Trial results for a pilot feasibility study of HypoPals, a mobile health program for improving hypoglycemia management in Type 1 Diabetes, were posted on 2025-06-18, indicating that 20 participants completed the intervention.
Background
Type 1 Diabetes requires diligent management to maintain blood glucose levels within a target range. A significant challenge for individuals with Type 1 Diabetes is hypoglycemia, or low blood sugar, which can be dangerous if not promptly recognized and treated. Effective hypoglycemia management relies on an individual's ability to detect symptoms early. Mobile health programs, especially those integrating data from continuous glucose monitoring (CGM) systems, offer a promising avenue to enhance symptom detection skills and improve how patients perceive and respond to low blood sugar events.
Trial design
This completed pilot feasibility study, identified as Phase NA, enrolled 40 participants with Type 1 Diabetes and Hypoglycemia. The study aimed to evaluate the smooth operation and user utility of "HypoPals," a mobile health program designed to sharpen low blood sugar symptom detection skills and influence perceptions of hypoglycemia. HypoPals incorporates data from continuous glucose monitoring systems and sends personalized text messages. The study also sought to refine research methods for a potential final study. Participants were assigned to different groups, including Hypoglycemia Symptom Detection Training, Education Plus, a combination of both, and Usual Care, to assess retention rates.
Key results
The posted results provide insights into recruitment feasibility and participant retention for the HypoPals program:
- 20 participants completed the intervention.
- A total of 227 potential candidates were contacted during the entire recruitment period.
- The percentage of contacted potential candidates who were eligible was 35.1 percent.
- Participant retention rates at 12 weeks were:
- Hypoglycemia Symptom Detection Training: 9 participants
- Education Plus: 10 participants
- Hypoglycemia Symptom Detection Training and Education Plus: 11 participants
- Usual Care: 10 participants
- Participant retention rates at 26 weeks were:
- Hypoglycemia Symptom Detection Training: 9 participants
- Education Plus: 10 participants
- Hypoglycemia Symptom Detection Training and Education Plus: 10 participants
- Usual Care: 10 participants
- Participant retention rates at 52 weeks for the Hypoglycemia Symptom Detection Training group was 9 participants.
What this means
The results from this pilot feasibility study suggest that the HypoPals mobile health program is viable for further investigation in individuals with Type 1 Diabetes. The successful recruitment of 20 participants who completed the intervention, alongside a 35.1 percent eligibility rate among contacted candidates, indicates a reasonable pathway for participant enrollment in future studies. The observed retention rates across the different intervention groups (ranging from 9 to 11 participants at 12 and 26 weeks, and 9 at 52 weeks for one group) provide valuable data for optimizing engagement strategies in a larger trial. These findings support the potential for HypoPals to be developed into an effective tool for improving hypoglycemia symptom detection and management, ultimately benefiting patients with Type 1 Diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05916131, titled "Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.", were posted on 2025-06-18 on clinicaltrials.gov.