N/A
Completed N=40
Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.
Source: ClinicalTrials.gov NCT05916131 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Jun 2025
Primary outcomePrimary: The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention — 20 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention |
20 | — |
| SECONDARY Number of Potential Candidates Contacted During the Entire Recruitment Period |
227 | — |
| SECONDARY Percentage of Contacted Potential Candidates Being Eligible |
35.1 | — |
| SECONDARY Rate of Participant Retention at 12 Weeks |
9; 10; 11; 10 | — |
| SECONDARY Rate of Participant Retention at 26 Weeks |
9; 10; 10; 10 | — |
| SECONDARY Rate of Participant Retention at 52 Weeks |
9; 10; 10; 10 | — |
| SECONDARY Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks |
9; 10; 11; 10 | — |
| SECONDARY Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks |
9; 10; 11; 10 | — |
| SECONDARY Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks |
9; 10; 11; 9 | — |
| SECONDARY Participants Reporting Reading Message Content at the End of the Intervention |
6; 9; 9; 2; 0; 1 | — |
| SECONDARY Participants Finding Message Content Helpful (Positive) at the End of the Intervention |
4; 3; 1; 3; 1; 4 | — |
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)
Data sourced from ClinicalTrials.gov (NCT05916131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.