Impact of pharmacist outreach on glucagon prescribing.

BACKGROUND: Hypoglycemia is a major limiting factor in the glycemic management of diabetes. As a method of treating hypoglycemia, the American Diabetes Association recommends glucagon to be prescribed for all individuals at increased risk of clinically impactful hypoglycemia. Glucagon Emergency Kits have been shown to reduce emergency department visits and overall health care costs. Despite these known benefits, glucagon continues to be underprescribed. Previous pharmacist-led interventions embedded in a single clinic have been shown to positively affect the rate of glucagon prescribing in patients with diabetes. OBJECTIVE: This study aimed to compare the rate of glucagon prescribing between quality improvement remote pharmacist outreach to multiple primary care and endocrinology specialty clinics and the control group in 1 month following a pharmacist-led provider outreach. METHODS: This was a single-center, 2-arm study with a simple randomization design. RESULTS: On pharmacist outreach, 61 of 109 patients (56.0%) in the outreach group were prescribed a glucagon product within 1 month of their primary care provider (PCP) or endocrinology appointment compared with 1 of 113 (0.9%) of patients in the control group (P < 0.001). Glucagon prescribing occurred in 25 of 35 Black patients (71.4%) compared with 36 of 73 white patients (49.3%) in the outreach group. Glucagon prescribing was associated with race (P = 0.03; chi-square test). CONCLUSIONS: The pharmacist-led provider outreach before a PCP or endocrinology appointment has a positive and statistically significant impact on glucagon prescribing rates. The pharmacist outreach had a higher impact on Black patients than white patients, possibly because of a lower rate of glucagon prescribing in Black patients before the outreach.

Feasibility of Electronic Health Record Integration of a SMART Application to Facilitate Patient-Provider Communication for Medication Management.

Increased treatment complexity in patients with diabetes contributes to medication nonadherence. Patient portals that are accessible through electronic health records may offer improved patient-provider communication and better medication management in patients with diabetes and uncontrolled hypertension. We conducted a prospective, mixed-methods evaluation of the Duke PillBox application, a SMART-on-FHIR medication management application integrated into the electronic health record patient portal. Adults with active portal status, diabetes, and uncontrolled hypertension participated in a usability/feasibility survey and communicated with a pharmacist via the portal-based application who conducted medication reconciliation and discussed medication indications, side effects, and barriers to use with patients. Of the eligible patients (n = 285), 29 (10%) were interested, and 12 (8%) participated. Challenges to usability were due to the electronic health record-portal communication interface (91%), browser access and compatibility (55%), and persistent lists of unused medications in the electronic health record (27%). The findings of this study suggest that electronic health record-integrated medication applications are desirable as indicated in patient interactions at the outset and conclusion of the study. Persistent challenges included electronic health record integration, interoperability, user interface, and browser connectivity for both patients and providers.

General Behavioral Engagement and Changes in Clinical and Cognitive Outcomes of Patients with Type 2 Diabetes Using the Time2Focus Mobile App for Diabetes Education: Pilot Evaluation.

BACKGROUND: Type 2 diabetes affects 30 million Americans, representing a significant cause of morbidity and mortality. Self-management support is an important component of chronic illness care and is a key pillar of the chronic care model. Face-to-face teaching and patient education materials suffer from being static or incompatible with mobile lifestyles. Digital apps provide a self-management support alternative that is convenient and scalable. OBJECTIVE: This pilot study tested the real-world deployment of a self-guided mobile app for diabetes education (Time2Focus app; MicroMass Communications Inc, Cary, NC), which utilizes evidence-based content and gamification to deliver an interactive learning experience. METHODS: Primary care providers were approached for permission to invite their patients to participate. Eligible patients were 18 to 89 years of age, had a diagnosis of type 2 diabetes, hemoglobin A1c (HbA1c) ≥8% and <12% in the past 3 months, an active online patient portal account (tied to the electronic health record), and access to an iOS or Android smartphone. Interested patients were emailed a baseline survey, and once this was completed, were sent instructions for downloading the Time2Focus app. After completing all 12 levels, participants were sent a follow-up survey. The primary outcome was the change in HbA1c. Secondary outcomes included medication adherence, self-care activities, self-reporting of physical activities, diabetes self-efficacy, illness perceptions, diabetes distress scale, and users' engagement with and rating of the app. RESULTS: Of 1355 potentially eligible patients screened, 201 were consented. Of these 201 patients, 101 (50.2%) did not download the app. Of the 100 participants (49.8%) who downloaded the app, 16 (16.0%) completed 0 levels, 26 (26.0%) completed 1 to 4 levels, 10 (10.0%) completed 5 to 11 levels, and 48 (48.0%) completed all 12 levels of the app and the follow-up survey. Those completing one or more levels had a mean pre/post-HbA1c change of -0.41% (compared to -0.32% among those who completed zero levels); however, the unadjusted two-tailed t test indicated no significant difference between the two groups (P=.73). Diabetes self-efficacy showed a large and significant increase during app usage for completers (mean change 1.28, P<.001, d=.83). Severity of illness perceptions showed a small but significant decrease during app usage for completers (mean change -0.51, P=.004, d=.43). Diabetes distress showed a small but significant decrease during app usage for completers (mean change -0.45, P=.006, d=.41). The net promoter score was 62.5, indicating that those who completed all levels of the app rated it highly and would recommend it to others. CONCLUSIONS: Participants who engaged in all 12 levels of the Time2Focus mobile app showed an improvement in diabetes self-efficacy and a decrease in severity of illness perceptions. The decrease in HbA1c observed in app users relative to nonusers during this limited pilot study was not statistically significant. However, uptake and application of lessons learned from self-management support may be delayed. Further research is needed to address how to increase engagement through self-management support and to investigate if follow up over a longer period demonstrates a significant change in outcomes such as HbA1c.

Characteristics and Delivery of Diabetes Shared Medical Appointments in North Carolina.

BACKGROUND Successful diabetes care requires patient engagement and health self-management. Diabetes shared medical appointments (SMAs) are an evidence-based approach that enables peer support, diabetes group education, and medication management to improve outcomes. The purpose of this study is to learn how diabetes SMAs are being delivered in North Carolina, including the characteristics of diabetes SMAs across the state.METHOD Twelve health systems in the state of North Carolina were contacted to explore clinical workflow and intervention characteristics with a member of the SMA care delivery team. Surveys were used to assess intervention characteristics and delivery.RESULTS Diabetes SMAs were offered in 10 clinics in 5 of the 12 health systems contacted with considerable heterogeneity across sites. The majority of SMAs were open cohorts (80%), offered monthly (60%) for 1.5 hours (60%). SMAs included a mean of 7.5 ± 3.4 patients with a maximum of 11.2 ± 2.7 patients. Survey data revealed barriers (cost-sharing and provider buy-in) to, and facilitators (leadership support and clinical champions) of, clinical adoption and sustained implementation.LIMITATIONS External validity is limited due to the small sample size and geographic clustering.CONCLUSION There is significant heterogeneity in the delivery and characteristics of diabetes SMAs in North Carolina with only modest uptake across the health systems. Further research to determine best practices and effectiveness in diverse, real-world clinical settings is required to inform implementation and dissemination efforts.

Leveraging Student Volunteers to Connect Patients with Social Risk to Resources On a Coordinated Care Platform: A Case Study with Two Endocrinology Clinics.

Introduction: Although unmet social needs can impact health outcomes, health systems often lack the capacity to fully address these needs. Our study describes a model that organized student volunteers as a community-based organisation (CBO) to serve as a social referral hub on a coordinated social care platform, NCCARE360. Description: Patients at two endocrinology clinics were systematically screened for social needs. Patients who screened positive and agreed to receive help were referred via NCCARE360 to student 'Help Desk' volunteers, who organised as a CBO. Trained student volunteers called patients to place referrals to resources and document them on the platform. The platform includes documentation at several levels, acting as a shared information source between healthcare providers, volunteer student patient navigators, and community resources. Navigators followed up with patients to problem-solve barriers and track referral outcomes on the platform, visible to all parties working with the patient. Discussion: Of the 44 patients who screened positive for social needs and were given referrals by Help Desk, 41 (93%) were reached for follow-up. Thirty-six patients (82%) connected to at least one resource. These results speak to the feasibility and utility of organising undergraduate student volunteers into a social referral hub to connect patients to resources on a coordinated care platform. Conclusion: Organising students as a CBO on a centralized social care platform can help bridge a critical gap between healthcare and social services, addressing health system capacity and ultimately improving patients' connections with resources.

Improving glycemic control in diabetes through virtual interdisciplinary rounds.

OBJECTIVE: A team-based disease management approach that considers comorbid conditions, social drivers of health, and clinical guidelines improves diabetes care but can be costly and complex. Developing innovative models of care is crucial to improving diabetes outcomes. The objective of this analysis was to evaluate the efficacy of virtual interdisciplinary diabetes rounds in improving glycemic control. STUDY DESIGN: Retrospective cohort study using observational data from July 2018 to December 2021. METHODS: This study employed difference-in-differences analysis to compare change in hemoglobin A1c (HbA1c) in a group of patients whose providers received advice as part of virtual interdisciplinary rounds and a group of patients whose providers did not receive rounds advice. Patients with diabetes were identified for rounding (1) based on attribution to an accountable care organization along with an upcoming primary care appointment and an HbA1c between 8% and 9% or (2) via provider referral. RESULTS: The rounded group consisted of 481 patients and the comparison group included 1806 patients. There was a 0.3-point reduction in HbA1c (95% CI, 0.1-0.4) associated with rounds overall. In a subanalysis comparing provider adoption of recommendations among those rounded, provider adoption was associated with an HbA1c reduction of 0.5 points (95% CI, 0.1-0.9) at 6 months post rounds, although there was no significant difference in the full year post rounds. CONCLUSIONS: Interdisciplinary rounds can be an effective approach to proactively provide diabetes-focused recommendations. This modality allows for efficient, low-cost, and timely access to an endocrinologist and team to support primary care providers in diabetes management.

ParallelED-A novel screening and referral intervention using emergency department wait times to identify and address unmet social needs.

Background: People arriving at the emergency department (ED) often have unmet health-related social needs (HRSN). We implemented an intervention that used undergraduate student volunteers to screen patients in the ED waiting room (WR) for unmet social drivers of health and subsequently referred patients to community resources. Methods: This cross-sectional quality improvement study included patients who were approached to complete a HRSN screening questionnaire, subsequently referred to community resources, and followed up by phone from October 2021 to October 2022 in an ED WR of an academic medical center. Primary measures were the proportions of patients who had unmet HRSN and the proportions enrolled in a statewide database of social care resources-NCCARE360. Patient demographics and geospatial distribution were also assessed to better understand the population served. Results: Our intervention reached 3297 unique patients, with 398 patients (12%) agreeing to complete screening. Of those screened, 93% were positive for at least one social need and 95% of the aforementioned were interested in receiving assistance. A total of 60% of those who screened positive were enrolled into NCCARE360. Persons identifying as female or non-Hispanic Black were disproportionately represented at a higher rate among those who screened positive for at least one social need, with food and housing insecurity emerging as the most common referral categories. Conclusion: Our results demonstrate patients' willingness to be screened in the ED WR and a high identification of HRSN. Our findings show that idle time in the ED WR can be used to identify patients with unmet HRSN and refer them to resources.

Low-threshold Buprenorphine Treatment in a Syringe Services Program: Program Description and Outcomes.

OBJECTIVES: Low-threshold buprenorphine treatment aims to reduce barriers to evidence-based opioid use disorder treatment. We aimed to describe the treatment philosophy, practices, and outcomes of a low-threshold syringe services program (SSP)-based buprenorphine program developed through an SSP-academic medical center partnership. METHODS: We included all SSP participants who received 1 or more buprenorphine prescription from Feb 5, 2019 to October 9, 2020. We collected data on patient characteristics, substance use, buprenorphine prescriptions, and urine drug tests (UDTs). We evaluated buprenorphine treatment retention using prescription data and buprenorphine adherence using UDTs. We used 2 retention definitions: (1) percentage of patients with buprenorphine prescriptions at 30, 90, and 180 days; and (2) total percentage of days "covered" with buprenorphine prescriptions through 180 days. RESULTS: One-hundred and eighteen patients received 1 or more buprenorphine prescriptions. Patients were largely middle-aged (mean age 44, standard deviation 11), male (68%), Hispanic (31%) or Non-Hispanic Black (32%), with heroin (90%) and crack/cocaine (62%) use, and injection drug use (59%). Retention was 62%, 43%, and 31% at 30, 90, and 180 days, respectively. The median percentage of days covered with buprenorphine prescriptions through 180 days was 43% (interquartile range 8%-92%). Of the 82 patients who completed 2 or more UDTs, the median percentage of buprenorphine-positive UDTs was 71% (interquartile range 40%-100%). CONCLUSIONS: In an SSP-based low-threshold buprenorphine treatment program, approximately one-third of patients continued buprenorphine treatment for 180 days or more, and buprenorphine adherence was high. SSPs can be a pathway to buprenorphine treatment for patients at high risk for opioid-related harms.

Effects of pregabalin on heart rate variability in patients with painful diabetic neuropathy.

UNLABELLED: Many studies have demonstrated that low heart rate variability (HRV) is a risk for high mortality and morbidity in patients with cardiovascular diseases. The primary purpose of the study was to evaluate whether pregabalin improves HRV in patients with diabetes and painful peripheral neuropathy. Resting heart rates were collected by using the LifeShirt System, developed by VivoMetrics (Ventura, Calif), at baseline and at the end of a 4-week intervention of pregabalin or placebo in patients with painful diabetic peripheral neuropathy. Heart rate variability analysis was performed on the collected R-R intervals using the Vivo- VMLA-036-00 3 Logic of the LifeShirt system. Of the 40 patients enrolled in the study, 70% completed the end of 4-week assessments (n = 15 in pregabalin and n = 14 in placebo). Compared with placebo, pregabalin treatment resulted in significant improvement in HRV measured by frequency domain analysis, that is, a reduction in low frequency-high frequency ratio (-1.30 ± 2.89 vs 0.37 ± 0.33, P = 0.03) and power of normalized low frequency (-0.049 ± 0.092 vs 0.0066 ± 0.023, P = 0.02), as well as an increase in power of normalized high frequency (0.039 ± 0.094 vs -0.038 ± 0.066, P = 0.02). Furthermore, pregabalin resulted in greater reduction of pain and symptoms of anxiety and greater improvement of quality of life. The improvement of HRV measures were not correlated with change of those measures. In conclusion, 4-week pregabalin treatment improved HRV in patients with painful diabetic peripheral neuropathy. TRIAL REGISTRATION: NCT00573261 (clinicaltrials.gov).

Osteoporosis in lung transplant candidates compared to matched healthy controls.

PURPOSE: Advanced lung disease increases the risk for diminished bone mineral density (BMD). The prevalence and severity of osteoporosis in lung transplant candidates is unclear. METHODS: We retrospectively evaluated BMD of subjects screened for lung transplant at our institution. Observed prevalence of osteoporosis and osteopenia within our cohort was compared to the expected prevalence of each from the Third National Health and Nutrition Examination Survey (NHANES III) data matched for age, gender, and race. Lateral chest radiographs were evaluated for vertebral fractures. RESULTS: High prevalence rates of osteoporosis (37%) and combined osteoporosis/osteopenia (86%) were observed. Subjects with pulmonary fibrosis had higher BMD and T-scores compared to all other subgroups. All subjects within the cohort had a higher observed combined rate of osteoporosis/osteopenia at all bone sites compared to expected rates from healthy, matched controls. Vertebral fractures were present in 23% of subjects but did not correlate with BMD or the diagnosis of osteoporosis. CONCLUSIONS: Abnormal BMD was prevalent in most pre-lung transplant subjects, with striking differences noted in comparison with a healthy, matched cohort. Lateral chest radiographs in combination with BMD data give a more complete picture of bone abnormalities. Osteoporosis screening prior to lung transplantation should be performed to identify high-risk subjects for fracture and allow for intervention.

Painful diabetic peripheral neuropathy: Health care costs and complications from 2010 to 2015.

OBJECTIVE: To quantify health care resource utilization and risk of complications in painful diabetic peripheral neuropathy (pDPN). METHODS: Adult patients diagnosed with diabetes mellitus or diabetic peripheral neuropathy (DPN) were identified in MarketScan from January 2010 to December 2015. Subgroups (pDPN and nonpainful DPN) were based on the use of pain medications 6 months before a new indexed diagnosis and 1 year thereafter. Health care costs were collected for up to 5 years, and complications charted for those with at least 1 and 2 years of follow-up. Complication comparisons were made using χ2 or Fisher exact tests, and a multivariable regression cost model was fit with log link function using generalized estimating equations. RESULTS: Among 360,559 patients with diabetes (62 ± 14 years; 54.3% female), 84,069 (23.3%) developed pDPN, 17,267 (4.8%) experienced nonpainful DPN, and the majority (259,223, 71.9%) were controls with diabetes without neuropathy. At baseline, costs associated with pDPN patients were 20% higher than diabetic controls (95% confidence interval [CI] [1.19, 1.21], p < 0.001), which increased to 31% in the 5th year (95% CI [1.27, 1.34], p < 0.001). Patients with pDPN had 200%, 356%, and 224% of the odds of using opioids, anticonvulsants, and antidepressants, respectively, compared with diabetic controls. The amputation risk in the pDPN subgroup was 16.24 times that of diabetic controls (95% CI [2.15, 122.72], p = 0.0003), and 87% more patients with pDPN experienced lower extremity infections (95% CI [1.43, 2.46], p < 0.0001) within a year. Within 2 years, 2.2% of patients with pDPN had falls and fall-related injuries compared with 1.1% of diabetic controls (p < 0.0001). CONCLUSIONS: Our study characterizes a substantial pDPN cohort in the United States, demonstrating considerable morbidity and economic costs.

Measures of Referral vs Receipt of Social Services Among Patients With Health-Related Social Needs.

This cohort study compares measures of referral vs receipt in evaluating social resource platform outcomes among patients with health-related social needs.

Research use of electronic health records: patients' perspectives on contact by researchers.

Objective: The use of electronic health records (EHRs) for research has the potential to improve the diagnosis and treatment of disease, yet contact with patients based on results of EHR phenotyping has received little attention. Researchers will almost certainly discover discrepancies in EHRs that call for resolution and, in some cases, raise the ethical dilemma of whether to contact patients about a potentially undiagnosed or untreated health concern. The objective of this study was to explore patients' attitudes and opinions about potential contact by researchers who have had access to their EHRs. Materials and methods: We conducted 15 focus groups in four diverse counties in the southeastern United States. We designed vignettes to describe different situations in which researchers conducting a hypothetical study might have reason to consider contact with patients. Results: Many patients believed it was important for researchers to take action if they discovered information suggesting a current serious health concern. Relaying the information through patients' physicians was considered the most appropriate course of action. Across vignettes, there were significant differences between urban and rural sites. Discussion and conclusions: Researchers may increasingly encounter situations involving contact with patients following EHR phenotyping. They should carefully consider the possibility of such contact when planning their studies, including the time and expertise needed to adjudicate potentially serious discrepancies. Our focus group results are one source of input for the development of ethical approaches to the research use of EHRs.

Substance use disorders and medical comorbidities among high-need, high-risk patients with diabetes.

BACKGROUND: The majority of the U.S. healthcare resources are utilized by a small population characterized as high-risk, high-need persons with complex care needs (e.g., adults with multiple chronic conditions). Substance use disorders (SUDs) and mental health disorders (MHDs) are a driver of poor health and additional healthcare costs, but they are understudied among high-need patients. OBJECTIVE: We examine the prevalence and correlates of SUDs and MHDs among adults with high-risk diabetes, who are patients at the top 10% risk score for developing poor outcomes (hospital admission or death). METHODS: A risk algorithm developed from Duke University Health System electronic health records (EHRs) data was used to identify patients with high-risk diabetes for targeting home-based primary care. The EHR data of the 263 patients with high-risk diabetes were analyzed to understand patterns of SUDs and MHDs to inform care-coordinating efforts. RESULTS: Both SUDs (any SUD 48.3%, alcohol 12.5%, tobacco 38.8%, drug 23.2%) and MHDs (any MHD 74.9%, mood 53.2%, sleep 37.3%, anxiety 32.7%, schizophrenia/psychotics/delusional 14.8%, dementia/delirium/amnestic/cognitive 14.4%, adjustment 9.1%) were prevalent. Overall, 81.7% of the sample had SUD or MHD. Elevated odds of SUD were noted among men (tobacco, alcohol) and those who were never-married (alcohol, cannabis). African-American race (vs. other race/ethnicity) was associated with lower odds of anxiety disorders. CONCLUSION: While data are limited to one large academic health system, they provide clinical evidence revealing that 82% of patients with high-risk diabetes had SUD and/or MHD recorded in their EHRs, highlighting a need for developing service models to optimize high-risk care.

Medicare utilization, screening, and costs among participants in the Southeastern Diabetes Initiative: A population-based evaluation.

AIMS: Type 2 diabetes mellitus imposes significant burdens on patients and health care systems. Population-level interventions are being implemented to reach large numbers of patients at risk of or diagnosed with diabetes. We describe a population-based evaluation of the Southeastern Diabetes Initiative (SEDI) from the perspective of a payer, the Centers for Medicare & Medicaid Services (CMS). The purpose of this paper is to describe the population-based evaluation approach of the SEDI intervention from a Medicare utilization and cost perspective. METHODS: We measured associations between the SEDI intervention and receipt of diabetes screening (i.e., HbA1c test, eye exam, lipid profile), health care resource use, and costs among intervention enrollees, compared with a control cohort of Medicare beneficiaries in geographically adjacent counties. RESULTS: The intervention cohort had slightly lower 1-year screening in 2 of 3 domains (4% for HbA1c; 9% for lipid profiles) in the post-intervention period, compared with the control cohort. The SEDI intervention cohort did not have different Medicare utilization or total Medicare costs in the post-intervention period from surrounding control counties. CONCLUSIONS: Our analytic approach may be useful to others evaluating CMS demonstration projects in which population-level health is targeted for improvement in a well-defined clinical population.

Assessing electronic health record phenotypes against gold-standard diagnostic criteria for diabetes mellitus.

OBJECTIVE: We assessed the sensitivity and specificity of 8 electronic health record (EHR)-based phenotypes for diabetes mellitus against gold-standard American Diabetes Association (ADA) diagnostic criteria via chart review by clinical experts. MATERIALS AND METHODS: We identified EHR-based diabetes phenotype definitions that were developed for various purposes by a variety of users, including academic medical centers, Medicare, the New York City Health Department, and pharmacy benefit managers. We applied these definitions to a sample of 173 503 patients with records in the Duke Health System Enterprise Data Warehouse and at least 1 visit over a 5-year period (2007-2011). Of these patients, 22 679 (13%) met the criteria of 1 or more of the selected diabetes phenotype definitions. A statistically balanced sample of these patients was selected for chart review by clinical experts to determine the presence or absence of type 2 diabetes in the sample. RESULTS: The sensitivity (62-94%) and specificity (95-99%) of EHR-based type 2 diabetes phenotypes (compared with the gold standard ADA criteria via chart review) varied depending on the component criteria and timing of observations and measurements. DISCUSSION AND CONCLUSIONS: Researchers using EHR-based phenotype definitions should clearly specify the characteristics that comprise the definition, variations of ADA criteria, and how different phenotype definitions and components impact the patient populations retrieved and the intended application. Careful attention to phenotype definitions is critical if the promise of leveraging EHR data to improve individual and population health is to be fulfilled.

The agreement of patient-reported versus observed medication adherence in type 2 diabetes mellitus (T2DM).

OBJECTIVE: Medication adherence in type 2 diabetes mellitus (T2DM) improves glycemic control and is associated with reduced adverse clinical events, and accurately assessing adherence assessment is important. We aimed to determine agreement between two commonly used adherence measures-the self-reported Morisky Medication Adherence Scale (MMAS) and direct observation of medication use by nurse practitioners (NPs) during home visits-and determine the relationship between each measure and glycated hemoglobin (HbA1c). RESEARCH DESIGN AND METHODS: We evaluated agreement between adherence measures in the Southeastern Diabetes Initiative (SEDI) prospective clinical intervention home visit cohort, which included high-risk patients (n=430) in 4 SEDI-participating counties. The mean age was 58.7 (SD 11.6) years. The majority were white (n=210, 48.8%), female (n=236, 54.9%), living with a partner (n=316, 74.5%), and insured by Medicare/Medicaid (n=361, 84.0%). Medication adherence was dichotomized to 'adherent' or 'not adherent' using established cut-points. Inter-rater agreement was evaluated using Cohen's κ coefficient. Relationships among adherence measures and HbA1c were evaluated using the Wilcoxon rank-sum test and c-statistics. RESULTS: Fewer patients (n=261, 61%) were considered adherent by self-reported MMAS score versus the NP-observed score (n=338; 79%). Inter-rater agreement between the two adherence measures was fair (κ=0.24; 95% CI 0.15 to 0.33; p<0.0001). Higher adherence was significantly associated with lower HbA1c levels for both measures, yet discrimination was weak (c-statistic=0.6). CONCLUSIONS: Agreement between self-reported versus directly observed medication adherence was lower than expected. Though scores for both adherence measures were significantly associated with HbA1c, neither discriminated well for discrete levels of HbA1c.