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

NCT05916131 | Completed Results

• 2 other identifiers: HUM002284841K23DK129724-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

hypoglycemia; mobile health technology; text messaging

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention

  This number will include participants that were enrolled and received part or all of the intervention.

  Approximately 4.5 months

Secondary Outcomes (10)

• Number of Potential Candidates Contacted During the Entire Recruitment Period

  Approximately 1 year (recruitment period)

• Percentage of Contacted Potential Candidates Being Eligible

  Approximately 1 year (recruitment period)

• Rate of Participant Retention at 12 Weeks

  12 weeks

• Rate of Participant Retention at 26 Weeks

  6 months

• Rate of Participant Retention at 52 Weeks

  1 year

Study Arms (4)

Hypoglycemia Symptom Detection Training

EXPERIMENTAL

To provide Hypoglycemia Symptom Detection Training intervention.

Behavioral: Basic Education; Behavioral: Hypoglycemia Symptom Detection Training

Education Plus

EXPERIMENTAL

To provide Education Plus intervention.

Behavioral: Basic Education; Behavioral: Education Plus

Hypoglycemia Symptom Detection Training and Education Plus

EXPERIMENTAL

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

Behavioral: Basic Education; Behavioral: Hypoglycemia Symptom Detection Training; Behavioral: Education Plus

Usual Care

OTHER

Continuing usual care after basic education.

Behavioral: Basic Education

Interventions

Basic Education BEHAVIORAL

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

Education Plus; Hypoglycemia Symptom Detection Training; Hypoglycemia Symptom Detection Training and Education Plus; Usual Care

Hypoglycemia Symptom Detection Training BEHAVIORAL

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

Hypoglycemia Symptom Detection Training; Hypoglycemia Symptom Detection Training and Education Plus

Education Plus BEHAVIORAL

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

Education Plus; Hypoglycemia Symptom Detection Training and Education Plus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

This is a pilot feasibility trial focused on the feasibility of running similar studies.

Results Point of Contact

• Title: Yu Kuei Lin, MD
• Organization: University of Michigan

yuklin@med.umich.edu

734-232-1573

Study Officials

• Yu Kuei Alex Lin, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Model Details: Adaptive randomization with minimization method will be conducted to ensure equal number of participants (n=10) will be randomized into the same number of the 4 experimental conditions (i.e., in 1:1:1:1 ratio). The randomization will be stratified based on whether the participant have severe hypoglycemia within the year or spending greater or equal to 1 percent of time in level 2 hypoglycemia on CGM, and the status of closed-loop pump use.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: September 19, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 12, 2025
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)