Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to assess the utility of the Contour Diabetes App 2.0 when used with the Contour Next One meter (the Onyx system).
Detailed description
The purpose of this study is to assess the utility of the Contour Diabetes App 2.0 when used with the Contour Next One meter (the Onyx system) in the hands of subjects with type 1 diabetes or insulin-using subjects with type 2 diabetes. It is designed to determine the subjects' self-reported success in utilizing the features of the system. Each feature will be evaluated independently, by including a series of statements about each feature set for which a numerical score or rating will be provided by subjects.
Interventions
Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Be aged 18-75 years, male or female * Read and understand English * Have diagnosis of type 1 (goal is 40% to 70%) or insulin-using type 2 diabetes for at least 6 months * Be taking multiple daily insulin injections (MDI) of at least two pre-meal bolus insulin injections daily or using an insulin pump (Goal is not more than 30% of subjects using insulin pump therapy) * Performing self-monitoring of blood glucose at home at least twice daily * Have an iOS mobile device or Android mobile device with Bluetooth capability iOS device: iPod, iPad, or iPhone 5 or later version with iOS 9.x or 10.x software Android: smart phone, software version 6.x. Bluetooth: software version 4.0 or higher * Agree NOT to update the software on their mobile device until after the study is concluded, as follows: * No updates of Android device to upcoming Android version 7 (Nougat) * Be willing to utilize the Contour Next One meter and the Contour Diabetes App 2.0 on personal mobile device which communicates to meter to manage diabetes and be willing to keep a study diary
Exclusion criteria
* Known Hemophilia or any other bleeding disorder * Pregnancy (reported by subject; no pregnancy test required) * Current user of Contour Next One BGMS including Contour Diabetes App. * Physical, visual or neurological impairments that would make the person unable to perform testing with the Contour Next One BGMS or to use the Contour Diabetes App * Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company. * Immediate family members are the subject's parents, spouse, children, and siblings, including the parent's spouse; step children and adopted children and their spouses. * A competitive medical device company is a company that provides a medical device or components of a device that is related to diabetes. For example, people who are not eligible are those who work for companies that create or manufacture the following (or a company that is in a partnership with a company that provides such devices): lancing devices, blood glucose monitoring systems, continuous glucose monitoring systems, insulin pens, or systems related to the measurement of HbA1c. People who are eligible are those who work for companies associated with products such as wound dressings, medications or dietary products. * A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee on the subject disposition form).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 6 weeks | 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'. |
| 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 | 6 weeks | 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 |
| 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 | 6 weeks | 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'. |
| 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 | 6 weeks | 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c% From Study Start to End of Study | 6 weeks | 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. |
| Average Change in Total Daily Insulin Dose From Study Start to End of Study | 6 weeks | 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). |
| Change in Fructosamine (µmol/L) From Study Start to End of Study | 6 Weeks | Laboratory reports were used to compare fructosamine results from subjects at visit 1 with frustosamine results at Visit 2 (end of study). |
| Average Change in Subject Body Weight From Study Start to End of Study | 6 weeks | The average change in subject body weight from study start (Visit 1) to end of study (Visit 2). |
| Average Change in Subject BMI From Study Start to End of Study | 6 weeks | Subject BMI results at visit 1 were compared with BMI results at Visit 2 (end of study). |
Countries
United States
Participant flow
Recruitment details
17 March 2017 - 05 May 2017 AMCR Institute, Escondido CA
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Anroid phone software incompatibility | 1 |
Baseline characteristics
| Characteristic | Users of the Onyx Blood Glucose Meter/ App System at Home |
|---|---|
| Age, Continuous | 50 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Region of Enrollment United States | 46 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 2 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
Primary
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
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
Population: 46 people with insulin-dependent diabetes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Users of the Onyx Blood Glucose Meter/ App System at Home | 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
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
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
Population: 46 people with insulin-dependent diabetes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Users of the Onyx Blood Glucose Meter/ App System at Home | 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 |
Primary
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
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
Population: 46 people with insulin-dependent diabetes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Users of the Onyx Blood Glucose Meter/ App System at Home | 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 |
| Users of the Onyx Blood Glucose Meter/ App System at Home | 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
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.
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
Population: 46 people with insulin-dependent diabetes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Users of the Onyx Blood Glucose Meter/ App System at Home | 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 |
Secondary
Average Change in Subject BMI From Study Start to End of Study
Subject BMI results at visit 1 were compared with BMI results at Visit 2 (end of study).
Time frame: 6 weeks
Population: 46 people with insulin-dependent diabetes
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Users of the Onyx Blood Glucose Meter/ App System at Home | Average Change in Subject BMI From Study Start to End of Study | Site Visit 1 | 29.723913 Kg/m^2 | Standard Error 0.10903799 |
| Users of the Onyx Blood Glucose Meter/ App System at Home | 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
Average Change in Subject Body Weight From Study Start to End of Study
The average change in subject body weight from study start (Visit 1) to end of study (Visit 2).
Time frame: 6 weeks
Population: 46 people with insulin-dependent diabetes
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Users of the Onyx Blood Glucose Meter/ App System at Home | Average Change in Subject Body Weight From Study Start to End of Study | Site Visit 1 | 194.4 lbs | Standard Deviation 59.51 |
| Users of the Onyx Blood Glucose Meter/ App System at Home | Average Change in Subject Body Weight From Study Start to End of Study | Site Visit 2 | 193.8 lbs | Standard Deviation 59.3 |
Secondary
Average Change in Total Daily Insulin Dose From Study Start to End of Study
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
Population: change in insulin dose from visit 1 to visit 2.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Users of the Onyx Blood Glucose Meter/ App System at Home | Average Change in Total Daily Insulin Dose From Study Start to End of Study | Site Visit 1 | 76.869565 IU | Standard Error 1.466816 |
| Users of the Onyx Blood Glucose Meter/ App System at Home | Average Change in Total Daily Insulin Dose From Study Start to End of Study | Site Visit 2 | 78.326087 IU | Standard Error 1.466816 |
Secondary
Change in Fructosamine (µmol/L) From Study Start to End of Study
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
Population: 46 people with insulin-dependent diabetes
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Users of the Onyx Blood Glucose Meter/ App System at Home | Change in Fructosamine (µmol/L) From Study Start to End of Study | Visit 1 | 332.8 µmol/L |
| Users of the Onyx Blood Glucose Meter/ App System at Home | Change in Fructosamine (µmol/L) From Study Start to End of Study | Visit 2 | 322.7 µmol/L |
Secondary
Change in HbA1c% From Study Start to End of Study
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
Population: 46 people with insulin-dependent diabetes (1 subject was not included in this analysis due to dropping out of study before Visit 2)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Users of the Onyx Blood Glucose Meter/ App System at Home | Change in HbA1c% From Study Start to End of Study | Site Visit 1 | 7.7273003 change in HbA1c% |
| Users of the Onyx Blood Glucose Meter/ App System at Home | Change in HbA1c% From Study Start to End of Study | Site Visit 2 | 7.6993933 change in HbA1c% |