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CompletedNCT05666596Updated Feb 28, 2023

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

An observational study in Type 1 Diabetes, sponsored by Ege University. Completed at 2 sites in Turkey. Open to participants aged 5 Years to 25 Years. Per ClinicalTrials.gov, last updated 2023-02-28.

Sponsored by Ege University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
29
Ages
5 Years to 25 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 29 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No
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)

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

No with major medical problems as

  • celiac disease,
  • cystic fibrosis,
  • psychiatric disorders
  • communication difficulties
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
29 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day1

  2. 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.

    Time frame: 3rd month

  3. 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.

    Time frame: 6th month

  4. HbA1c

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

    Time frame: Day 1

  5. 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.

    Time frame: 3rd month

  6. 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.

    Time frame: 6th month

  7. 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

    Time frame: Day1

  8. 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.

    Time frame: 3rd month

  9. 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.

    Time frame: 6th month

  10. Body mass index (kg/m2)

    As a follow-up weight related issues parameter

    Time frame: Day1

  11. Body mass index(kg/m2)

    As a follow-up weight related issues parameter

    Time frame: 3rd month

  12. Body mass index(kg/m2)

    As a follow-up weight related issues parameter

    Time frame: 6th month

07

Study locations

2 sites
  • Ege University, Medical Faculty, Division of Pediatric Endocrinology
    İzmir, Bornova 35100, Turkey
  • Ege University Faculty of Medicine Department of Pediatrics
    İzmir, 35100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05666596
Lead sponsor
Ege University
Responsible party
Yasemin Atik Altinok (Dietician, PhD, Ege University) — Principal investigator
First posted
Dec 28, 2022
Start date
Jan 7, 2021
Primary completion
Dec 30, 2022
Completion
Jan 30, 2023
Last update
Feb 28, 2023

Study contacts

Yelda Mansuroglu
study chair · ege university department of pediatrics
Günay Demir, MSc
study chair · ege university department of pediatrics
Hanife Balkı, Dr
study chair · ege university department of pediatrics
Samim Özen, Assoc Prof Dr
study chair · ege university department of pediatrics
Sukran Darcan, Prof Dr
study chair · ege university department of pediatrics
Damla Goksen, Prof Dr
study director · ege university department of pediatrics
yasemin Atik-Altinok, PhD
principal investigator · ege university department of pediatrics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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