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Clinical Trials/NCT00205335
NCT00205335CompletedNot Applicable

The Impact of Increased Availability of Test Strips on Blood Glucose Control in Patients With Diabetes

University of Wisconsin, Madison1 site in 1 country22 target enrollmentStarted: January 1, 2004Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Blood pressure

Study Overview

Brief Summary

This study is designed to determine if there is an impact on blood glucose control in patients who receive free test strips. Patients in the study have no insurance or insurance that does not cover the purchase of test strips. A comparison of weight, blood pressure, and Hemoglobin A1C from entry to the final visit will be used to compare patients' management of their diabetes. Recommended values for these parameters will be used as the standard for comparisons. The investigators anticipate that patients receiving free test strips will show an improvement in the listed parameters as well as in satisfaction with their care.

Detailed Description

According to the National Institutes of Diabetes and Digestive and Kidney Diseases, an estimated 16 million people in the United States have diabetes mellitus. About one third of these people don't know they have diabetes and are therefore, not receiving treatment. Another 798,000 people are diagnosed with diabetes each year.

Diabetes is the fourth leading cause of death in Wisconsin, as stated at the Wisconsin Department of Health and Family Services website. Diabetes costs an estimated annual $2.1 billion in health care costs and lost productivity. Each year, over 3,600 Wisconsin residents die from diabetes. Others experience disabling complications, including blindness, amputations, heart and kidney disease. In 1998, in Dane County alone, the direct costs of diabetes were estimated at $82.0 million and indirect costs at $100.4 million.

Two landmark studies in the United States and the United Kingdom proved that the level of blood sugar control predicts the onset and severity of diabetes-related complications for both Type 1 and Type 2 diabetes. Thus, people who are able to keep their blood sugars as close to normal as possible can reduce their risks of complications and live relatively "normal" lives. Moreover, the costs to the community will also be reduced.

In order to do this, persons with diabetes need to test blood sugar levels multiple times per day. There are a variety of meters available for testing. Many people have insurance that covers the cost of the meters and related test strips. For those who do not have this coverage, meters are often available free of charge. Unfortunately, this is not true of the test strips, which average $1 each. A person testing four times a day, seven days a week would need almost $1470 to purchase strips for a year.

In the past year, the investigators have seen 35 patients followed in either the East or West Diabetes Clinics who do not have insurance and thus, no way to pay for test strips. It can be assumed that without an adequate number of test strips, these patients are not getting the necessary information to achieve optimal blood sugar control. This puts them at risk for more complications of their diabetes with concurrent emotional and financial costs to them and their families. Further, the cost to the community in the long run is increased.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with a diagnosis of diabetes who have no health insurance or insurance that does not pay for purchase of blood test strips

Exclusion Criteria

  • •Patients with a diagnosis of diabetes who have health insurance that pays for purchase of blood test strips

Arms & Interventions

glucose monitoring

Other

Each participant received a Bayer Breeze Monitor and glucose test strips for monitoring blood sugar.

Intervention: Ascencia Breeze Glucose meter (Device)

glucose monitoring

Other

Each participant received a Bayer Breeze Monitor and glucose test strips for monitoring blood sugar.

Intervention: Breeze Glucose Monitor (Bayer) (Device)

Outcomes

Primary Outcomes

Blood pressure

Time Frame: one year

Weight

Time Frame: one year

Hemoglobin A1C

Time Frame: one year

Secondary Outcomes

  • Satisfaction with care(one year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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