NCT05528770

Evaluation of The Postprandial Impact of Automated Priming Bolus for Full Closed Loop Insulin Delivery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Marc Breton · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand the impact of the automated priming boluses on the safety and feasibility of a new fully automated AP controller.

Detailed description

Study participants will be admitted to the hotel for a 4-night study, receiving the two sessions in random order: 1) Fully control loop (FCL) with the bolus priming system (BPS) activated, 2) FCL without the BPS, with a 24-hour washout period in between. During the admission, participants will receive structured meals and have blood glucose control followed to compare time in range 70-180 mg/dL between Controller sessions. After the first 24 hour period on the first FCL approach (BPS vs. no BPS,) that the participant has been randomized to, there will be a 24 hour challenge period before shifting to the other randomized approach; during this session participants will undergo further testing of the control algorithm, including meal challenges and a high-intensity interval training bout.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	FCL+BPS	The automated insulin delivery system includes the Bolus Priming System, a software automatically analyzing past continuous glucose monitoring values to trigger priming insulin bolus delivery isn the suspected presence of meal like glycemic disturbances
DEVICE	FCL	The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses.

Timeline

• Start date: 2022-10-20
• Primary completion: 2023-01-13
• Completion: 2023-01-15
• First posted: 2022-09-06
• Last updated: 2025-09-08
• Results posted: 2024-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study