Improving Outcomes Among Young Adults with type 1 diabetes: The D1 Now Randomised Pilot Study Protocol.

Area of Science:

• Endocrinology and Metabolism
• Public Health
• Digital Health

Background:

• Young adults (18-25) with type 1 diabetes often experience suboptimal glycemic control, increasing long-term complication risks.
• A complex intervention, D1 Now, was developed using health psychology and a patient-centered approach.
• D1 Now integrates a support worker, interactive messaging, and an agenda-setting tool for clinic consultations.

Purpose of the Study:

• To evaluate the acceptability and feasibility of the D1 Now intervention in young adults with type 1 diabetes.
• To gather data for refining the D1 Now intervention.
• To determine the feasibility of conducting a definitive Randomized Control Trial (RCT) for this intervention.

Main Methods:

• A pilot study involving diabetes clinics across Ireland, randomizing participants aged 18-25 with type 1 diabetes (≥12 months) to D1 Now or usual care.
• Outcome measures include HbA1c, clinic attendance, severe hypoglycemia/DKA episodes, diabetes distress, self-management, quality of life, and perceived control.
• Data collection involves baseline and 12-month follow-up for descriptive statistics, alongside fidelity assessment, health economic analysis, and a qualitative sub-study.

Main Results:

• Pilot study data collection and analysis are ongoing.
• Acceptability and feasibility metrics will guide intervention refinement.
• Feasibility for a full RCT will be assessed based on recruitment, retention, and outcome data.

Conclusions:

• The D1 Now intervention shows promise for improving outcomes in young adults with type 1 diabetes.
• This pilot study is crucial for informing the design of a definitive RCT.
• Further research is needed to confirm the efficacy of D1 Now in a larger trial.