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

NCT06717841 | Active Not Recruiting

• 1 other identifier: CELTEC2020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitis; Celiac Disease

Keywords

Type 1 Diabetes Mellitus; Celiac disease

Outcome Measures

Primary Outcomes (2)

• Differences on metabolic control between cohort A and B

  time-in-range

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

• Differences on glycemic variability between cohort A and B

  glycemic variability coefficient

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

Secondary Outcomes (3)

• Differences on metabolic control between patients on different therapeutic regimen

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

• Differences on glycemic variability between patients on different therapeutic regimen

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

• Differences on total daily insulinic intake between cohort A and B

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

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged \< 18 years at enrollement with type 1 diabetes and celiac disease or with only type 1 diabetes, treated with continuous subcutaneous insulin infusion or multidaily injections and using the continuous glycemic monitoring sensor.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Celiac Disease; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Giulio Maltoni, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start: October 9, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-10

Locations

IT (1)