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

University of Ljubljana, Faculty of Medicine250 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Diabetes Mellitus, Type 1

Interventions

MiniMed 780G with SmartGuard activatedDEVICE

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.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time in range (%)

Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)

Time frame: 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)

Time frame: 6 months

Time above range level 2 (%)

Time spent with sensor glucose \> 250 mg/dl (13.9 mmol/L)

Time frame: 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)

Time frame: 6 months

Time below range level 2 (%)

Time spent with sensor glucose \< 54 mg/dl (3.0 mmol/L)

Time frame: 6 months

Mean sensor glucose (mg/dl or mmol/L)

Time frame: 6 months

Coefficient of variation (%)

Time frame: 6 months

Secondary Outcomes

BMI Z-score

Time frame: Baseline, 3 months, 6 months

Weight Z-score

Time frame: Baseline, 3 months, 6 months

Height Z-score

Time frame: Baseline, 3 months, 6 months

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts