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

Diabetes Mellitus, Type 1 Clinical Trial

— CHOco-AID  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05866900
• Other study ID #: CHOco-AID
• Status: Not yet recruiting
• Start date: May 15, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: May 2023
• Source: University of Ljubljana, Faculty of Medicine
• Contact: Klemen Dovc, MD, PHD
• Phone: +38615229235
• Email: klemen.dovc[@]kclj.si
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: October 31, 2023
• Est. primary completion date: August 31, 2023
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Ljubljana, Faculty of Medicine	University of Messina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in range (%)	Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)	6 months
Primary	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
Primary	Time above range level 2 (%)	Time spent with sensor glucose > 250 mg/dl (13.9 mmol/L)	6 months
Primary	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
Primary	Time below range level 2 (%)	Time spent with sensor glucose < 54 mg/dl (3.0 mmol/L)	6 months
Primary	Mean sensor glucose (mg/dl or mmol/L)		6 months
Primary	Coefficient of variation (%)		6 months
Secondary	BMI Z-score		Baseline, 3 months, 6 months
Secondary	Weight Z-score		Baseline, 3 months, 6 months
Secondary	Height Z-score		Baseline, 3 months, 6 months