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The goal of this interventional study is to compare glycemic outcomes after missed meal bolus in children and adolescents with type 1 diabetes (CwD) treated by one of the three most common used types of hybrid closed loop (HCL) systems - Medtronic MiniMed 780G, Tandem Control-IQ, Ypsomed CamAPS. The main questions it aims to answer are:
Participants will have a precisely defined amount of enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast during eight different days under predetermined conditions. They will administer premeal bolus only for half of these meals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention with and without premeal bolus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast | Other | Participants who are already treated by one of the HCL systems (MiniMed 780G, Tandem Control-IQ, Ypsomed CamAPS) will have a precisely defined amount of enteral nutrition (Resource Fibre, 2 kcal/ml) for breakfast during eight different days under predetermined conditions. They will administer premeal bolus only for half of these meals. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in an area under the curve of a glucose concentration change 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems. | 4 hour after a meal |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in a maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems. | 4 hours after a meal | |
| Difference in time to maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alžbeta Šantová, MD | Contact | +420 773 707 270 | alzbetkasantova@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motol University Hospital | Recruiting | Prague | 15006 | 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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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| D062408 | Breakfast |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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|
| 4 hours after a meal |
| Difference in CGM parameters 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems. | time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (> 13.9 mmol/L; >250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (< 3.0 mmol/L; <54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL) | 4 hours after a meal |
| Difference in an area under the curve of a glucose concentration change 4 hours after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using different types of insulin analogs | insulin analogs - aspart and ultra-rapid lispro | 4 hours after a meal |
| Difference in a maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using two different types of insulin analogs | insulin analogs - aspart and ultra-rapid lispro | 4 hours after a meal |
| Difference in time to maximal glucose rise from baseline after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using two different types of insulin analogs | insulin analogs - aspart and ultra-rapid lispro | 4 hours after a meal |
| Difference in CGM parameters after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using insulin ultra-rapid lispro | time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (> 13.9 mmol/L; >250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (< 3.0 mmol/L; <54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL) | 4 hours after a meal |
| Difference in CGM parameters after a meal (30 g and 50 g of carbohydrates) with a missed premeal bolus between individual HCL systems using insulin aspart. | time in range TIR (3.9-10.0 mmol/L; 70-180 mg/dL) time above range level 1 TAR1 (10.1-13.9 mmol/L; 181-250 mg/dL) time above range level 2 TAR2 (> 13.9 mmol/L; >250 mg/dL) time below range level 1 TBR1 (3.0-3.8 mmol/L; 54-69 mg/dL) time below range level 2 TBR2 (< 3.0 mmol/L; <54 mg/dL) time in tight range TITR (3.9-7.8 mmol/L; 70-140 mg/dL) | 4 hours after a meal |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D062407 |
| Meals |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |