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

NCT ID: NCT05916131

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2025-02-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Hypoglycemia Symptom Detection Training

To provide Hypoglycemia Symptom Detection Training intervention.

Group Type: EXPERIMENTAL

Basic Education

Intervention Type: BEHAVIORAL

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

Hypoglycemia Symptom Detection Training

Intervention Type: BEHAVIORAL

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

Education Plus

To provide Education Plus intervention.

Group Type: EXPERIMENTAL

Basic Education

Intervention Type: BEHAVIORAL

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

Education Plus

Intervention Type: BEHAVIORAL

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

Hypoglycemia Symptom Detection Training and Education Plus

To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously.

Group Type: EXPERIMENTAL

Basic Education

Intervention Type: BEHAVIORAL

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

Hypoglycemia Symptom Detection Training

Intervention Type: BEHAVIORAL

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

Education Plus

Intervention Type: BEHAVIORAL

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

Usual Care

Continuing usual care after basic education.

Group Type: OTHER

Basic Education

Intervention Type: BEHAVIORAL

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

Interventions

Basic Education

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

Intervention Type: BEHAVIORAL

Hypoglycemia Symptom Detection Training

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

Intervention Type: BEHAVIORAL

Education Plus

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Signed and dated informed consent form
• Self-reported diagnosis of type 1 diabetes for at least 5 years
• Previous attendance of structured diabetes education program
• Using CGM greater or equal to (≥1) year
• Ongoing Dexcom CGM use time ≥70% based on CGM report at screening
• Have had experienced ≥1 episode of severe hypoglycemia in the past year while using CGMs or spending ≥1% of time in level 2 hypoglycemia at the time of pre-screening
• Using cellphone with functionality for sharing real-time data to Dexcom Clarity and receiving text messages
• Be able to communicate in English (spoken and written)
• Willing to comply with all study procedures including sharing CGM glucose information, receiving and reading intervention text messages, and completing study questionnaires

Exclusion Criteria

• Active participation in clinical trials on diabetes/hypoglycemia interventions
• Pregnancy or planning for pregnancy within a year
• Untreated adrenal insufficiency or hypothyroidism
• Uncontrolled mental disorder or chronic cognitive dysfunctions (include but not limited to uncontrolled schizophrenia, depression and bipolar disorders; learning disability; active alcohol and substance dependence; dementia or cognitive impairment independent of hypoglycemia)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Yu Kuei Alex Lin

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu Kuei Alex Lin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1K23DK129724-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00228484

Identifier Type: -

Identifier Source: org_study_id