A pilot trial of 'HypoPals': Assessing trial procedures feasibility and intervention acceptability for a prospective...

Despite advances in diabetes technology, hypoglycemia remains a major problem for people with type 1 diabetes (T1D). We developed HypoPals, a scalable digital behavioral intervention program comprised of two intervention components, (i) hypoglycemia symptom detection training ('SDT') and (ii) psychoeducation to address unhelpful hypoglycemia beliefs (Education Plus, 'ED+'), to improve hypoglycemia self-management in adults with T1D.

A 52-week pilot study was conducted to assess the feasibility of a prospective decentralized 2 × 2 factorial trial with the following characteristics: participant recruitment from a national T1D patient registry; minimization randomization; and remote outcome data collection to evaluate the effectiveness of HypoPals intervention components. This pilot study's primary outcome was the number of participants needed to achieve 20 participants completing the intervention. Intervention acceptability was also assessed.

Forty participants were randomized to receive 10 weeks of either SDT only; ED+ only; both; or usual care only. All participants completed the intervention. Thus, 20 participants were recruited to achieve 20 participants completing the intervention. No significant differences in baseline characteristics were observed across randomization groups. Retention was 98% at the 26- and 52-week follow-ups, and 98% of participants provided complete outcome data. The majority (88%) found HypoPals at least somewhat helpful. No adverse events were determined to be related to the intervention.

This pilot trial demonstrated the feasibility of both integrating multiple advanced trial strategies and the intervention's acceptability. Results supported the conduct of a large-scale, decentralized, factorial trial to evaluate HypoPals' effectiveness in reducing hypoglycemia in adults with T1D.