Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT04235504
Status:
COMPLETED
Last Update Posted:
2023-03-27
First Post:
2020-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes
Sponsor:
Medtronic Diabetes
Organization:
Study Overview
Official Title:
ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAPT
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: