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

Type 1 Diabetes Mellitus Clinical Trial

— SAFEDRIVE  

Official title:

Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems (Insulin Pump and Continuous Glucose Monitor) Versus Conventional Treatment in Different Life Situations - an Observational Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382350
• Other study ID #: KHL-002-2024
• Status: Recruiting
• Start date: May 29, 2024
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: University Hospital, Motol
• Contact: Eva Al Jamal, Mgr.
• Phone: 224 431 017
• Email: eva.aljamal[@]fnmotol.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

Study group:

• type 1 diabetes
• patients aged =18 year
• diabetes duration =3 years
• regularly driving (non-professional drivers only)
• treated with insulin pump MiniMed 780 G for at least 6 months with closed-loop setting treatment
• willing to fill in the study questionnaires
• signed patient's informed consent form

Control group:

• type 1 diabetes
• patients aged =18 years
• diabetes duration =3 years
• regularly driving (non-professional drivers only)
• treatment with multiple daily injections (MDI) of insulin therapy and the use of CGM for at least 6 months
• willing to fill in the study questionnaires
• signed patient's informed consent form Exclusion Criteria (for study and control groups)
• professional drivers
• pregnancy
• inability to be present at the follow-up visit
• inability to complete the study questionnaires
• participation in another clinical study within the last 3 months

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Drive
• Hypoglycemia
• Type 1 Diabetes Mellitus
• Type 1 Diabetes Mellitus With Hypoglycemia

Intervention

Device:
• MiniMed 780 G
none, observational study

Locations

Country	Name	City	State
Czechia	UH Motol	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analysis of glycemia	This outcome evaluates the mean glycemia and glycemia variability (SD) during the periods of driving and compares them with the same compared with the same variables obtained during the non-driving periods.	10 days of CGM measurement
Other	Number of alarms generated by the insulin pump	This outcome assesses the frequency of alarms generated by the insulin pump during preriods of driving and compares them ther same variable generated in non-driving time.	10 days of CGM measurement
Other	Insulin dosing	This is to assess the insulin dosing (insulin units/minute) during driving and compare them with the same variable in non-driving time.	10 days of CGM measurement
Other	Food intake	This is to assess the food intake (frequency of food intake) while driving and compare them with non-driving time.	10 days of CGM measurement
Other	Glycemia during the periods of sleep	The outcome evaluates glycemia (mmol/l) during a night sleep.	10 days of CGM measurement
Other	Glycemia during the periods of occupation	The outcome evaluates glycemia (mmol/l) during periods of occupation.	10 days of CGM measurement
Other	Glycemia during the periods of physical activity	The outcome evaluates glycemia (mmol/l) during the periods of physical activity.	10 days of CGM measurement
Other	Glycemia during the periods of stress	The outcome evaluates glycemia (mmol/l) during the periods of stress.	10 days of CGM measurement
Primary	The frequency of hypoglycemia during the driving periods	This outcome evaluates the number of hypoglycemic events (drop of glycemia <3.9 mmol/l) during the driving periods.	10 days of CGM measurement
Secondary	Amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during the driving periods.	The outcome evaluates the amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during driving.	10 days of CGM measurement