Trial Outcomes & Findings for User Performance of the Thunder Plus BGMS (NCT NCT04008836)

Last Updated: 2024-06-17

Results Overview

Number of participants with results within ±15mg/dL of laboratory method at glucose concentration \<100 mg/dL and within ±15% at glucose concentrations ≥100 mg/dL

Recruitment status

COMPLETED

Study phase

Target enrollment

384 participants

Primary outcome timeframe

One day

Results posted on

2024-06-17

Participant Flow

Recruitment was from 10Jun2019 to 31Jul2019.

Participant milestones

Participant milestones
Measure	Untrained Subjects WITH Diabetes Use the T-PLUS BGMS Untrained subjects WITH Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the T-PLUS BGMS. All blood glucose results are compared to reference method results. Also, study staff test subject's venous blood and the blood glucose results are compared to the reference method results. T-PLUS Meter: Blood Glucose Monitoring System (BGMS)
Overall Study STARTED	384
Overall Study COMPLETED	384
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

User Performance of the Thunder Plus BGMS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subject Fingerstick Self Testing n=384 Participants Each subject performs fingerstick testing using the Thunder Plus meter.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	269 Participants n=5 Participants
Age, Categorical >=65 years	115 Participants n=5 Participants
Age, Continuous	56.5 years STANDARD_DEVIATION 14.01 • n=5 Participants
Sex: Female, Male Female	224 Participants n=5 Participants
Sex: Female, Male Male	160 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	331 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants
Race (NIH/OMB) Asian	38 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	75 Participants n=5 Participants
Race (NIH/OMB) White	260 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	384 participants n=5 Participants

PRIMARY outcome

Timeframe: One day

Number of participants with results within ±15mg/dL of laboratory method at glucose concentration \<100 mg/dL and within ±15% at glucose concentrations ≥100 mg/dL

Outcome measures

Outcome measures
Measure	Untrained Subjects WITH Diabetes Use the T-PLUS BGMS n=381 Participants Untrained subjects WITH Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the T-PLUS BGMS. All blood glucose results are compared to reference method results. Also, study staff test subject's venous blood and the blood glucose results are compared to the reference method results. T-PLUS Meter: Blood Glucose Monitoring System (BGMS)
Number of Participants With Accurate BGMS Fingerstick Results	373 Participants

SECONDARY outcome

Timeframe: One day

Count of BGMS Palm (AST) from persons with diabetes within ±15mg/dL of laboratory method at glucose concentration \<100 mg/dL and within ±15% at glucose concentrations ≥100 mg/d results

Outcome measures

Outcome measures
Measure	Untrained Subjects WITH Diabetes Use the T-PLUS BGMS n=365 Participants Untrained subjects WITH Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the T-PLUS BGMS. All blood glucose results are compared to reference method results. Also, study staff test subject's venous blood and the blood glucose results are compared to the reference method results. T-PLUS Meter: Blood Glucose Monitoring System (BGMS)
Number of Participants With Accurate BGMS Palm (AST) Results.	344 Participants

SECONDARY outcome

Timeframe: One day

A Labeling evaluation (Ease of Use) was performed by the subjects who answered a survey to evaluate the ease of use of the test and the instructions in the package insert. A numerical score or rating will be reported by subjects for statement. The allowed response are 1) Strongly Disagree, 2) Disagree, 3) Neutral, 4) Agree, or 5) Strongly Agree. The number of responses for each statement that is 3,4, or 5 will be reported; 3,4, and 5 are considered favorable responses.

Outcome measures

Outcome measures
Measure	Untrained Subjects WITH Diabetes Use the T-PLUS BGMS n=332 Participants Untrained subjects WITH Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the T-PLUS BGMS. All blood glucose results are compared to reference method results. Also, study staff test subject's venous blood and the blood glucose results are compared to the reference method results. T-PLUS Meter: Blood Glucose Monitoring System (BGMS)
Number of Responses to Questionnaire 1 That Are Within Specified Criteria.	327 Participants

SECONDARY outcome

Timeframe: One day

Number of participant's results from venous blood that are within 15% of the reference analyzer.

Outcome measures

Outcome measures
Measure	Untrained Subjects WITH Diabetes Use the T-PLUS BGMS n=327 Participants Untrained subjects WITH Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the T-PLUS BGMS. All blood glucose results are compared to reference method results. Also, study staff test subject's venous blood and the blood glucose results are compared to the reference method results. T-PLUS Meter: Blood Glucose Monitoring System (BGMS)
Number of Participants With Accurate BGMS Venous Blood Results	327 Participants

Adverse Events

Untrained Subjects WITH Diabetes Use the T-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