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RecruitingNCT06382350

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

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Trial Parameters

ConditionType 1 Diabetes Mellitus
SponsorUniversity Hospital, Motol
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment120
SexALL
Min Age18 Years
Max AgeN/A
Start Date2024-05-29
Completion2025-09
Interventions
MiniMed 780 G

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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

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

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