Do Advanced Hybrid Closed Loop Systems Effect Nutrient Intake?: Real Life Data
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

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.
    

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)