Improving outcomes among young adults with type 1 diabetes: the D1 Now randomized pilot study protocol

BACKGROUND Young adults (aged 18-25 years) living with type 1 diabetes mellitus often have sub-optimal glycaemic levels, which can increase their risk of long-term diabetes complications. Informed by health psychology theory and using a young adult-centred approach (public and patient involvement), we have developed a complex intervention, entitled D1 Now, to improve outcomes in this target group. The D1 Now intervention has three components: (1) a support worker; 2) an interactive messaging system; and 3) an agenda-setting tool for use during clinic consultations. AIMS To gather and analyse acceptability and feasibility data to allow us to (1) refine the D1 Now intervention, and (2) determine the feasibility of a definitive randomized controlled trial of the intervention. METHODS Diabetes clinics on the island of Ireland will be recruited and randomized to a D1 Now intervention arm or a usual care control arm. For a participant to be eligible they should be aged 18-25 years and living with type 1 diabetes for at least 12 months. RESULTS AND DISCUSSION Participant outcomes (influenced by a core outcome set) include change in HbA1c , clinic attendance, number of episodes of severe hypoglycaemia and of diabetic ketoacidosis, diabetes distress, self-management, quality of life and perceived level of control over diabetes. These outcomes will be measured at baseline and after 12 months of follow-up for descriptive statistics only. An assessment of treatment fidelity, a health economic analysis and a qualitative sub-study will also be incorporated into the pilot study.