RECRUITINGOBSERVATIONAL
Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems
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
About This Trial
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
Who May Be Eligible (Plain English)
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 willing to sign a consent form 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 willing to sign a consent form 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
MiniMed 780 G
none, observational study
Locations (1)
UH Motol
Prague, Czechia