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Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390167
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : April 20, 2017
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ascensia Diabetes Care

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Diabetes
Intervention Device: ONYX NEXT BGMS
Enrollment 376
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Period Title: Overall Study
Started 376
With Diabetes 333
Without Diabetes 43
Completed 375
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Overall Number of Baseline Participants 376
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 376 participants
52.1
(18 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 376 participants
Female
202
  53.7%
Male
174
  46.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Number of responses
Number Analyzed 376 participants
Hispanic/Latino 50
Not Hispanic or Latino 321
Ethnicity Unknown or Not Reported 5
American Indian or Alaska Native 7
Asian 23
Native Hawaiian or Other Pacific Islander 2
Black or African American 52
White 292
Race Unknown or Not Reported 9
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 376 participants
376
1.Primary Outcome
Title Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Hide Description Untrained subjects WITH Diabetes (332) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
329 (332 with diabetes-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.
Arm/Group Title Persons With Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Overall Number of Participants Analyzed 329
Measure Type: Number
Unit of Measure: Percent of Results within 15mg/dL/15%
99.4
2.Secondary Outcome
Title Percent of Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
Hide Description Untrained subjects WITH Diabetes (332) self-tested Alternate Site (AST) palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
318 (332 with diabetes -14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.
Arm/Group Title Persons With Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary palm blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Overall Number of Participants Analyzed 318
Measure Type: Number
Unit of Measure: Percent of Results within 15mg/dL/15%
97.2
3.Secondary Outcome
Title Percent of Subject Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff
Hide Description Study staff tested subject (332 WITH diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
332 Blood glucose results from subjects with diabetes were analyzed.
Arm/Group Title Persons With Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

Overall Number of Participants Analyzed 332
Measure Type: Number
Unit of Measure: Percent of Results within 15mg/dL/15%
99.7
4.Secondary Outcome
Title Percent of Venous Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff
Hide Description Study staff tested venous blood of 332 subjects WITH diabetes using an Investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI venous plasma) and +/- 15% (>=100 mg/dL YSI venous plasma).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
330 (332-2) Blood glucose results were analyzed. Two (2) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.
Arm/Group Title Persons With Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 330
Measure Type: Number
Unit of Measure: Percent of Results within 15mg/dL/15%
100
5.Secondary Outcome
Title Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range
Hide Description Untrained subjects WITH Diabetes (332) and WITHOUT Diabetes (43) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
372 (375-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 372
Measure Type: Number
Unit of Measure: Percent of Results within 15%
99.5
6.Secondary Outcome
Title Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range
Hide Description Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested Fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
372 (375-3) Blood glucose results were analyzed. Three subjects did not contain meter BG results after three attempts.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 372
Measure Type: Number
Unit of Measure: Percent of Results within 20%
99.7
7.Secondary Outcome
Title Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range
Hide Description Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 361
Measure Type: Number
Unit of Measure: Percent of Results within 15%
96.7
8.Secondary Outcome
Title Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range
Hide Description Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 361
Measure Type: Number
Unit of Measure: Percent of Results within 20%
98.6
9.Secondary Outcome
Title Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Tested By Study Staff
Hide Description Study staff tested subject (332 WITH and 43 WITHOUT diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory method across the entire tested YSI glucose range.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
375 Blood glucose results were analyzed.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 375
Measure Type: Number
Unit of Measure: Percent of Results within 15%
99.7
10.Secondary Outcome
Title Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Tested By Study Staff
Hide Description Study staff tested subject (332 WITH and 43 WITHOUT diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory method across the entire tested YSI glucose range.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
375 Blood glucose results were analyzed.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 375
Measure Type: Number
Unit of Measure: Percent of Results within 20%
100
11.Secondary Outcome
Title Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100 mg/dL) of Laboratory Glucose Method
Hide Description Untrained subjects WITH Diabetes (332) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 12.5 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 12.5% (>=100 mg/dL YSI capillary plasma).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
329 (332-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.
Arm/Group Title Persons With Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 329
Measure Type: Number
Unit of Measure: Percent of Results within12.5mg/dL/12.5%
98.5
12.Secondary Outcome
Title Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS
Hide Description Staff obtained responses from persons WITH Diabetes (332) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Persons With Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 332
Measure Type: Number
Unit of Measure: Percent of Subjects who responded
I find it easy to do a blood test with this meter. 97.9
The meter display was easy to see and read. 98.2
It was easy to understand my test results. 99.7
I like the overall meter design. 97.3
I find the meter easy to use. 97.9
Instructions (User Guide) were easy to understand. 97.6
Instructions clearly explain how to run a test. 98.5
Instructions clearly explain meter error messages. 99.4
13.Secondary Outcome
Title Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS
Hide Description Staff obtained responses from persons WITH and WITHOUT Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 375
Measure Type: Number
Unit of Measure: Percent of Subjects who responded
I find it easy to do a blood test with this meter. 98.1
The meter display was easy to see and read. 98.4
It was easy to understand my test results. 99.7
I like the overall meter design. 97.6
I find the meter easy to use. 98.1
Instructions (User Guide) were easy to understand. 97.6
Instructions clearly explain how to run a test. 98.7
Instructions clearly explain meter error messages. 99.2
14.Secondary Outcome
Title Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose
Hide Description Staff obtained responses from persons WITH Diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'Choose Not to Answer'.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Persons With Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 332
Measure Type: Number
Unit of Measure: Percent of Subjects who responded
Acc:important to help me talk w my HCP. 100
Acc:important to help w self-monitor satisfaction. 99.70
Acc:important to help w managing my diabetes. 99.40
Acc:important to help prevent low blood sugar 99.69
Acc:important to understand food/exercise effects. 99.70
Acc:help w using results to better control diabete 99.40
Acc:important to achieve greater peace of mind. 99.09
I prefer the meter I just used to my regular meter 92.09
I use my meter - my care provider gave it to me. 85.27
I use my current meter -my insurance covers strips 85.62
I use my current meter-I think it is most accurate 84.09
15.Secondary Outcome
Title Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method
Hide Description Untrained subject WITH and WITHOUT diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
372 (375 - 3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 372
Measure Type: Number
Unit of Measure: Percent of Results within 15mg/dL/15%
99.7
16.Secondary Outcome
Title Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method
Hide Description Untrained subject WITH and WITHOUT diabetes self-tested Alternate Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
366 (375-9) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol.
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description:

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

Overall Number of Participants Analyzed 366
Measure Type: Number
Unit of Measure: Percent of Results within 15mg/dL/15%
97.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Persons With and Without Diabetes
Hide Arm/Group Description

Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).

The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.

All-Cause Mortality
Persons With and Without Diabetes
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Persons With and Without Diabetes
Affected / at Risk (%) # Events
Total   0/375 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Persons With and Without Diabetes
Affected / at Risk (%) # Events
Total   8/375 (2.13%)    
Endocrine disorders   
Hypoglycemia * [1]  8/375 (2.13%)  8
*
Indicates events were collected by non-systematic assessment
[1]
Subjects with hypoglycemia (defined by site as BG level < 70 mg/dL) had diabetes and hypoglycemia was resolved at the visit.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jane Wallace, Deputy Director for Global Clinical Affairs
Organization: Ascensia Diabetes Care
Phone: 574-257-3063
EMail: jane.wallace@ascensia.com
Layout table for additonal information
Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT02390167     History of Changes
Other Study ID Numbers: GCA-PRO-2014-004-01
First Submitted: March 11, 2015
First Posted: March 17, 2015
Results First Submitted: December 30, 2016
Results First Posted: April 20, 2017
Last Update Posted: July 17, 2019