Opportunistic Screening for Prediabetes and Early Diabetes in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00787839
Recruitment Status : Completed
First Posted : November 10, 2008
Results First Posted : December 23, 2014
Last Update Posted : April 27, 2015
Emory University
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
People who might have prediabetes or unrecognized diabetes will be screened for these problems at an outpatient visit. For screening, they will take a sugary drink containing 50 grams of glucose, and have a blood sample one hour later. The blood sample will be tested for glucose and A1c (a measure of blood glucose over the previous two months). They will also fill out questionnaires that ask about their health history and how they would feel about exercising and trying to lose weight if they are found to have prediabetes or diabetes. At a subsequent visit, they will have an oral glucose tolerance test (OGTT) - a blood sample, then a sugary drink containing 75 grams of glucose, and a repeat blood sample 2 hours later. We will evaluate the costs of finding out if people have prediabetes or diabetes. For people who are found to have these problems, we will also evaluate how well their doctors treat these problems.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Prediabetic State Other: Glucose challenge test Other: Glucose tolerance test

Detailed Description:

RELEVANCE TO VETERANS' HEALTH: Lack of a good strategy to identify prediabetes - probably ~10 years prior to the development of diabetes that is recognized clinically - may be the greatest present impediment to diabetes care. We are developing a new way to screen for prediabetes, and it should constitute a major opportunity to improve the health of ~4 million veterans; early recognition of glucose intolerance would permit institution of preventive strategies which are efficacious, convenient, and cost-effective - improving the health of individual veterans, reducing diabetes-related health care resource use and costs for the VA, and helping to spare VA funds for management of other disorders.

BACKGROUND: Prediabetes is a major public health problem which confers risk of diabetes and cardiovascular disease (CVD), but veterans with prediabetes are not detected, and cannot receive interventions to reduce their risks; CVD events, health resource use, and cost all rise before diabetes is diagnosed. Diabetes can be prevented or delayed by lifestyle change or medication, but since we do not identify prediabetes, glucose intolerance progresses for 5-10 years, and many patients have early diabetes complications and increased CVD risk when they are finally recognized. We are developing a new screening test for prediabetes, a "glucose challenge test" (GCT): patients have a 50g oral glucose challenge at any time of day, regardless of meal status, with a single 1 hr sample. If the GCT exceeds a cutoff, they have a 75g oral glucose tolerance test after an overnight fast, with 0 and 2 hr samples (OGTT). Our GCRC-based Preliminary Data show ROC AUC 0.83 (70% specificity, 82% sensitivity) and $51 per case identified; the GCT should constitute an effective, convenient, inexpensive, cost-effective screen for prediabetes - a critical indicator of individual, VA health care system, and societal risk.

OBJECTIVES: To translate our findings into improved health for VA patients, the GCT will need to be implemented in VA primary care settings - where practitioners often do not screen for prediabetes, or manage diabetes optimally. Such barriers must be overcome in order to conduct definitive studies aimed to show that use of the GCT to detect prediabetes (and previously unrecognized diabetes) in primary care leads to improved outcomes. Thus, VA policies for system-wide implementation of GCT screening must be preceded by logical next steps: validation and demonstration of likely cost-effectiveness.

METHODS: AIM #1. Validation: (A) To establish feasibility, we will interact with VA primary care providers to solve logistical problems, and determine optimal screening strategies. (B) To assess test performance, we will (a) perform GCTs and measure A1c in ~1,800 patients, (b) evaluate OGTTs in all subjects, and (c) compare sensitivity, specificity, and ROC curves from GCT vs. A1c or "predictive model" screening in primary care to those in our GCRC studies. Availability of this dataset will also permit (d) subsequent management of diabetes/prediabetes to be evaluated relative to standardized guidelines. AIM #2. Costs: To evaluate impact, we will (a) capture the costs of diagnostic tests, staff effort, and patient time; (b) express cost per case identified from both VA health system and societal perspectives; and (c) compare GCT vs. alternative strategies with a wide range of assumptions about false-(+)/false-(-) costs to reflect downstream cost implications of test imperfections. Engagement with this process will also provide (d) for those study patients with prediabetes who go on to develop diabetes, an opportunity to explore VA resource use and costs before and after the diagnosis of diabetes. This will provide preliminary data for subsequent proposals to compare resource use and costs vs. those of other VA patients who are newly diagnosed with diabetes in settings where there is no screening for prediabetes.

Study Type : Observational
Actual Enrollment : 1939 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Screening for Prediabetes and Early Diabetes in Primary Care
Study Start Date : June 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Group/Cohort Intervention/treatment
Group 1
Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, the American Diabetes Association, and the National Institutes of Health
Other: Glucose challenge test
At a first outpatient visit, at different times of the day and without a prior fast, subjects will have a 50 gram glucose drink followed by measurement of plasma and capillary glucose along with A1c one hour later. They will also fill out questionnaires. At a second outpatient visit, in the morning after fasting overnight, they will have a 75 gram oral glucose tolerance test.

Other: Glucose tolerance test
Subjects found to have diabetes or prediabetes on the initial glucose tolerance test may be requested to have a repeat glucose tolerance test and A1c.

Primary Outcome Measures :
  1. Ability of Different Screening Tests Which Can be Performed Opportunistically (During Outpatient Visits -- at Any Time of Day, Regardless of Meal Status) to Predict Findings With the Oral Glucose Tolerance Test (in the Morning, After an Overnight Fast) [ Time Frame: 3 years ]

    Area under ROC curve (AROC) for prediction of diabetes (based on OGTT) and high-risk dysglycemia (based on OGTT, IGT with 2 hour OGTT glucose 140-199 mg/dl, and/or IFG with fasting glucose 110-125 mg/dl).

    ROC curves are plots of (1-sensitivity) vs. (1-specificity) for all possible screening cutoffs, so a higher AROC indicates higher predictive accuracy. A perfect test would have an AROC of 1.00, while a test equivalent to tossing a coin (random) would have an AROC of 0.50; if confidence limits include 0.50, predictive accuracy is no better than chance.

    It is important to appreciate that while AROC analysis can show the relative accuracy of different screening tests, and aid the selection of which test to use in clinical practice, such an analysis does not define what the optimal screening test cutoff is. Selection of the optimal cutoff generally requires consideration of other factors, such as costs and/or the clinical importance of having higher or lower sensitivity.

Secondary Outcome Measures :
  1. Cost to Identify a Single Case of High-risk Dysglycemia or Previously Unrecognized Diabetes [ Time Frame: 3 years ]
    Cost was expressed as cost (dollars) to identify a single case, with cases defined as (i) diabetes or (ii) high-risk dysglycemia. Cost projections for screening were conducted from both Medicare and VA perspectives. All screening projections assumed follow-up testing with an OGTT if the screening test exceeded a 70% specificity cut-off.

Biospecimen Retention:   None Retained
blood samples

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
initial primary study population will be drawn primarily from veterans receiving primary care at the Decatur Clinic CBOC in metropolitan Atlanta, GA

Inclusion Criteria:

  • veteran status,
  • ambulatory outpatient at Atlanta VA Medical Center,
  • visit to primary care clinic, AND
  • meet criteria for screening (age >= 45 years or other risk factors [body mass index >=25 or hypertension or systolic blood pressure >=140 or HDL cholesterol <35 in men or <45 in women or fasting triglycerides >250 or first-degree relative with diabetes or minority race or minority ethnicity or history of diabetes during pregnancy or history of having a baby weighing >9 pounds or history of polycystic ovary syndrome])

Exclusion Criteria:

  • known to have diabetes, OR
  • taking steroids OR pregnant, OR
  • not well enough to have worked during the previous week (actual employment not necessary)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00787839

United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
VA Office of Research and Development
Emory University
Principal Investigator: Lawrence S Phillips, MD Atlanta VA Medical and Rehab Center, Decatur, GA

Publications of Results:

Responsible Party: VA Office of Research and Development Identifier: NCT00787839     History of Changes
Other Study ID Numbers: IIR 07-138
First Posted: November 10, 2008    Key Record Dates
Results First Posted: December 23, 2014
Last Update Posted: April 27, 2015
Last Verified: October 2014

Keywords provided by VA Office of Research and Development:
type 2 diabetes mellitus
prediabetic state
mass screening
glucose tolerance test

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases