Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to evaluate if the meal marker and reminder feature of the Contour meter along with education maintains or increases frequency of testing blood sugar after meals and enables behavioral changes that may lead to improvement in glycemic control.
Interventions
DEVICEEducation + new meter
Diabetes education and a new meter with basic features
DEVICEEducation + new meter + feature activation
Diabetes education and a new meter with advanced features
Sponsors
Ascensia Diabetes Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Persons with type 1 or type 2 diabetes 2. Persons who are on a pump or are taking at least 1 mealtime injection of insulin a day 3. Persons at least 21 years of age 4. Persons willing to complete all study visits and study procedures including: * Using the meal-marker + reminder feature regularly (Group 2 subjects only) * Using the paper logbook provided (both Groups) 5. Testing their BG at least 3 times a day during the entire study. 6. Persons who are able to speak, read and understand English 7. Persons who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more
Exclusion criteria
1. Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months 2. Persons who test over 6 times/day regularly 3. Persons who wear a BG sensor 2 weeks or more during each month. 4. Persons with home heath aides who assist with their BG testing. 5. Persons with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study: * Significant visual impairment * Significant hearing impairment * Cognitive disorder * Significant unstable co-morbidity (with notable change within the past 3 months) 6. Any other condition as per investigator's discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2 | Over six month period | Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Level1 Basic Meter Features Adults with type 1 and type 2 diabetes using basic meter features | 106 |
| Level 2 Advanced Meter Features Adults with type 1 and type 2 diabetes using advanced meter features. | 105 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 15 |
Baseline characteristics
| Characteristic | Level1 Basic Meter Features | Level 2 Advanced Meter Features | Total |
|---|---|---|---|
| Age, Customized | 53 years | 56 years | 55 years |
| Region of Enrollment United States | 106 participants | 105 participants | 211 participants |
| Sex: Female, Male Female | 53 Participants | 60 Participants | 113 Participants |
| Sex: Female, Male Male | 53 Participants | 45 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 94 | 0 / 99 |
| serious Total, serious adverse events | 12 / 106 | 6 / 105 |
Outcome results
Primary
Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features
Time frame: 6 months
Population: For level 1, 14 subjects were lost to follow-up, that is they did not continue through the study's 4 visits, and data was not available. For level 2, 15 subjects were likewise lost to follow-up and data was not available. For units analyzed, 74 and 68 refer to the number of logbooks available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Level1 Basic Meter Features | Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features | 7.1 number of post-prandial tests per week | Standard Error 0.72 |
| Level 2 Advanced Meter Features | Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features | 10.2 number of post-prandial tests per week | Standard Error 0.72 |
Secondary
Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2
Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree.
Time frame: Over six month period
Population: 63 surveys were available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Level1 Basic Meter Features | Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2 | 72.4 percent of Level 2 participants |