Clinical trial NCT05666596: Do Advanced Hybrid Closed Loop Systems Effect Nutrient Intake?: Real Life Data
Official title: Do Advanced Hybrid Closed Loop Systems Effect Nutrient Intake?: Short Term Follow-up Study, Real Life Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 29
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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)

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Macronutrient intake distribution
timeFrame: Day1
measure: Macronutrient intake distribution
timeFrame: 3rd month
measure: Macronutrient intake distribution
timeFrame: 6th month
measure: HbA1c
timeFrame: Day 1
measure: HbA1c
timeFrame: 3rd month
measure: HbA1c
timeFrame: 6th month
measure: Time in range (Time in range is the amount of time you spend in the target blood glucose range)
timeFrame: Day1
measure: Time in range(Time in range is the amount of time you spend in the target blood glucose range)
timeFrame: 3rd month
measure: Time in range(Time in range is the amount of time you spend in the target blood glucose range)
timeFrame: 6th month
measure: Body mass index (kg/m2)
timeFrame: Day1
measure: Body mass index(kg/m2)
timeFrame: 3rd month
measure: Body mass index(kg/m2)
timeFrame: 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University, Medical Faculty, Division of Pediatric Endocrinology
state: Bornova
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine Department of Pediatrics
Study officials:
affiliation: ege university department of pediatrics
name: Yelda Mansuroglu
role: STUDY_CHAIR
affiliation: ege university department of pediatrics
name: Günay Demir, MSc
role: STUDY_CHAIR
affiliation: ege university department of pediatrics
name: Hanife Balkı, Dr
role: STUDY_CHAIR
affiliation: ege university department of pediatrics
name: Samim Özen, Assoc Prof Dr
role: STUDY_CHAIR
affiliation: ege university department of pediatrics
name: Sukran Darcan, Prof Dr
role: STUDY_CHAIR
affiliation: ege university department of pediatrics
name: Damla Goksen, Prof Dr
role: STUDY_DIRECTOR
affiliation: ege university department of pediatrics
name: yasemin Atik-Altinok, PhD
role: PRINCIPAL_INVESTIGATOR
References: