Glucose Meter Study

Diabetes Mellitus Clinical Trial

Official title:

A New Contour Blood Glucose Monitoring System With High Frequency Testing Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782496
• Other study ID #: CTD-2008-09
• Status: Completed
• Phase: N/A
• First received: October 28, 2008
• Last updated: January 29, 2016
• Start date: November 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Education + new meter
Diabetes education and a new meter with basic features
• Education + new meter + feature activation
Diabetes education and a new meter with advanced features

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	International Diabetes Center	Minneapolis	Minnesota
United States	Mount Sinai School of Medicine	New York City	New York
United States	University of Washington Medical Center/Diabetes Care Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features		6 months	No
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.	Over six month period	No