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:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-25 @ 2:25 AM
NCT ID:
NCT06645834
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.
Study:
NCT06645834
Study Brief:
Protocol Section:
NCT06645834