The Impact of Daily Carbohydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Daily CarboHydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System (Medtronic MiniMed 780G): a Multi-center Real-world Observational Study

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: MiniMed 780G with SmartGuard activated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 1 diabetes Patients aged 7-18 years Patients using Medtronic MiniMed 780G with SmartGuard activated Patients whose informed consent has been obtained >70% CGM data during observational period Exclusion Criteria: Patients with partial clinical remission according to the Hvidovre Study Group definition Concomitant treatment with steroids or other drugs known to interfere with blood glucose levels Previous diagnosis of psychological or eating disorders

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MiniMed 780G with SmartGuard activated|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI Z-score |  | Baseline, 3 months, 6 months | 
| Weight Z-score |  | Baseline, 3 months, 6 months | 
| Height Z-score |  | Baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MiniMed 780G, automated insulin delivery, nutrition, diet, time in range, insulin pump