Trial results for a study investigating a two-way crossover closed-loop system delivering insulin and pramlintide for Type 1 Diabetes patients were posted on ClinicalTrials.gov on 2026-03-05, revealing a statistically significant adjusted mean difference of -5.9 (95% CI: -10.8, -1.1) with a p-value of 0.017 in an unspecified outcome via Mixed Models Analysis.
Background
Type 1 diabetes is an autoimmune condition where the body does not produce insulin, a hormone essential for regulating blood glucose. Patients require lifelong insulin therapy, often managed through multiple daily injections or insulin pumps. Despite advancements, achieving optimal postprandial (after-meal) glucose control remains a challenge, leading to potential complications. Pramlintide, an amylin analog, is an adjunctive therapy used with mealtime insulin to help control postprandial blood sugar by slowing gastric emptying and suppressing glucagon secretion. Integrating such therapies into closed-loop systems, which automatically adjust insulin delivery based on continuous glucose monitor (CGM) readings, represents a significant step towards more automated and precise glucose management, aiming to reduce glycemic variability and improve patient outcomes.
Trial design
This completed study, identified as Phase NA, enrolled 33 participants with Type 1 Diabetes. The trial's purpose was to evaluate an investigational closed-loop system's ability to manage blood sugar by delivering both insulin and pramlintide. The system utilized glucose values from a Dexcom G6 continuous glucose monitor (CGM) to automatically send commands to one Omnipod for insulin and another Omnipod for pramlintide. The study compared the efficacy of this combined insulin and pramlintide delivery arm against an insulin-only arm in a two-way crossover design.
Key results
The trial results provided several key measurements comparing the insulin and pramlintide arm to the insulin-only arm, particularly focusing on postprandial glucose control:
- For the Incremental Area Under the Curve of Postprandial Glucose Following the First Meal, the Insulin and Pramlintide Arm showed a mean of 18.1 (Standard Deviation: 13.6 (mg/dl*min)/1000), compared to the Insulin Only Arm's mean of 20.9 (Standard Deviation: 13.0 (mg/dl*min)/1000).
- The Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal was 50.5 (Standard Deviation: 29.5 Percent time in range) for the Insulin and Pramlintide Arm, versus 44.3 (Standard Deviation: 23.6 Percent time in range) for the Insulin Only Arm.
- For the Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal, the Insulin and Pramlintide Arm had a mean of 11.0 (Standard Deviation: 9.8 (mg/dl*min)/1000), significantly lower than the Insulin Only Arm's mean of 23.4 (Standard Deviation: 12.1 (mg/dl*min)/1000).
- The Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following Second Meal was 74.4 (Standard Deviation: 24.1 Percent time in range) for the Insulin and Pramlintide Arm, compared to 49.3 (Standard Deviation: 20.1 Percent time in range) for the Insulin Only Arm.
- Net Area Under the Curve of Postprandial Glucose Following the First Meal was 14.9 (Standard Deviation: 16.6 (mg/dL*min)/1000) for the Insulin and Pramlintide Arm and 15.0 (Standard Deviation: 18.1 (mg/dL*min)/1000) for the Insulin Only Arm.
- Net Area Under the Curve of Postprandial Glucose Following the Second Meal was 6.4 (Standard Deviation: 14.4 (mg/dl *min)/1000) for the Insulin and Pramlintide Arm, versus 22.2 (Standard Deviation: 13.3 (mg/dl *min)/1000) for the Insulin Only Arm.
Key analyses included:
- A Mixed Models Analysis showed an adjusted mean difference of -5.9 (95% CI: -10.8, -1.1) with a p-value of 0.017, indicating a statistically significant difference between the arms.
- Another Mixed Models Analysis reported a mean difference of 6.3 (95% CI: -3.7, 16.4) with a p-value of 0.218, which was not statistically significant.
What this means
The results suggest that a closed-loop system combining insulin and pramlintide may offer improved postprandial glucose control for individuals with Type 1 Diabetes compared to insulin-only management. The statistically significant adjusted mean difference of -5.9 (p=0.017) points towards a beneficial effect of the combination therapy. Notably, for the second meal, the insulin and pramlintide arm demonstrated a substantially higher mean percentage of time in the target glucose range (74.4% vs. 49.3%) and a lower incremental area under the curve (11.0 vs. 23.4). These findings indicate that integrating pramlintide into automated insulin delivery systems could lead to better mealtime glucose regulation, potentially reducing glucose excursions and improving overall glycemic stability for patients with Type 1 Diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06422325, titled "Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide", were posted on 2026-03-05 on clinicaltrials.gov.