An observational study in Type 1 Diabetes Mellitis and Celiac Disease, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Active, not recruiting at 1 site in Italy. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
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.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 126 observational studies indexed under Celiac Disease.
Browse Celiac Disease studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Differences on metabolic control between cohort A and B
time-in-range
Time frame: 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
Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
Differences on metabolic control between patients on different therapeutic regimen
time-in-range
Time frame: 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
glycemic variability coefficient
Time frame: 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
U/kg/die
Time frame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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IRCCS Azienda Ospedaliero-Universitaria di Bologna