Trial Outcomes & Findings for Evaluation of an Ascensia Blood Glucose Meter and App System (NCT NCT02568384)

Results Overview

For "software operations" tasks, subjects rated statements about software operations tasks as 1Strongly Agree, 2Agree, 3Neither Agree nor Disagree, 4Disagree, 5Strongly Disagree, or 6No opinion. Software operations tasks included: * Obtain a synced blood glucose reading * Initiation and use of insulin bolus calculator * Access and interpret glucose displays such as expanded graph (modal day) and sequential views.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

3 weeks

Results posted on

2017-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Users of Onyx BG Meter / App System Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population: 1. 40 to 70% of subjects will have type 1 diabetes 2. Not more than 30% of subjects will use an insulin pump Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
Overall Study STARTED	45
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Users of Onyx BG Meter / App System Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population: 1. 40 to 70% of subjects will have type 1 diabetes 2. Not more than 30% of subjects will use an insulin pump Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
Overall Study Mobile devices incompatible with App	2

Baseline Characteristics

Evaluation of an Ascensia Blood Glucose Meter and App System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Users of Onyx BG Meter / App System n=45 Participants Subjects with diabetes used the Onyx BG Meter / App System at home. The enrollment goal for the intended use population: 1. 40 to 70% of subjects will have type 1 diabetes 2. Not more than 30% of subjects will use an insulin pump Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
Age, Continuous	45.9 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	40 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	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.

For "software operations" tasks, subjects rated statements about software operations tasks as 1Strongly Agree, 2Agree, 3Neither Agree nor Disagree, 4Disagree, 5Strongly Disagree, or 6No opinion. Software operations tasks included: * Obtain a synced blood glucose reading * Initiation and use of insulin bolus calculator * Access and interpret glucose displays such as expanded graph (modal day) and sequential views.

Outcome measures

Outcome measures
Measure	Users of Onyx BG Meter / App System n=43 Participants Subjects with diabetes used the Onyx BG Meter / App System at home. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
Percent of Responses From Persons Who Performed Each "Software Operations" Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. I could successfully sync my BG reading with App	95.4 Percent of Responses
Percent of Responses From Persons Who Performed Each "Software Operations" Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. I could successfully initiate/use Bolus Calculator	89.7 Percent of Responses
Percent of Responses From Persons Who Performed Each "Software Operations" Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. I could access/interpret displays in the App.	95.4 Percent of Responses

SECONDARY outcome

Timeframe: 3 weeks

Population: While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.

Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the basic operation of the Onyx Glucose Meter and App System. Subjects could respond '1Very Simple' or '2Simple' or '3Neither Simple nor Difficult' or '4Difficult' or '5Very Difficult' or '6No Opinion'.

Outcome measures

Outcome measures
Measure	Users of Onyx BG Meter / App System n=43 Participants Subjects with diabetes used the Onyx BG Meter / App System at home. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult Accessing the Expanded Graph view was:	97.6 Percentage of Responses
Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult Accessing the My Readings view was:	97.7 Percentage of Responses
Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult Using the My Readings view was:	100 Percentage of Responses
Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult Using the Edit view was:	97.6 Percentage of Responses
Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult Using the Meal Marker Selection screen was:	97.5 Percentage of Responses
Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult I am satisfied w how easily meter BG syncs w App.	90.7 Percentage of Responses

SECONDARY outcome

Timeframe: 3 weeks

Population: While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.

Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the clarity and utility of user instructions for the Onyx Glucose Meter and App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.

Outcome measures

Outcome measures
Measure	Users of Onyx BG Meter / App System n=43 Participants Subjects with diabetes used the Onyx BG Meter / App System at home. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Clarity and Utility of User Instructions For Onyx Glucose Meter and App System The User Guide was helpful in using Onyx system.	100 percentage of responses <or = 3
Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Clarity and Utility of User Instructions For Onyx Glucose Meter and App System The Quick Reference Guide was helpful.	100 percentage of responses <or = 3
Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Clarity and Utility of User Instructions For Onyx Glucose Meter and App System The App Help section was helpful in using Onyx.	100 percentage of responses <or = 3

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 weeks

Population: Change in %HbA1c.

Laboratory reports were used to compare HbA1c results from subjects at visit 1 with HbA1c results at Visit 2 (end of study).

Outcome measures

Outcome measures
Measure	Users of Onyx BG Meter / App System n=43 Participants Subjects with diabetes used the Onyx BG Meter / App System at home. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
HbA1c% From Study Start to End of Study Study Visit 1	8.04 %HbA1c Interval 5.7 to 11.9
HbA1c% From Study Start to End of Study Study Visit 2	7.78 %HbA1c Interval 5.7 to 12.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 weeks

Population: Change in umol/L

Laboratory reports were used to compare Fructosamine results from subjects at visit 1 with Fructosamine results at Visit 2 (end of study).

Outcome measures

Outcome measures
Measure	Users of Onyx BG Meter / App System n=43 Participants Subjects with diabetes used the Onyx BG Meter / App System at home. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
Average Change in Subject Fructosamine From Study Start to End of Study Study Visit 1	331.5 umol/L Interval 230.0 to 533.0
Average Change in Subject Fructosamine From Study Start to End of Study Study Visit 2	312.3 umol/L Interval 206.0 to 525.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 weeks

Subject Body Weight results at visit 1 were compared with Body Weight results at Visit 2 (end of study).

Outcome measures

Outcome measures
Measure	Users of Onyx BG Meter / App System n=43 Participants Subjects with diabetes used the Onyx BG Meter / App System at home. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
Average Change in Subject Body Weight From Study Start to End of Study Study Visit 1	189.5 pounds Interval 107.0 to 297.0
Average Change in Subject Body Weight From Study Start to End of Study Study Visit 2	190.0 pounds Interval 108.0 to 294.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 weeks

Subjects' self-reported Total Daily Insulin Doses at visit 1 were compared with their self-reported Total Daily Insulin Doses at Visit 2 (end of study).

Outcome measures

Outcome measures
Measure	Users of Onyx BG Meter / App System n=43 Participants Subjects with diabetes used the Onyx BG Meter / App System at home. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
Average Change in Total Daily Insulin Dose From Study Start to End of Study Study Visit 1	58.6 insulin units Interval 10.0 to 162.0
Average Change in Total Daily Insulin Dose From Study Start to End of Study Study Visit 2	61.5 insulin units Interval 10.0 to 234.0

Adverse Events

Users of Onyx BG Meter / App System

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, Deputy Director for Global Clinical Affairs

Ascensia Diabetes Care

Phone: 574-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60