Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01469715 | A Clinical Study of the Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM) | PHASE2 | COMPLETED | 16 | — | — | Nov 1, 2011 | Jul 1, 2012 | Jul 31, 2015 | 1 | United States |
ARD=100\*(G\_sensor-G\_reference)/G\_reference Calculated for when patient's G\_ref was Normal (70-180 mg/dl), Hyperglycemic (\>180 mg/dl) and Hypoglycemic (\<70 mg/dl) The study data includes 208 paired sensor-YSI plasma glucose readings (G\_reference) for each GBP CGM sensor (G\_sensor) inserted for 24 hours during hyperglycemic and hypoglycemic challenge conditions. Data pairs will permit the detailed evaluation of sensor performance parameters, including static accuracy metrics such as median and mean absolute deviations and median and mean absolute relative deviation and Point CG-EGA, as well as dynamic parameters, such as warm-up time, trend accuracy (Rate CG-EGA), and sensor lag.
| Arm | Type | Description |
|---|---|---|
| GBP-CGM | EXPERIMENTAL | All participants will wear one active GBP-CGM and one inactive GBP-CGM |
| Name | Type | Description |
|---|---|---|
| GBP CGM | DEVICE | Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active \& one mock device simultaneously during hyperglycemic \& hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 \& 4: Subjects will return to the research center approximately 24 \& 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 \& 5. |
Inclusion Criteria: * Clinical diagnosis of type 1 diabetes mellitus for ≥1 year. For an individual to be enrolled at least one criterion from each list must be met. * Criteria for documented hyperglycemia (at least 1 must be met): 1. Fasting glucose ≥126 mg/dL - confirmed 2. Two-hour oral Glu...