Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00205335
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2005-09-13
Brief Title:
Free Test Strips and Blood Glucose Control
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
The Impact of Increased Availability of Test Strips on Blood Glucose Control in Patients With Diabetes
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dont know they have diabetes and are therefore not receiving treatment Another 798000 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 21 billion in health care costs and lost productivity Each year over 3600 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 820 million and indirect costs at 1004 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
2 Describe the design of your study Use care to distinguish experimental interventions from standard medical treatment Specifically include the following information
The investigators will enroll 35 subjects identified in either the East or West diabetes clinic who do not have insurance or who are underinsured Underinsured indicates patients with insurance that does not cover the purchase of test strips Certified Diabetes Educators CDE identified other patients after an initial visit when lack of adequate insurance coverage was noted The list of identified patients was sent to the patients physician and CDE Two patients were eliminated who are self-pay by choice they are self-employed and have adequate resources Other subjects were eliminated for the following criteria discharge from UWHC Diabetes Clinic to a primary care provider patients whose diabetes is controlled by diet alone patients who are incarcerated and currently have coverage through the penal system
Subjects will be provided a voucher to obtain free test strips Subjects routinely return to the clinic at 4-month intervals study entry months 4812 During these visits subjects will undergo a Hemoglobin A1C check height weight and blood pressure and complete satisfaction questionnaires at study entry and month 12 Only the questionnaires would not be considered standard of care
3 What methods will you use to recruit subjects Will these methods involve material inducements Subjects who meet the eligibility criteria will be offered participation Subjects will receive testing strips clinic visits at entry and at months 48 and 12 and Hemoglobin A1C HA1C testing at the above intervals free of charge
4 Does your study have a statistical justification for its sample size For the analysis of its results If you answer yes to these questions briefly describe each justification
No
C Identify the potential risks to subjects of participation in your study Describe the expected frequency severity and reversibility of the major risks you identify Include possible late effects of participation eg secondary cancers
All subject records will be kept strictly confidential according to HIPPA privacy rules Subject records will contain only a study number The key to the study numbering will be kept in a locked filing cabinet Subjects may experience slight pain and bruising from the blood draws of the HA1C
D Identify the expected benefits to subjects of participation in your study Also identify any potential scientific benefits produced by your study
Subjects will receive free testing strips and free HA1C testing for a year Subjects may experience better control of their diabetes as a result of testing their blood sugar levels
E Describe the procedure for obtaining the consent of each subject or the subjects parent or representative Confirm that you have attached a copy of each consent form The form should include all the elements of consent listed in the HSC Guidelines
Subjects will be given the informed consent and allowed ample time to read the informed consent or have it read to them Once the consent form has been read subjects will have as much time as needed to ask any questions they may have Once the subject has had all of their questions answered and agrees to participate the subject will sign the consent form in the presence of the PI or a delegate Subjects will be given a copy of the signed consent form for their records
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 21 billion in health care costs and lost productivity Each year over 3600 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 820 million and indirect costs at 1004 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
2 Describe the design of your study Use care to distinguish experimental interventions from standard medical treatment Specifically include the following information
The investigators will enroll 35 subjects identified in either the East or West diabetes clinic who do not have insurance or who are underinsured Underinsured indicates patients with insurance that does not cover the purchase of test strips Certified Diabetes Educators CDE identified other patients after an initial visit when lack of adequate insurance coverage was noted The list of identified patients was sent to the patients physician and CDE Two patients were eliminated who are self-pay by choice they are self-employed and have adequate resources Other subjects were eliminated for the following criteria discharge from UWHC Diabetes Clinic to a primary care provider patients whose diabetes is controlled by diet alone patients who are incarcerated and currently have coverage through the penal system
Subjects will be provided a voucher to obtain free test strips Subjects routinely return to the clinic at 4-month intervals study entry months 4812 During these visits subjects will undergo a Hemoglobin A1C check height weight and blood pressure and complete satisfaction questionnaires at study entry and month 12 Only the questionnaires would not be considered standard of care
3 What methods will you use to recruit subjects Will these methods involve material inducements Subjects who meet the eligibility criteria will be offered participation Subjects will receive testing strips clinic visits at entry and at months 48 and 12 and Hemoglobin A1C HA1C testing at the above intervals free of charge
4 Does your study have a statistical justification for its sample size For the analysis of its results If you answer yes to these questions briefly describe each justification
No
C Identify the potential risks to subjects of participation in your study Describe the expected frequency severity and reversibility of the major risks you identify Include possible late effects of participation eg secondary cancers
All subject records will be kept strictly confidential according to HIPPA privacy rules Subject records will contain only a study number The key to the study numbering will be kept in a locked filing cabinet Subjects may experience slight pain and bruising from the blood draws of the HA1C
D Identify the expected benefits to subjects of participation in your study Also identify any potential scientific benefits produced by your study
Subjects will receive free testing strips and free HA1C testing for a year Subjects may experience better control of their diabetes as a result of testing their blood sugar levels
E Describe the procedure for obtaining the consent of each subject or the subjects parent or representative Confirm that you have attached a copy of each consent form The form should include all the elements of consent listed in the HSC Guidelines
Subjects will be given the informed consent and allowed ample time to read the informed consent or have it read to them Once the consent form has been read subjects will have as much time as needed to ask any questions they may have Once the subject has had all of their questions answered and agrees to participate the subject will sign the consent form in the presence of the PI or a delegate Subjects will be given a copy of the signed consent form for their records
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None