Clinical trial NCT06382350: Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes Mellitus
Type 1 Diabetes Mellitus With Hypoglycemia
Drive
Keywords: Type 1 diabetes mellitus
Driving
Closed-loop system
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 1 diabetes patients

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.

Eligibility 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

Primary outcomes:
measure: The frequency of hypoglycemia during the driving periods
timeFrame: 10 days of CGM measurement
Secondary outcomes:
measure: Amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during the driving periods.
timeFrame: 10 days of CGM measurement
Other outcomes:
measure: Analysis of glycemia
timeFrame: 10 days of CGM measurement
measure: Number of alarms generated by the insulin pump
timeFrame: 10 days of CGM measurement
measure: Insulin dosing
timeFrame: 10 days of CGM measurement
measure: Food intake
timeFrame: 10 days of CGM measurement
measure: Glycemia during the periods of sleep
timeFrame: 10 days of CGM measurement
measure: Glycemia during the periods of occupation
timeFrame: 10 days of CGM measurement
measure: Glycemia during the periods of physical activity
timeFrame: 10 days of CGM measurement
measure: Glycemia during the periods of stress
timeFrame: 10 days of CGM measurement
Locations:
city: Prague
country: Czechia
facility: UH Motol
Study officials:
affiliation: Second Medical Faculty, Charles University
name: Jan Brož, MUDr., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: