Trial Outcomes & Findings for Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood (NCT NCT00797563)

Results Overview

Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

One hour

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With Diabetes Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
Overall Study STARTED	102
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects With Diabetes Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
Overall Study Adverse Event	1

Baseline Characteristics

Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Diabetes n=102 Participants Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Region of Enrollment United States	102 participants n=5 Participants

PRIMARY outcome

Timeframe: One hour

Population: One subject had a non-serious, non-device related anticipated adverse event (a low blood glucose concentration). The subject was treated and discontinued the study. The tube collected for the capillary lab glucose assay from one subject was lost in processing, so 100 capillary and 101 venous samples were compared with the lab method.

Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.

Outcome measures

Outcome measures
Measure	Subjects With Diabetes n=101 Participants Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method Subjects: Capillary Plasma (n=300)	273 number of blood glucose (BG) results
Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method HCPs: Capillary Plasma (n=300)	274 number of blood glucose (BG) results
Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method Subjects: Capillary Whole Blood (n=300)	280 number of blood glucose (BG) results
Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method HCPs: Capillary Whole Blood (n=299)	273 number of blood glucose (BG) results
Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method HCPs: Venous Plasma (n=605)	597 number of blood glucose (BG) results
Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method HCPs: Venous Whole Blood (n=606)	603 number of blood glucose (BG) results

SECONDARY outcome

Timeframe: One hour

Population: per protocol

Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was: 1. Successful 2. Successful after being referred to user instructions 3. Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)

Outcome measures

Outcome measures
Measure	Subjects With Diabetes n=102 Participants Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
Percentage of Participants Rated as <=3 (Labeling Comprehension) Perform BG measurement (102/102)	100 percent of participants
Percentage of Participants Rated as <=3 (Labeling Comprehension) Select Before/After Meal(Autolog feature) (99/102)	97 percent of participants

SECONDARY outcome

Timeframe: One hour

Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).

Outcome measures

Outcome measures
Measure	Subjects With Diabetes n=101 Participants Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter 4 Excellent	68 number of participants
Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter 3 Very Good	22 number of participants
Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter 2 Good	11 number of participants
Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter 1 Poor	0 number of participants
Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter 0 Unacceptable	0 number of participants

Adverse Events

Subjects With Diabetes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carmine Greene, Senior Clinical Research Scientist

Ascensia Diabetes Care

Phone: 574-257-3040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60