Trial Outcomes & Findings for Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial (NCT NCT01328717)

Results Overview

Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results \>=75mg/dL) and within +/- 15mg/dL(for reference BG results \<75mg/dL) of the reference method results.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

1 hour

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Intended Users of the System Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
Overall Study STARTED	78
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intended Users of the System Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
Overall Study Adverse Event	1

Baseline Characteristics

Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Users of the System n=77 Participants Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
Age, Customized	55 years n=93 Participants
Sex: Female, Male Female	41 Participants n=93 Participants
Sex: Female, Male Male	36 Participants n=93 Participants
Region of Enrollment United States	77 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, one subject did not complete the study. The remaining 77 subjects tested 2 test strip lots on the system. 2x77(154) test results were available.

Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results \>=75mg/dL) and within +/- 15mg/dL(for reference BG results \<75mg/dL) of the reference method results.

Outcome measures

Outcome measures
Measure	Intended Users of the System n=154 Blood Glucose Test Results Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method	95.5 Percentage of BG test results

SECONDARY outcome

Timeframe: 1 hour

Population: Per protocol

Subjects read User Guide(UG)to learn to use the system and performed meter tasks. Study staff observed, then rated subjects' success (1 to 4) at performing tasks. Scale: 1.Performed tasks correctly without assistance. 2.Performed tasks correctly, but was directed to a specific part of the UG by the study staff as in a Customer Service call. 3.Performed tasks correctly, but required additional review/assistance similar to review of a specific function during a Customer Service call. 4.Subject incorrectly performed part of the testing regimen and was unaware of the error.

Outcome measures

Outcome measures
Measure	Intended Users of the System n=77 Participants Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) Turn meter on and off	77 Number of Participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) Set meter time and date	77 Number of Participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) Perform fingerstick blood test	77 Number of Participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation) Perform control test	77 Number of Participants

Adverse Events

Intended Users of the System

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intended Users of the System n=78 participants at risk Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
Endocrine disorders hypoglycemia	2.6% 2/78 • Number of events 2

Additional Information

Dr. Daniel Brown

Ascensia Diabetes Care

Phone: 574-256-7754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place