Improving outcomes among young adults with type 1 diabetes: the D1 Now pilot cluster randomised controlled trial

Abstract

Background The D1 Now intervention is designed to improve outcomes in young adults living with type 1 diabetes. It consists of three components: an agenda-setting tool, an interactive messaging system and a support worker. The aim of the D1 Now pilot cluster randomised controlled trial (RCT) was to gather and analyse acceptability and feasibility data to allow (1) further refinement of the D1 Now intervention, and (2) determination of the feasibility of evaluating the D1 Now intervention in a future definitive RCT. Methods A pilot cluster RCT with two intervention arms and a control arm was conducted over 12 months. Quantitative data collection was based on a core outcome set and took place at baseline and 12 months. Semi-structured interviews with participants took place at 6, 9 and 12 months. Fidelity and health economic costings were also assessed. Results Four diabetes centres and 57 young adults living with type 1 diabetes took part. 50% of eligible young adults were recruited and total loss to follow-up was 12%. Fidelity, as measured on a study delivery checklist, was good but there were three minor processes that were not delivered as intended in the protocol. Overall, the qualitative data demonstrated that the intervention was considered acceptable and feasible, though this differed across intervention components. The agenda-setting tool and support worker intervention components were acceptable to both young adults and staff, but views on the interactive messaging system were mixed. Conclusions Some modifications are required to the D1 Now intervention components and research processes but with these in place progression to a definitive RCT is considered feasible. Trial registration ISRCTN (ref: ISRCTN74114336)

Reimagining care for young adults living with type 1 diabetes

“…When trialed during the D1 Now pilot randomized controlled trial, this question was sometimes answered with ‘HbA1c’, but more frequently answered with requests for new diabetes technology or education, considerations of other comorbid health conditions, and questions around exercise, motivation, college life, travel, alcohol, career changes, hypos, stress, support groups and driving licenses. Experience with introducing the agenda setting tool into routine clinical practice has highlighted the importance of providing training for clinicians in its use 13 . These intervention components serve as two examples of how aspects of care can be co‐designed to enhance the clinical encounter and allow all parties to work together to create a plan that fits at that point of life.…”

Piloting an Intervention to Improve Outcomes in Young Adults Living With Type 1 Diabetes: The Experience of the D1 Now Support Worker

“…Details of the development process and the three intervention components: (i) a Support Worker; (ii) an interactive messaging system, ‘Florence’; and (iii) an Agenda-Setting Tool - have been described in a number of recent publications (see Figure 1 ) ( 21 , 22 ). A pilot cluster randomised controlled trial (RCT) of the D1 Now intervention was carried out during 2019-2020 with the primary aim of gathering and analysing acceptability and feasibility data ( 23 , 24 ).…”