Skip to main content
OpenTrials
Completed

NCT Number: NCT05666596

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ege University, Medical Faculty, Division of Pediatric Endocrinology, Izmir, Bornova, Turkey (Türkiye)

Loading trial locations.

About this study

In all participants, height was measured to the nearest centimeter using a rigid stadiometer. Weight was measured unclothed to the nearest 0.1 kg using a calibrated balance scale. Body mass index (BMI) was calculated by the weight (kg)/height (m²) equation. Standard deviation scores (SDS) for weight, height, and BMI were calculated according to age and gender using reference values for Turkish children and adolescents (1). For young adults, a BMI of 18.5-24.9 kg/ m² is considered normal weight Participants recorded all food and beverage (including dressings) consumed and the servings reported by weight, before and after (3rd, 6th month) switching to MiniMed 780GTM. Before entering data in the nutrient analysis program, the research team dietician reviewed all completed diet records and asked for supplementary information if needed. The analysis included 1076 snacks and meals (750 meals, 326 snacks) dietary records. Total energy intake (kcal), fat (energy %), protein (energy %), carbohydrate (energy %), saturated fatty acids (energy %), cholesterol (mg), and dietary fiber (g/1000 kcal) intake were calculated using the Ebispro for Windows,; Turkish Version (BeBiS 8.2) (Stuttgart, Germany).

HbA1c was measured by turbidimetric inhibition immunoassay (Roche Cobas c513 analyzer using the Tina quant® HbA1c Gen. 3 assay, Germany). MiniMed 780GTM data uploaded to CareLinkTM personal software during the follow-up by individuals who provided constent for their data to be aggregated were analyzed (CareLink; https://carelink.medtronic.eu). Time in range (TIR: 70-180 mg/dl), time below range (TBR: 70 mg/dl), time above range (TAR: >180 mg/dl), coefficient of variation (CV), glucose management indicator (GMI), sensor usage, time spent in AHCL and mean sensor glucose values were evaluated. Active insulin time was 2,5 hours and the target blood glucose value as 100 mg/dl in all patients at the initiation of AHCL and changed when necessary.

Statistical analyses were conducted using Statistical Package for the Social Sciences version 25.0 (SPSS Inc., Chicago, IL, USA). The level of significance was defined as p<0.05. Categorical variables were represented as counts and percentage values. Normal distribution was tested for quantitative variables. Continuous variables with normal or skewed distribution were presented as mean (standard deviation) or median (interquartile range). Group differences were investigated using the independent t-test for normally distributed data, the Mann-Whitney test for skewed data, and the chi-square tests used for categorical variables. Repeated values differences were investigated using One Way Anova for normally distributed data and the Friedman test for skewed data.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

No with major medical problems as

  • celiac disease,
  • cystic fibrosis,
  • psychiatric disorders
  • communication difficulties

Treatment and study plan

Primary outcomes

  1. Macronutrient intake distribution

    Time frame: Day1

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

  2. Macronutrient intake distribution

    Time frame: 3rd month

    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.

  3. Macronutrient intake distribution

    Time frame: 6th month

    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.

  4. HbA1c

    Time frame: Day 1

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

  5. HbA1c

    Time frame: 3rd month

    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.

  6. HbA1c

    Time frame: 6th month

    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.

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

    Time frame: Day1

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

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

    Time frame: 3rd month

    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.

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

    Time frame: 6th month

    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.

  10. Body mass index (kg/m2)

    Time frame: Day1

    As a follow-up weight related issues parameter

  11. Body mass index(kg/m2)

    Time frame: 3rd month

    As a follow-up weight related issues parameter

  12. Body mass index(kg/m2)

    Time frame: 6th month

    As a follow-up weight related issues parameter

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Do Advanced Hybrid Closed Loop Systems Effect Nutrient Intake?: Short Term Follow-up Study, Real Life Data

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 28, 2022
Registry last updated
Feb 28, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.