Trial Outcomes & Findings for Performance of the L-PLUS BGMS by Persons With Diabetes Mellitus (NCT NCT04033315)

Last Updated: 2024-06-13

Results Overview

Accuracy of BGMS test with fingerstick blood. The results of the fingerstick meter test performed by the participant will be compared to results of the same blood on a laboratory reference analyzer using pre-specified accuracy criteria.

Recruitment status

COMPLETED

Target enrollment

130 participants

Primary outcome timeframe

Day 1

Results posted on

2024-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	Untrained Subjects With Diabetes Use the L-PLUS BGMS Untrained subjects with Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the L-PLUS BGMS. All blood glucose results are compared to reference method results obtained with subject capillary plasma. Also, study staff test venous blood and blood glucose results are compared to reference method results obtained from subject venous plasma. L-PLUS meter: Blood Glucose Monitoring System
Overall Study STARTED	130
Overall Study COMPLETED	129
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Performance of the L-PLUS BGMS by Persons With Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Untrained Subjects With Diabetes Use the L-PLUS BGMS n=130 Participants Untrained subjects with Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the L-PLUS BGMS. All blood glucose results are compared to reference method results obtained with subject capillary plasma. Also, study staff test venous blood and blood glucose results are compared to reference method results obtained from subject venous plasma. L-PLUS meter: Blood Glucose Monitoring System
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	106 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Age, Continuous	54.4 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	31 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Region of Enrollment United States	130 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Persons with diabetes perform finger stick tests.

Outcome measures

Outcome measures
Measure	Untrained Subjects With Diabetes Use the L-PLUS BGMS n=128 Participants Untrained subjects with Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the L-PLUS BGMS. All blood glucose results are compared to reference method results obtained with subject capillary plasma. Also, study staff test venous blood and blood glucose results are compared to reference method results obtained from subject venous plasma. L-PLUS meter: Blood Glucose Monitoring System
Accuracy of BGMS Compared to the Reference Analyzer - Fingerstick Blood Test	127 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Persons test their blood from palm.

Accuracy of BGMS test with palm blood. The results of the palm blood meter test performed by the participant will be compared to results of the same blood on a laboratory reference analyzer using pre-specified accuracy criteria

Outcome measures

Outcome measures
Measure	Untrained Subjects With Diabetes Use the L-PLUS BGMS n=121 Participants Untrained subjects with Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the L-PLUS BGMS. All blood glucose results are compared to reference method results obtained with subject capillary plasma. Also, study staff test venous blood and blood glucose results are compared to reference method results obtained from subject venous plasma. L-PLUS meter: Blood Glucose Monitoring System
Accuracy of BGMS Compared to the Reference Analyzer - Palm Alternative Site Test (AST)	119 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Venous blood is tested on each participant.

Accuracy of BGMS using venous blood compared to the reference analyzer for all subjects using pre-specified accuracy criteria

Outcome measures

Outcome measures
Measure	Untrained Subjects With Diabetes Use the L-PLUS BGMS n=129 Participants Untrained subjects with Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the L-PLUS BGMS. All blood glucose results are compared to reference method results obtained with subject capillary plasma. Also, study staff test venous blood and blood glucose results are compared to reference method results obtained from subject venous plasma. L-PLUS meter: Blood Glucose Monitoring System
Accuracy of BGMS Compared to the Reference Analyzer - Venous Blood	129 Participants

Adverse Events

Untrained Subjects With Diabetes Use the L-PLUS BGMS

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