A Clinical Study of the Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM)

PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Type 1 Diabetes Mellitus
Interventions
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.

Trial Locations (1)

22908

University of Virginia, Charlottesville

All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

Becton, Dickinson and Company

INDUSTRY

lead

University of Virginia

OTHER