Trial results investigating exercise-induced hypoglycemia prevention in adults with Type 1 Diabetes using an artificial pancreas system were posted on ClinicalTrials.gov on 2026-05-05. The experimental system demonstrated 0 median hypoglycemic occurrences during exercise, compared to 1 with the control system.
Background
Type 1 Diabetes Mellitus is an autoimmune condition where the body does not produce insulin, requiring individuals to manage blood glucose levels through insulin therapy. A significant challenge for people with Type 1 Diabetes, especially during physical activity, is the risk of hypoglycemia (low blood sugar). Exercise can increase insulin sensitivity and glucose utilization, making precise insulin management critical to prevent dangerous drops in blood glucose. Artificial pancreas (AP) systems aim to automate insulin delivery, potentially reducing the burden of manual management and mitigating the risk of exercise-induced hypoglycemia, thereby improving safety and quality of life for patients.
Trial design
This randomized crossover trial, designated as Phase NA, was completed with an enrollment of 15 participants. The study investigated conditions including Type 1 Diabetes Mellitus and Hypoglycemia. Participants were randomized to receive either the Control AP system (rMPC - Naïve Model Predictive Control) or the Experimental AP system (EnMPC - Ensemble Model Predictive Control) over approximately 4 months, including a 28-day data collection phase with regimented exercise activities. While specific primary outcomes were not listed, key measurements focused on the prevention of exercise-induced hypoglycemia.
Key results
The trial reported several key measurements comparing the Experimental AP system (APEX) to the Control AP system (HCL) in relation to exercise activity:
- Number of Hypoglycemic Occurrences in Relation to Exercise Activity:
- The APEX group showed a median of 0 occurence.
- The HCL group showed a median of 1 occurence.
- Average CGM:
- The APEX group had a mean of 141.9 mg/dl (Standard Deviation 20.3).
- The HCL group had a mean of 136.9 mg/dl (Standard Deviation 19.9).
- Percent Time CGM Below 54 mg/dL:
- Both APEX and HCL groups showed a median of 0 percentage of time.
- Percent Time CGM Below 70 mg/dL:
- The APEX group showed a mean of 0 percentage of time.
- The HCL group showed a mean of 1.3 percentage of time.
- Percent Time CGM Between 70 and 180 mg/dL:
- Both APEX and HCL groups showed a mean of 81 percentage of time (APEX Standard Deviation 15.7; HCL Standard Deviation 12.4).
- Percent Time CGM Between 70 and 140 mg/dL:
- The APEX group showed a mean of 58.4 percentage of time (Standard Deviation 15.3).
- The HCL group showed a mean of 62 percentage of time (Standard Deviation 14.1).
What this means
The results suggest that the experimental artificial pancreas system (APEX) may be effective in preventing exercise-induced hypoglycemia in adults with Type 1 Diabetes. The observation of 0 median hypoglycemic occurrences and 0 percent time with CGM below 70 mg/dL in the APEX group, compared to 1 occurrence and 1.3 percent time in the control group, indicates a potential benefit. While average CGM values were slightly higher in the APEX group, the critical reduction in hypoglycemic events during exercise could significantly enhance safety and confidence for individuals managing Type 1 Diabetes, allowing for more consistent physical activity without the heightened risk of low blood sugar.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03859401, titled "Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas", were posted on 2026-05-05 on clinicaltrials.gov.