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A single arm, interventional study with 12 weeks study phase preceded by a 2-week run in phase, aiming to evaluate the effectiveness and applicability of the Tandem Mobi automated insulin delivery system (Tandem Mobi Pump System) for competitive youth athletes with type 1 diabetes in real-world conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tandem Mobi Hybrid Closed Loop (HCL) pump | Experimental | Tandem Mobi Hybrid Closed Loop (HCL) pump with an integrated Control-IQ algorithm (CIQ), the Dexcom G7 continuous glucose monitoring sensor (CGM ) and Tandem Mobi Mobile App |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandem Mobi Hybrid Closed Loop (HCL) pump | Device | Tandem Mobi Hybrid Closed Loop (HCL) pump with an integrated Control-IQ algorithm (CIQ), the Dexcom G7 continuous glucose monitoring sensor (CGM ) and Tandem Mobi Mobile App |
| Measure | Description | Time Frame |
|---|---|---|
| Sensor glucose percentage of time in range (70-180 mg/dl) | At the end of the 12 weeks intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of sensor glucose readings <54 mg/dl | At the end of the 12 weeks intervention period | |
| Percentage of sensor glucose readings >180 mg/dl | At the end of the 12 weeks intervention period | |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events (SAE) | At the end of the 12 weeks intervention period | |
| Diabetic Ketoacidosis (DKA) events | At the end of the 12 weeks intervention period | |
| Severe Hypoglycemia events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alona Hamou, Msc | Contact | 972-545-950277 | alonah@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Marie Muller, MD | Schneider Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical Center of Israel | Petah Tikva | 4920235 | Israel |
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| Percentage of sensor glucose readings >250 mg/dl |
| At the end of the 12 weeks intervention period |
| HbA1c | At the end of the 12 weeks intervention period |
| At the end of the 12 weeks intervention period |
| Percentage of sensor glucose readings in the range 70 to 140 mg/dL | At the end of the 12 weeks intervention period |
| Percentage of sensor glucose readings in the range 70 to 180 mg/dL | At the end of the 12 weeks intervention period |
| Percentage of sensor glucose readings >180 mg/dL | At the end of the 12 weeks intervention period |
| CGM derived indices- Mean glucose | At the end of the 12 weeks intervention period |
| CGM derived indices: Coefficient of variation | At the end of the 12 weeks intervention period |
| CGM derived indices: Peak glucose and change in glucose from the start of the meal to the peak (only calculated for post-meal periods) | At the end of the 12 weeks intervention period |
| CGM derived indices: change in glucose from the start of the exercise to the nadir. | At the end of the 12 weeks intervention period |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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