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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05666596
• Other study ID #: AHCLS T1D
• Status: Completed
• Start date: January 7, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: February 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Medicine Department of Pediatrics	Izmir
Turkey	Ege University, Medical Faculty, Division of Pediatric Endocrinology	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	HbA1c	As a metabolic control parameter of the beginning of follow-up period	Day 1
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Body mass index (kg/m2)	As a follow-up weight related issues parameter	Day1
Primary	Body mass index(kg/m2)	As a follow-up weight related issues parameter	3rd month
Primary	Body mass index(kg/m2)	As a follow-up weight related issues parameter	6th month