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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniMed 780 G | Device | none, observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 days of CGM measurement |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 days of CGM measurement |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 days of CGM measurement |
| Number of alarms generated by the insulin pump |
Inclusion criteria
Study group:
Control group:
Exclusion Criteria (for study and control groups)
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Type 1 diabetes patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Al Jamal, Mgr. | Contact | 224 431 017 | +420 | eva.aljamal@fnmotol.cz |
| Veronika Šourková | Contact | 224 431 004 | +420 | veronika.sourkova@fnmotol.cz |
| Name | Affiliation | Role |
|---|---|---|
| Jan Brož, MUDr., Ph.D. | Second Medical Faculty, Charles University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Motol | Recruiting | Prague | 150 00 | Czechia |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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. |
| 10 days of CGM measurement |
| 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. | 10 days of CGM measurement |
| Food intake | This is to assess the food intake (frequency of food intake) while driving and compare them with non-driving time. | 10 days of CGM measurement |
| Glycemia during the periods of sleep | The outcome evaluates glycemia (mmol/l) during a night sleep. | 10 days of CGM measurement |
| Glycemia during the periods of occupation | The outcome evaluates glycemia (mmol/l) during periods of occupation. | 10 days of CGM measurement |
| Glycemia during the periods of physical activity | The outcome evaluates glycemia (mmol/l) during the periods of physical activity. | 10 days of CGM measurement |
| Glycemia during the periods of stress | The outcome evaluates glycemia (mmol/l) during the periods of stress. | 10 days of CGM measurement |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |