NCT05916131Completed
Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.
Pilot and Feasibility Trial of HypoPals, a Mobile Health Intervention for Improving Hypoglycemia Self-management in Type 1 Diabetes Adults Using Advanced Diabetes Technologies
Source: ClinicalTrials.gov · Last updated 18 Jun 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 14 Jun 2023
- Start date
- 19 Sept 2023
- Primary completion date
- 2 Feb 2024
- Lead sponsor
- University of Michigan
- Diseases
- Type 1 diabetes
- NCT number
- NCT05916131
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 19 Sept 2023 to the primary completion date, 2 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active participation in clinical trials on diabetes/hypoglycemia interventions
- 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)
Other
- Pregnancy or planning for pregnancy within a year
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.