Diabetes MellitusNCT00007696
Finding Diabetes Mellitus Among Veterans
An observational study of Diabetes Mellitus, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 1,276 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1998to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Veterans between the ages of 45 and 64.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CSP #705D - Screening for Diabetes Mellitus in Veterans
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.
Read the 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: N/A
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 10,350 surveys mailed and 4,500 surveys returned (43%). Enrollment concluded 7/31/99 with 1,253 new subjects enrolled. Follow-up of the enrolled subjects is ongoing. Some descriptive analyses of the data revealed the prevalence of undiagnosed diabetes was 4.5%. 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.
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus,DM,glycemic control
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2001 (estimated)
- Study startApr 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- David Edelman, MD MHS, Study chair, Durham VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007696
- Sponsor's protocol ID
- 705D
- Status last verified
- Feb 2011
- First submitted
- 29 Dec 2000
- Last updated
- 3 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #705D - Screening for Diabetes Mellitus in Veterans
- ClinicalTrials.gov ID
- NCT00007696
- Acronym / sponsor ID
- 705D
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus,DM,glycemic control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,276 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 1998
- First posted
- 4 Jan 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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: N/A
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 10,350 surveys mailed and 4,500 surveys returned (43%). Enrollment concluded 7/31/99 with 1,253 new subjects enrolled. Follow-up of the enrolled subjects is ongoing. Some descriptive analyses of the data revealed the prevalence of undiagnosed diabetes was 4.5%. 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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Veterans between the ages of 45 and 64.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Edelman, MD MHS study chair
Durham VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2011.