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The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for the self-management of diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | FreeStyle Libre Flash Glucose Monitoring System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre Flash Glucose Monitoring System | Device | Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days followed by 8 weeks unmasked wear. During the 2 weeks of masked device wear participants will use the BG strip port for self-monitoring of blood glucose (SMBG). Scanning the sensor at least every 8 hours during this phase. Followed by 8 weeks of unmasked device wear when participants will use the device (Sensor glucose and SMBG) according to labelling for their day to day management. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Time in Range | Time in range (Sensor glucose 3.9-10.0 mmol/L [70-180 mg/dL]) in days 56-70 minus time in range at baseline (days 1-15). | Baseline and days 56 to 70 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinder- und Jugendkrankenhaus | Hanover | 30173 | Germany | |||
| National Children's Hospital |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Dublin |
| 24 |
| Ireland |
| Temple Street Children's University Hospital | Dublin | 7 | Ireland |
| Royal Belfast Hospital for Sick Children | Belfast | County Antrim | BT12 6BE | United Kingdom |
| Antrim Area Hospital | Antrim | BT41 2RL | United Kingdom |
| Ulster Hospital | Belfast | BT16 | United Kingdom |
| St. James University Hospital, Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
| Altnagelvin Hospital | Londonderry | BT47 6SB | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| Southampton University Hospital NHS Trust | Southampton | SO16 6YD | United Kingdom |