Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645834
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Smart MDI Study CIP343
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Smart MDI Randomized Controlled Trial in Subjects with Type 1 Diabetes Smart MDI Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 isCGMCGM 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None