Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems

Recruiting

• Conditions: Type 1 Diabetes Mellitus With Hypoglycemia; Drive; Type 1 Diabetes Mellitus
• Interventions: Device: MiniMed 780 G

• Registration Number: NCT06382350
• Lead Sponsor: University Hospital, Motol

Brief Summary

The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy

Detailed Description

This national multi-center prospective observational controlled study focuses on the safety of insulin pump closed-loop in patients over 18 with type 1 diabetes while driving. A total of 100 patients (treated with MiniMed 780 G + CGM) will be enrolled in the study group and 20 patients in the control group (treated by multiple daily injections (MDI) + CGM) at 10-20 study centers.

After the inclusion and exclusion criteria evaluation and informed consent signing, each patient receives the Patient Diary. The diary will be used to record the times of observed events during the study period lasting ten days: periods of driving (from-to), periods of night sleep, periods of occupation, periods of physical activity, periods of stress (self-defined), an extra dose of insulin not covered by carbohydrates, an extra dose of carbohydrates not covered by insulin (more variables are required to hide a little bit the primary target of the study).

CGM data obtained during the study period will also be downloaded at the end of the study period.

Finally, the data from the CGM and the patient diary will be compared and analyzed, especially regarding the course of glycemia during driving and the presence of hypoglycemia.

Study Timeline

• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-19
• Study First Posted: 2024-04-24
• Study Start: 2024-05-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-02
• Last Update Posted: 2024-06-04
• Primary Completion: 2025-09
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	MiniMed 780 G	Type 1 diabetes patients with insulin pump MiniMed 780 G +CGM (continuous glucose monitoring)

Primary Outcome Measures

Name	Time	Method
The frequency of hypoglycemia during the driving periods	10 days of CGM measurement	This outcome evaluates the number of hypoglycemic events (drop of glycemia \<3.9 mmol/l) during the driving periods.

Secondary Outcome Measures

Name	Time	Method
Amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during the driving periods.	10 days of CGM measurement	The outcome evaluates the amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during driving.

Trial Locations

Locations (1)

UH Motol; 🇨🇿 Prague, Czechia