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Completed

NCT Number: NCT05916131

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

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).

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Basic Education

Behavioral

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

Hypoglycemia Symptom Detection Training

Behavioral

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

Education Plus

Behavioral

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

Primary outcomes

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

    Time frame: Approximately 4.5 months

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

Secondary outcomes

  1. Number of Potential Candidates Contacted During the Entire Recruitment Period

    Time frame: Approximately 1 year (recruitment period)

    This number includes all potential candidates for enrollment contacted during the entire recruitment period, regardless of whether or not they ultimately enrolled in the study.

  2. Percentage of Contacted Potential Candidates Being Eligible

    Time frame: Approximately 1 year (recruitment period)

    Percentage of contacted potential candidates who were eligibility-assessed and determined to be eligible for the study.

  3. Rate of Participant Retention at 12 Weeks

    Time frame: 12 weeks

    Number of participants who completed 12 weeks of the intervention

  4. Rate of Participant Retention at 26 Weeks

    Time frame: 6 months

    Number of participants who completed 26-week follow-up visit

  5. Rate of Participant Retention at 52 Weeks

    Time frame: 1 year

    Number of participants who completed 52-week follow-up visit

  6. Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks

    Time frame: 12 weeks

    Percentage of participants whose CGM data was successfully collected at 12 weeks. Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.

  7. Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks

    Time frame: 6 months

    Percentage of participants whose CGM data was successfully collected at 26 weeks. Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.

  8. Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks

    Time frame: 1 year

    Percentage of participants whose CGM data was successfully collected at 52 weeks. Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.

  9. Participants Reporting Reading Message Content at the End of the Intervention

    Time frame: 12 weeks

    Assessed with a question adapted from mSustain questionnaire: "When you receive a HypoPals message, how much of it do you read?" Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.

  10. Participants Finding Message Content Helpful (Positive) at the End of the Intervention

    Time frame: 12 weeks

    Assessed with a study-purposed question: "Overall, HypoPals was helpful for me". Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 23, 2023
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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