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Analysis of glycemic control, frequency of hypoglycemia, glycemic variability, patient satisfaction and patient-perceived quality of life in patients with type 1 diabetes mellitus and continuous real-time glucose monitoring, the use of a smart pen compared to a closed loop system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed loop system | Active Comparator | Minimed 780G (Medtronic) |
|
| SmartPen | Experimental | InPen (Medtronic) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InPen Medtronic | Device | Patients with DM1 ≥ 18 years of age who initiate Inpen system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range | To assess the difference on the glycemic control expressed as time in range (% of time between 70-180 mg/dl of interstitial glucose). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| A1c levels | To assess the differences in serum A1c levels (%) | 12 months |
| Time below range | To assess the difference on the glycemic control expressed as time in below range (% of time < 70 mg/dl of interstitial glucose). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lía Nattero-Chávez, MD.PhD | Hospital Ramón y CajaDiabetes, Obesity and Human Reproduction Research Group, Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
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| Minimed 780G system | Device | Patients with DM1 ≥ 18 years of age who initiate Minimed 780G system. |
|
| 12 months |
| Time above range | To assess the difference on the glycemic control expressed as time in above range (% of time >180 mg/dl of interstitial glucose). | 12 months |
| Health-Related Quality of Life in Patients with Type 1 Diabetes | Assess health-related quality of life in patients with type 1 diabetes (by ViDa1 questionnaire).ViDa1 questionnaire has four-dimensional structure: Interference of diabetes in everyday life, Self-care, Well-being, and Worry about the disease. | 12 months |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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