A Clinical Study of the Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM) (SMA002)
The purpose of this study is to assess the accuracy of the Becton Dickenson (BD) Technologies Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients with Type 1 diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high (>180mg/dL) glucose levels over a 24 hour period. This will be achieved by monitoring blood sugar levels when a regular dinner meal is given, when a liquid breakfast meal (BOOST Original containing 41 grams Carbohydrates (CHO), 4 grams fat, 10 grams protein) is given, when subcutaneous insulin is dosed to induce hypoglycemia to a goal of 55 mg/dL, and when a regular lunch meal is given. A Continuous Glucose Monitor (CGM) is an electronic device that measures and displays blood sugar (glucose) levels in the body throughout the day and night. The method being used to detect blood sugar in the investigational Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) is different than the method that is currently in use by commercially available models.
Some sensors cannot tell the difference between glucose (sugar) and other substances such as Tylenol, aspirin or citric acid etc. Because they cannot tell the difference, they may give false readings. The GBP CGM is made to only recognize glucose in the body rather than other substances (e.g., Tylenol, aspirin, citric acid, etc.). As a result, the investigators expect the new GBP CGM to be more accurate at detecting low blood sugar levels than the current devices.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Clinical Study of the Warm-Up, Accuracy, and Lag Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM)|
- Absolute Relative Difference (ARD) [ Time Frame: 25.5 hours ] [ Designated as safety issue: No ]
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.
|Study Start Date:||November 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
All participants will wear one active GBP-CGM and one inactive GBP-CGM
Device: GBP CGM
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.
Other Name: Glucose binding protein-based continuous glucose monitor
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469715
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Stacey Anderson, MD||University of Virginia, Center for Diabetes Technology|