Comparing blood sugar levels in type 1 diabetes patients using insulin pumps while driving
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
University Hospital, Motol · NCT06382350
This study is testing how well blood sugar levels are managed in people with type 1 diabetes while driving, comparing those using insulin pumps to those using daily injections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Motol (other) |
| Locations | 1 site (Prague) |
| Trial ID | NCT06382350 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess glycemic excursions in patients with type 1 diabetes during various life situations, particularly focusing on driving. It involves a comparison between patients using a closed-loop insulin pump system and those on multiple daily insulin injections. A total of 120 participants will be monitored over ten days, recording their activities and corresponding blood sugar levels using continuous glucose monitoring (CGM) technology. The study seeks to understand the safety and effectiveness of closed-loop systems in managing blood sugar during critical activities.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with type 1 diabetes who have been using an insulin pump or multiple daily injections for at least six months.
Not a fit: Patients who are professional drivers or those who cannot complete the study questionnaires may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety of driving for patients with type 1 diabetes by improving blood sugar management.
How similar studies have performed: Previous studies have shown promising results in managing type 1 diabetes with closed-loop systems, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Prague
- UH Motol — Prague, Czechia (RECRUITING)
Study contacts
- Principal investigator: Jan Brož, MUDr., Ph.D. — Second Medical Faculty, Charles University
- Study coordinator: Eva Al Jamal, Mgr.
- Email: eva.aljamal@fnmotol.cz
- Phone: 224 431 017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus With Hypoglycemia, Drive, Type 1 diabetes mellitus, Driving, Closed-loop system