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

NCT05916131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-18

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • Yu Kuei Alex Lin, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2024-02-02
Completion
2025-02-12

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05916131 on ClinicalTrials.gov