NCT06382350 Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems
| NCT ID | NCT06382350 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Motol |
| Condition | Type 1 Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-05-29 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-05-29 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Jan Brož, MUDr., Ph.D.
PRINCIPAL INVESTIGATOR
Second Medical Faculty, Charles University
Frequently Asked Questions
Who can join the NCT06382350 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06382350 currently recruiting?
Yes, NCT06382350 is actively recruiting participants. Contact the research team at eva.aljamal@fnmotol.cz for enrollment information.
Where is the NCT06382350 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT06382350 clinical trial?
NCT06382350 is sponsored by University Hospital, Motol. The principal investigator is Jan Brož, MUDr., Ph.D. at Second Medical Faculty, Charles University. The trial plans to enroll 120 participants.
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