Celiac Disease, Type 1 Diabetes Mellitis
Conditions
Keywords
Type 1 Diabetes Mellitus, Celiac disease
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed