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

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ClinicalTrials.gov Identifier: NCT03165110
Recruitment Status : Completed
First Posted : May 24, 2017
Results First Posted : June 4, 2019
Last Update Posted : June 4, 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: Supportive Care
Condition Diabetes Mellitus
Intervention Device: Onyx BG Meter / App System
Enrollment 47
Recruitment Details 17 March 2017 - 05 May 2017 AMCR Institute, Escondido CA
Pre-assignment Details  
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 47
Completed 46
Not Completed 1
Reason Not Completed
Anroid phone software incompatibility             1
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description

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 Number of Baseline Participants 46
Hide Baseline Analysis Population Description
46 people with insulin-dependent diabetes
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 46 participants
50
(20 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
26
  56.5%
Male
20
  43.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Hispanic or Latino
3
   6.5%
Not Hispanic or Latino
43
  93.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
46
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 46 participants
46
 100.0%
1.Primary Outcome
Title 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.
Hide Description 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'.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
46 people with insulin-dependent diabetes
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description:

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 Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of participants
89.13
2.Primary Outcome
Title 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
Hide Description 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"
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
46 people with insulin-dependent diabetes
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description:

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 Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly Agree, Agree, or Neither Agree/Disagree
26
  56.5%
No opinion
20
  43.5%
3.Primary Outcome
Title 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
Hide Description 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'.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
46 people with insulin-dependent diabetes
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description:

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 Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
46
 100.0%
4.Primary Outcome
Title 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
Hide Description 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'.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
46 people with insulin-dependent diabetes
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description:

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 Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
45
  97.8%
5.Secondary Outcome
Title Change in HbA1c% From Study Start to End of Study
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
46 people with insulin-dependent diabetes (1 subject was not included in this analysis due to dropping out of study before Visit 2)
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description:

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 Number of Participants Analyzed 45
Least Squares Mean (Full Range)
Unit of Measure: change in HbA1c%
Site Visit 1
7.7273003
(5.6 to 11)
Site Visit 2
7.6993933
(5.6 to 11)
6.Secondary Outcome
Title Change in Fructosamine (µmol/L) From Study Start to End of Study
Hide Description Laboratory reports were used to compare fructosamine results from subjects at visit 1 with frustosamine results at Visit 2 (end of study).
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
46 people with insulin-dependent diabetes
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description:

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 Number of Participants Analyzed 46
Least Squares Mean (Full Range)
Unit of Measure: µmol/L
Visit 1
332.8
(211 to 555)
Visit 2
322.7
(211 to 555)
7.Secondary Outcome
Title Average Change in Subject Body Weight From Study Start to End of Study
Hide Description The average change in subject body weight from study start (Visit 1) to end of study (Visit 2).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
46 people with insulin-dependent diabetes
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description:

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 Number of Participants Analyzed 46
Least Squares Mean (Standard Deviation)
Unit of Measure: lbs
Site Visit 1 194.4  (59.51)
Site Visit 2 193.8  (59.30)
8.Secondary Outcome
Title Average Change in Subject BMI From Study Start to End of Study
Hide Description Subject BMI results at visit 1 were compared with BMI results at Visit 2 (end of study).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
46 people with insulin-dependent diabetes
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description:

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 Number of Participants Analyzed 46
Least Squares Mean (Standard Error)
Unit of Measure: Kg/m^2
Site Visit 1 29.723913  (0.10903799)
Site Visit 2 29.636304  (0.10903799)
9.Secondary Outcome
Title Average Change in Total Daily Insulin Dose From Study Start to End of Study
Hide Description 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).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
change in insulin dose from visit 1 to visit 2.
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description:

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 Number of Participants Analyzed 46
Least Squares Mean (Standard Error)
Unit of Measure: IU
Site Visit 1 76.869565  (1.4668160)
Site Visit 2 78.326087  (1.4668160)
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Users of the Onyx Blood Glucose Meter/ App System at Home
Hide Arm/Group Description

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.

All-Cause Mortality
Users of the Onyx Blood Glucose Meter/ App System at Home
Affected / at Risk (%)
Total   0/46 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Users of the Onyx Blood Glucose Meter/ App System at Home
Affected / at Risk (%) # Events
Total   0/46 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Users of the Onyx Blood Glucose Meter/ App System at Home
Affected / at Risk (%) # Events
Total   2/46 (4.35%)    
Musculoskeletal and connective tissue disorders   
Shoulder pain *  1/46 (2.17%)  1
Renal and urinary disorders   
Bladder Infection *  1/46 (2.17%)  1
*
Indicates events were collected by non-systematic assessment
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
Organization: Ascensia Diabetes
Phone: (574) 850-1467
EMail: jane.wallace@ascensia.com
Layout table for additonal information
Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT03165110     History of Changes
Other Study ID Numbers: GCA-PRO-2016-001-01
First Submitted: April 7, 2017
First Posted: May 24, 2017
Results First Submitted: January 21, 2019
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019