Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Motol
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
type 1 diabetes
patients aged ≥18 year
diabetes duration ≥3 years
regularly driving (non-professional drivers only)
Disqualifiers
professional drivers
pregnancy
inability to be present at the follow-up visit
inability to complete the study questionnaires
Trial population
Type 1 diabetes patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MiniMed 780 G
Devicenone, observational study
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Study group1 intervention
Group B: Control group0 interventions
Trial outcomes
Primary outcomes
1
The frequency of hypoglycemia during the driving periods
This outcome evaluates the number of hypoglycemic events (drop of glycemia \<3.9 mmol/l) during the driving periods.
Time frame
10 days of CGM measurementSecondary outcomes
1
Amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during the driving periods.
The outcome evaluates the amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during driving.
Time frame
10 days of CGM measurementOther outcomes
1
Analysis of glycemia
This outcome evaluates the mean glycemia and glycemia variability (SD) during the periods of driving and compares them with the same compared with the same variables obtained during the non-driving periods.
Time frame
10 days of CGM measurement2
Number of alarms generated by the insulin pump
This outcome assesses the frequency of alarms generated by the insulin pump during preriods of driving and compares them ther same variable generated in non-driving time.
Time frame
10 days of CGM measurement3
Insulin dosing
This is to assess the insulin dosing (insulin units/minute) during driving and compare them with the same variable in non-driving time.
Time frame
10 days of CGM measurement4
Food intake
This is to assess the food intake (frequency of food intake) while driving and compare them with non-driving time.
Time frame
10 days of CGM measurementSponsors and contacts
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Source ClinicalTrials.gov