Mary Clare O’Hara

The Irish DAFNE Study Protocol: A cluster randomised trial of group versus individual follow-up after structured education for Type 1 diabetes

BackgroundStructured education programmes for individuals with Type 1 diabetes have become a recognised means of delivering the knowledge and skills necessary for optimal self-management of the condition. The Dose Adjustment for Normal Eating (DAFNE) programme has been shown to improve biomedical (HbA1c and rates of severe hypoglycaemia) and psychosocial outcomes for up to 12 months following course delivery. The optimal way to support DAFNE graduates and maintain the benefits of the programme has not been established. We aimed to compare 2 different methods of follow-up of DAFNE graduates in a pragmatic clinical trial delivered in busy diabetes clinics on the island of Ireland.MethodsSix participating centres were cluster randomised to deliver either group follow-up or a return to traditional one-to-one clinic visits. In the intervention arm group follow-up was delivered at 6 and 12 months post DAFNE training according to a curriculum developed for the study. In the control arm patients were seen individually in diabetes clinics as part of routine care. Study outcomes included HbA1c levels, self-reported rates of severe hypoglycaemia, body weight and measures of diabetes wellbeing and quality of life. These were measured at 6, 12 and 18 months after recruitment. Generalisability (external validity) was maximised by recruiting study participants from existing DAFNE waiting lists in each centre, by using broad inclusion criteria (including HbA1c values less than 13 percent with no lower limit) and by using existing clinic staff to deliver the training and follow-up. Internal validity and treatment fidelity were maximised by quality assuring the training of all DAFNE educators, by external peer review of the group follow-up sessions and by striving for full attendance at follow-up visits. Assays of HbA1c were undertaken in a central laboratory.DiscussionThis pragmatic clinical trial evaluating group follow-up after a structured education programme has been designed to have broad generalisability. The results should inform how best to manage the well educated patient with Type 1 diabetes in the real world of clinical practiceTrial registrationCurrent Controlled Trials ISRCTN79759174

Group follow-up compared to individual clinic visits after structured education for type 1 diabetes: A cluster randomised controlled trial☆

AIM To compare the effectiveness of group follow-up with individual follow-up after participation in the Dose Adjustment for Normal Eating (DAFNE) structured education programme. METHODS Cluster randomised controlled trial involving 437 adults with type 1 diabetes attending hospital diabetes clinics in Ireland. All participants received DAFNE at baseline. Intervention arm participants received 2 group education sessions post-DAFNE and did not attend clinics. Control arm participants received 2 one-to-one clinic visits post-DAFNE. RESULTS We observed no significant difference in the primary outcome (change in HbA1c) at 18 months follow-up (mean difference 0.14%; 95% CI -0.33 to 0.61; p=0.47). Secondary outcomes, including rates of severe hypoglycaemia, anxiety, depression, the burden of living with diabetes and quality of life did not differ between groups. Mean level of HbA1c for the entire sample (regardless of treatment arm) did not change between baseline and 18 month follow-up (p=0.09), but rates of severe hypoglycaemia, diabetes related hospital attendance, levels of anxiety, depression, the burden of living with diabetes, quality of life and treatment satisfaction all significantly improved. CONCLUSIONS Our data suggest that group follow-up as the sole means of follow-up after structured education for individuals with type 1 diabetes is as effective as a return to one-to-one clinic visits.

Predictors of quality of life gains among people with type 1 diabetes participating in the Dose Adjustment for Normal Eating (DAFNE) structured education programme.

AIMS To examine predictors of quality of life gains among people with type 1 diabetes following the Dose Adjustment for Normal Eating (DAFNE) self-management training programme. METHODS Clinical and questionnaire data were collected from 437 patients from 6 hospital centres before, and 18 months post-DAFNE intervention. Glycated haemoglobin (HbA(1c)), weight, height, and blood pressure levels were recorded by clinicians during clinic appointments. Questionnaires included the Diabetes-Specific Quality of Life Scale (DSQOLS), the Problem Areas in Diabetes Scale (PAID) and the Hospital Anxiety and Depression Scale (HADS). Basic demographics were recorded at baseline. Linear mixed models were fitted to identify predictors of change in quality of life at an 18 month follow-up assessment. RESULTS Patients with high levels of diabetes-related distress experienced greatest improvement in DSQOLS quality of life scores (p = 0.001). Patients with poor glycaemic control (higher levels of HbA(1c); p = 0.03) and those with high levels of anxiety (p = 0.001) experienced the greatest reductions in diabetes-related distress. CONCLUSIONS Patients with higher baseline levels of anxiety, higher levels of diabetes-related distress and higher baseline levels of HbA(1c) are most likely to experience quality of life gain from participation in self-management programmes such as DAFNE.

Cost effectiveness of group follow-up after structured education for type 1 diabetes: a cluster randomised controlled trial

BackgroundThis study examines the cost effectiveness of group follow-up after participation in the Dose Adjustment for Normal Eating (DAFNE) structured education programme for type 1 diabetes.MethodsEconomic evaluation conducted alongside a cluster randomised controlled trial involving 437 adults with type 1 diabetes in Ireland. Group follow-up involved two group education ‘booster’ sessions post-DAFNE. Individual follow-up involved two standard one-to-one hospital clinic visits. Incremental costs, quality-adjusted life years (QALYs) gained and cost effectiveness were estimated at 18 months. Uncertainty was explored using sensitivity analysis and by estimating cost effectiveness acceptability curves.ResultsGroup follow-up was associated with a mean reduction in QALYs gained of 0.04 per patient (P value, 0.052; 95% CI, −0.08 to 0.01, intra-class correlation (ICC), 0.033) and a mean reduction in total healthcare costs of €772 (P value, 0.020; 95% CI, −1,415 to −128: ICC, 0.016) per patient. At alternative threshold values of €5,000, €15,000, €25,000, €35,000, and €45,000, the probability of group follow-up being cost effective was estimated to be 1.000, 0.762, 0.204, 0.078, and 0.033 respectively.ConclusionsThe results do not support implementation of group follow-up as the sole means of follow-up post-DAFNE. Given the reported cost savings, future studies should explore the cost effectiveness of alternative models of group care for diabetes.Trial registrationCurrent Controlled Trials ISRCTN79759174 (assigned: 9 February 2007).

Is diabetes self-management education still the Cinderella of diabetes care?

This paper reflects on the status of diabetes self-management education (DSME) as a branch of diabetology in Europe and discusses some opportunities for better supporting DSME delivery. DSME (also commonly known as Therapeutic Patient Education) has been evolving as a therapy for diabetes for decades. As a continent, Europe is fortunate to have nurtured many pioneers in DSME, and currently has many experts in the field progressing the knowledge base and striving to improve access to DSME for people with diabetes. While there is a wide variety of DSME programmes being delivered throughout Europe, for most people diabetes education is not truly embedded in routine clinical care, being seen as more of an optional add-on to conventional therapies. In comparison to drugs and devices, DSME lacks investment, and funding for DSME research lags far behind other therapies. The rigour with which forms of DSME are developed and evaluated varies, and there is a lack of European quality standards. To try to address some of these deficiencies, greater pan-European collaboration and leadership is required.

A Mixed Methods Study Exploring the Factors and Behaviors That Affect Glycemic Control Following a Structured Education Program The Irish DAFNE Study

Aim: To explain the factors affecting glycemic control (measured by HbA1c) following the Dose Adjustment for Normal Eating (DAFNE) program. Background: DAFNE is a structured education program designed to assist persons with type 1 diabetes mellitus achieve optimal glycemic control. However, not all participants reach this goal. Few studies comprehensively explain why this is the case. Research Design: A concurrent mixed methods design. Data were collected from participants (n = 34) at three time points post DAFNE in five participating sites. Each data set was analyzed separately and then integrated. Results: Motivation and support differed for participants who were out of control and those in control. Conclusion: Setting targets/goals and motivations are key in helping participants attain optimal HbA1c.

A core outcomes set for clinical trials of interventions for young adults with type 1 diabetes: an international, multi-perspective Delphi consensus study

BackgroundAchieving consensus from a range of relevant stakeholders about an agreed set of core outcomes to be measured and reported as a minimum in clinical trials has the potential to enhance evidence synthesis and make findings more relevant and applicable. Intervention research to improve outcomes for young adults with type 1 diabetes (T1DM) is hampered by inconsistent use of outcome measures. This population frequently struggles to manage their condition and reports suboptimal clinical outcomes. Our aim was to conduct an international, e-Delphi consensus study to identify a core outcome set (COS) that key stakeholders (young adults with T1DM, diabetes health professionals, diabetes researchers and diabetes policy makers) consider as essential outcomes for future intervention research.MethodsUsing a list of 87 outcomes generated from a published systematic review, we administered two online surveys to a sample of international key stakeholders. Participants in the first survey (survey 1; n = 132) and the second survey (survey 2; n = 81) rated the importance of the outcomes. Survey 2 participants received information on total mean rating for each outcome and a reminder of their personal outcome ratings from Survey 1. Survey 2 results were discussed at a consensus meeting and participants (n = 12: three young adults with T1DM, four diabetes health professionals, four diabetes researchers and one diabetes policy maker) voted on outcomes. Final core outcomes were included provided that 70% of consensus group participants voted for their inclusion.ResultsEight core outcomes were agreed for inclusion in the final COS: measures of diabetes-related stress; diabetes-related quality of life; number of severe hypoglycaemic events; self-management behaviour; number of instances of diabetic ketoacidosis (DKA); objectively measured glycated haemoglobin (HbA1C); level of clinic engagement; and perceived level of control over diabetes.ConclusionsThis study is the first to identify a COS for inclusion in future intervention trials to improve outcomes for young adults with T1DM. Use of this COS will improve the quality of future research and increase opportunities for evidence synthesis. Future research is necessary to identify the most robust outcome measure instruments.