of those reporting unawareness . Baseline psychological distress was evident , with a PAID score of 25.2 and HADS scores of 5.3 ( anxiety ) and 4.8 ( depression ) , falling to 16.7 ( 8.5 [ 6.6–10.4 ] ) , 4.6 ( 0.7 [ 0.4–1.0 ] ) , and 4.2 ( 0.6 [ 0.3–0.8 ] ) , respectively ( all P < 0.001 at 1 year ) . Clinical ly relevant anxiety and depression ( HADS ≥8 ) fell from 24.4 to 18.0 % and 20.9 to 15.5 % , respectively . CONCLUSIONS A structured education program delivered in routine clinical practice not only improves HbA1c while reducing severe hypoglycemia rate and restoring hypoglycemia awareness but also reduces psychological distress and improves perceived well-being Abstract Objectives : To evaluate whether a course teaching flexible intensive insulin treatment combining dietary freedom and insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes . Design : R and omised design with participants either attending training immediately ( immediate DAFNE ) or acting as waiting list controls and attending “ delayed DAFNE ” training 6 months later . Setting : Secondary care diabetes clinics in three English health districts . Participants : 169 adults with type 1 diabetes and moderate or poor glycaemic control . Main outcome measures : Glycated haemoglobin ( HbA1c ) , severe hypoglycaemia , impact of diabetes on quality of life ( ADDQoL ) . Results : At 6 months , HbA1c was significantly better in immediate DAFNE patients ( mean 8.4 % ) than in delayed DAFNE patients ( 9.4 % ) ( t=6.1 , P<0.0001 ) . The impact of diabetes on dietary freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients ( t=−5.4 , P<0.0001 ) , as was the impact of diabetes on overall quality of life ( t=2.9 , P<0.01 ) . General wellbeing and treatment satisfaction were also significantly improved , but severe hypoglycaemia , weight , and lipids remained unchanged . Improvements in “ present quality of life ” did not reach significance at 6 months but were significant by 1 year . Conclusion : Skills training promoting dietary freedom improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk . This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation Summary The objectives of the present analyses were to assess the association between HbA1 c levels and severe hypoglycaemia ( SH , treatment with glucose i. v. or glucagon injection ) and to identify predictors of SH in a prospect i ve multicentre trial . The study population consisted of 636 insulin-dependent diabetic patients who had participated in a structured 5-day in-patient group treatment and teaching programme for intensification of insulin therapy ( ITTP ) in one of 10 hospitals and who were re-examined after 1 , 2 , 3 , and 6 years including assessment of demographic , disease and treatment related parameters , diabetes-related knowledge , behaviour , and emotional coping . At baseline , age ( mean ± SD ) was 27 ± 7 years , diabetes duration 9 ± 7 years and HbA1 c 8.3 ± 1.9 % . During the 6-year follow-up , the mean HbA1 c value improved to 7.6 % , and in patients with a diabetes duration of more than 1 year at entry into the study ( n = 538 ) the incidence of SH decreased from 0.28 cases/patient/year during the year preceding the ITTP to 0.17 cases/patient/year . The patient group was divided into decile groups according to mean follow-up HbA1 c values . In each group more than 230 patient years could be analysed . Groups with mean HbA1 c values of 5.7 , 7.0 , 7.4 , 7.7 and 8.9 % had comparable risks of SH ( 0.15–0.19 cases/patient/year ) . In a logistic regression analysis , mean HbA1 c during follow-up , a history of SH during the year preceding the ITTP , C-peptide level , emotional coping , carrying emergency carbohydrates ( as assessed at the 1-year follow-up ) , and age at onset of diabetes were significant independent predictors of SH . The incidence of SH between centres varied between 0.05 and 0.27 cases/patient/year . In conclusion , in the present analyses no linear or exponential relationship between HbA1 c and severe hypoglycaemia could be identified by using simple group comparisons . Applying complex regression analyses , various patient-related predictors of severe hypoglycaemia were identified . [ Diabetologia ( 1997 ) 40 : 926–932
target: 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: 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 .