Trial Outcomes & Findings for Evaluation of an Ascensia Diabetes Care Blood Glucose Meter and App System (NCT NCT03165110)

Results Overview

Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the success of syncing the blood glucose value on the meter with the App 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'.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

6 weeks

Results posted on

2019-06-04

Participant Flow

17 March 2017 - 05 May 2017 AMCR Institute, Escondido CA

Participant milestones

Participant milestones
Measure	Users of the Onyx Blood Glucose Meter/ App System at Home All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Overall Study STARTED	47
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Users of the Onyx Blood Glucose Meter/ App System at Home All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Overall Study Anroid phone software incompatibility	1

Baseline Characteristics

Evaluation of an Ascensia Diabetes Care Blood Glucose Meter and App System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Users of the Onyx Blood Glucose Meter/ App System at Home n=46 Participants All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 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	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	46 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	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 46 people with insulin-dependent diabetes

Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the success of syncing the blood glucose value on the meter with the App 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 the Onyx Blood Glucose Meter/ App System at Home n=46 Participants All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Percent of Responses From Persons With Diabetes That 'Strongly Agree' or 'Agree' or 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success With Syncing the Reading on the Onyx Glucose Meter and App.	89.13 percentage of participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 46 people with insulin-dependent diabetes

Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on accessing and using the Smart Reminders feature in the Onyx App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.Recognize and use "Smart Reminders"

Outcome measures

Outcome measures
Measure	Users of the Onyx Blood Glucose Meter/ App System at Home n=46 Participants All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success in Accessing and Using Smart Reminders Feature in the Onyx App System Strongly Agree, Agree, or Neither Agree/Disagree	26 Participants
Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success in Accessing and Using Smart Reminders Feature in the Onyx App System No opinion	20 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 46 people with insulin-dependent diabetes

Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the subjects ability to access the Expanded Graph and My Readings views in Onyx 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 the Onyx Blood Glucose Meter/ App System at Home n=46 Participants All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success at Accessing the Expanded Graph and My Readings View in the Onyx App System	46 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 46 people with insulin-dependent diabetes

Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the subjects ability to interpret the Expanded Graph and My Readings views in Onyx the 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 the Onyx Blood Glucose Meter/ App System at Home n=46 Participants All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success in Interpreting the Expanded Graph and My Readings View in the Onyx App System	45 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: 46 people with insulin-dependent diabetes (1 subject was not included in this analysis due to dropping out of study before Visit 2)

Laboratory reports were used to compare HbA1c results from subjects at visit 1 with HbA1c results at Visit 2 (end of study). The average change of HbA1c for all subjects at Visit 1 were compared to the average change of HbA1c for all subjects at Visit 2. Lower scores are better outcomes.

Outcome measures

Outcome measures
Measure	Users of the Onyx Blood Glucose Meter/ App System at Home n=45 Participants All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Change in HbA1c% From Study Start to End of Study Site Visit 1	7.7273003 change in HbA1c% Interval 5.6 to 11.0
Change in HbA1c% From Study Start to End of Study Site Visit 2	7.6993933 change in HbA1c% Interval 5.6 to 11.0

SECONDARY outcome

Timeframe: 6 Weeks

Population: 46 people with insulin-dependent diabetes

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

Outcome measures

Outcome measures
Measure	Users of the Onyx Blood Glucose Meter/ App System at Home n=46 Participants All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Change in Fructosamine (µmol/L) From Study Start to End of Study Visit 1	332.8 µmol/L Interval 211.0 to 555.0
Change in Fructosamine (µmol/L) From Study Start to End of Study Visit 2	322.7 µmol/L Interval 211.0 to 555.0

SECONDARY outcome

Timeframe: 6 weeks

Population: 46 people with insulin-dependent diabetes

The average change in subject body weight from study start (Visit 1) to end of study (Visit 2).

Outcome measures

Outcome measures
Measure	Users of the Onyx Blood Glucose Meter/ App System at Home n=46 Participants All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Average Change in Subject Body Weight From Study Start to End of Study Site Visit 1	194.4 lbs Standard Deviation 59.51
Average Change in Subject Body Weight From Study Start to End of Study Site Visit 2	193.8 lbs Standard Deviation 59.30

SECONDARY outcome

Timeframe: 6 weeks

Population: 46 people with insulin-dependent diabetes

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

Outcome measures

Outcome measures
Measure	Users of the Onyx Blood Glucose Meter/ App System at Home n=46 Participants All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Average Change in Subject BMI From Study Start to End of Study Site Visit 1	29.723913 Kg/m^2 Standard Error 0.10903799
Average Change in Subject BMI From Study Start to End of Study Site Visit 2	29.636304 Kg/m^2 Standard Error 0.10903799

SECONDARY outcome

Timeframe: 6 weeks

Population: change in insulin dose from visit 1 to visit 2.

A 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 the Onyx Blood Glucose Meter/ App System at Home n=46 Participants All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Average Change in Total Daily Insulin Dose From Study Start to End of Study Site Visit 1	76.869565 IU Standard Error 1.4668160
Average Change in Total Daily Insulin Dose From Study Start to End of Study Site Visit 2	78.326087 IU Standard Error 1.4668160

Adverse Events

Users of the Onyx Blood Glucose Meter/ App System at Home

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Users of the Onyx Blood Glucose Meter/ App System at Home n=46 participants at risk All participants in the study have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin in their diabetes management. Onyx BG Meter / App System: Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Musculoskeletal and connective tissue disorders Shoulder pain	2.2% 1/46 • Number of events 1 • 6 weeks
Renal and urinary disorders Bladder Infection	2.2% 1/46 • Number of events 1 • 6 weeks

Additional Information

Jane Wallace

Ascensia Diabetes

Phone: (574) 850-1467

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place