Trials / Withdrawn
WithdrawnNCT06692153
Embecta AID System in Adults With Type 2 Diabetes
A Multicenter, Pivotal, Randomized Controlled Trial Comparing the Safety and Efficacy of an Automated Insulin Delivery System With the Standard of Care in Adults With Type 2 Diabetes (EMBRACE-T2D)
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Embecta Corp. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, randomized control study that will evaluate the safety and effectiveness of the embecta Automated Insulin Delivery System in adults with Type 2 diabetes requiring insulin therapy
Detailed description
This outpatient study consists of 2 phases. Phase 1 (Single Arm) will establish the initial safety of the embecta AID system prior to initiating the phase 2 (RCT). Participants will follow the same protocol as the RCT AID group. During the treatment period all participants will undergo supervised exercise and meal challenges. Phase 2 (Randomized Control Trial (RCT)) will be a 13-week parallel group RCT to evaluate the safety and efficacy with a 2:1 randomization to intervention with AID versus standard of care (SC) insulin therapy. The RCT AID group will use the embeca AID with Tidepool Loop app as well as the Dexcom G6 continuous glucose monitor (CGM). Participants in both phases will do in-clinic or virtual visits at least monthly for a total of 9 visits. During the treatment period all participants will undergo supervised exercise and meal challenges.
Conditions
- Type 2 Diabetes
- Type 2 Diabetes Mellitus (T2DM)
- Type 2 DM
- T2DM With Inadequate Glycemic Control
- T2DM (Type 2 Diabetes Mellitus)
- T2D
- T2DM
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | An AID System. | The embecta Automated Insulin Delivery (AID) System is a closed loop system comprised of 3 components: the embecta insulin pump, a Smartphone with the Tidepool Loop app, and the Dexcom G6 CGM |
| OTHER | Standard of Care (SC) | Participants will continue to use their current therapy for T2D. |
Timeline
- Start date
- 2025-01-01
- Primary completion
- 2026-03-01
- Completion
- 2026-05-01
- First posted
- 2024-11-18
- Last updated
- 2024-12-16
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06692153. Inclusion in this directory is not an endorsement.