Drive, Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus With Hypoglycemia
Conditions
Keywords
Type 1 diabetes mellitus, Driving, Closed-loop system
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.
Interventions
DEVICEMiniMed 780 G
none, observational study
Sponsors
University Hospital, Motol
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The frequency of hypoglycemia during the driving periods | 10 days of CGM measurement | This outcome evaluates the number of hypoglycemic events (drop of glycemia \<3.9 mmol/l) during the driving periods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during the driving periods. | 10 days of CGM measurement | The outcome evaluates the amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during driving. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Insulin dosing | 10 days of CGM measurement | This is to assess the insulin dosing (insulin units/minute) during driving and compare them with the same variable in non-driving time. |
| Food intake | 10 days of CGM measurement | This is to assess the food intake (frequency of food intake) while driving and compare them with non-driving time. |
| Glycemia during the periods of sleep | 10 days of CGM measurement | The outcome evaluates glycemia (mmol/l) during a night sleep. |
| Analysis of glycemia | 10 days of CGM measurement | 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. |
| Glycemia during the periods of physical activity | 10 days of CGM measurement | The outcome evaluates glycemia (mmol/l) during the periods of physical activity. |
| Glycemia during the periods of stress | 10 days of CGM measurement | The outcome evaluates glycemia (mmol/l) during the periods of stress. |
| Glycemia during the periods of occupation | 10 days of CGM measurement | The outcome evaluates glycemia (mmol/l) during periods of occupation. |
| Number of alarms generated by the insulin pump | 10 days of CGM measurement | 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. |
Countries
Czechia
Contacts
Primary ContactEva Al Jamal, Mgr.
Backup ContactVeronika Šourková
Outcome results
None listed