NCT05916131

Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.

Pilot and Feasibility Trial of HypoPals, a Mobile Health Intervention for Improving Hypoglycemia Self-management in Type 1 Diabetes Adults Using Advanced Diabetes Technologies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A mobile health program "HypoPals", which incorporates data from continuous glucose monitoring systems (CGMs) and sends personalized text messages to help people sharpen their low blood sugar symptom detection skills, and help people consider how they think of low blood sugar, was devised. The goal of the current study is to make sure that HypoPals runs smoothly, users find the intervention useful, and the way the researchers conduct the final study will be correct (i.e., there is a need for 'pilot testing' the developed technology and research methods). All participants will receive basic hypoglycemia education text messages, and then be randomized to one of the four experimental conditions: Hypoglycemia Symptom Detection Training, Education Plus, both Symptom Detection Training and Education Plus, and usual care. Participants may receive additional interventional text messages based on the experimental condition participants are assigned to. The study may terminate after collecting sufficient data to evaluate the primary outcome (i.e., determining the number of participants recruited to reach 20 participants who complete the intervention).

Conditions

• Type 1 Diabetes
• Hypoglycemia

Interventions

Type	Name	Description
BEHAVIORAL	Basic Education	2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
BEHAVIORAL	Hypoglycemia Symptom Detection Training	10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms.
BEHAVIORAL	Education Plus	10-week text message intervention for helping people consider how they think of hypoglycemia.

Timeline

• Start date: 2023-09-19
• Primary completion: 2024-02-02
• Completion: 2025-02-12
• First posted: 2023-06-23
• Last updated: 2025-06-18
• Results posted: 2025-06-18

Locations

1 site across 1 country: United States