Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT04235504
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.
Study:
NCT04235504
Study Brief:
Protocol Section:
NCT04235504