Trial Outcomes & Findings for A Clinical Study of the Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM) (NCT NCT01469715)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

25.5 hours

Results posted on

2015-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	GBP-CGM All participants will wear one active GBP-CGM and one inactive GBP-CGM 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.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GBP-CGM n=12 Participants All participants will wear one active GBP-CGM and one inactive GBP-CGM 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.
Age, Continuous	42 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Duration of Diabetes	22 years STANDARD_DEVIATION 11 • n=5 Participants

PRIMARY outcome

Timeframe: 25.5 hours

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.

Outcome measures

Outcome measures
Measure	GBP-CGM n=12 Participants All participants will wear one active GBP-CGM and one inactive GBP-CGM 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.
Absolute Relative Difference (ARD) Overall	19.1 percentage of error
Absolute Relative Difference (ARD) Hyperglycemia (>180mg/dl)	14.9 percentage of error
Absolute Relative Difference (ARD) Hypoglycemia (<70mg/dl)	21.8 percentage of error
Absolute Relative Difference (ARD) Normal (70-180mg/dl)	20.4 percentage of error

Adverse Events

GBP-CGM

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GBP-CGM n=16 participants at risk All participants will wear one active GBP-CGM and one inactive GBP-CGM 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.
Skin and subcutaneous tissue disorders Erythema (score=2)	25.0% 4/16 • Number of events 4

Additional Information

Stacey Anderson, MD

University of Virginia

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place