Trial results for a study investigating the effect of closed-loop devices on glycemic control in Type 1 Diabetes patients were posted on ClinicalTrials.gov on 2026-03-12, with 410 participants enrolled.
Background
Type 1 Diabetes is a chronic autoimmune condition where the pancreas produces little or no insulin, requiring lifelong insulin therapy. Maintaining optimal glycemic control is crucial to prevent both short-term complications like hypoglycemia and hyperglycemia, and long-term complications affecting the eyes, kidneys, nerves, and heart. Closed-loop insulin delivery systems, often referred to as artificial pancreas systems, integrate continuous glucose monitoring with an insulin pump, using algorithms to automatically adjust insulin delivery. These systems aim to reduce the burden of diabetes management and improve glycemic outcomes, making real-world data on their effectiveness valuable for patient care.
Trial design
This completed study enrolled 410 participants to evaluate the effect of closed-loop devices on glycemic control in patients with Type 1 Diabetes. The trial aimed to gather real-life data from diabetic patients managed in endocrinology departments of secondary care hospitals.
Key results
The trial reported several key measurements related to glycemic control in Type 1 Diabetes patients using closed-loop pumps:
- HbA1c Level (percentage of HBA1c):
- A mean HbA1c of 6.9 (Standard Deviation 0.5) was observed.
- Another mean HbA1c was 7.0 (Standard Deviation 0.5).
- A third mean HbA1c was 7.0 (Standard Deviation 0.5).
- Time in Range (percentage of time spent in range):
- A mean Time in Range of 75 (Standard Deviation 9.4) was observed.
- Another mean Time in Range was 74 (Standard Deviation 9.7).
- A third mean Time in Range was 74 (Standard Deviation 9.7).
- Time Below Range (percentage of time spent below range):
- A mean Time Below Range of 2 (Standard Deviation 2.1) was observed.
- Another mean Time Below Range was 2 (Standard Deviation 1.8).
- A third mean Time Below Range was 2 (Standard Deviation 2.8).
- Time Above Range (percentage of time spent above range):
- A mean Time Above Range of 22 (Standard Deviation 9.1) was observed.
- Another mean Time Above Range was 22 (Standard Deviation 9.3).
- A third mean Time Above Range was 23 (Standard Deviation 8.9).
What this means
The real-world data from this study indicates that Type 1 Diabetes patients using closed-loop pumps achieved favorable glycemic control. The reported mean HbA1c levels of 6.9% to 7.0% are consistent with or below the typical target of 7.0% for many adults with Type 1 Diabetes. Furthermore, the mean Time in Range values of 74% to 75% suggest that patients spent a significant portion of their day within the target glucose range, while Time Below Range remained low at 2%. These findings support the effectiveness of closed-loop systems in helping patients manage their blood glucose levels in a real-life setting, potentially reducing the risk of both hyperglycemia and hypoglycemia.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study titled "Real-life Data From Diabetic Patients on Closed-loop Pumps" were posted on 2026-03-12 on clinicaltrials.gov.