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The Aim of this interventional study in to assess the effect of the use of a smartpen connected by an APP to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control.
Primary endpoint: time in range Secondary endpoints: other glucometrics, Hba1c, treatment satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| smartpen | Experimental | patients treated by smartpen, glucose sensor and connected by a digital application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smartpen | Device | use of a smartpen connected with glucose sensor by an digital application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in range | Percentage of the time spent by 70-180 mg/dl | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| time below range | percentage of time < 70 mg/dl | 3 months |
| time above range | percentage of time spent > 180 mg/dl | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Riccardo Bonfanti, M.D. | IRCCS San Raffaele | Principal Investigator |
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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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| coefficient of variation (CV) | percentage of variation of glicaemic values | 3 months |
| HbA1c | percentage of glicated haemoglobin | 3 months |
| ITSRQ | questionnaire on patient's satisfaction about the use of insulin device | end of the study |
| DIDS | questionnaire on patient's satisfaction about the use of insulin device | 3 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |