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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35100
    • Ege University Faculty of Medicine Department of Pediatrics
  • Bornova
    • İzmir, Bornova, Turkey, 35100
      • Ege University, Medical Faculty, Division of Pediatric Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Study Chair: 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 Director: Damla Goksen, Prof Dr, ege university department of pediatrics; Principal Investigator: yasemin Atik-Altinok, PhD, ege university department of pediatrics

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 18, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 25, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: AHCLS T1D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No