The Impact of Increased Availability of Test Strips on Blood Glucose Control in Patients With Diabetes
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
Each participant received a Bayer Breeze Monitor and glucose test strips for monitoring blood sugar.
Intervention: Ascencia Breeze Glucose meter (Device)
glucose monitoring
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)
