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NCT Number: NCT05866900

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

1Department of Human Pathology in Adult and Developmental Age "Gaetano Barresi," University ofMessina, Messina, Italy

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MiniMed 780G with SmartGuard activated

Device

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.

Primary outcomes

  1. Time in range (%)

    Time frame: 6 months

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

  2. Time above range level 1 (%)

    Time frame: 6 months

    Time spent with sensor glucose between 180 and 250 mg/dl (10.1 and 13.9 mmol/L)

  3. Time above range level 2 (%)

    Time frame: 6 months

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

  4. Time below range level 1 (%)

    Time frame: 6 months

    Time spent with sensor glucose between 54 and 70 mg/dl (3.0 and 3.8 mmol/L)

  5. Time below range level 2 (%)

    Time frame: 6 months

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

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

    Time frame: 6 months

  7. Coefficient of variation (%)

    Time frame: 6 months

Secondary outcomes

  1. BMI Z-score

    Time frame: Baseline, 3 months, 6 months

  2. Weight Z-score

    Time frame: Baseline, 3 months, 6 months

  3. Height Z-score

    Time frame: Baseline, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

University of Ljubljana, Faculty of Medicine

Other

Collaborators

  • University of Messina

Registry information

Official study 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

Acronym: CHOco-AID

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 19, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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