Clinical trial NCT00782496: Glucose Meter Study
Official title: A New Contour Blood Glucose Monitoring System With High Frequency Testing Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 211
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features
timeFrame: 6 months
Secondary outcomes:
measure: Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2
timeFrame: Over six month period
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: New York City
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Seattle
country: United States
facility: University of Washington Medical Center/Diabetes Care Center
state: Washington
Study officials:
affiliation: University of Washington Medical Center/Diabetes Care Center
name: Dace Trence, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Diabetes Associates
name: Bruce W Bode, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Ronald Tamler, MD, Phd, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center at Park Nicollet
name: Richard M Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
References: