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

NCT ID: NCT05866900

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2023-10-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Messina

OTHER

Sponsor Role collaborator

University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Klemen Dovc, MD, PHD

Role: CONTACT

+38615229235

Other Identifiers

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CHOco-AID

Identifier Type: -

Identifier Source: org_study_id

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