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

Active, not recruiting

• Conditions: Type 1 Diabetes Mellitis; Celiac Disease

• Registration Number: NCT06717841
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-10-09
• Status Verified: 2024-10
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-01
• Last Update Submitted: 2024-12-01
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences on metabolic control between cohort A and B	in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020	time-in-range
Differences on glycemic variability between cohort A and B	in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020	glycemic variability coefficient

Secondary Outcome Measures

Name	Time	Method
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	time-in-range
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	glycemic variability coefficient
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	U/kg/die

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy