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AzTrials

Type 1 DiabetesNCT05666596

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

An observational study of Type 1 Diabetes, run by Ege University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 5 to 25 years
Conditions the study is for
Type 1 Diabetes
How many people
29 participants
Where
2 sitesTurkey (Türkiye)
Study dates
7 Jan 2021to 30 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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)

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Ege University, Medical Faculty, Division of Pediatric Endocrinology

    Izmir, Bornova, 35100

  • Ege University Faculty of Medicine Department of Pediatrics

    Izmir, 35100

Other trials in Turkey (Türkiye)

About this study

Official title: 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

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.

Conditions
Type 1 Diabetes
Medical subject headings
Diabetes Mellitus, Type 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 6th month

  4. HbA1c

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

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 6th month

  10. Body mass index (kg/m2)

    As a follow-up weight related issues parameter

    Measured: Day1

  11. Body mass index(kg/m2)

    As a follow-up weight related issues parameter

    Measured: 3rd month

  12. Body mass index(kg/m2)

    As a follow-up weight related issues parameter

    Measured: 6th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2022
  2. Study start7 Jan 2021
  3. Primary completion30 Dec 2022
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05666596
Sponsor's protocol ID
AHCLS T1D
Status last verified
Feb 2023
First submitted
2 Dec 2022
Last updated
28 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38459160

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by Ege University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Macronutrient intake distribution (time frame: Day1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05666596, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.

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