Trial Outcomes & Findings for A New Glucose Meter With Alternative Site Testing (NCT NCT00797212)

Results Overview

Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

One hour

Results posted on

2016-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With Diabetes Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A New Glucose Meter With Alternative Site Testing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Diabetes n=50 Participants Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: One hour

Population: per protocol

Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP

Outcome measures

Outcome measures
Measure	Subjects With Diabetes n=50 Participants Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results Results from palm (subject blood) (n=101)	96 number of AST Blood Glucose Results
Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results Results from forearm (subject blood) (n=100)	93 number of AST Blood Glucose Results

SECONDARY outcome

Timeframe: One hour

Population: per protocol

Study staff rated participants as to their success at performing meter testing. 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=50 Participants Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
Percentage of Participants Rated as <=3 (Labeling Comprehension) Fingerstick glucose result	100 percent of participants
Percentage of Participants Rated as <=3 (Labeling Comprehension) Alternative site glucose result	100 percent of participants

SECONDARY outcome

Timeframe: One hour

Population: per protocol

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

Outcome measures

Outcome measures
Measure	Subjects With Diabetes n=50 Participants Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
Percentage of Participant Ratings for Overall Testing Experience With This Meter 4 Excellent	68 percent of participants
Percentage of Participant Ratings for Overall Testing Experience With This Meter 3 Very Good	26 percent of participants
Percentage of Participant Ratings for Overall Testing Experience With This Meter 2 Good	6 percent of participants
Percentage of Participant Ratings for Overall Testing Experience With This Meter 1 Poor	0 percent of participants
Percentage of Participant Ratings for Overall Testing Experience With This Meter 0 Unacceptable	0 percent 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