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OpenTrials
Active, Not Recruiting

NCT Number: NCT06717841

Metabolic Control and Glycemic Variability in Type 1 Diabetes and Celiac Disease

This is an observational, retrospective study focused on differences of time-in-range and glycemic variability between a cohort of patients with both type 1 diabetes and celiac disease, and a cohort of patients with only type 1 diabetes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 1 Diabetes Mellitis Autoimmune Diseases Celiac Disease Diabetes Mellitus Diabetes Mellitus, Type 1 Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Glucose Metabolism Disorders Immune System Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

The study design provides for 2 cohorts of pediatric and adolescent patients using the continuous glycemic monitoring sensor. Cohort A consists of patients with type 1 diabetes and celiace disease, while cohort B consists of patients with only type 1 diabetes.

The primary aim of the study is to assess whether cohort A patients can achieve the same metabolic control and glycemic variability goals (expressed as Time-In-Range and glycemic Variability Coefficient) as cohort B patients.

The secondary aims are: assessing differences in Time-In-Range and glycemic Variability Coefficient between cohort A patients treated with multidaily injections, and those treated with continuous subcutaneous insulin infusion; assessing differences on total daily insulinic intake between cohort A and cohort B.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients < 18 years of age at enrollment;
  • patients with type 1 diabetes onset since at least 1 year and celiac disease (COHORT A);
  • patients only with type 1 diabetes onset since at least 1 year (COHORT B);
  • using the continuous glycemic monitoring sensor;
  • being on treatment with continuous subcutaneous insulin infusion or multidaily injections;
  • obtaining informed consent from parents/legal guardian of pediatric patients.

Exclusion criteria

  • patients with diabetes other than type1 diabetes;
  • patients not using the glycemic monitoring sensor.

Treatment and study plan

Primary outcomes

  1. Differences on metabolic control between cohort A and B

    Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020

    time-in-range

  2. Differences on glycemic variability between cohort A and B

    Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020

    glycemic variability coefficient

Secondary outcomes

  1. Differences on metabolic control between patients on different therapeutic regimen

    Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020

    time-in-range

  2. Differences on glycemic variability between patients on different therapeutic regimen

    Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020

    glycemic variability coefficient

  3. Differences on total daily insulinic intake between cohort A and B

    Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020

    U/kg/die

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Evaluation of Time-in-range and Glycemic Variability in Patients With Type 1 Diabates Mellitus and Celiac Disease With a Glycemic Monitoring Sensor

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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