Glucose Meter Study

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Education + new meter + feature activation; Device: Education + new meter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00782496

CTD-2008-09

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 2 patient groups

Level1 Basic Meter Features

Experimental group

Description:

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.

Treatment:

Device: Education + new meter

Level 2 Advanced Meter Features

Experimental group

Description:

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.

Treatment:

Device: Education + new meter + feature activation