Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
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.
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 or insulin-using type 2 diabetes for at least 6 months * Be taking multiple daily injections (MDI) of at least two pre-meal bolus injections daily or using an insulin pump * Performing self-monitoring of blood glucose at home at least twice daily * Have an iOS mobile device or Android mobile device with blue tooth capability * iOS device: iPod or iPhone 5 or later version with iOS 8.0 software or higher (no tablets) * Android: smart phone, 4.4 version and higher (no tablets) * Be willing to utilize the ONYX App on personal mobile device which communicates to meter to manage diabetes (including use of the bolus calculator) * Be ambulatory and have transportation to the study site
Exclusion criteria
* Hemophilia or any other bleeding disorder * Pregnancy * Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM * 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). * Proliferative retinopathy or history of retinal laser surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Responses From Persons Who Performed Each Software Operations Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. | 3 weeks | 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: * Obtain a synced blood glucose reading * Initiation and use of insulin bolus calculator * Access and interpret glucose displays such as expanded graph (modal day) and sequential views. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 weeks | 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'. |
| 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 | 3 weeks | 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'. |
Other
| Measure | Time frame | Description |
|---|---|---|
| HbA1c% From Study Start to End of Study | 3 weeks | Laboratory reports were used to compare HbA1c results from subjects at visit 1 with HbA1c results at Visit 2 (end of study). |
| Average Change in Total Daily Insulin Dose From Study Start to End of Study | 3 weeks | 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). |
| Average Change in Subject Fructosamine From Study Start to End of Study | 3 weeks | Laboratory reports were used to compare Fructosamine results from subjects at visit 1 with Fructosamine results at Visit 2 (end of study). |
| Average Change in Subject Body Weight From Study Start to End of Study | 3 weeks | Subject Body Weight results at visit 1 were compared with Body Weight results at Visit 2 (end of study). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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:
1. 40 to 70% of subjects will have type 1 diabetes
2. Not more than 30% of subjects will use an insulin pump
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. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Mobile devices incompatible with App | 2 |
Baseline characteristics
| Characteristic | Users of Onyx BG Meter / App System |
|---|---|
| Age, Continuous | 45.9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
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: * Obtain a synced blood glucose reading * Initiation and use of insulin bolus calculator * Access and interpret glucose displays such as expanded graph (modal day) and sequential views.
Time frame: 3 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Users of Onyx BG Meter / App System | Percent of Responses From Persons Who Performed Each Software Operations Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. | I could successfully sync my BG reading with App | 95.4 Percent of Responses |
| Users of Onyx BG Meter / App System | Percent of Responses From Persons Who Performed Each Software Operations Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. | I could successfully initiate/use Bolus Calculator | 89.7 Percent of Responses |
| Users of Onyx BG Meter / App System | Percent of Responses From Persons Who Performed Each Software Operations Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree. | I could access/interpret displays in the App. | 95.4 Percent of Responses |
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'.
Time frame: 3 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Users of Onyx BG Meter / App System | 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 | The User Guide was helpful in using Onyx system. | 100 percentage of responses <or = 3 |
| Users of Onyx BG Meter / App System | 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 | The Quick Reference Guide was helpful. | 100 percentage of responses <or = 3 |
| Users of Onyx BG Meter / App System | 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 | The App Help section was helpful in using Onyx. | 100 percentage of responses <or = 3 |
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'.
Time frame: 3 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Users of Onyx BG Meter / App System | 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 | Accessing the Expanded Graph view was: | 97.6 Percentage of Responses |
| Users of Onyx BG Meter / App System | 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 | Accessing the My Readings view was: | 97.7 Percentage of Responses |
| Users of Onyx BG Meter / App System | 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 | Using the My Readings view was: | 100 Percentage of Responses |
| Users of Onyx BG Meter / App System | 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 | Using the Edit view was: | 97.6 Percentage of Responses |
| Users of Onyx BG Meter / App System | 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 | Using the Meal Marker Selection screen was: | 97.5 Percentage of Responses |
| Users of Onyx BG Meter / App System | 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 | I am satisfied w how easily meter BG syncs w App. | 90.7 Percentage of Responses |
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).
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Users of Onyx BG Meter / App System | Average Change in Subject Body Weight From Study Start to End of Study | Study Visit 1 | 189.5 pounds |
| Users of Onyx BG Meter / App System | Average Change in Subject Body Weight From Study Start to End of Study | Study Visit 2 | 190.0 pounds |
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).
Time frame: 3 weeks
Population: Change in umol/L
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Users of Onyx BG Meter / App System | Average Change in Subject Fructosamine From Study Start to End of Study | Study Visit 1 | 331.5 umol/L |
| Users of Onyx BG Meter / App System | Average Change in Subject Fructosamine From Study Start to End of Study | Study Visit 2 | 312.3 umol/L |
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).
Time frame: 3 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Users of Onyx BG Meter / App System | Average Change in Total Daily Insulin Dose From Study Start to End of Study | Study Visit 1 | 58.6 insulin units |
| Users of Onyx BG Meter / App System | Average Change in Total Daily Insulin Dose From Study Start to End of Study | Study Visit 2 | 61.5 insulin units |
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).
Time frame: 3 weeks
Population: Change in %HbA1c.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Users of Onyx BG Meter / App System | HbA1c% From Study Start to End of Study | Study Visit 1 | 8.04 %HbA1c |
| Users of Onyx BG Meter / App System | HbA1c% From Study Start to End of Study | Study Visit 2 | 7.78 %HbA1c |