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

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

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

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes Mellitus; Type 1 Diabetes Mellitus With Hypoglycemia; Drive
• Intervention / Treatment: Device: MiniMed 780 G

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Eva Al Jamal, Mgr.; Phone Number: +420 224 431 017; Email: eva.aljamal@fnmotol.cz
• Study Contact Backup: Name: Veronika Šourková; Phone Number: +420 224 431 004; Email: veronika.sourkova@fnmotol.cz

Study Locations

• Czechia
  • Prague, Czechia, 150 00
    • Recruiting
    • UH Motol
    • Contact: Eva Al Jamal, Mgr.; Phone Number: +420 224 431 017; Email: eva.aljamal@fnmotol.cz
    • Contact: Veronika Šourková; Phone Number: +420 224 431 004; Email: veronika.sourkova@fnmotol.cz
    • Principal Investigator: Pavlina Krollova, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Type 1 diabetes patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Type 1 diabetes patients with insulin pump MiniMed 780 G +CGM (continuous glucose monitoring)	Device: MiniMed 780 G; none, observational study
Control group; Type 1 diabetes patients with patients treated by multiple daily injections (MDI) + CGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Glycemia during the periods of sleep	The outcome evaluates glycemia (mmol/l) during a night sleep.	10 days of CGM measurement
Glycemia during the periods of occupation	The outcome evaluates glycemia (mmol/l) during periods of occupation.	10 days of CGM measurement
Glycemia during the periods of physical activity	The outcome evaluates glycemia (mmol/l) during the periods of physical activity.	10 days of CGM measurement
Glycemia during the periods of stress	The outcome evaluates glycemia (mmol/l) during the periods of stress.	10 days of CGM measurement

Collaborators and Investigators

• Sponsor: University Hospital, Motol
• Investigators: Principal Investigator: Jan Brož, MUDr., Ph.D., Second Medical Faculty, Charles University

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 2, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Driving; Type 1 diabetes mellitus; Closed-loop system
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: KHL-002-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes