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The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone.
The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c generally assesses the average/long term quality of glycemic control. On a daily basis, patients assess their glycemic control through finger stick measurements (SMBG), which allows them to adjust their therapy. A device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less frequently.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guardian RT Telemetered Glucose Monitoring System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Change in A1c (%) between continuous use of CGM and control | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in change in A1c (%) between biweekly use of CGM and control | 12 weeks | |
| Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sud Francilien | Corbeil-Essonnes | France | ||||
| CH Robert Debre |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| 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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| Paris |
| France |
| Klinik fur Allgemeine Charite | Berlin | Germany |
| Schneider Children Centre | Petah Tikva | Israel |
| U.O. Medicina Generale | Milan | Italy |
| University Children's Hospital | Ljubljana | Slovenia |
| Huddinge University Hospital | Huddinge | Sweden |
| Royal Bournemouth Hospital | Dorset | United Kingdom |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |