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| Name | Class |
|---|---|
| University of Messina | OTHER |
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Lifestyle factors, including diet, play an important role in the achievement of glycemic targets in patients with diabetes, even with the use of automated insulin delivery (AID) systems. Advanced hybrid closed-loop systems (AHCL), by implementing innovative and powerful control algorithms, have been shown to improve the post-meal glycemic control in their users through the delivery of automatic correction boluses. However, data about the influence of the daily amount of carbohydrate intake on glycemic outcomes in youth with type 1 diabetes using AHCL are missing. Therefore, this study will evaluate the association between daily carbohydrate intakes and meal patterns on glycemic control of young people living with type 1 diabetes using an AHCL system (Medtronic MiniMed 780G; Medtronic, Northridge, California) under real-life conditions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniMed 780G with SmartGuard activated | Device | The MiniMed 780G system consists of a MiniMed 780G Insulin Pump connected to Guardian 4 Sensor or Guardian 3 Sensor, using an automated insulin delivery algorithm called SmartGuard. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range (%) | Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L) | 6 months |
| Time above range level 1 (%) | Time spent with sensor glucose between 180 and 250 mg/dl (10.1 and 13.9 mmol/L) | 6 months |
| Time above range level 2 (%) | Time spent with sensor glucose > 250 mg/dl (13.9 mmol/L) | 6 months |
| Time below range level 1 (%) | Time spent with sensor glucose between 54 and 70 mg/dl (3.0 and 3.8 mmol/L) | 6 months |
| Time below range level 2 (%) | Time spent with sensor glucose < 54 mg/dl (3.0 mmol/L) | 6 months |
| Mean sensor glucose (mg/dl or mmol/L) | 6 months | |
| Coefficient of variation (%) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI Z-score | Baseline, 3 months, 6 months | |
| Weight Z-score | Baseline, 3 months, 6 months | |
| Height Z-score |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from electronical records of two Pediatric Diabetes departments located in Slovenia and Italy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1Department of Human Pathology in Adult and Developmental Age "Gaetano Barresi," University ofMessina | Messina | Italy | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40478457 | Result | Bombaci B, Hropot T, Bratina N, Smigoc Schweiger D, Passanisi S, Salzano G, Di Candia F, Lombardo F, Battelino T, Dovc K. Daily Carbohydrate Entries and Glycemic Outcomes Following Automated Insulin Delivery System Initiation in Youth With Type 1 Diabetes: A Real-World Multinational Longitudinal Study. Diabetes Care. 2025 Aug 1;48(8):1434-1437. doi: 10.2337/dc25-0283. |
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| Baseline, 3 months, 6 months |
| Medical Faculty - University of Ljubljana |
| Ljubljana |
| 1000 |
| Slovenia |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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