Trial Outcomes & Findings for Performance of a New Glucose Meter System in Children and Young Adults (NCT NCT00985257)

Results Overview

Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG values \>/=75mg/dL) of the reference method results.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

123 participants

Primary outcome timeframe

1-2 hours

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With Diabetes Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
Overall Study STARTED	123
Overall Study COMPLETED	123
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Performance of a New Glucose Meter System in Children and Young Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Diabetes n=123 Participants Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
Age, Customized Age 4-12 years	41 participants n=5 Participants
Age, Customized Age 13 to 17 years	30 participants n=5 Participants
Age, Customized Age 18 to 24 years	52 participants n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Region of Enrollment United States	123 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-2 hours

Population: To achieve glucose concentrations across the meter test range, 47 blood samples were modified. The total glucose distribution (total 121 natural capillary samples plus 47 modified) ranged from 25.7 to 563.5mg/dL. Two sets of subject results were not analyzed because sufficient sample was not obtained for the YSI reference test.

Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG values \>/=75mg/dL) of the reference method results.

Outcome measures

Outcome measures
Measure	Subjects With Diabetes n=242 capillary blood glucose results Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method Subject Tests Natural Capillary n=242=2 x 121	97.1 percent of blood glucose results
Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method Combine Natural+Modified n=336=2 x (121+47)	97.9 percent of blood glucose results

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