Trial results for a study evaluating a two-way crossover closed-loop Model Predictive Control (MPC) system for Type 1 Diabetes were posted on ClinicalTrials.gov on 2026-03-06, indicating similar glucose control compared to the Control IQ system, with a time in range (70-180 mg/dl) of 56% for the MPC intervention.
Background
Type 1 Diabetes is an autoimmune condition where the body does not produce insulin, requiring individuals to manage blood glucose levels through exogenous insulin administration. Advanced technologies, such as artificial pancreas (AP) or closed-loop systems, aim to automate insulin delivery to improve glucose control and reduce the burden of diabetes management. These systems continuously monitor glucose levels and adjust insulin delivery accordingly. One challenge in automated insulin delivery is managing missed meal boluses, where a user fails to manually input meal information, potentially leading to post-meal hyperglycemia. The development of algorithms to detect and respond to missed meals is an ongoing area of research to enhance the effectiveness of these systems.
Trial design
This completed, non-phase study enrolled 29 participants with Type 1 Diabetes. The trial was designed as a two-way crossover study comparing a closed-loop Model Predictive Control (MPC) system, which included a missed meal bolus detection algorithm, against the participant's usual care, specifically the t:slim X2 pump with Control IQ enabled. The primary aim was to test how well the new algorithm managed glucose compared to the established Control IQ system, with a focus on metrics related to time in target glucose range, hypoglycemia, and hyperglycemia.
Key results
The trial results presented several key measurements related to glucose control for both the MPC intervention and the Control group:
- Percent of Time With Sensed Glucose Between 70-180 mg/dl: The MPC Intervention group showed a mean of 56% (Standard Deviation: 12), while the Control group showed a mean of 56.8% (Standard Deviation: 12.7).
- Percent of Time With Sensed Glucose < 54 mg/dl: The MPC Intervention group had a mean of 0.14% (Standard Deviation: 0.3), compared to the Control group's mean of 0.05% (Standard Deviation: 0.19).
- Percent of Time With Sensed Glucose < 70 mg/dl: The MPC Intervention group recorded a mean of 0.59% (Standard Deviation: 0.69), while the Control group had a mean of 0.51% (Standard Deviation: 0.73).
- Percent of Time With Sensed Glucose > 180 mg/dl: The MPC Intervention group showed a mean of 43.4% (Standard Deviation: 12.1), and the Control group had a mean of 42.7% (Standard Deviation: 12.9).
- Mean Sensed Glucose: The MPC Intervention group's mean was 182 mg/dl (Standard Deviation: 19), closely matching the Control group's mean of 181 mg/dl (Standard Deviation: 24).
- Coefficient of Variation of Glucose (Unitless): The MPC Intervention group had a mean of 34.6 (Standard Deviation: 5.2), similar to the Control group's mean of 34.7 (Standard Deviation: 4.7).
What this means
The posted results indicate that the closed-loop MPC system, incorporating a missed meal bolus detection algorithm, achieved glucose control metrics that were largely comparable to the established Control IQ system in individuals with Type 1 Diabetes. Specifically, the primary measure of time in the target glucose range (70-180 mg/dl) was very similar, with the MPC system showing 56% and Control IQ showing 56.8%. Other metrics, including mean sensed glucose and time spent in hypoglycemic or hyperglycemic ranges, also showed close values between the two systems. These findings suggest that while the MPC system with its novel algorithm maintained effective glucose management, it did not demonstrate a substantial improvement over the Control IQ system in this study population. Further research might explore specific scenarios or patient populations where such an algorithm could offer distinct advantages, particularly in reducing the impact of missed meal boluses.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05799781, titled "Two Way Crossover Closed Loop MPC vs Control IQ", were posted on 2026-03-06 on clinicaltrials.gov.