跳至主要内容
临床试验/NCT00205335
NCT00205335已完成不适用

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

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Blood pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Blood pressure

时间窗: one year

Weight

时间窗: one year

Hemoglobin A1C

时间窗: one year

次要结局

  • Satisfaction with care(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Free Test Strips and Blood Glucose Control | 临床试验