Do Advanced Hybrid Closed Loop Systems Effect Nutrient Intake?: Real Life Data

NCT05666596 | Completed

• 1 other identifier: AHCLS T1D
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

This 6-month follow-up study was conducted to investigate the effect of AHCLS on the energy and macronutrient intake of children, adolescents, and young adults with Type 1 diabetes (T1D). All participants with T1D on an AHCLS (MiniMed 780GTM) receiving care at the Pediatric Endocrinology and Diabetes Clinic of Ege University (Izmir, Turkey) were eligible for the study. The children and adolescents with T1D with at least 3 days of food diary available before AHCLS and at 3rd and 6th months at AHCLS were included in the study

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (12)

• Macronutrient intake distribution

  At the beginning of the follow-up, the macronutrient distribution of the participant diets will be evaluated for compliance with national and international guidelines.

  Day1

• Macronutrient intake distribution

  In the third month of the follow-up, the compliance of the macronutrient distribution of the participant's diets with national and international guidelines and the change from the beginning of the follow-up will be evaluated.

  3rd month

• Macronutrient intake distribution

  In the 6th month of the follow-up, the compliance of the macronutrient distribution of the participant's diets with national and international guidelines and the change from the beginning of the follow-up will be evaluated.

  6th month

• HbA1c

  As a metabolic control parameter of the beginning of follow-up period

  Day 1

• HbA1c

  As a metabolic control parameter at the 3rd month of the follow-up and the change from the beginning of the follow-up will be evaluated.

  3rd month

• HbA1c

  As a metabolic control parameter at the 6th month of the follow-up and the change from the beginning of the follow-up will be evaluated.

  6th month

• Time in range (Time in range is the amount of time you spend in the target blood glucose range)

  As a metabolic control parameter of beginning of the follow-up period

  Day1

• Time in range(Time in range is the amount of time you spend in the target blood glucose range)

  As a metabolic control parameter at the 3rd month of the follow-up and the change from the beginning of the follow-up will be evaluated.

  3rd month

• Time in range(Time in range is the amount of time you spend in the target blood glucose range)

  As a metabolic control parameter at the 6th month of the follow-up and the change from the beginning of the follow-up will be evaluated.

  6th month

• Body mass index (kg/m2)

  As a follow-up weight related issues parameter

  Day1

• Body mass index(kg/m2)

  As a follow-up weight related issues parameter

  3rd month

• Body mass index(kg/m2)

  As a follow-up weight related issues parameter

  6th month

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children, adolescents, and young adults with type 1 diabetes on an advanced hybrid closed-loop system pump therapy (MiniMed 780G™,Medtronic, Northridge, CA USA) ) receiving care at the Pediatric Endocrinology and Diabetes Clinic of Ege University (Izmir, Turkey)

You may qualify if:

• Use an advanced hybrid closed-loop system pump therapy (MiniMed 780G™, Medtronic, Northridge, CA USA)

You may not qualify if:

• No with major medical problems as
• celiac disease,
• cystic fibrosis,
• psychiatric disorders
• communication difficulties

Sponsors & Collaborators

• Ege University: lead

Study Sites (2)

Ege University, Medical Faculty, Division of Pediatric Endocrinology

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Ege University Faculty of Medicine Department of Pediatrics

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• Atik-Altinok Y, Mansuroglu Y, Demir G, Balki HG, Ozen S, Darcan S, Goksen D. Does minimed 780GTM insulin pump system affect energy and nutrient intake?: long-term follow-up study. Eur J Clin Nutr. 2024 Jul;78(7):615-621. doi: 10.1038/s41430-024-01422-y. Epub 2024 Mar 8.

  PMID: 38459160 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yelda Mansuroglu

  ege university department of pediatrics

  STUDY CHAIR

• Günay Demir, MSc

  ege university department of pediatrics

  STUDY CHAIR

• Hanife Balkı, Dr

  ege university department of pediatrics

  STUDY CHAIR

• Samim Özen, Assoc Prof Dr

  ege university department of pediatrics

  STUDY CHAIR

• Sukran Darcan, Prof Dr

  ege university department of pediatrics

  STUDY CHAIR

• Damla Goksen, Prof Dr

  ege university department of pediatrics

  STUDY DIRECTOR

• yasemin Atik-Altinok, PhD

  ege university department of pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietician, PhD

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 28, 2022
• Study Start: January 7, 2021
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)