Glucose Meter Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Level1 Basic Meter Features Adults with type 1 and type 2 diabetes use only basic features (Level 1) to test their blood. The CONTOUR meter has the basic features such as small meter size, easy to use , No Coding™ technology, 5-second test time, small sample size (0.6 µL), automatic control solution marking, 480 reading memory capacity. |
Device: Education + new meter
Diabetes education and a new meter with basic features
|
| Experimental: Level 2 Advanced Meter Features Adults with type 1 and type 2 diabetes additionally access and use more advanced meter features(Level 2)during blood glucose testing. The advanced features include ability to mark blood glucose values as obtained before or after meals or to set an audible reminder to test. |
Device: Education + new meter + feature activation
Diabetes education and a new meter with advanced features
|
Outcome Measures
Primary Outcome Measures
- Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features [6 months]
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Persons with type 1 or type 2 diabetes
-
Persons who are on a pump or are taking at least 1 mealtime injection of insulin a day
-
Persons at least 21 years of age
-
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)
-
Testing their BG at least 3 times a day during the entire study.
-
Persons who are able to speak, read and understand English
-
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:
-
Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months
-
Persons who test over 6 times/day regularly
-
Persons who wear a BG sensor 2 weeks or more during each month.
-
Persons with home heath aides who assist with their BG testing.
-
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)
- Any other condition as per investigator's discretion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atlanta Diabetes Associates | Atlanta | Georgia | United States | 30309 |
| 2 | International Diabetes Center | Minneapolis | Minnesota | United States | 55416 |
| 3 | Mount Sinai School of Medicine | New York City | New York | United States | 10029 |
| 4 | University of Washington Medical Center/Diabetes Care Center | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Ascensia Diabetes Care
Investigators
- Principal Investigator: Dace Trence, MD, University of Washington Medical Center/Diabetes Care Center
- Principal Investigator: Bruce W Bode, MD, Atlanta Diabetes Associates
- Principal Investigator: Ronald Tamler, MD, Phd, MBA, Icahn School of Medicine at Mount Sinai
- Principal Investigator: Richard M Bergenstal, MD, International Diabetes Center at Park Nicollet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTD-2008-09
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Level1 Basic Meter Features | Level 2 Advanced Meter Features |
|---|---|---|
| Arm/Group Description | Adults with type 1 and type 2 diabetes using basic meter features | Adults with type 1 and type 2 diabetes using advanced meter features. |
| Period Title: Overall Study | ||
| STARTED | 106 | 105 |
| COMPLETED | 92 | 90 |
| NOT COMPLETED | 14 | 15 |
Baseline Characteristics
| Arm/Group Title | Level1 Basic Meter Features | Level 2 Advanced Meter Features | Total |
|---|---|---|---|
| Arm/Group Description | Adults with type 1 and type 2 diabetes using basic meter features | Adults with type 1 and type 2 diabetes using advanced meter features. | Total of all reporting groups |
| Overall Participants | 106 | 105 | 211 |
| Age, Customized (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
53
|
56
|
55
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
53
50%
|
60
57.1%
|
113
53.6%
|
| Male |
53
50%
|
45
42.9%
|
98
46.4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
106
100%
|
105
100%
|
211
100%
|
Outcome Measures
| Title | Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features |
|---|---|
| Description | |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Level1 Basic Meter Features | Level 2 Advanced Meter Features |
|---|---|---|
| Arm/Group Description | Adults with type 1 and type 2 diabetes using basic meter features | Adults with type 1 and type 2 diabetes using advanced meter features. |
| Measure Participants | 74 | 68 |
| Mean (Standard Error) [number of post-prandial tests per week] |
7.1
(0.72)
|
10.2
(0.72)
|
| Title | Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 63 surveys were available for analysis. |
| Arm/Group Title | Level 2 Advanced Meter Features |
|---|---|
| Arm/Group Description | Adults with type 1 and type 2 diabetes using advanced meter features. |
| Measure Participants | 63 |
| Number [percent of Level 2 participants] |
72.4
68.3%
|
Adverse Events
| Time Frame | 6 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All serious adverse events were not linked to the study device. | |||
| Arm/Group Title | Level1 Basic Meter Features | Level 2 Advanced Meter Features | ||
| Arm/Group Description | Adults with type 1 and type 2 diabetes using basic meter features | Adults with type 1 and type 2 diabetes using advanced meter features. | ||
All Cause Mortality |
||||
| Level1 Basic Meter Features | Level 2 Advanced Meter Features | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Level1 Basic Meter Features | Level 2 Advanced Meter Features | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/106 (11.3%) | 6/105 (5.7%) | ||
| Blood and lymphatic system disorders | ||||
| Sepsis | 1/106 (0.9%) | 1 | 0/105 (0%) | 0 |
| Lower leg edema | 1/106 (0.9%) | 1 | 0/105 (0%) | 0 |
| Lymphadema of arm | 0/106 (0%) | 0 | 1/105 (1%) | 1 |
| Cardiac disorders | ||||
| Heart attack | 1/106 (0.9%) | 1 | 0/105 (0%) | 0 |
| Hypotensive | 2/106 (1.9%) | 3 | 0/105 (0%) | 0 |
| Coronary artery bypass | 0/106 (0%) | 0 | 1/105 (1%) | 1 |
| Endocrine disorders | ||||
| Hypoglycemia | 1/106 (0.9%) | 1 | 0/105 (0%) | 0 |
| Hyperglycemia | 2/106 (1.9%) | 2 | 0/105 (0%) | 0 |
| Adrenal growth | 1/106 (0.9%) | 1 | 0/105 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Diverticulosis | 0/106 (0%) | 0 | 1/105 (1%) | 1 |
| GI Bleeding | 1/106 (0.9%) | 1 | 0/105 (0%) | 0 |
| Upper abdominal pain | 0/106 (0%) | 0 | 1/105 (1%) | 1 |
| Psychiatric disorders | ||||
| Eating disorder | 1/106 (0.9%) | 1 | 0/105 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Mastectomy | 0/106 (0%) | 0 | 1/105 (1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Trachial infection | 0/106 (0%) | 0 | 1/105 (1%) | 1 |
| Shortness of breath | 1/106 (0.9%) | 1 | 0/105 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Level1 Basic Meter Features | Level 2 Advanced Meter Features | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/94 (0%) | 0/99 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Carmine Greene, Senior Clinical Research Scientist |
|---|---|
| Organization | Ascensia Diabetes Care |
| Phone | 574-257-3040 |
| carmine.greene@ascensia.com |
- CTD-2008-09