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| Name | Class |
|---|---|
| International Society for Pediatric and Adolescent Diabetes | UNKNOWN |
| Kinderkrankenhaus auf der Bult, Hannover, Germany | UNKNOWN |
| Department of Pediatrcs, Endocrinology and Diabetes Medical University of Silesia in Katowice, Poland |
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The purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with T1D. The study adopts an open-label, multi-centre, multinational, prospective registry-based population cohort design contrasting CGM use to SMBG alone in young children with type 1 diabetes over 12 months.
The primary endpoint is the difference between treatment modalities (CGM vs SMBG alone) in glycaemic variability, measured as the coefficient of variation of glucose levels, during the 12 months observational period. Other Key edpoints include time in range 70-180 mg/dl, time below range 70 mg/dl and time above range 180 mg/dl.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM | CGM users | ||
| SMBG | Non-CGM users |
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| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of variation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range | Time in Range 70 - 180 mg/dl | 1 year |
| Time Above Range | Time in Range above 180 mg/dl | 1 year |
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Key inclusion criteria:
Key exclusion criteria:
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Pre-school children below age of 7 years with type 1 diabetes (for at least 6 months) and treated with insulin pump fo at least 3 months.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Faculty - University of Ljubljana | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, University City Hospital of Verona, Verona, Italy | UNKNOWN |
| Yale University | OTHER |
| Pediatric Endocrinology Unit, Paediatrics Department, Maternal and Paediatrics Centre, São João University and Hospital Centre, Porto, Porto, Portugal | UNKNOWN |
| Department of Pediatrics, Section on Diabetes and Metabolism, V. Buzzi Children's Hospital, University of Milan, Milan, Italy | UNKNOWN |
| Pediatric Endocrinology Unit. Hospital Pediátrico. Centro Hospitalar e Universitário de Coimbra. Coimbra. Portugal | UNKNOWN |
| Diaboss, Amsterdam, Netherlands | UNKNOWN |
| Medical School, University of Valparaiso, San Felipe, Chile. | UNKNOWN |
| Department of Pediatric Endocrinology and Diabetes, Koç University Hospital, İstanbul, Turkey. | UNKNOWN |
| University of Roma La Sapienza | OTHER |
| Department of Pediatrics, San Raffaele Scientific Institute , Milan, Italy | UNKNOWN |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |