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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Differences on metabolic control between cohort A and B | time-in-range | 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 | in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Differences on metabolic control between patients on different therapeutic regimen | time-in-range | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Giulio Maltoni, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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glycemic variability coefficient |
| 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 | in the 14 days prior to the most recent outpatient visit between February 2019 and February 2020 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |