Clinical trial NCT06717841: Metabolic Control and Glycemic Variability in Type 1 Diabetes and Celiac Disease
Official title: Evaluation of Time-in-range and Glycemic Variability in Patients With Type 1 Diabates Mellitus and Celiac Disease With a Glycemic Monitoring Sensor
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Type 1 Diabetes Mellitis
Celiac Disease
Keywords: Type 1 Diabetes Mellitus
Celiac disease
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 200
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences on metabolic control between cohort A and B
timeFrame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
measure: Differences on glycemic variability between cohort A and B
timeFrame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
Secondary outcomes:
measure: Differences on metabolic control between patients on different therapeutic regimen
timeFrame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
measure: Differences on glycemic variability between patients on different therapeutic regimen
timeFrame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
measure: Differences on total daily insulinic intake between cohort A and B
timeFrame: in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Giulio Maltoni, MD
role: PRINCIPAL_INVESTIGATOR
References: