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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Users of the Onyx Blood Glucose Meter/ app System at home | Experimental | Participants have a diagnosis of either type 1 or type 2 diabetes for at least 6 months and use insulin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onyx BG Meter / App System | Device | Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | 6 weeks |
| 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" | 6 weeks |
| 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'. | 6 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
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Inclusion Criteria:
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.
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).
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Bailey, MD | AMCR Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92026 | United States |
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17 March 2017 - 05 May 2017 AMCR Institute, Escondido CA
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
46 people with insulin-dependent diabetes
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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'. | 46 people with insulin-dependent diabetes | Posted | Number | percentage of participants | 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Wallace | Ascensia Diabetes | (574) 850-1467 | jane.wallace@ascensia.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2016 | Jan 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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'.
| 6 weeks |
| 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). | 6 Weeks |
| 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). | 6 weeks |
| 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). | 6 weeks |
| 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). | 6 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
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| 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" | 46 people with insulin-dependent diabetes | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 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'. | 46 people with insulin-dependent diabetes | Posted | Count of Participants | Participants | 6 weeks |
|
|
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| 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'. | 46 people with insulin-dependent diabetes | Posted | Count of Participants | Participants | 6 weeks |
|
|
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| 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. | 46 people with insulin-dependent diabetes (1 subject was not included in this analysis due to dropping out of study before Visit 2) | Posted | Least Squares Mean | Full Range | change in HbA1c% | 6 weeks |
|
|
|
| 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). | 46 people with insulin-dependent diabetes | Posted | Least Squares Mean | Full Range | µmol/L | 6 Weeks |
|
|
|
| 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). | 46 people with insulin-dependent diabetes | Posted | Least Squares Mean | Standard Deviation | lbs | 6 weeks |
|
|
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| 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). | 46 people with insulin-dependent diabetes | Posted | Least Squares Mean | Standard Error | Kg/m^2 | 6 weeks |
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|
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| 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). | change in insulin dose from visit 1 to visit 2. | Posted | Least Squares Mean | Standard Error | IU | 6 weeks |
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| 0 |
| 46 |
| 0 |
| 46 |
| 2 |
| 46 |
| Bladder Infection | Renal and urinary disorders | Non-systematic Assessment |
|
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