The Impact of Daily Carbohydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- NCT05866900
- Lead Sponsor
- University of Ljubljana, Faculty of Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time below range level 1 (%) 6 months Time spent with sensor glucose between 54 and 70 mg/dl (3.0 and 3.8 mmol/L)
Time above range level 2 (%) 6 months Time spent with sensor glucose \> 250 mg/dl (13.9 mmol/L)
Time above range level 1 (%) 6 months Time spent with sensor glucose between 180 and 250 mg/dl (10.1 and 13.9 mmol/L)
Time below range level 2 (%) 6 months Time spent with sensor glucose \< 54 mg/dl (3.0 mmol/L)
Mean sensor glucose (mg/dl or mmol/L) 6 months Coefficient of variation (%) 6 months Time in range (%) 6 months Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)
- Secondary Outcome Measures
Name Time Method BMI Z-score Baseline, 3 months, 6 months Weight Z-score Baseline, 3 months, 6 months Height Z-score Baseline, 3 months, 6 months