Diabetes Mellitus
Conditions
Keywords
diabetes, glucose, glucometer
Brief summary
This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of glycemic control. This study will evaluate a user's ability to use the enhanced meter feature.
Interventions
Sponsors
AgaMatrix, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
IC 1. Age of subject is 18 years or older IC 2. Type I or type II diabetes inclusive of the following populations: 1. Mixed insulin therapies 2. Basal insulin therapies 3. Bolus insulin therapies 4. CSII therapies 5. MDI therapies 6. Non-insulin diabetic treatments (oral and injectable) 7. Life style (exercise and diet) diabetes management IC 3. Able to speak and read English proficiently
Exclusion criteria
EC 1. Pregnant EC 2. Hct \<20 or \>60 EC 3. Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott) EC 4. Homeless EC 5. Incarcerated EC 6. Institutionalized EC 7. Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol. EC 8. Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study. EC 9. Previous experience using the MyStar Extra BGMS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enhanced Meter Feature Usability | 4 weeks | The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Demographics Age group ranged from ages 18-86, Male and female with both Type 1 and Type 2 diabetics. Race was both white, black/African American and Hispanic who are able to read and understand English per the subject consent form. | 113 |
| Total | 113 |
Baseline characteristics
| Characteristic | Demographics |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 38 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 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 | 107 Participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 113 |
| serious Total, serious adverse events | 0 / 113 |
Outcome results
Primary
Enhanced Meter Feature Usability
The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1).
Time frame: 4 weeks
Population: All diabetic subjects who volunteer for the study and qualify in accordance with the study inclusion and exclusion criteria, the user requirements established by the manufacturer for the blood-glucose system, and applicable regulatory requirements, shall be eligible to participate in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subject Population, Inclusion and Exclusion | Enhanced Meter Feature Usability | 50 Participants |