NCT03216460

Insulet Artificial Pancreas Free-Living IDE3

Evaluating Glucose Control in Patients With Type 1 Diabetes Under Free-living Conditions With the Insulet Automated Glucose Control System: IDE3

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 2 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.

Detailed description

The study schedule will consist of a standard therapy data collection week followed by a hybrid closed-loop phase. Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting. The hybrid closed-loop phase will begin prior to lunch on Study Day 1. During the hybrid closed-loop phase, subjects will participate in specific setpoint challenges, meal challenges, and exercise. Hybrid closed-loop will be discontinued approximately 5 hours after breakfast time on Study Day 5. Subjects will be asked to complete a post-study questionnaire regarding their experience with the system. Subjects will be discharged home when stable and all discharge criteria are met. Subjects will consume a snack or meal after discontinuation of hybrid closed-loop before they leave the study site.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Insulet automated glucose control system	Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4Share® AP System and personalized model predictive control algorithm.

Timeline

• Start date: 2019-02-04
• Primary completion: 2019-05-28
• Completion: 2019-05-28
• First posted: 2017-07-13
• Last updated: 2019-08-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study