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| Name | Class |
|---|---|
| Estonian Research Council | UNKNOWN |
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To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.
Primary objective To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.
Primary endpoint To compare time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
Trial design This is a 28-day long prospective randomized open-label single-center crossover clinical study with a 14-day long run-in phase.
Trial population A total of 30 subjects with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard-bolus | Active Comparator | Standard boluses for all meal |
|
| Dual-bolus | Experimental | Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-bolus | Device | Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. | To compare time in range duration during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time in range (3.9-10 mmol/L) will be measured. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. | Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time below range (<3,9 mmol/L) | 14 days |
| Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria after the Run-in period
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Tartu | 51014 | Estonia |
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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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Randomized open-label single-center crossover clinical study
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| Standard bolus | Device | Standard boluses for all meals |
|
Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time below range (>10.0 mmol/L) |
| 14 days |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |