Trial results for a study on Type 2 Diabetes were posted on ClinicalTrials.gov on 2026-03-27, showing that an AI-based closed loop glucose control system maintained 97.25% of glucose values within the 70-180 mg/dL range in 3 participants.
Background
Type 2 Diabetes is a chronic condition characterized by high blood sugar levels resulting from insulin resistance or insufficient insulin production. Effective glucose management is crucial to prevent both acute complications like hyper- and hypoglycemia, and long-term complications affecting various organ systems. Maintaining blood glucose within a target range is a continuous challenge, particularly in dynamic clinical environments such as intensive care units (ICUs), where patient conditions can fluctuate rapidly. Advanced systems, like artificial intelligence-based closed loop glucose control, aim to automate and optimize this process, reducing the burden on clinical staff and improving patient safety and outcomes.
Trial design
This completed study, designated as Phase NA, was a proof-of-concept safety study that enrolled 3 participants with Diabetes Mellitus, Type 2. The trial investigated a novel artificial intelligence-based closed loop glucose control system, referred to as the FUSION system in the results, designed for use in the intensive care unit setting. The objective was to control subjects' glucose to a range of 100-140 mg/dL for a 24-hour period, during which participants consumed three standardized meals.
Key results
The trial reported the following key measurements for the FUSION Closed Loop Glucose Control System:
- Percent of All Glucose Values Within Glucose Range < 70 mg/dL: A mean of 0% (Standard Deviation 0).
- Percent of All Glucose Values Within Glucose Range 70-180 mg/dL: A mean of 97.25% (Standard Deviation 2.75).
- Percent of All Glucose Values Within Glucose Range < 54 mg/dL: A mean of 0% (Standard Deviation 0).
- Percent of All Glucose Values Within Glucose Range > 180 mg/dL: A mean of 2.4% (Standard Deviation 2.4).
- Percentage of Coefficient of Variation: A mean of 19.65% (Standard Error 6.65).
- Percent of All Glucose Values Within Glucose Range > 250 mg/dL: A mean of 0.3% (Standard Deviation 0.3).
- Average Glucose Value: A mean of 123 mg/dL (Standard Deviation 2).
What this means
The results from this proof-of-concept study suggest that the FUSION artificial intelligence-based closed loop glucose control system effectively maintained blood glucose levels within a desirable range for patients with Type 2 Diabetes over a 24-hour period. Notably, the system achieved a high percentage of glucose values within the 70-180 mg/dL range (97.25%) and, critically, reported 0% of glucose values below 70 mg/dL or 54 mg/dL, indicating no instances of hypoglycemia. While these findings are based on a very small sample size of 3 participants, they provide initial safety and efficacy data for this novel system in an intensive care unit setting, warranting further investigation in larger clinical trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05386849, titled "Closed Loop Glucose Control in Patients With Type 2 Diabetes", were posted on 2026-03-27 on clinicaltrials.gov.