NCT06645834

Smart MDI Study (CIP343)

Smart MDI Randomized Controlled Trial in Subjects With Type 1 Diabetes (Smart MDI Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Smart MDI System	The Smart MDI system consists of the InPen™ system and Simplera™ system. The InPen™ system includes a reusable smart bolus insulin pen injector with Bluetooth combined with the InPen™ app to help users take insulin doses. And InPen™ app which communicates with the InPen™ injector and compatible continuous glucose monitoring (CGM) devices to collect and display information on insulin delivered by the injector as well as current and past glucose values. The Simplera™ system consists of a disposable integrated sensor-transmitter platform (Simplera™ Sensor) and the Simplera™ app which receives data from the Simplera™ sensor via Bluetooth Low Energy (BLE) radio signal

Timeline

• Start date: 2024-12-06
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-10-17
• Last updated: 2025-12-09

Locations

18 sites across 6 countries: Belgium, Czechia, France, Germany, Italy, Sweden

Regulatory

• FDA-regulated device study