NCT06717841

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitis
• Celiac Disease

Timeline

• Start date: 2020-10-09
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-12-05
• Last updated: 2024-12-05

Locations

1 site across 1 country: Italy