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

University Hospital, Motol

Status: Enrolling

Conditions: Type 1 Diabetes Mellitus; Drive; Type 1 Diabetes Mellitus With Hypoglycemia

Treatments: Device: MiniMed 780 G

Study type: Observational

Funder types: Other

Identifiers

NCT06382350

KHL-002-2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

120 participants in 2 patient groups

Study group

Description:

Type 1 diabetes patients with insulin pump MiniMed 780 G +CGM (continuous glucose monitoring)

Treatment:

Device: MiniMed 780 G

Control group

Description:

Type 1 diabetes patients with patients treated by multiple daily injections (MDI) + CGM