OBJECTIVETo simulate the outcomes of alternative strategies for screening the U.S. population 45-74 years of age for type 2 diabetes.RESEARCH DESIGN AND METHODSWe simulated screening with random plasma glucose (RPG) and cut points of 100, 130, and 160 mg/dl and a multivariate equation including RPG and other variables. Over 15 years, we simulated screening at intervals of 1, 3, and 5 years. All positive screening tests were followed by a diagnostic fasting plasma glucose or an oral glucose tolerance test. Outcomes include the numbers of false-negative, true-positive, and false-positive screening tests and the direct and indirect costs.RESULTSAt year 15, screening every 3 years with an RPG cut point of 100 mg/dl left 0.2 million false negatives, an RPG of 130 mg/dl or the equation left 1.3 million false negatives, and an RPG of 160 mg/dl left 2.8 million false negatives. Over 15 years, the absolute difference between the most sensitive and most specific screening strategy was 4.5 million true positives and 476 million false-positives. Strategies using RPG cut points of 130 mg/dl or the multivariate equation every 3 years identified 17.3 million true positives; however, the equation identified fewer false-positives. The total cost of the most sensitive screening strategy was $42.7 billion and that of the most specific strategy was $6.9 billion.CONCLUSIONSScreening for type 2 diabetes every 3 years with an RPG cut point of 130 mg/dl or the multivariate equation provides good yield and minimizes false-positive screening tests and costs.

OBJECTIVETo develop and validate an empirical equation to screen for diabetes.RESEARCH DESIGN AND METHODSA predictive equation was developed using multiple logistic regression analysis and data collected from 1,032 Egyptian subjects with no history of diabetes. The equation incorporated age, sex, BMI, postprandial time (self-reported number of hours since last food or drink other than water), and random capillary plasma glucose as independent covariates for prediction of undiagnosed diabetes. These covariates were based on a fasting plasma glucose level >/=126 mg/dl and/or a plasma glucose level 2 h after a 75-g oral glucose load >/=200 mg/dl. The equation was validated using data collected from an independent sample of 1,065 American subjects. Its performance was also compared with that of recommended and proposed static plasma glucose cut points for diabetes screening.RESULTSThe predictive equation was calculated with the following logistic regression parameters: P = 1/(1 - e(-x)), where x = -10.0382 + [0.0331 (age in years) + 0.0308 (random plasma glucose in mg/dl) + 0.2500 (postprandial time assessed as 0 to >/=8 h) + 0.5620 (if female) + 0.0346 (BMI)]. The cut point for the prediction of previously undiagnosed diabetes was defined as a probability value >/=0.20. The equation's sensitivity was 65%, specificity 96%, and positive predictive value (PPV) 67%. When applied to a new sample, the equation's sensitivity was 62%, specificity 96%, and PPV 63%.CONCLUSIONSThis multivariate logistic equation improves on currently recommended methods of screening for undiagnosed diabetes and can be easily implemented in a inexpensive handheld programmable calculator to predict previously undiagnosed diabetes.

OBJECTIVE Care for chronic diseases may compete with preventive health care. To test this hypothesis, we examined the association between diabetes-related processes of care and preventive care in women. RESEARCH DESIGN AND METHODS Using data from a prospective cohort study of diabetes care in managed care settings, we reviewed the care 540 diabetic women received from 355 primary care providers within 14 provider groups from one health plan. Of the 540 women, 278 were eligible to receive mammograms and 314 were eligible to receive Pap smears. Mammography performance was measured as at least one mammogram over a 2-year period and Pap performance was measured as at least one Pap smear over a 3-year period. To assess the association between diabetes-related processes of care and preventive services, we used hierarchical logistic regression models, accounted for clustering within provider groups, and adjusted for patient age, race, income and education level, diabetes treatment and duration, and health status, as well as physician age, sex, years of practice, and specialty. Diabetes-related processes of care were defined as dilated retinal examinations, urine microalbumin/protein testing, foot examinations, lipid and HbA(1c) testing, recommendations to take aspirin, and influenza vaccinations received over a 1-year period. RESULTS In this cohort, 73% of eligible women received mammograms and 56% received Pap smears. After adjustment of models, better diabetes-related processes of care, better health status, and non-Medicaid insurance were associated with mammography performance. Better diabetes-related processes of care, younger patient age, and any visit to a gynecologist were associated with Pap performance. CONCLUSIONS Better processes of diabetes care were associated with better women's preventive health care. Diabetes management did not compete with sex-specific screening.

Objectives: To investigate the cross-sectional relationships among self-reported frequencies of symptomatic hyperglycemia and hypoglycemia, HbA1c, and symptoms in the Quality of Well-Being Self-Administered (QWB-SA), and to examine the associations among these measures of glycemia and health utility scores. Research design and methods: The study group included 1522 patients with diabetes who attended University of Michigan Health System clinics. Published studies were reviewed to identify symptoms in the QWB-SA that might be associated with measures of glycemia. Linear regression analyses were performed to evaluate the strength of the associations among the frequency of self-reported measures of glycemia, QWB-SA symptoms, and QWB-SA-derived health utility scores. Results: Frequency of hyperglycemic symptoms was associated with 3% of the variance in the QWB-SA-derived health utility score in type 1 diabetes and with 5% of the variance in type 2 diabetes. Frequency of hypoglycemic symptoms was not associated with the QWB-SA-derived health utility score in type 1 diabetes but was associated with 1% of the variance in type 2 diabetes. HbA1c levels were not significantly associated with QWB-SA-derived health utility scores. After controlling for age, gender, and complications, frequency of hyperglycemic symptoms was significantly associated with QWB-SA-derived health utility scores in type 1 and type 2 diabetes. Conclusions: Reported frequency of hyperglycemic symptoms is associated with symptoms included in the QWB-SA and with QWB-SA-derived health utility scores. The QWB-SA may be an appropriate measure to assess the health burden of hyperglycemia.

OBJECTIVE:Since 1997, the American Diabetes Association has recommended that nondiabetic individuals >/=45 years of age be screened for diabetes at least every 3 years. We sought to characterize the frequency, methods, and results of diabetes screening in routine clinical practice.RESEARCH DESIGN AND METHODS:We studied opportunistic screening in nondiabetic members of a health maintenance organization >/=45 years of age who were assigned to a large, integrated, academic health care delivery system. Screening was defined as the first glucose, HbA(1c), or oral glucose tolerance test (OGTT) performed between 1 January 1998 and 31 December 2000. Chart review was performed to determine the prevalence of diabetes risk factors and to describe follow-up.RESULTS:Of 8,286 nondiabetic patients >/=45 years of age, 69% (n = 5,752) were screened. The frequency of screening was greater in patients with one or more primary care visits and increased with age. Women were more likely to be screened than men, and patients with at least one diabetes risk factor were more likely to be screened than those without risk factors. Random plasma glucose was the most common screening test (95%). Four percent (n = 202) of those screened had abnormal results. Only 38% (n = 77) of those with abnormal results received appropriate follow-up, and 17% (n = 35) were diagnosed with diabetes within 6 months of screening. The yield of screening was very low (0.6%, 35 of 5,752).CONCLUSIONS:Despite frequent screening and appropriate targeting of high-risk patients, follow-up of patients with abnormal results is uncommon and the yield of screening is low. Interventions are needed to help physicians recognize and provide appropriate follow-up for patients with potentially abnormal random glucose levels.

OBJECTIVE:To describe and evaluate a community-based diabetes screening program supported by the Michigan Department of Community Health.RESEARCH DESIGN AND METHODS:Between 1 June 1999 and 31 December 1999, community screening for diabetes was conducted by voluntary organizations using a standard protocol, American Diabetes Association (ADA) questionnaires, and ADA capillary plasma glucose criteria.RESULTS:A total of 3506 individuals were screened, 14% of whom did not meet criteria for screening. Of the 3031 individuals appropriately screened, 57% were classified as being at high risk based on the ADA questionnaire and 5% had positive screening tests based on ADA capillary plasma glucose criteria. Despite systematic follow-up, the screening program's yield of individuals with undiagnosed diabetes was <1%.CONCLUSIONS:Community screening for diabetes conducted according to ADA recommendations was extremely inefficient at identifying individuals with undiagnosed diabetes. The ADA diabetes screening questionnaire resulted in many false positive tests, and the ADA criteria for positive plasma glucose tests likely missed a substantial portion of individuals with undiagnosed diabetes. Relying on biochemical tests such as random plasma glucose, changing the criteria for a positive plasma glucose test, targeting racial and ethnic minority groups, and targeting medically underserved individuals might improve the yield of community-based diabetes screening.

OBJECTIVE To evaluate the impact of systematic patient evaluation and patient and provider feedback on the processes and intermediate outcomes of diabetes care in Independent Practice Association model internal medicine practices. RESEARCH DESIGN AND METHODS Nine practices providing care to managed care patients were randomly assigned as intervention or comparison sites. Intervention-site subjects had Annual Diabetes Assessment Program (ADAP) assessments (HbA(1c), blood pressure, lipids, smoking, retinal photos, urine microalbumin, and foot examination) at years 1 and 2. Comparison-site subjects had ADAP assessments at year 2. At Intervention sites, year 1 ADAP results were reviewed with subjects, mailed to providers, and incorporated into electronic medical records with guideline-generated suggestions for treatment and follow-up. Medical records were evaluated for both groups for the year before both the year 1 and year 2 ADAP assessments. Processes and intermediate outcomes were compared using linear and logistic mixed hierarchical models. RESULTS Of 284 eligible subjects, 103 of 173 (60%) at the Intervention sites and 71 of 111 (64%) at the comparison sites participated; 83 of 103 (81%) of the intervention-site subjects returned for follow-up at year 2. Performance of the six recommended assessments improved in intervention-site subjects at year 2 compared with year 1 (5.8 vs. 4.3, P = 0.0001) and compared with comparison-site subjects at year 2 (4.2, P = 0.014). No significant changes were noted in intermediate outcomes. CONCLUSIONS The ADAP significantly improved processes of care but not intermediate outcomes. Additional interventions are needed to improve intermediate outcomes.

OBJECTIVE:To describe the direct medical costs associated with type 2 diabetes, as well as its treatments, complications, and comorbidities.RESEARCH DESIGN AND METHODS:We studied a random sample of 1,364 subjects with type 2 diabetes who were members of a Michigan health maintenance organization. Demographic characteristics, duration of diabetes, diabetes treatments, glycemic control, complications, and comorbidities were assessed by surveys and medical chart reviews. Annual resource utilization and costs were assessed using health insurance claims. The log-transformed annual direct medical costs were fitted by multiple linear regression to indicator variables for demographics, treatments, glycemic control, complications, and comorbidities.RESULTS:The median annual direct medical costs for subjects with diet-controlled type 2 diabetes, BMI 30 kg/m(2), and no microvascular, neuropathic, or cardiovascular complications were 1,700 dollars for white men and 2,100 dollars for white women. A 10-kg/m(2) increase in BMI, treatment with oral antidiabetic or antihypertensive agents, diabetic kidney disease, cerebrovascular disease, and peripheral vascular disease were each associated with 10-30% increases in cost. Insulin treatment, angina, and MI were each associated with 60-90% increases in cost. Dialysis was associated with an 11-fold increase in cost.CONCLUSIONS:Insulin treatment and diabetes complications have a substantial impact on the direct medical costs of type 2 diabetes. The estimates presented in this model may be used to analyze the cost-effectiveness of interventions for type 2 diabetes.

OBJECTIVE—Cost-utility analyses use information on health utilities to compare medical treatments that have different clinical outcomes and impacts on survival. The purpose of this study was to describe the health utilities associated with diabetes and its treatments, complications, and comorbidities. RESEARCH DESIGN AND METHODS—We studied 2,048 subjects with type 1 and type 2 diabetes recruited from specialty clinics at a university medical center. We administered a questionnaire to each individual to assess demographic characteristics, type and duration of diabetes, treatments, complications, and comorbidities, and we used the Self-Administered Quality of Well Being index (QWB-SA) to calculate a health utility score. We then created regression models to fit the QWB-SA-derived health utility scores to indicator variables for type 1 and type 2 diabetes and each demographic variable, treatment, and complication. The coefficients were arranged in clinically meaningful ways to develop models to describe penalties from the health utility scores for nonobese diabetic men without additional treatments, complications, or comorbidities. RESULTS—The utility scores for nonobese diet-controlled men and women with type 2 diabetes and no microvascular, neuropathic, or cardiovascular complications were 0.69 and 0.65, respectively. The utility scores for men and women with type 1 diabetes and no complications were slightly lower (0.67 and 0.64, respectively). Blindness, dialysis, symptomatic neuropathy, foot ulcers, amputation, debilitating stroke, and congestive heart failure were associated with lower utility scores. CONCLUSIONS—Major diabetes complications are associated with worse health-related quality of life. The health utility scores provided should facilitate studies of the health burden of diabetes and the cost-utility of alternative strategies for the prevention and treatment of diabetes.

Objectives: This study was undertaken to examine the rates of preconception counseling in managed care for women with diabetes and associated patient and physician characteristics.Study design: Participants included women aged 18 to 45 years enrolled in a study of diabetes care in managed care. Women were asked if they recalled discussions regarding glucose control before conception (n = 236) and use of family planning until Glucose control was achieved (n = 227). Hierarchical logistic regression models accounted for patient and physician characteristics.Results: Fifty-two percent of women recalled being counseled about glucose control and 31% recalled family planning advice. In adjusted models, patient age (years) (odds ratio [OR] 0.91 95% CI 0.86-0.96) and body mass index (BMI) (kg/m(2)) (OR 0.96. 95% CI 0.93-0.99) remained significant predictors of glucose control counseling. Similarly, patient age (years) (OR 0.94. 95% CI 0.89-0.99) and BMI (kg/m(2)) (0.96,95% Cl 0.93-0.99) remained significant predictors of family planning counseling,Conclusions: Preconception counseling rates for diabetic women are low and associated with younger age and lower BMI. (C) 2005 Elsevier Inc. All rights reserved.

We read the article by Tabaei and Herman (1) in the November 2002 issue of Diabetes Care with great interest and feel that it covers an exciting and vital area of diabetes research. We applaud the authors’ attempts to improve current standards of diabetes screening and the journal’s willingness to publish important new findings in the field. However, when we reviewed the article, we found the results difficult to reproduce, especially as there were no numerical examples provided in the text. Using the precise formula given in the article, our calculations produced negative probability values. We …

OBJECTIVE:To describe risk factors associated with microalbuminuria (MA) in subjects with diabetes, investigate the predictive value of MA as a marker of risk for diabetic nephropathy (DN), and define risk factors associated with the development and progression of MA. RESEARCH DESIGN AND METHODS:We conducted a prospective longitudinal study of 23 diabetic subjects with persistent MA and 209 diabetic subjects without MA who attended diabetes clinics at the University of Michigan Medical Center in 1989 and 1990. Both groups were examined at baseline and after 7 years. At baseline, urinary albumin-to-creatinine ratios were studied in random, first morning, and 24-h urine samples. At follow-up, a 12-h overnight urine sample was collected and analyzed for albumin and creatinine. At baseline, MA was defined by at least two separate urine specimens with albumin-to-creatinine ratios between 30 and 299 microg albumin per milligram of creatinine. RESULTS:MA regressed in 56% of subjects with baseline MA without systematic application of corrective measures and developed in 16% of subjects without baseline MA. The predictive value positive of MA as a marker of risk for DN was 43%, and the predictive value negative was 77%. In the combined cohort, the incidence and progression of MA were significantly associated with poor glycemic control and duration of diabetes between 10 and 14 years. CONCLUSIONS:MA may not be as sensitive and specific a predictor of DN as previously suggested. Other markers of risk for DN are needed for optimal clinical management.

Subjects with the Q268X mutation in the hepatocyte nuclear factor (HNF)-4alpha gene (RW pedigree/maturity-onset diabetes of the young [MODY]-1) have diminished insulin and glucagon secretory responses to arginine. To determine if pancreatic polypeptide (PP) secretion is likewise involved, we studied PP responses to insulin-induced hypoglycemia in 17 RW pedigree members: 6 nondiabetic mutation-negative [ND(-)], 4 nondiabetic mutation-positive [ND(+)], and 7 diabetic mutation-positive [D(+)]. Subjects received 0.08 U/kg body wt human regular insulin as an intravenous bolus to produce moderate self-limited hypoglycemia. PP areas under the curve (PP-AUCs) were compared among groups. With hypoglycemia, the PP-AUC was lower in the D(+) group (14,907 +/- 6,444 pg/ml, P = 0.03) and the ND(+) group (14,622 +/- 6,015 pg/ml, P = 0.04) compared with the ND(-) group (21,120 +/- 4,158 pg/ml). In addition, to determine if the beta-cell secretory defect in response to arginine involves amylin in addition to insulin secretion, we analyzed samples from 17 previously studied RW pedigree subjects. We compared the AUCs during arginine infusions for the 3 groups both at euglycemia and hyperglycemia as well as their C-peptide-to-amylin ratios. The D(+) and ND(+) groups had decreased amylin AUCs during both arginine infusions compared with the ND(-) group, but had similar C-peptide-to-amylin ratios. These results suggest that the HNF-4alpha mutation in the RW/MODY1 pedigree confers a generalized defect in islet cell function involving PP cells in addition to beta- and alpha-cells, and beta-cell impairment involving proportional deficits in insulin and amylin secretion.