Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007696
Status:
COMPLETED
Last Update Posted:
2011-02-03
First Post:
2000-12-29
Brief Title:
Finding Diabetes Mellitus Among Veterans
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 705D - Screening for Diabetes Mellitus in Veterans
Status:
COMPLETED
Status Verified Date:
2011-02
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:
Population-based screening for diabetes mellitus in non-pregnant adults remains controversial For a screening strategy to be successful patients identified by surveillance will have to have better outcomes than if they had been diagnosed at a later more symptomatic phase of disease However little is known about the fate of patients diagnosed with diabetes by screening Additionally while about half of the cases of diabetes among the general population at any given time are undiagnosed the prevalence of undiagnosed diabetes among veterans is unknown The annual incidence of diabetes among veterans is also unknown
Assessing risk factors prior to blood testing will improve the specificity with little cost in sensitivity of screening for diabetes in a medical center setting The target population which optimizes the potential value of diabetes screening is patients with at least 1 of the above 3 risk factors for diabetes obesity hypertension family history Hypertension is strongly associated with unrecognized diabetes in veterans VA and other health care providers considering whether to perform systematic screening for diabetes should use known risk factors to identify an appropriate target population for screening
Assessing risk factors prior to blood testing will improve the specificity with little cost in sensitivity of screening for diabetes in a medical center setting The target population which optimizes the potential value of diabetes screening is patients with at least 1 of the above 3 risk factors for diabetes obesity hypertension family history Hypertension is strongly associated with unrecognized diabetes in veterans VA and other health care providers considering whether to perform systematic screening for diabetes should use known risk factors to identify an appropriate target population for screening
Detailed Description:
Primary Objectives To measure the prevalence of undiagnosed Diabetes Mellitus DM and the annual incidence of new cases of DM among veterans between the ages of 45 and 64 and to compare the health-related quality of life HRQoL of veterans with undiagnosed DM to those without DM but who are at comparable risk for DM both at baseline and over three years of follow-up
Secondary Objectives To describe the clinical state of veterans with diabetes newly diagnosed by screening and to describe the process of usual care for veterans with diabetes newly diagnosed by screening
Primary Outcomes The primary outcomes are 1 prevalence of undiagnosed non-insulin-dependent diabetes mellitus NIDDM 2 HRQoL as measured by SF-36 3 glycemic control as measured by HbA1C and 4 calculation of the 3-year direct utilization-related cost from the perspective of the VA associated with early diagnosis of DM and comparison of this to the 3-year direct utilization-related cost for veterans who are screened for diabetes but do not have diabetes
Intervention NA
Study Abstract Population-based screening for diabetes mellitus in non-pregnant adults remains controversial For a screening strategy to be successful patients identified by surveillance will have to have better outcomes than if they had been diagnosed at a later more symptomatic phase of disease However little is known about the fate of patients diagnosed with diabetes by screening Additionally while about half of the cases of diabetes among the general population at any given time are undiagnosed the prevalence of undiagnosed diabetes among veterans is unknown The annual incidence of diabetes among veterans is also unknown
A mail-out survey for this study was completed with 10350 surveys mailed and 4500 surveys returned 43 Enrollment concluded 73199 with 1253 new subjects enrolled Follow-up of the enrolled subjects is ongoing Some descriptive analyses of the data revealed the prevalence of undiagnosed diabetes was 45 Factors associated with unrecognized diabetes were the diagnosis of hypertension and history of a parent or sibling with diabetes Having a primary care provider did not raise or lower the risk for unrecognized diabetes Based on the new diagnosis most patients found to have diabetes required a change in treatment either of their blood sugar or comorbid hypertension or hyperlipidemia in order to achieve targets recommended in published treatment guidelines Patients reporting a primary care provider were no less likely to require a change in treatment
Conclusions If diabetes screening is an effective intervention opportunistic screening for diabetes may be the preferred method for screening as there is substantial potential for case-finding in a medical center outpatient setting A majority of patients with diabetes diagnosed at opportunistic screening will require a change in treatment of blood sugar blood pressure or lipids to receive optimal care
Secondary Objectives To describe the clinical state of veterans with diabetes newly diagnosed by screening and to describe the process of usual care for veterans with diabetes newly diagnosed by screening
Primary Outcomes The primary outcomes are 1 prevalence of undiagnosed non-insulin-dependent diabetes mellitus NIDDM 2 HRQoL as measured by SF-36 3 glycemic control as measured by HbA1C and 4 calculation of the 3-year direct utilization-related cost from the perspective of the VA associated with early diagnosis of DM and comparison of this to the 3-year direct utilization-related cost for veterans who are screened for diabetes but do not have diabetes
Intervention NA
Study Abstract Population-based screening for diabetes mellitus in non-pregnant adults remains controversial For a screening strategy to be successful patients identified by surveillance will have to have better outcomes than if they had been diagnosed at a later more symptomatic phase of disease However little is known about the fate of patients diagnosed with diabetes by screening Additionally while about half of the cases of diabetes among the general population at any given time are undiagnosed the prevalence of undiagnosed diabetes among veterans is unknown The annual incidence of diabetes among veterans is also unknown
A mail-out survey for this study was completed with 10350 surveys mailed and 4500 surveys returned 43 Enrollment concluded 73199 with 1253 new subjects enrolled Follow-up of the enrolled subjects is ongoing Some descriptive analyses of the data revealed the prevalence of undiagnosed diabetes was 45 Factors associated with unrecognized diabetes were the diagnosis of hypertension and history of a parent or sibling with diabetes Having a primary care provider did not raise or lower the risk for unrecognized diabetes Based on the new diagnosis most patients found to have diabetes required a change in treatment either of their blood sugar or comorbid hypertension or hyperlipidemia in order to achieve targets recommended in published treatment guidelines Patients reporting a primary care provider were no less likely to require a change in treatment
Conclusions If diabetes screening is an effective intervention opportunistic screening for diabetes may be the preferred method for screening as there is substantial potential for case-finding in a medical center outpatient setting A majority of patients with diabetes diagnosed at opportunistic screening will require a change in treatment of blood sugar blood pressure or lipids to receive optimal care
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