RecruitingNCT06382350
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
Sponsor
University Hospital, Motol
Enrollment
120 participants
Start Date
May 29, 2024
Study Type
OBSERVATIONAL
Conditions
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
Eligibility
Min Age: 18 Years
Inclusion Criteria16
- 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 Criteria5
- 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
Interventions
DEVICEMiniMed 780 G
none, observational study
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06382350
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