Background: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study has enrolled a racially and ethnically diverse population with type 2 diabetes, performed extensive phenotyping, and randomly assigned the participants to one of four second-line diabetes medications. The continuous glucose monitoring (CGM) substudy has been added to determine whether there are racial/ethnic differences in the relationship between average glucose (AG) and hemoglobin A1c (HbA1c). CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups. Methods: The observational CGM substudy will enroll up to 1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared: Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other. CGM will be performed for 2 weeks in proximity to a GRADE annual visit, during which an oral glucose tolerance test will be performed and HbA1c and glycated albumin measured. Indicators of interindividual variation in red blood cell turnover, based on specialized erythrocyte measurements, will also be measured to explore the potential causes of interindividual HbA1c variations. Conclusions: The GRADE CGM substudy will provide new insights into whether differences exist in the relationship between HbA1c and AG among different racial/ethnic groups and whether glycemic profiles differ among frequently used diabetes medications and their potential clinical implications. Understanding such differences is important for clinical care and adjustment of diabetes medications in patients of different races or ethnicities.

This longitudinal retrospective cohort study evaluated implementation of an intervention to improve management of osteoporosis after a fracture in a nonprofit group‐model health maintenance organization (HMO) in the U.S. Pacific Northwest with 480,000 members and electronic medical record data. Participants were female HMO members aged 67 and older who sustained a qualifying clinical fracture(s) and who had not received a bone mineral density (BMD) measurement or osteoporosis treatment in the 12 months before the fracture (N=3,588). Phase 1 included outreach to clinicians and patients; Phase 2 added clinician and staff incentives. Primary outcome was “osteoporosis management”—receipt of a BMD measurement or osteoporosis medication in the 6 months after an index fracture. Before the intervention, 13.4% (95% confidence interval (CI)=12.0–14.8%) of patients had received osteoporosis management, and the time trend was not significant. Postintervention, the probability of osteoporosis management increased on average 3.1% (95% CI=2.6–3.5%) every 2 months throughout both study phases without a significant added improvement in Phase 2. Improvement varied according to clinic and was less likely for patients with dementia. Overall, the probability of osteoporosis management increased from the baseline level of 13.4% to 44.0% (95% CI=40.0–48.0%) by the end of the study period (20 months post‐intervention). The study found that an outreach program to primary care providers and patients improved the management of osteoporosis after a fracture. If widely implemented, this intervention could substantially improve the secondary prevention of osteoporosis. More‐individualized interventions may be necessary for high‐risk subgroups.

Patients suffering from chronic inflammatory conditions often take glucocorticoid medications over long periods of time. More than a million patients in the United States receive these agents each year. One of the most serious side effects of this treatment is glucocorticoid-induced osteoporosis (GIOP). This study characterized glucocorticoid use and osteoporosis screening and treatment patterns within a large U.S. health maintenance organization (HMO). This retrospective cohort study ( n =3,031) used the HMO’s electronic medical record and databases to identify patients who were dispensed the equivalent of >5 mg of prednisone per day for at least 90 days from January 2000 through December 2001. It assessed the primary outcomes, the percent who received a bone mineral density (BMD) measurement from January 1996 through 6 months after the index glucocorticoid prescription and the percent dispensed an osteoporosis medication within 6 months before or after the index glucocorticoid prescription. The participants’ mean age was 61.4 years, 60% were women, and the mean daily dose of corticosteroids was 20.0 mg of prednisone equivalents. The most frequent diagnoses associated with glucocorticoid use were chronic obstructive pulmonary disease, 25.8%; asthma, 21.4%; rheumatoid arthritis, 17.2%. Overall, only 9.8% of the population received a BMD measurement—13% of women and 4.9% of men; 38% were dispensed osteoporosis medications—57.1% of women and 8.9% of men; only 14.5% received treatment with antiresorptive medications other than hormone replacement therapy—18.3% of women and 8.9% of men. Our study found that a substantial proportion of patients receiving long-term glucocorticoid therapy did not receive BMD measurement or preventive therapy for osteoporosis, as recommended in GIOP practice guidelines. Future research should focus on understanding barriers to GIOP identification and facilitating osteoporosis management.

The burden of osteoporotic fractures in older men is significant. The objectives of our study were to: (1) characterize older men with fractures associated with osteoporosis, (2) determine if medication treatment rates for osteoporosis are improving and (3) identify patient, healthcare benefit and utilization, and clinician characteristics that are significantly associated with treatment. This retrospective cohort study assessed 1,171 men aged 65 or older with any new fracture associated with osteoporosis between 1 January 1998 and 30 June 2001 in a non-profit health maintenance organization in the United States. Multiple logistic regression was used to evaluate pre-fracture factors for their association with osteoporosis treatment in the 6-month post-fracture period. The main outcome measure was pharmacologic treatment for osteoporosis in the 6 months after the index fracture. Subjects' average age was 76.7 years; 3.3% had a diagnosis of osteoporosis and 15.2% a diagnosis or medication associated with secondary osteoporosis. Only 7.1% of the study population and 16.0% of those with a hip or vertebral fracture received a medication for osteoporosis following the index fracture, and treatment rates did not improve over time. In the multivariate model, factors significantly associated with drug treatment were a higher value on the Charlson Comorbidity Index (odds ratio 1.26, 95% confidence interval 1.05-1.51), having an osteoporosis diagnosis (odds ratio 8.11, 95% confidence interval 3.08-21.3), chronic glucocorticoid use (odds ratio 5.37, 95% confidence interval 2.37-12.2) and a vertebral fracture (odds ratio 16.6, 95% confidence interval 7.8-31.4). Bone mineral density measurement was rare (n =13, 1.1%). Our findings suggest that there is under-ascertainment and under-treatment of osteoporosis and modifiable secondary causes in older men with fractures. Information systems merging diagnostic and treatment information can help delineate gaps in patient management. Interventions showing promise in other conditions should be evaluated to improve care for osteoporosis.