Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-03 @ 5:56 AM
Study NCT ID:
NCT06382350
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems
Sponsor:
University Hospital, Motol
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFEDRIVE
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
Detailed Description:
This national multi-center prospective observational controlled study focuses on the safety of insulin pump closed-loop in patients over 18 with type 1 diabetes while driving. A total of 100 patients (treated with MiniMed 780 G + CGM) will be enrolled in the study group and 20 patients in the control group (treated by multiple daily injections (MDI) + CGM) at 10-20 study centers.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: