Trial results for a closed-loop glucose control system in patients with Type 1 Diabetes and Type 2 Diabetes were posted on ClinicalTrials.gov on 2025-07-17, showing a mean of 1.4% of glucose values below 54 mg/dL and 79.0% within the target range.
Background
Type 1 Diabetes is a chronic autoimmune condition requiring lifelong insulin therapy to manage blood glucose levels. Maintaining glucose within a target range is critical to prevent acute and long-term complications. Traditional management often involves active patient participation with multiple daily injections or insulin pumps. Closed-loop glucose control systems, or artificial pancreases, aim to automate insulin delivery based on continuous glucose monitoring, potentially improving glycemic control and reducing patient burden. This study evaluated a novel artificial intelligence-based closed-loop glucose control system for use in the intensive care unit, seeking to enhance precision in managing critically ill patients with diabetes.
Trial design
This completed proof-of-concept safety study enrolled 7 participants with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2. The study evaluated a novel artificial intelligence-based closed-loop glucose control system designed for use in the intensive care unit setting. Participants had their glucose controlled to a range of 100-140 mg/dL by the system for a period of 24 hours, consuming three standardized meals. The trial aimed to assess the safety and efficacy of this closed-loop system.
Key results
The trial results for the FUSION Closed Loop Glucose Control System Safety Study reported the following key measurements:
- Primary Safety Outcome: The mean percentage of all glucose values representing the primary safety outcome was 1.4% (Standard Deviation: 2.7%).
- Primary Efficacy Outcome: The mean percentage of all glucose values representing the primary efficacy outcome was 79.0% (Standard Deviation: 21.3%).
- Glucose Values Below 54 mg/dL: The mean percentage of all glucose values within this range was 0% (Standard Deviation: 0%).
- Glucose Values Above 180 mg/dL: The mean percentage of all glucose values within this range was 19.6% (Standard Deviation: 22.0%).
- Glucose Values Above 250 mg/dL: The mean percentage of all glucose values within this range was 2.9% (Standard Deviation: 4.4%).
- Average Glucose Value: The mean average glucose value was 148.4 mg/dL (Standard Deviation: 25.1 mg/dL).
- Hemoglobin A1c Percentage Level: The mean was 8.5% (Standard Deviation: 0.8%).
What this means
The results from this proof-of-concept study suggest that the FUSION closed-loop glucose control system can effectively manage blood glucose levels in patients with Type 1 and Type 2 Diabetes, particularly within an intensive care unit setting. The reported mean of 0% of glucose values below 54 mg/dL indicates a strong safety profile regarding severe hypoglycemia. Furthermore, the mean of 79.0% of glucose values falling within the primary efficacy range demonstrates the system's ability to maintain glycemic control. The average glucose value of 148.4 mg/dL, alongside low percentages of values above 180 mg/dL (19.6%) and 250 mg/dL (2.9%), supports the system's potential to reduce hyperglycemic episodes. These findings, while from a small safety study, indicate the feasibility and potential benefits of this AI-based closed-loop system for automated glucose management.
Source
The information for this condition update was sourced from ClinicalTrials.gov, a registry and results database of clinical studies. The results for the study NCT05644730, titled "Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes", were posted on 2025-07-17 on clinicaltrials.gov.