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

Sponsor

University of Ljubljana, Faculty of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05866900

Collaborator

University of Messina (Other)

250

Enrollment

5.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Device: MiniMed 780G with SmartGuard activated

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Outcome Measures

Primary Outcome Measures

Time in range (%) [6 months]
Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 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 above range level 2 (%) [6 months]
Time spent with sensor glucose > 250 mg/dl (13.9 mmol/L)
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 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]

Secondary Outcome Measures

BMI Z-score [Baseline, 3 months, 6 months]
Weight Z-score [Baseline, 3 months, 6 months]
Height Z-score [Baseline, 3 months, 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 18 Years

Sexes Eligible for Study:

All

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