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The purpose of this study is to assess the usability of the Onyx system in the hands of subjects with Insulin Dependent Diabetes Mellitus (IDDM) or insulin-using subjects with Non-IDDM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Users of Onyx BG Meter / App System | Experimental | Subjects with diabetes used the Onyx Blood Glucose (BG) Meter / App System at home. The enrollment goal for the intended use population:
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| 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 software operations, ease of use of the system, and clarity and utility of user instructions. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Responses From Persons Who Performed Each "Software Operations" Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. | 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:
| 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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'. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 weeks |
| Average Change in Subject Fructosamine From Study Start to End of Study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Bailey, MD | AMCR Institute Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92025 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
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. |
| 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 Who Performed Each "Software Operations" Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. | 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:
| 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. | Posted | Number | Percent of Responses | 3 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 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:
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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Wallace, Deputy Director for Global Clinical Affairs | Ascensia Diabetes Care | 574-257-3063 | jane.wallace@ascensia.com |
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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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| 3 weeks |
| 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 | 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'. | 3 weeks |
Laboratory reports were used to compare Fructosamine results from subjects at visit 1 with Fructosamine results at Visit 2 (end of study).
| 3 weeks |
| Average Change in Subject Body Weight From Study Start to End of Study | Subject Body Weight results at visit 1 were compared with Body Weight results at Visit 2 (end of study). | 3 weeks |
| Average Change in Total Daily Insulin Dose From Study Start to End of Study | 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). | 3 weeks |
| years |
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| 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 | Number | participants |
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| Secondary | 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 | 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'. | 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. | Posted | Number | Percentage of Responses | 3 weeks |
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| Secondary | 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 | 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'. | 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. | Posted | Number | percentage of responses <or = 3 | 3 weeks |
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| Other Pre-specified | 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). | Change in %HbA1c. | Posted | Mean | Full Range | %HbA1c | 3 weeks |
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| Other Pre-specified | Average Change in Subject Fructosamine From Study Start to End of Study | Laboratory reports were used to compare Fructosamine results from subjects at visit 1 with Fructosamine results at Visit 2 (end of study). | Change in umol/L | Posted | Mean | Full Range | umol/L | 3 weeks |
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| Other Pre-specified | Average Change in Subject Body Weight From Study Start to End of Study | Subject Body Weight results at visit 1 were compared with Body Weight results at Visit 2 (end of study). | Posted | Mean | Full Range | pounds | 3 weeks |
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| Other Pre-specified | Average Change in Total Daily Insulin Dose From Study Start to End of Study | 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). | Posted | Mean | Full Range | insulin units | 3 weeks |
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| 43 |
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| 43 |
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| Title | Measurements |
|---|---|
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| Using the Edit view was: |
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| Using the Meal Marker Selection screen was: |
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| I am satisfied w how easily meter BG syncs w App. |
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| The App Help section was helpful in using Onyx. |
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