Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems
NCT ID: NCT06382350
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2024-05-29
2026-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study group
Type 1 diabetes patients with insulin pump MiniMed 780 G +CGM (continuous glucose monitoring)
MiniMed 780 G
none, observational study
Control group
Type 1 diabetes patients with patients treated by multiple daily injections (MDI) + CGM
No interventions assigned to this group
Interventions
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MiniMed 780 G
none, observational study
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Motol
OTHER
Responsible Party
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Jan Broz
Principal Investigator
Principal Investigators
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Jan Brož, MUDr., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Second Medical Faculty, Charles University
Locations
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UH Motol
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KHL-002-2024
Identifier Type: -
Identifier Source: org_study_id
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