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

Status: Recruiting
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Contact Information
Primary
Eva Al Jamal, Mgr.
eva.aljamal@fnmotol.cz
224 431 017
Backup
Veronika Šourková
veronika.sourkova@fnmotol.cz
224 431 004
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2026-05
Participants
Target number of participants: 120
Treatments
Study group
Type 1 diabetes patients with insulin pump MiniMed 780 G +CGM (continuous glucose monitoring)
Control group
Type 1 diabetes patients with patients treated by multiple daily injections (MDI) + CGM
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Motol

This content was sourced from clinicaltrials.gov