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).
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
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.
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
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
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
HbA1c
As a metabolic control parameter of the beginning of follow-up period
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6th month
Body mass index (kg/m2)
As a follow-up weight related issues parameter
Measured: Day1
Body mass index(kg/m2)
As a follow-up weight related issues parameter
Measured: 3rd month
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.
- First posted28 Dec 2022
- Study start7 Jan 2021
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Atik Altinok, Ege University
- Investigators
- Yelda Mansuroglu, Study chair, ege university department of pediatricsGünay Demir, MSc, Study chair, ege university department of pediatricsHanife Balkı, Dr, Study chair, ege university department of pediatricsSamim Özen, Assoc Prof Dr, Study chair, ege university department of pediatricsSukran Darcan, Prof Dr, Study chair, ege university department of pediatricsDamla Goksen, Prof Dr, Study director, ege university department of pediatricsyasemin Atik-Altinok, PhD, Principal investigator, ege university department of pediatrics
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Advanced Hybrid Closed Loop Systems Effect Nutrient Intake?: Short Term Follow-up Study, Real Life Data
- ClinicalTrials.gov ID
- NCT05666596
- Acronym / sponsor ID
- AHCLS T1D
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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)
Key inclusion criteria (1 listed)
- Use an advanced hybrid closed-loop system pump therapy (MiniMed 780G™, Medtronic, Northridge, CA USA)
Key exclusion criteria (5 listed)
- No with major medical problems as
- celiac disease,
- cystic fibrosis,
- psychiatric disorders
- communication difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
HbA1c
Time frame: Day 1
As a metabolic control parameter of the beginning of follow-up period
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.
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.
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
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.
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.
Body mass index (kg/m2)
Time frame: Day1
As a follow-up weight related issues parameter
Body mass index(kg/m2)
Time frame: 3rd month
As a follow-up weight related issues parameter
Body mass index(kg/m2)
Time frame: 6th month
As a follow-up weight related issues parameter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 38459160Atik-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
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.