Glucose Meter Study

Ascensia Diabetes Care211 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

211

Conditions

Diabetes Mellitus

Interventions

Education + new meterDEVICE

Diabetes education and a new meter with basic features

Education + new meter + feature activationDEVICE

Diabetes education and a new meter with advanced features

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (4)

Atlanta Diabetes Associates

Atlanta, Georgia, United States

International Diabetes Center

Minneapolis, Minnesota, United States

Mount Sinai School of Medicine

New York, New York, United States

University of Washington Medical Center/Diabetes Care Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features

Time frame: 6 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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