Trials / Completed
CompletedNCT04235504
ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Medtronic MiniMed, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub-optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM). Patient with a diagnosis of Type 1 diabetes currently under MDI+ FGM or MDI+ CGM therapy will be enrolled.
Detailed description
This study is a pre-market, multi-center, prospective, open label, adaptative, randomized controlled trial in insulin-requiring adult subjects with type 1 diabetes on MDI therapy. The study will have three period: 1. Run-in Phase: The Run-in period is of 4 weeks (and can be extended for 2 additional ones) during which time a blinded CGM sensor will be worn for two weeks. 2. Study Phase: There will be a 6 months randomized study period with two arms: Treatment Arm (AHCL) and the Control Arm. 3. Continuation Phase: There will be a 6 months continuation phase during which time all the subjects will use the AHCL system. Approximately 124 subjects will be enrolled in the study up to 20 investigational centers in EMEA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | MDI | Subject continues their standard Multiple Daily Injections therapy with FGM or RT-CGM |
| DEVICE | AHCL | Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0. Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment. |
Timeline
- Start date
- 2020-07-13
- Primary completion
- 2021-12-02
- Completion
- 2022-05-30
- First posted
- 2020-01-22
- Last updated
- 2023-03-27
- Results posted
- 2023-03-09
Locations
14 sites across 3 countries: France, Germany, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04235504. Inclusion in this directory is not an endorsement.