Trial Outcomes & Findings for Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting (NCT NCT01614613)

Last Updated: 2016-02-29

Results Overview

Using samples with BG \< 70 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all \|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value.

Recruitment status

COMPLETED

Study phase

Target enrollment

146 participants

Primary outcome timeframe

6 hours

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Intended BGM Users Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal:safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips.
Overall Study STARTED	146
Overall Study COMPLETED	146
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended BGM Users n=146 Participants Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
Age, Continuous	53.0 years n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants
Region of Enrollment United States	146 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: Same number (135) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 85 unmodified capillary samples \<70 mg/dL and 50 samples were modified by glycolyzing them.

Outcome measures

Outcome measures
Measure	Intended BGM Users n=135 BG Results Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) Bayer G3/Tatsu System	2.03 mg/dL Standard Error 0.430
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) Freestyle Lite® Meter	2.77 mg/dL Standard Error 0.430
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) Accu-Chek® Aviva Nano Meter	3.34 mg/dL Standard Error 0.419
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) One Touch® VerioTM Pro Meter	4.53 mg/dL Standard Error 0.399
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) OneTouch® Ultra®2 Meter	10.20 mg/dL Standard Error 0.416
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) Truetrack® Meter	11.08 mg/dL Standard Error 0.416

SECONDARY outcome

Timeframe: 6 hours

Population: Same number (172) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided all 172 capillary samples (70 to 180 mg/dL) and no samples were modified.

Using samples with BG 70 mg/dL to 180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all\|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value.

Outcome measures

Outcome measures
Measure	Intended BGM Users n=172 BG results Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL One Touch® VerioTM Pro Meter	5.18 mg/dL Standard Error 0.543
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL Truetrack® Meter	9.71 mg/dL Standard Error 0.538
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL Bayer G3/Tatsu System	4.29 mg/dL Standard Error 0.520
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL Accu-Chek® Aviva Nano Meter	4.70 mg/dL Standard Error 0.527
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL Freestyle Lite® Meter	11.12 mg/dL Standard Error 0.532
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL OneTouch® Ultra®2 Meter	11.13 mg/dL Standard Error 0.533

SECONDARY outcome

Timeframe: 6 hours

Population: Same number (231) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 181 unmodified capillary samples \>180 mg/dL and 50 samples were modified by adding glucose solution.

Using samples with BG \>180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values was compared. MAD was calculated from the sum of all \|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value.

Outcome measures

Outcome measures
Measure	Intended BGM Users n=231 BG Results Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL Bayer G3/Tatsu System	7.81 mg/dL Standard Error 1.137
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL Accu-Chek® Aviva Nano Meter	8.77 mg/dL Standard Error 1.142
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL One Touch® VerioTM Pro Meter	11.83 mg/dL Standard Error 1.143
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL OneTouch® Ultra®2 Meter	18.78 mg/dL Standard Error 1.136
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL Truetrack® Meter	26.47 mg/dL Standard Error 1.129
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL Freestyle Lite® Meter	39.12 mg/dL Standard Error 1.116

SECONDARY outcome

Timeframe: 6 hours

Population: Same numbers (538) of BG results were possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 438 unmodified capillary samples and 100 samples were modified (21 to 496 mg/dL).

Variability of each meter system was determined by calculating the Standard Deviation derived from each meter's differences between Blood Glucose Meter (BGMS)results and corresponding YSI Blood Glucose (BG) results.

Outcome measures

Outcome measures
Measure	Intended BGM Users n=538 BG Results Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) One Touch® VerioTM Pro Meter	7.02 Standard Deviation
Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) OneTouch® Ultra®2 Meter	7.16 Standard Deviation
Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) Accu-Chek® Aviva Nano Meter	7.57 Standard Deviation
Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) Bayer G3/Tatsu System	8.05 Standard Deviation
Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) Truetrack® Meter	9.88 Standard Deviation
Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) Freestyle Lite® Meter	14.80 Standard Deviation

SECONDARY outcome

Timeframe: 1 hour

Population: Since subjects had the option to provide No Response at all to a question, some questionnaire statements had less than 146 participant responses possible (see numbers in parentheses)

Subjects responded to statements about meter accuracy and diabetes management. Subject responses: 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'or No Response. □1ACCURACY HELPS 1A-with my ability to talk with my HCP. 1B-my satisfaction with my self monitoring of diabetes. 1C-with my ability to manage my diabetes. 1D-prevent low BG. 1E-understand how food/exercise affects low BG. □2 I WOULD USE ONLY the meter and strips my insurance company pays for, even if a more accurate meter was available. □3 I USE MY CURRENT METER BECAUSE 3A-my HCP gave it to me. 3B-my insurance company covers the strips. 3C-I think it is the most accurate meter. □4 I WOULD SWITCH meters for a more accurate meter. □5BEING ABLE TO APPLY MORE BLOOD IS IMPORTANT 5A-as I have wasted test strips by not having enough blood to fill the strip 5B-as this would save test strips 5C-I would switch to a meter with this feature

Outcome measures

Outcome measures
Measure	Intended BGM Users n=146 Participants Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements ACCURACY - QUESTION 1A (of 146)	141 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements ACCURACY - QUESTION 1B (of 146)	136 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements ACCURACY - QUESTION 1C (of 146)	140 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements ACCURACY - QUESTION 1D (of 145)	138 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements ACCURACY - QUESTION 1E (of 146)	142 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements QUESTION 2 (of 139)	106 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements QUESTION 3A (of 130)	100 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements QUESTION 3B (of 132)	115 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements QUESTION 3C (of 141)	122 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements QUESTION 4 (of 139)	129 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements QUESTION 5A (of 144)	115 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements QUESTION 5B (of 144)	131 participants
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements QUESTION 5C (of 142)	129 participants

Adverse Events

Intended BGM Users

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intended BGM Users n=146 participants at risk Subjects were assigned to subgroups according to their initial glucose levels. Subgroup 1 goal:safely decrease subject glucose levels during the visit. Subgroup 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
Renal and urinary disorders Urinary tract infection	0.68% 1/146 • Number of events 1
Respiratory, thoracic and mediastinal disorders Bronchitis	0.68% 1/146 • Number of events 1
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	1.4% 2/146 • Number of events 2
Gastrointestinal disorders Nausea and vomiting	0.68% 1/146 • Number of events 1

Additional Information

Carmine Greene

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: GT60