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Performance of Recommended Screening
Tests for Undiagnosed Diabetes and
Dysglycemia
DEBORAH B. ROLKA,
MS
1
K. M. VENKAT NARAYAN,
MD
1
THEODORE J. THOMPSON,
MS
1
DONA GOLDMAN,
BSN
,
MPH
2
JOANN LINDENMAYER,
DVM
,
MPH
2
KATE ALICH,
MS, RD
3
DARCY BACALL,
RN
,
CDE
3
EVAN M. BENJAMIN,
MD
4
BETTY LAMB,
RN
,
MSN
1
DENNIS O. STUART,
MD
5
MICHAEL M. ENGELGAU,
MD
1
OBJECTIVE — To evaluate the performance, in settings typical of opportunistic and com-
munity screening programs, of screening tests currently recommended by the American Diabetes
Association (ADA) for detecting undiagnosed diabetes.
RESEARCH DESIGN AND METHODS — Volunteers aged ⱖ20 years without previ-
ously diagnosed diabetes (n ⫽ 1,471) completed a brief questionnaire and underwent recording
of postprandial time and measurement of capillary blood glucose (CBG) with a portable sensor.
Participants subsequently underwent a 75-g oral glucose tolerance test; fasting serum glucose
(FSG) and 2-h postload serum glucose (2-h SG) concentrations were measured. The screening
tests we studied included the ADA risk assessment questionnaire, the recommended CBG cut
point of 140 mg/dl, and an alternative CBG cut point of 120 mg/dl. Each screening test was
evaluated against several diagnostic criteria for diabetes (FSG ⱖ126 mg/dl, 2-h SG ⱖ200 mg/dl,
or either) and dysglycemia (FSG ⱖ110 mg/dl, 2-h SG ⱖ140 mg/dl, or either).
RESULTS — Among all participants, 10.7% had undiagnosed diabetes (FSG ⱖ126 or 2-h SG
ⱖ200 mg/dl), 52.1% had a positive result on the questionnaire, 9.5% had CBG ⱖ140 mg/dl, and
18.4% had CBG ⱖ120 mg/dl. The questionnaire was 72–78% sensitive and 50 –51% specific for
the three diabetes diagnostic criteria; CBG ⱖ140 mg/dl was 56 –65% sensitive and 95–96%
specific, and CBG ⱖ120 mg/dl was 75–84% sensitive and 86–90% specific. CBG ⱖ120 mg/dl
was 44– 62% sensitive and 89–90% specific for dysglycemia.
CONCLUSIONS — Low specificity may limit the usefulness of the ADA questionnaire.
Lowering the cut point for a casual CBG test (e.g., to 120 mg/dl) may improve sensitivity and still
provide adequate specificity.
Diabetes Care 24:1899 –1903, 2001
S
creening for undiagnosed diabetes
has been favored by some (1– 4) but
discouraged by others (5,6). A com-
prehensive review (7) found indirect evi-
dence supporting an opportunistic
screening approach (i.e., screening sub-
jects visiting a health care provider for
reasons unrelated to diabetes) but noted
that currently recommended screening
strategies have not been fully evaluated.
Understanding the performance of
screening strategies will also be important
if the interventions of the ongoing Diabe-
tes Prevention Program (8) are found to
be effective in reducing the onset of dia-
betes in subjects with impaired glucose
tolerance.
We evaluated the performance, in set-
tings typical of opportunistic and com-
munity screening programs, of several
screening strategies for type 2 diabetes
that are currently recommended by the
American Diabetes Association (ADA)
(4). The screening tests we evaluated in-
cluded the ADA risk assessment question-
naire and tests based on casual capillary
blood glucose (CBG) measures. The diag-
nostic criteria for this study were diabetes,
impaired fasting glucose (IFG), and im-
paired glucose tolerance (IGT), as deter-
mined by fasting serum glucose (FSG) or
2-h postload serum glucose (2-h SG) con-
centrations measured as part of a single
75-g oral glucose tolerance test (OGTT).
RESEARCH DESIGN AND
METHODS — Between September
1995 and July 1998, 1,471 volunteers
aged ⱖ20 years were recruited by health
care systems serving communities in
Springfield, MA; Robeson County, NC;
and Providence, Pawtucket, and Central
Falls, RI. Participants were recruited dur-
ing routine health center visits and at
community health fairs. Informed con-
sent was obtained from all participants,
and the study protocol was approved by
the institutional review boards at the Cen-
ters for Disease Control and Prevention
and each of the study sites. Persons who
had self-reported previously diagnosed
diabetes, had been pregnant or breast-
feeding within the previous 3 months, or
had been hospitalized within the previous
6 months were not eligible to participate
in the study.
Screening tests were administered at
recruitment. Eligible participants com-
pleted a 14-item questionnaire that in-
cluded the 7 items needed to score the
ADA questionnaire test (Table 1). A por-
table sensor (Accu Chek Advantage;
Roche Diagnostics, Indianapolis, IN) was
used to obtain a whole-blood glucose
●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●
From the
1
Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia; the
2
Rhode Island Department of Health, Providence, Rhode Island; the
3
Massachusetts Department of Public
Health, Boston, Massachusetts; the
4
Baystate Medical Center, Springfield, Massachusetts; and the
5
Robeson
Health Care Corporation, Fairmont, North Carolina.
Address correspondence and reprint requests to Deborah B. Rolka, Mailstop K-10, 4770 Buford Highway
NE, Atlanta, GA 30341. E-mail: drolka@cdc.gov.
Received for publication 6 March 2001 and accepted in revised form 26 July 2001.
Abbreviations: 2-h SG, 2-h postload serum glucose; ADA, American Diabetes Association; CBG, capillary
blood glucose; FSG, fasting serum glucose; IFG, impaired fasting glucose; IGT, impaired glucose tolerance;
OGTT, oral glucose tolerance test; WHO, World Health Organization.
A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion
factors for many substances.
Epidemiology/Health Services/Psychosocial Research
ORIGINAL ARTICLE
DIABETES CARE, VOLUME 24, NUMBER 11, NOVEMBER 2001 1899
level from a capillary (finger stick) sample
from each eligible participant, and time
since ingestion of any food or drink ex-
cept water (postprandial time) was re-
corded.
Participants were scheduled to return
for a 75-g OGTT on a subsequent morn-
ing (usually within 7 days) after fasting
overnight for ⱖ10 h. During this visit,
fasting and 2-h postload venous blood
specimens were collected and FSG and
2-h SG concentrations were analyzed in a
clinical laboratory using glucose oxidase
methodology.
We computed the sensitivity (i.e.,
proportion of participants with a positive
test, among those who satisfied the crite-
rion) and specificity (i.e., proportion of
participants with a negative test, among
those who did not satisfy the criterion) of
four screening tests for six diagnostic cri-
teria.
To investigate how covariates may ef-
fect performance characteristics and the
choice of appropriate cut points for the
CBG, we fit multiple regression models
relating CBG to diabetes (FSG ⱖ126 mg/
dl), age (⬍45 or ⱖ45 years), postprandial
time (⬍8orⱖ8 h), sex, and race/ethnicity
(Hispanic, non-Hispanic white, or Afri-
can-American). We also computed the
sensitivity and specificity of the four
screening tests for FSG ⱖ126 mg/dl sep-
arately by sex and race/ethnicity.
CBG measurements were valid in all
but 3 of the 1,471 eligible participants,
but postprandial time was not recorded
for 44 participants (3.0%). FSG values
were not recorded for 380 participants
(26%), and 2-h SG values were not re-
corded for 403 participants (27%). To re-
duce the potential for bias, we applied the
standard statistical technique of multiple
imputation (9). Every estimate we report
is the arithmetic mean of estimates ob-
tained from 10 imputed data sets. We
used the software program NORM (10) to
impute missing values and we used SAS
software (SAS Institute, Cary, NC) (11) to
analyze the data and combine the esti-
mates.
RESULTS — Participants included
Hispanics (58%), non-Hispanic whites
(19%), African-Americans (12%), Native
Americans (4%), and others (7%). The
mean age of the participants was 44 years
(20– 44 years, 43%; 45– 64 years, 25%;
65–89 years, 32%), and 70% of the par-
ticipants were women. A total of 34% of
the participants had a parent with diabe-
tes, and 17% had a sibling with diabetes;
67% of the participants reported little or
no physical activity in most weeks, and
51% of participants had BMI ⱖ27 kg/m
2
.
A total of 52% of all participants had a
positive score (ⱖ10 points) on the ADA
questionnaire; 9.5% had CBG ⱖ140 mg/
dl, and 18.4% had CBG ⱖ120 mg/dl.
Fasting and 2-h diagnostic criteria for di-
abetes, impaired glucose, and normogly-
cemia resulted in somewhat different
classifications of participants (Table 2).
We estimated that 157 subjects (10.7%)
had undiagnosed diabetes, according to
one or both of the two criteria, and that an
additional 221 (15.0%) had impaired glu-
cose (IFG or IGT) without satisfying ei-
ther of the criteria for diabetes.
The ADA questionnaire was moder-
ately sensitive (69 –78%) for all diagnostic
criteria for diabetes and dysglycemia;
however, its specificity did not exceed
54% (Table 3). The cut point of 140 mg/dl
for CBG was quite specific (95–97%) for
all of the diagnostic criteria but only 56–
65% sensitive for diabetes and 28 – 41%
sensitive for dysglycemia.
Empirical receiver operating charac-
teristic curves suggest that a CBG cut
point of 120 mg/dl may yield a good bal-
ance of sensitivity and specificity (Fig. 1).
Indeed, this test was 75– 84% sensitive for
diabetes, 44– 62% sensitive for dysglyce-
mia, and 86–90% specific for all of the
diagnostic criteria.
The ADA recommends that, in com-
munity screening programs, glycemic
testing should be performed only after ad-
ministration of a risk assessment ques-
tionnaire (4). This combination (a
positive ADA questionnaire and CBG
ⱖ120 mg/dl) was less sensitive and more
specific than either the questionnaire or
CBG ⱖ120 mg/dl alone (Table 3). The
ADA also recommends using a capillary
blood glucose cut point of 110 mg/dl (in-
stead of 140 mg/dl) for subjects who have
fasted for ⱖ8 h (4). Among study partic-
ipants who had not eaten for ⱖ8 h (37%
of all participants), CBG ⱖ110 mg/dl was
82–95% sensitive and 86 – 89% specific
for diabetes and 51– 80% sensitive and
89–94% specific for dysglycemia.
The ADA questionnaire was less sen-
sitive (65 vs. 77%) and more specific (56
vs. 47%) for diabetes (FSG ⱖ126 mg/dl)
in men than in women. The CBG tests
were more sensitive and less specific
among men than in women. CBG ⱖ140
mg/dl was 81% sensitive and 95% specific
in men and 56% sensitive and 96% spe-
cific in women. CBG ⱖ120 mg/dl was
90% sensitive and 86% specificinmen
and 80% sensitive and 88% specificin
women.
We derived estimated receiver oper-
ating characteristic curves from a linear
regression in which the natural log of
CBG was modeled as a function of dia-
betes (FSG ⱖ126 mg/dl), age, postpran-
dial time, and sex. We assumed normally
Table 1—Scoring the questionnaire test
Item Points
1. Woman who delivered a
macrosomic (ⱖ9 lb) infant
1
2. One or more siblings with
diabetes
1
3. One or more parents with
diabetes
1
4. BMI ⱖ27 kg/m
2
5
5. Age ⬍65 years and little
or no physical activity in
most weeks
5
6. Age 45–64 years 5
7. Age ⱖ65 years 9
Subjects with a total of ⱖ10 points were considered
to have had a positive result of the screening test.
Table 2—Classification of participants by OGTT results
ISG
2-h SG
⬍140 mg/dl
(normoglycemia)
140–199 mg/dl
(IGT)
ⱖ200 mg/dl
(diabetes) Total
⬍110 mg/dl (normoglycemia) 1,093 (74.3) 124 (8.4) 17 (1.2) 1,234 (83.9)
110–125 mg/dl (IFG) 63 (4.3) 34 (2.3) 15 (1.0) 112 (7.6)
ⱖ126 mg/dl (diabetes) 20 (1.3) 27 (1.9) 78 (5.3) 125 (8.5)
Total 1,176 (79.9) 185 (12.6) 110 (7.5) 1,471 (100)
Data are means (% of total) from 10 imputed data sets. A total of 3% of participants had missing FSG values,
and 27% had missing 2-h SG values.
Performance of diabetes screening tests
1900 DIABETES CARE, VOLUME 24, NUMBER 11, NOVEMBER 2001
Figure 1—Empirical receiver operating characteristic curves. Sensitivity vs. 1-specificity of CBG is plotted over a range of CBG cut points for
diabetes (top row) and dysglycemia (bottom row). Diagnostic criteria are FSG ⱖ126 mg/dl (A), 2-h SG ⱖ200 mg/dl (B), FSG ⱖ126 mg/dl or 2-h
SG ⱖ200 mg/dl (C), FSG ⱖ110 mg/dl (D), 2-h SG ⱖ140 mg/dl (E), FSG ⱖ110 mg/dl or 2-h SG ⱖ140 mg/dl (F).
Table 3—Sensitivity and specificity of four screening tests for six diabetes and dysglycemia criteria
ADA Questionnaire CBG ⱖ140 mg/dl CBG ⱖ120 mg/dl
ADA questionnaire and
CBG ⱖ120 mg/dl
Sensitivity Specificity Sensitivity Specificity Sensitivity Specificity Sensitivity Specificity
Diabetes criterion:
FSG ⱖ126 mg/dl 72 (69–75) 50 (49–50) 65 (63–68) 96 (95–96) 84 (78–89) 88 (87–88) 63 (58–68) 93 (92–93)
2-h SG ⱖ200 mg/dl 78 (73–84) 50 (50–51) 62 (55–68) 95 (94–95) 78 (72–84) 86 (86–87) 60 (54–67) 92 (91–93)
FSG ⱖ126 mg/dl or 2-h
SG ⱖ200 mg/dl
75 (72–79) 51 (50–51) 56 (53–59) 96 (96–96) 75 (70–80) 88 (88–89) 58 (54–62) 94 (93–94)
Dysglycemia criterion:
FSG ⱖ110 mg/dl 69 (66–72) 51 (50–52) 41 (39–43) 97 (96–97) 62 (57–66) 90 (89–91) 45 (42–48) 95 (94–95)
2-h SG ⱖ140 mg/dl 72 (69–75) 53 (52–54) 33 (31–35) 96 (96–97) 48 (45–50) 89 (88–90) 36 (34–39) 94 (94–95)
FSG ⱖ110 mg/dl or 2-h
SG ⱖ140 mg/dl
69 (67–71) 54 (53–55) 28 (27–29) 97 (97–97) 44 (41–47) 90 (90–91) 32 (30–34) 95 (95–96)
Data are % (95% CI). The 95% CIs account only for the uncertainty due to missing data and are computed as (mean point estimate) ⫾ [(t
.975, 9
) ⫻ (1 ⫹ 1/10)
1/2
⫻
(SD of 10 point estimates)].
Rolka and Associates
DIABETES CARE, VOLUME 24, NUMBER 11, NOVEMBER 2001 1901
distributed errors and heterogeneous
variances (varying by diabetes and post-
prandial time). Cut points for the CBG
test that were optimal (maximizing the
sum of sensitivity and specificity) tended
to be lower for younger subjects and those
with longer postprandial times and higher
for men. CBG performed somewhat bet-
ter (larger areas under the curves) for men
than for women and for subjects with
postprandial time ⱖ8 h than for those
with postprandial time ⬍8 h (Fig. 2).
The sensitivities and specificities of
the four screening tests varied little by
race or ethnicity, and we did not find sub-
stantial racial or ethnic differences in the
performance of CBG for diabetes (FSG
ⱖ126 mg/dl) after controlling for age,
postprandial time, and sex.
CONCLUSIONS — This is the first
comprehensive evaluation of screening
tests that use a questionnaire or casual
CBG measure to detect undiagnosed dia-
betes or dysglycemia in patient popula-
tions and settings typical of current U.S.
screening initiatives. Using several diag-
nostic criteria for diabetes and dysglyce-
mia, we found that the ADA questionnaire
favored sensitivity, whereas CBG ⱖ140
mg/dl (the recommended cut point) fa-
vored specificity.
The ADA questionnaire was devel-
oped from the Second U.S. National
Health and Nutritional Examination Sur-
vey using a binary classification algorithm
(12). The ADA questionnaire yielded
lower specificity in our study than it did
in previous evaluations. In the current
study, the questionnaire was 78% sensi-
tive and 50% specific for the World
Health Organization (WHO) diabetes cri-
terion (2-h SG ⱖ200 mg/dl) (13). Sensi-
tivity for this WHO criterion was 79%,
and specificity was 65% in the initial eval-
uation of the ADA questionnaire (12). In
an evaluation that was conducted using
the Netherlands’ Hoorn Study popula-
tion, sensitivity was 72% and specificity
was 56% (14).
CBG screening tests for diabetes have
been suggested because they use current
self-monitoring technology and require
minimal technical skill and laboratory
support compared with more laboratory-
based tests (e.g., serum glucose or HbA
1c
).
Previous evaluations of CBG screening
tests have reported sensitivities of 50–
70% at 90% specificity (15,16). In our
study, CBG was ⬎70% sensitive for the
WHO diabetes criterion (13) at 90% spec-
ificity.
The performance of CBG tests may
depend on postprandial time and other
factors such as age or sex (7,15,17). Con-
sistent with a previous study (15), we
found that optimal CBG cut points may
be lower for younger subjects and those
with longer (ⱖ8 h) postprandial times. In
contrast with that study, in which the best
performance was observed among those
with the shortest postprandial times (15),
we found that CBG performed somewhat
better in individuals with longer post-
prandial times than in those with post-
prandial times ⬍8 h. In our study, we also
observed better performance and slightly
higher optimal cut points in men than in
women.
Diabetes screening tests have been
evaluated in homogeneous populations
(15,18–22) but rarely in racially hetero-
geneous populations. We were able to ex-
amine the potential effects of race or
ethnicity and found that the performance
characteristics of the ADA questionnaire
and the CBG measure did not vary sub-
stantially by race or ethnicity.
Detection of IFG or IGT is not a goal
of most current diabetes screening efforts.
This may change, however, if the lifestyle
and/or medication interventions of the
Diabetes Prevention Program (8) are
shown to be effective. We included diag-
nostic criteria for dysglycemia (i.e., diabe-
tes and IFG or IGT) and examined the
performance of current diabetes screen-
ing tests when applied to these broader
diagnostic criteria. Our data suggest that
CBG measures do not discriminate dys-
glycemia from normoglycemia as well as
they discriminate subjects with diabetes
from those without diabetes.
Our study has some limitations. Be-
cause our volunteers and participating
clinics were not probability samples, we
do not make formal statistical inference
beyond the study population. We believe
that the participation of subjects from ur-
ban and rural areas in three states yielded
a study population reflecting the hetero-
geneity of U.S. populations. However, be-
cause it would be inappropriate to use this
study population to develop new screen-
ing tests and strategies, we focused our
evaluation on existing screening tests.
Missing data may have biased our esti-
mates for the study population; we at-
tempted to minimize this bias through the
use of multiple imputation. Also, clinical
diagnosis requires repeat testing, and the
diagnostic criteria that we defined are
based on a single OGTT. Therefore, our
sensitivities and specificities were esti-
mated relative to imperfect criteria.
Our estimates can be used to help
project resource needs and expected
yields. For example, suppose that a pro-
gram plans to use a casual CBG test to
screen a population of 5,000 individuals
for diabetes (FSG ⱖ126 mg/dl). We esti-
mated that the screening test CBG ⱖ120
mg/dl is 84% sensitive and 88% specific.
If the population prevalence of diabetes is
assumed to be 8%, then screening with
CBG ⱖ120 mg/dl can be projected to
Figure 2—Estimated receiver operating characteristic curves by age, sex, and postprandial time.
Sensitivity and specificity of CBG for the diabetes criterion of FSG ⱖ126 mg/dl were estimated
using the multiple regression model described in the text, in which the natural log of CBG is
modeled as a function of diabetes, age, postprandial time, sex, and diabetes ⫻ sex.
Performance of diabetes screening tests
1902 DIABETES CARE, VOLUME 24, NUMBER 11, NOVEMBER 2001
yield 8% ⫻ 84% ⫻ 5,000 ⫽ 336 true
positives (new cases), 92% ⫻ 12% ⫻
5,000 ⫽ 552 false positives, and 8% ⫻
16% ⫻ 5,000 ⫽ 64 false negatives
(missed cases). The projected positive pre-
dictive value (proportion of actual cases
among those who have positive tests)
would be 336 ⫼ (336 ⫹ 552) ⫽ 29.8%.
The U.S. Preventive Services Task
Force has voiced concern about the lack
of a practical screening test that is both
sensitive and specific (5). We found that
the usefulness of the ADA questionnaire
as a screening test may indeed be limit-
ed by its low specificity. The casual CBG
measure offers better performance and
the flexibility to select threshold cut points
that balance sensitivity and specificity
with the available resources; lowering the
cut point (e.g., to 120 mg/dl) may im-
prove sensitivity and still provide ade-
quate specificity.
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