Trial Outcomes & Findings for Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults (NCT NCT05449795)

Results Overview

At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration ≥100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations \<100 mg/dL(5.55 mmol/L).

Recruitment status

COMPLETED

Target enrollment

120 participants

Primary outcome timeframe

1 day

Results posted on

2025-01-17

Participant Flow

Unit of analysis: blood samples

Participant milestones

Participant milestones
Measure	Arterial Blood Results Samples collected and tested in duplicate by BGMS and compared to laboratory results
Overall Study STARTED	120 240
Overall Study COMPLETED	120 240
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arterial Blood Results n=240 blood samples Samples collected and tested in duplicate by BGMS and compared to laboratory results
Age, Continuous	59.2 years STANDARD_DEVIATION 16.1 • n=120 Participants
Sex: Female, Male Female	39 Participants n=120 Participants
Sex: Female, Male Male	81 Participants n=120 Participants
Region of Enrollment Australia	120 participants n=120 Participants

PRIMARY outcome

Timeframe: 1 day

Population: arterial samples

At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration ≥100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations \<100 mg/dL(5.55 mmol/L).

Outcome measures

Outcome measures
Measure	Arterial Blood Results n=240 blood samples Samples collected and tested in duplicate by BGMS and compared to laboratory results
Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values	236 blood samples

PRIMARY outcome

Timeframe: 1 day

Population: Arterial samples tested.

At least 98% of values should be within ±12.5% of reference values (laboratory method) for glucose concentration ≥75 mg/dL(4.16 mmol/L) and within ±15 mg/dL(±0.83 mmol/L) at glucose concentrations \< 75 mg/dL(4.16 mmol/L).

Outcome measures

Outcome measures
Measure	Arterial Blood Results n=240 blood samples Samples collected and tested in duplicate by BGMS and compared to laboratory results
Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values	240 blood samples

Adverse Events

Arterial Blood Results

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

Jane Wallace

Ascensia Diabetes Care

Phone: 5748501467

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place