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

May 10, 2023 updated by: University of Ljubljana, Faculty of Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from electronical records of two Pediatric Diabetes departments located in Slovenia and Italy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range (%)
Time Frame: 6 months
Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)
6 months
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)
6 months
Time above range level 2 (%)
Time Frame: 6 months
Time spent with sensor glucose > 250 mg/dl (13.9 mmol/L)
6 months
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)
6 months
Time below range level 2 (%)
Time Frame: 6 months
Time spent with sensor glucose < 54 mg/dl (3.0 mmol/L)
6 months
Mean sensor glucose (mg/dl or mmol/L)
Time Frame: 6 months
6 months
Coefficient of variation (%)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
BMI Z-score
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Weight Z-score
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Height Z-score
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ljubljana, Faculty of Medicine

Collaborators

University of Messina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2023

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHOco-AID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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