CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Basic Education +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05916131
NCT05916131N/ACompleted

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

University of Michigan·interventional·Posted Jun 23, 2023·Updated Jun 18, 2025

In Brief

A clinical study evaluating Basic Education, Hypoglycemia Symptom Detection Training, and 1 other intervention for Type 1 Diabetes and Hypoglycemia. Completed, enrolled 40 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedJun 23, 2023
Enrollment StartSep 19, 2023
Primary CompletionFeb 2, 2024
Study CompletionFeb 12, 2025
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.0 years ago

Interventions

Basic Educationbehavioral

2-week text message intervention for providing knowledge about hypoglycemia management and prevention.

Hypoglycemia Symptom Detection Trainingbehavioral

10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms.

Education Plusbehavioral

10-week text message intervention for helping people consider how they think of hypoglycemia.