Trials / Recruiting
RecruitingNCT07039942
French Prospective Multicentric Study in Real World
Omnipod 5 - A French Prospective Multicentric Study in Real World
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 304 (estimated)
- Sponsor
- Insulet Corporation · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.
Detailed description
Twelve-month, real-world, non-interventional, prospective follow-up of adult and pediatric patients aged more than 2 years old, prescribed one of the Dexcom (Dexcom G6 or G7) configurations commercially available of the Omnipod 5 Automated Insulin Delivery System in France. OPTIMAL-A study (Omnipod 5 - A French Prospective Multicentric Study in Real World), aims to provide the requisite real-world data on the glycemic control, quality of life, safety, and device usage profiles of users of the Omnipod 5 System during the 12 months after starting using Omnipod 5 in automated mode.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Omnipod 5 | The Omnipod 5 Automated Insulin Delivery System (Omnipod 5 System) is a tubeless insulin pump with a mono-hormonal insulin delivery system designed to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in people aged 2 years and older who require insulin. The Omnipod 5 System is intended to function as an automated insulin delivery system when used with compatible Continuous Glucose Monitoring (CGM) systems. |
Timeline
- Start date
- 2025-07-23
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2025-06-26
- Last updated
- 2026-04-09
Locations
24 sites across 1 country: France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07039942. Inclusion in this directory is not an endorsement.