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

BACKGROUND: Achieving 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. METHODS: Using 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. RESULTS: Eight 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. CONCLUSIONS: This 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

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

Journal articleAim - 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.HRB Irelan

Strength in Numbers: an international consensus conference to develop a novel approach to care delivery for young adults with type 1 diabetes, the D1 Now Study

Many young adults with type 1 diabetes struggle with the day-to-day management of their condition. They often find it difficult to find the time to attend their clinic appointments and to meet with their diabetes healthcare team. Young adults living with type 1 diabetes are not routinely involved in research that may help improve health services other than being invited to take part in studies as research participants. A 3-day international conference was held in Galway in June 2016 called “Strength In Numbers: Teaming up to improve the health of young adults with type 1 diabetes”. It aimed to bring together people from a broad variety of backgrounds with an interest in young adults with type 1 diabetes. Young people with type 1 diabetes came together with healthcare professionals, researchers, software developers and policy makers to come up with and agree on a new approach for engaging young adults with type 1 diabetes with their health services and to improve how they manage their diabetes. The people involved in the conference aimed to reach agreement (consensus) on a fixed set of outcome measures called a core outcome set (COS) that the group would recommend future studies involving young adults with type 1 diabetes to use, to suggest a new approach (intervention) for providing health services to young adults with type 1 diabetes, and to come up with health technology ideas that could help deliver the new intervention. Over the 3 days, this diverse international group of people that included young adults living with type 1 diabetes, agreed on a COS, 3 key parts of a new intervention and 1 possible health technology idea that could help with how the overall intervention could be delivered. Involving young adults living with type 1 diabetes in a 3-day conference along with other key groups is an effective method for coming up with a new approach to improve health services for young adults with type 1 diabetes and better support their self-management.The conference was supported by the Health Research Board through a Knowledge Exchange and Dissemination Scheme (Ref KEDS-2015-1644)