Trials / Completed
CompletedNCT03064906
Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)
Evaluating Meal Performance and Effect of Moderate Intensity Exercise in Patients With Type 1 Diabetes With the Insulet Automated Glucose Control System: IDE 2
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Insulet Corporation · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To assess the safety and performance of the Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise.
Detailed description
The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour, hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Insulet AP (artificial pancreas) System | Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm. |
Timeline
- Start date
- 2017-03-18
- Primary completion
- 2017-04-07
- Completion
- 2017-04-07
- First posted
- 2017-02-27
- Last updated
- 2018-06-12
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03064906. Inclusion in this directory is not an endorsement.