Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT06645834
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2024-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smart MDI Study (CIP343)
Sponsor:
Medtronic Diabetes
Organization:
Study Overview
Official Title:
Smart MDI Randomized Controlled Trial in Subjects With Type 1 Diabetes (Smart MDI Study)
Status:
COMPLETED
Status Verified Date:
2025-12
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:
None
Brief Summary:
The purpose of the study is to evaluate the effectiveness of the Smart MDI system with InPen™ and Simplera™ in comparison with Multiple Daily Injection (MDI) therapy with intermittent scanning or real-time Continuous Glucose Monitoring (isCGM/CGM) over 6 months duration in people with type 1 diabetes to support the market access and therapy adoption of the Smart MDI system.
Detailed Description:
This is a post-market, prospective, open-label, multi-center, randomized controlled trial in adult and pediatric subjects with type 1 diabetes.
The study consists of a run-in phase of 3 weeks and a study phase of 6 months.
The purpose of the run-in phase is to collect baseline HbA1c and CGM data while subjects are on their current therapy.
During the 6-month study phase, subjects will be randomized to continue with their current therapy or to start using the Smart MDI system.
Approximately 140 subjects with type 1 diabetes aged 2 years and older will be enrolled in the study at up to 20 investigational centers in Europe to achieve approximately 112 subjects randomized and completing the 6-month study phase.
The study consists of a run-in phase of 3 weeks and a study phase of 6 months.
The purpose of the run-in phase is to collect baseline HbA1c and CGM data while subjects are on their current therapy.
During the 6-month study phase, subjects will be randomized to continue with their current therapy or to start using the Smart MDI system.
Approximately 140 subjects with type 1 diabetes aged 2 years and older will be enrolled in the study at up to 20 investigational centers in Europe to achieve approximately 112 subjects randomized and completing the 6-month study phase.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: