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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Active, not recruiting

Conditions: Celiac Disease; Type 1 Diabetes Mellitis

Study type: Observational

Funder types: Other

Identifiers

NCT06717841

CELTEC2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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.