Screening for Prediabetes
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/1/2014 |
| Start Date: | June 2009 |
| End Date: | December 2012 |
| Contact: | Jennifer A Michaels, MLS |
| Email: | Jennifer.Michaels@va.gov |
| Phone: | (404) 321-6111 |
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.
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.
~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.
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)
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