Screening for Prediabetes

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00787839
First received: November 6, 2008
Last updated: October 2, 2014
Last verified: October 2014

November 6, 2008
October 2, 2014
June 2009
December 2012   (final data collection date for primary outcome measure)
Ability of the glucose challenge test to predict findings with the oral glucose tolerance test [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Identification of diabetes or prediabetes based on an oral glucose tolerance test
Ability of the glucose challenge test to predict findings with the oral glucose tolerance test [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00787839 on ClinicalTrials.gov Archive Site
  • Costs of identifying cases of prediabetes or previously unrecognized diabetes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Behavior of providers when diabetes or prediabetes is identified [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Referral for assistance in lifestyle change, initiation or change in dosage of medication intended to control glucose, blood pressure, and lipid levels
Costs of identifying cases of prediabetes or previously unrecognized diabetes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Screening for Prediabetes
Screening for Prediabetes and Early Diabetes in Primary Care

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   None Retained
Description:

blood samples

Non-Probability Sample

initial primary study population will be drawn primarily from veterans receiving primary care at the Decatur Clinic CBOC in metropolitan Atlanta, GA

  • Type 2 Diabetes Mellitus
  • Prediabetic State
  • 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.
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
Interventions:
  • Other: Glucose challenge test
  • Other: Glucose tolerance test

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1939
December 2012
December 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00787839
IIR 07-138
No
Department of Veterans Affairs
Department of Veterans Affairs
Emory University
Principal Investigator: Lawrence S Phillips, MD Atlanta VA Medical and Rehab Center, Decatur
Department of Veterans Affairs
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP