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Background: Incorporating social determinants of health into care delivery for chronic diseases is a priority., Objectives: The goal of this study was to evaluate the impact of group medical visits and/or microfinance on blood pressure reduction., Methods: The authors conducted a cluster randomized trial with 4 arms and 24 clusters: 1) usual care (UC); 2) usual care plus microfinance (MF); 3) group medical visits (GMVs); and 4) GMV integrated into MF (GMV-MF). The primary outcome was 1-year change in systolic blood pressure (SBP). Mixed-effects intention-to-treat models were used to evaluate the outcomes., Results: A total of 2,890 individuals (69.9% women) were enrolled (708 UC, 709 MF, 740 GMV, and 733 GMV-MF). Average baseline SBP was 157.5 mm Hg. Mean SBP declined -11.4, -14.8, -14.7, and -16.4 mm Hg in UC, MF, GMV, and GMV-MF, respectively. Adjusted estimates and multiplicity-adjusted 98.3% confidence intervals showed that, relative to UC, SBP reduction was 3.9 mm Hg (-8.5 to 0.7), 3.3 mm Hg (-7.8 to 1.2), and 2.3 mm Hg (-7.0 to 2.4) greater in GMV-MF, GMV, and MF, respectively. GMV and GMV-MF tended to benefit women, and MF and GMV-MF tended to benefit poorer individuals. Active participation in GMV-MF was associated with greater benefit., Conclusions: A strategy combining GMV and MF for individuals with diabetes or hypertension in Kenya led to clinically meaningful SBP reductions associated with cardiovascular benefit. Although the significance threshold was not met in pairwise comparison hypothesis testing, confidence intervals for GMV-MF were consistent with impacts ranging from substantive benefit to neutral effect relative to UC. Incorporating social determinants of health into care delivery for chronic diseases has potential to improve outcomes. (Bridging Income Generation With Group Integrated Care [BIGPIC]; NCT02501746)., Competing Interests: Funding Support and Author Disclosures The BIGPIC trial is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award no. R01HL125487. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. All authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to compare health care utilization and costs among diabetes patients with physician, nurse practitioner (NP), or physician assistant (PA) primary care providers (PCPs)., Research Design and Methods: Cohort study using Veterans Affairs (VA) electronic health record data to examine the relationship between PCP type and utilization and costs over 1 year in 368,481 adult, diabetes patients. Relationship between PCP type and utilization and costs in 2013 was examined with extensive adjustment for patient and facility characteristics. Emergency department and outpatient analyses used negative binomial models; hospitalizations used logistic regression. Costs were analyzed using generalized linear models., Results: PCPs were physicians, NPs, and PAs for 74.9% (n=276,009), 18.2% (n=67,120), and 6.9% (n=25,352) of patients respectively. Patients of NPs and PAs have lower odds of inpatient admission [odds ratio for NP vs. physician 0.90, 95% confidence interval (CI)=0.87-0.93; PA vs. physician 0.92, 95% CI=0.87-0.97], and lower emergency department use (0.67 visits on average for physicians, 95% CI=0.65-0.68; 0.60 for NPs, 95% CI=0.58-0.63; 0.59 for PAs, 95% CI=0.56-0.63). This translates into NPs and PAs having ~$500-$700 less health care costs per patient per year (P<0.0001)., Conclusions: Expanded use of NPs and PAs in the PCP role for some patients may be associated with notable cost savings. In our cohort, substituting care patterns and creating similar clinical situations in which they practice, NPs and PAs may have reduced costs of care by up to 150-190 million dollars in 2013.

Introduction: Low potassium intake can affect cardiovascular disease (CVD) risk and cardiometabolic risk factors., Objective: We hypothesize that potassium chloride (KCl) supplementation can improve cardiovascular risk metabolomic profile., Methods: In this secondary analysis of a pilot randomized clinical trial (RCT) of 26 participants with prediabetes randomized to KCl or placebo, we performed targeted mass-spectrometry-based metabolomic profiling on baseline and 12-week (end-of-study) plasma samples. Principal component analysis (PCA) was used to reduce the many correlated metabolites into fewer, independent factors that retain most of the information in the original data., Results: Those taking KCl had significant reductions (corresponding to lower cardiovascular risk) in the branched-chain amino acids (BCAA) factor (P = 0.004) and in valine levels (P = 0.02); and non-significant reductions in short-chain acylcarnitines (SCA) factor (P = 0.11)., Conclusions: KCl supplementation may improve circulating BCAA levels, which may reflect improvements in overall cardiometabolic risk profile., Clinical Trials Registry: Clinicaltrials.gov identifier: NCT02236598; https://clinicaltrials.gov/ct2/show/NCT02236598.

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., (©2019 by the North Carolina Institute of Medicine and The Duke Endowment. All rights reserved.)

Growing demand for services is leading primary care organizations to explore new delivery models. One approach incorporates multiple primary care providers on a team. Effective incorporation of multiple clinicians into teams requires well-defined roles, including the usual provider (who provides the majority of primary care) and supplemental providers (who provide a minority of primary care visits). Using data from the Veterans Health Administration, we examined whether differences in diabetes outcomes exist among patients with different types of primary and supplemental providers (physicians, physician assistants (PAs), and NPs). No clinically meaningful differences were observed based on the profession of the usual provider or supplemental provider, or whether physicians provided supplemental care to patients with PAs or NPs as usual providers. These results suggest that physicians, PAs, and NPs can perform a variety of roles depending on the needs of the organization and patient population.

Diabetes, regardless of type, is a complex disease. Successful management to achieve both short- and long-term health goals and outcomes is highly dependent on learning, mastery, and regular implementation and execution of self-care behaviors. The importance of a positive mental outlook and minimization of psychosocial barriers to care is increasingly identified as important in managing the whole person with diabetes and, as appropriate, the caregivers. Ongoing support from HCP and increasingly ongoing support from peers are critical elements of quality diabetes care. With the availability of virtually accessible technologies for social media and networking, the volume of peer support among people with diabetes and their caregivers has increased exponentially and will likely continue to do so. With the value of ongoing peer support recognized as an important element in diabetes health, a growing number of peer support communities and increasing engagement in these communities among some diabetes educators, the American Association of Diabetes Educators (AADE) embarked on an initiative to more formally work with diabetes peer support communities and their leaders. To initiate this effort AADE held and supported a consensus meeting in 2017. This article reviews the history and goals of this effort and details the meeting outcomes. It also discusses the collaborations completed since the initial meeting along with plans for the near future. This collaboration is unique and presents a model for similar endeavors in diabetes or other chronic diseases.

Background: Continuity of care is a cornerstone of primary care and is important for patients with chronic diseases such as diabetes. The study objective was to examine patient, provider and contextual factors associated with interpersonal continuity of care (ICoC) among Veteran's Health Administration (VHA) primary care patients with diabetes., Methods: This patient-level cohort study (N = 656,368) used electronic health record data of adult, pharmaceutically treated patients (96.5% male) with diabetes at national VHA primary care clinics in 2012 and 2013. Each patient was assigned a "home" VHA facility as the primary care clinic most frequently visited, and a primary care provider (PCP) within that home clinic who was most often seen. Patient demographic, medical and social complexity variables, provider type, and clinic contextual variables were utilized. We examined the association of ICoC, measured as maintaining the same PCP across both years, with all variables simultaneously using logistic regression fit with generalized estimating equations., Results: Among VHA patients with diabetes, 22.3% switched providers between 2012 and 2013. Twelve patient, two provider and two contextual factors were associated with ICoC. Patient characteristics associated with disruptions in ICoC included demographic factors, medical complexity, and social challenges (example: homeless at any time during the year OR = 0.79, CI = 0.75-0.83). However, disruption in ICoC was most likely experienced by patients whose providers left the clinic (OR = 0.09, CI = 0.07-0.11). One contextual factor impacting ICoC included NP regulation (most restrictive NP regulation (OR = 0.79 CI = 0.69-0.97; reference least restrictive regulation)., Conclusions: ICoC is an important mechanism for the delivery of quality primary care to patients with diabetes. By identifying patient, provider, and contextual factors that impact ICoC, this project can inform the development of interventions to improve continuity of chronic illness care.

Background: Cardiovascular disease (CVD) is the leading cause of mortality worldwide, with >80% of CVD deaths occurring in low and middle income countries (LMICs). Diabetes mellitus and pre-diabetes are risk factors for CVD, and CVD is the major cause of morbidity and mortality among individuals with DM. There is a critical period now during which reducing CVD risk among individuals with diabetes and pre-diabetes may have a major impact. Cost-effective, culturally appropriate, and context-specific approaches are required. Two promising strategies to improve health outcomes are group medical visits and microfinance., Methods/design: This study tests whether group medical visits integrated into microfinance groups are effective and cost-effective in reducing CVD risk among individuals with diabetes or at increased risk for diabetes in western Kenya. An initial phase of qualitative inquiry will assess contextual factors, facilitators, and barriers that may impact integration of group medical visits and microfinance for CVD risk reduction. Subsequently, we will conduct a four-arm cluster randomized trial comparing: (1) usual clinical care, (2) usual clinical care plus microfinance groups only, (3) group medical visits only, and (4) group medical visits integrated into microfinance groups. The primary outcome measure will be 1-year change in systolic blood pressure, and a key secondary outcome measure is 1-year change in overall CVD risk as measured by the QRISK2 score. We will conduct mediation analysis to evaluate the influence of changes in social network characteristics on intervention outcomes, as well as moderation analysis to evaluate the influence of baseline social network characteristics on effectiveness of the interventions. Cost-effectiveness analysis will be conducted in terms of cost per unit change in systolic blood pressure, percent change in CVD risk score, and per disability-adjusted life year saved., Discussion: This study will provide evidence regarding effectiveness and cost-effectiveness of interventions to reduce CVD risk. We aim to produce generalizable methods and results that can provide a model for adoption in low-resource settings worldwide., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Expanded use of nurse practitioners (NPs) and physician assistants (PAs) is a potential solution to workforce issues, but little is known about how NPs and PAs can best be used. Our study examines whether medical and social complexity of patients is associated with whether their primary care provider (PCP) type is a physician, NP, or PA. In this national retrospective cohort study, we use 2012-2013 national Veterans Administration (VA) electronic health record data from 374 223 veterans to examine whether PCP type is associated with patient, clinic, and state-level factors representing medical and social complexity, adjusting for all variables simultaneously using a generalized logit model. Results indicate that patients with physician PCPs are modestly more medically complex than those with NP or PA PCPs. For the group having a Diagnostic Cost Group (DCG) score >2.0 compared with the group having DCG <0.5, odds of having an NP or a PA were lower than for having a physician PCP (NP odds ratio [OR] = 0.83, 95% confidence interval [CI]: 0.79-0.88; PA OR = 0.85, CI: 0.80-0.89). Social complexity is not consistently associated with PCP type. Overall, we found minor differences in provider type assignment. This study improves on previous work by using a large national dataset that accurately ascribes the work of NPs and PAs, analyzing at the patient level, analyzing NPs and PAs separately, and addressing social as well as medical complexity. This is a requisite step toward studies that compare patient outcomes by provider type.

Objective: The statistical analysis for a 2-arm randomised controlled trial (RCT) with a baseline outcome followed by a few assessments at fixed follow-up times typically invokes traditional analytic methods (eg, analysis of covariance (ANCOVA), longitudinal data analysis (LDA)). 'Constrained' longitudinal data analysis (cLDA) is a well-established unconditional technique that constrains means of baseline to be equal between arms. We use an analysis of fasting lipid profiles from the Group Medical Clinics (GMC) longitudinal RCT on patients with diabetes to illustrate applications of ANCOVA, LDA and cLDA to demonstrate theoretical concepts of these methods including the impact of missing data., Methods: For the analysis of the illustrated example, all models were fit using linear mixed models to participants with only complete data and to participants using all available data., Results: With complete data (n=195), 95% CI coverage are equivalent for ANCOVA and cLDA with an estimated 11.2 mg/dL (95% CI -19.2 to -3.3; p=0.006) lower mean low-density lipoprotein (LDL) cholesterol in GMC compared with usual care. With all available data (n=233), applying the cLDA model yielded an LDL improvement of 8.9 mg/dL (95% CI -16.7 to -1.0; p=0.03) for GMC compared with usual care. The less efficient, LDA analysis yielded an LDL improvement of 7.2 mg/dL (95% CI -17.2 to 2.8; p=0.15) for GMC compared with usual care., Conclusions: Under reasonable missing data assumptions, cLDA will yield efficient treatment effect estimates and robust inferential statistics. It may be regarded as the method of choice over ANCOVA and LDA., Competing Interests: Conflicts of Interest: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Aim: To explore whether Video-Shared Medical Appointments (video-SMA), where group education and medication titration were provided remotely through video-conferencing technology would improve diabetes outcomes in remote rural settings., Methods: We conducted a pilot where a team of a clinical pharmacist and a nurse practitioner from Honolulu VA hospital remotely delivered video-SMA in diabetes to Guam. Patients with diabetes and HbA1c ≥7% were enrolled into the study during 2013-2014. Six groups of 4-6 subjects attended 4 weekly sessions, followed by 2 bi-monthly booster video-SMA sessions for 5 months. Patients with HbA1c ≥7% that had primary care visits during the study period but not referred/recruited for video-SMA were selected as usual-care comparators. We compared changes from baseline in HbA1c, blood-pressure, and lipid levels using mixed-effect modeling between video-SMA and usual care groups. We also analyzed emergency department (ED) visits and hospitalizations. Focus groups were conducted to understand patient's perceptions., Results: Thirty-one patients received video-SMA and charts of 69 subjects were abstracted as usual-care. After 5 months, there was a significant decline in HbA1c in video-SMA vs. usual-care (9.1±1.9 to 8.3±1.8 vs. 8.6±1.4 to 8.7±1.6, P=0.03). No significant change in blood-pressure or lipid levels was found between the groups. Patients in the video-SMA group had significantly lower rates of ED visits (3.2% vs. 17.4%, P=0.01) than usual-care but similar hospitalization rates. Focus groups suggested patient satisfaction with video-SMA and increase in self-efficacy in diabetes self-care., Conclusion: Video-SMA is feasible, well-perceived and has the potential to improve diabetes outcomes in a rural setting., (Published by Elsevier Ireland Ltd.)

Background: Recent studies have found low-normal potassium (K) to be associated with increased diabetes risk. We sought to verify these associations in a multi-ethnic US cohort; and to determine if these associations extend to US Hispanics and Asian-Americans., Methods: We analyzed data from Multi-Ethnic Study of Atherosclerosis (MESA) participants who were free-of-diabetes at baseline. We examined cross-sectional associations between measures of K-serum, dietary, and urine-with fasting glucose and HOMA-IR. We examined longitudinal associations between K and diabetes risk over 8 years., Findings: In multivariable models, compared to those with higher serum K (≥4.5mmol/L), those with lower serum K (<4.0mmol/L) had significantly higher fasting glucose [1.3 mg/dL (95%CI 0.2, 2.4), P-value = 0.03]. Incident diabetes developed in 1281 of 5415 at-risk participants. In minimally-adjusted models, we found inverse associations between serum and dietary K and diabetes risk. Compared to those with higher serum K, those with lower serum K had an HR (95% CI) of incident diabetes of 1.23 (1.04, 1.47), P-value = 0.02. However, these associations were attenuated in fully-adjusted models. We found no significant interaction between potassium and ethnicity., Conclusions: In this multi-ethnic cohort, we found a significant inverse association between serum K and fasting glucose but no significant association with longer-term diabetes risk. This inverse association between potassium and glucose must be studied further to understand the physiology and its potential impact on chronic health.

Background: We sought to determine the impacts of serum and dietary potassium measures on glucose metabolism and diabetes risk in older adults., Methods: Among participants of the Cardiovascular Health Study, a community-based cohort of older American adults, we examined a) cross-sectional associations between potassium and measures of insulin sensitivity and secretion estimated from oral glucose tolerance tests and b) longitudinal associations of serum and dietary potassium with diabetes risk., Results: Among 4,754 participants aged ≥65 years at baseline, there were 445 cases of incident diabetes during a median follow-up of 12 years. In multivariate models, baseline serum and dietary potassium were both associated with lower insulin sensitivity and greater insulin secretion. Compared with those with a serum potassium ≥4.5 mEq/L, participants with a serum potassium <4.0mEq/L had an adjusted mean difference in Matsuda insulin sensitivity index of -0.18 (-0.39, 0.02). Compared with those in the highest quartile, participants in the lowest quartile of dietary potassium intake had a corresponding adjusted mean difference in Matsuda insulin sensitivity index of -0.61 (-0.94, -0.29). In multivariate models, neither serum nor dietary potassium intake was associated with long-term diabetes risk., Conclusions: Although we did not identify serum and dietary potassium as risk factors for incident diabetes in older adults, results from cross-sectional analyses suggest that both may be associated with increased insulin resistance. This relationship with insulin resistance needs to be confirmed, and its importance on diabetes risk, cardiovascular risk, and conditions specific to older adults should be determined as well., (© The Author 2014. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: Shared medical appointments (SMAs) are an increasingly used system-redesign strategy for improving access to and quality of chronic illness care. We conducted a systematic review of the existing literature on SMA interventions for patients with diabetes in order to understand their impact on outcomes., Data Sources: MEDLINE, EMBASE, CINAHL, PsycINFO, and Web of Science from January 1996 through April 2012. PubMed search updated June 2013., Study Selection: English-language peer-reviewed publications of randomized controlled trials (RCTs), nonrandomized cluster controlled trials, controlled before-and-after studies, or interrupted time-series designs conducted among adult patients with diabetes. Two independent reviewers used prespecified criteria to screen titles and abstracts for full text review., Study Appraisal and Synthesis Methods: Two different reviewers abstracted data and rated study quality and strength of evidence. When possible, we used random-effects models to synthesize the effects quantitatively, reporting by a weighted difference of the means when the same scale was used across studies, and a standardized mean difference when the scales differed. We measured heterogeneity in study effects using Forest Plots, Cochran's Q, and I(2), and explored heterogeneity by using subgroup analyses for categorical variables and meta-regression analyses for continuous or discrete variables. Outcomes not suitable to meta-analysis were summarized qualitatively., Results: Twenty-five articles representing 17 unique studies compared SMA interventions with usual care. Among patients with diabetes, SMAs improved hemoglobin A1c (∆ = -0.55 percentage points [95 % CI, -0.11 to -0.99]); improved systolic blood pressure (∆ = -5.2 mmHg [95 % CI, -3.0 to -7.4]); and did not improve LDL cholesterol (∆ = -6.6 mg/dl [95 % CI, 2.8 to -16.1]). Nonbiophysical outcomes, including economic outcomes, were reported too infrequently to meta-analyze, or to draw conclusions from. The A1c result had significant heterogeneity among studies, likely secondary to the heterogeneity among included SMA interventions., Limitation: Heterogeneity among the components of diabetes SMAs leads to uncertainty about what makes a particular SMA successful., Conclusion: SMA interventions improve biophysical outcomes among patients with diabetes. There was inadequate literature to determine SMA effects on patient experience, utilization, and costs.

Background: Low and low-normal serum potassium is associated with an increased risk of diabetes. We hypothesized that the protective effect of valsartan on diabetes risk could be mediated by its effect of raising serum potassium., Methods: We analyzed data from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial, which randomized participants at risk for diabetes to either valsartan (up to 160mg daily) or no valsartan. Using Cox models, we evaluated the effect of valsartan on diabetes risk over a median of 4 years of follow-up and calculated the mediation effect of serum potassium as the difference in treatment hazard ratios from models excluding and including 1-year change in serum potassium. The 95% confidence interval (CI) for the difference in log hazard ratios was computed by bootstrapping., Results: The hazard ratio for developing diabetes among those on valsartan vs. no valsartan was 0.866 (95% CI = 0.795-0.943) vs. 0.868 (95% CI = 0.797-0.945), after controlling for 1-year change in potassium. The bootstrap 95% CI for a difference in these log hazard ratios was not statistically significant (-0.003 to 0.009)., Conclusions: Serum potassium does not appear to significantly mediate the protective effect of valsartan on diabetes risk.

Aims: Examine potential associations between inclusion of mid-level providers in United States Veterans Affairs (VA) primary care programs and diabetes control., Methods: We established a cohort of diabetes patients (alive October 1, 1999) using the VA Diabetes Registry and VA corporate databases. 1999 VA Survey of Primary Care Practices data were combined with individual-patient information. We used a two-level hierarchical model to determine the relationship between staffing characteristics and hemoglobin A1c (HbA1c), among 88,682 patients from 198 clinics., Results: Inclusion of nurse practitioners (NPs) at relatively limited levels (% of all providers who are NPs) in the primary care program was significantly associated with HbA1c lower by 0.31 percentage points (95% CI, -0.50% to -0.12%) compared to programs that did not include NPs. Having some level of NP staffing vs. no NP staffing was associated HbA1c lower by 0.25%. Inclusion of physician assistants (PAs) in primary care programs was generally not associated with a statistically significant difference in HbA1c. The exception is that moderate levels of PA staffing were associated with slightly higher HbA1c [0.18%, 95% CI, 0.02-0.34)]., Conclusions: Diabetes control among primary care patients appeared to benefit from inclusion of NPs, while an analogous association was not found for PAs., (Published by Elsevier Ltd.)

Background: Although others have reported national disparities in the quality of diabetes care between the Veterans Affairs (VA) and private health care delivery systems, it is not known whether these differences persist among internal medicine resident providers in academic settings., Objective: We compared the quality of diabetes primary care delivered by resident physicians in either a private academic health care system (AHS) or its affiliated VA health care system., Design: Cross-sectional observational study, Participants: We included patients who: had a diagnosis of diabetes, had >2 primary care visits with the same resident provider during 2005, and were not separately managed by an attending physician or endocrinologist. A total of 640 patients met our criteria and were included in the analysis., Measurements and Results: Compared to the VA, patients in the AHS were more likely to be younger, female, have fewer medications, and be treated with insulin, but had less comorbidity. Patients in the VA were more likely to be referred for an annual eye exam (94% vs. 78%), receive lipid screening (88% vs. 74%), receive proteinuria screening (63% vs. 34%), and receive a complete foot exam (85% vs. 32%) in analyses adjusted for patient demographics and comorbidities (p-value <0.001 for all comparisons). In adjusted analyses, there were no significant differences in HbA1(c), blood pressure, or LDL cholesterol control., Conclusions: In spite of similar resident providers and practice models, there were substantial differences in the diabetes quality of care delivered in the VA and AHS. Understanding how these factors influence subsequent practice patterns is an important area for study.

Objective: Diabetes is underdiagnosed. About one third of people with diabetes do not know they have it, and the average lag between onset and diagnosis is 7 yr. This report reconsiders the criteria for diagnosing diabetes and recommends screening criteria to make case finding easier for clinicians and patients., Participants: R.M.B. invited experts in the area of diagnosis, monitoring, and management of diabetes to form a panel to review the literature and develop consensus regarding the screening and diagnosis of diabetes with particular reference to the use of hemoglobin A1c (HbA1c). Participants met in open session and by E-mail thereafter. Metrika, Inc. sponsored the meeting., Evidence: A literature search was performed using standard search engines., Consensus Process: The panel heard each member's discussion of the issues, reviewing evidence prior to drafting conclusions. Principal conclusions were agreed on, and then specific cut points were discussed in an iterative consensus process., Conclusions: The main factors in support of using HbA1c as a screening and diagnostic test include: 1) HbA1c does not require patients to be fasting; 2) HbA1c reflects longer-term glycemia than does plasma glucose; 3) HbA1c laboratory methods are now well standardized and reliable; and 4) errors caused by nonglycemic factors affecting HbA1c such as hemoglobinopathies are infrequent and can be minimized by confirming the diagnosis of diabetes with a plasma glucose (PG)-specific test. Specific recommendations include: 1) screening standards should be established that prompt further testing and closer follow-up, including fasting PG of 100 mg/dl or greater, random PG of 130 mg/dl or greater, or HbA1c greater than 6.0%; 2) HbA1c of 6.5-6.9% or greater, confirmed by a PG-specific test (fasting plasma glucose or oral glucose tolerance test), should establish the diagnosis of diabetes; and 3) HbA1c of 7% or greater, confirmed by another HbA1c- or a PG-specific test (fasting plasma glucose or oral glucose tolerance test) should establish the diagnosis of diabetes. The recommendations are offered for consideration of the clinical community and interested associations and societies.

Objective: Screening for diabetes has the potential to be an effective intervention, especially if patients have intensive treatment of their newly diagnosed diabetes and comorbid hypertension. We wished to determine the process and quality of diabetes care for patients diagnosed with diabetes by systematic screening., Research Design and Methods: A total of 1,253 users of the Durham Veterans Affairs Medical Center aged 45-64 years who did not report having diabetes were screened for diabetes with an HbA(1c) test. All subjects with an HbA(1c) level > or =6.0% were invited for follow-up blood pressure and fasting plasma glucose (FPG) measurements. A case of unrecognized diabetes was defined as HbA(1c) > or =7.0% or FPG > or =126 mg/dl. For each of the 56 patients for whom we made a new diagnosis of diabetes, we notified the patient's primary care provider of this diagnosis. One year after diagnosis, we reviewed these patients' medical records for traditional diabetes performance measures as well as blood pressure. Follow-up blood pressure was also ascertained from medical record review for all subjects with HbA(1c) > or =6.0% who did not have diabetes. We compared blood pressure changes between patients with and without diabetes., Results: Among patients diagnosed with diabetes at screening, 34 of 53 (64%) had evidence of diet or medical treatment for their diabetes, 42 of 53 (79%) had HbA(1c) measured within the year after diagnosis, 32 of 53 (60%) had cholesterol measured, 25 of 53 (47%) received foot examinations, 29 of 53 (55%) had eye examinations performed by an eye specialist, and 16 of 53 (30%) had any measure of urine protein. The mean blood pressure decline over the year after diagnosis for patients with diabetes was 2.3 mmHg; this decline was similar to that found for 183 patients in the study without diabetes (change in blood pressure, -3.6 mmHg). At baseline, 48% of patients with diabetes had blood pressure <140/90, compared with 40% of patients without diabetes; 1 year later, the same 48% of patients with diabetes had blood pressure <140/90, compared with 56% of patients without diabetes (P = 0.31 for comparing the change in percent in control between groups)., Conclusions: Patients with diabetes diagnosed at screening achieve less tight blood pressure control than similar patients without diabetes. Primary care providers do not appear to manage diabetes diagnosed at screening as intensively as long-standing diabetes and do not improve the management of hypertension given the new diagnosis of diabetes.

Objective: Diagnosis of a chronic illness can have a negative impact on patients' perception of their well-being ("labeling" effect). We sought to determine the effects of a new diagnosis of diabetes, discovered by systematic screening, on patients' health-related quality of life (HRQoL) 1 year after diagnosis., Research Design and Methods: We performed diabetes screening at the Durham Veterans Affairs Medical Center of 1,253 outpatients, aged 45-64 years, who did not report having diabetes. Our initial screen was a serum HbA(1c) measurement. All subjects with HbA(1c) > or = 6.0% were invited for follow-up measurement of blood pressure and fasting plasma glucose. A case of unrecognized diabetes was defined as HbA(1c) > or = 7.0% or fasting plasma glucose > or = 7 mmol/dl. HRQoL was measured by Medical Outcomes Study Short Form 36 (SF-36) for all patients at baseline and 1 year after enrollment. Linear multivariable models were used to determine the independent effect of the new diagnosis of diabetes on HRQoL., Results: Mean SF-36 Physical Component Score (PCS) for all patients was 36.2, and mean Mental Component Score (MCS) was 49.6. A total of 56 patients (4.5%) were found to have diabetes at screening. Patients found to have diabetes at screening had mean PCS of 35.6, which was not different from a mean PCS of 36.3 for those patients found not to have diabetes (P = 0.67). After adjusting for baseline PCS values, PCS 1 year after screening was similar for patients with and without diabetes found at screening (P = 0.95). Similarly, patients found to have diabetes at screening had mean MCS of 48.8; those found not to have diabetes had MCS of 49.6 (P = 0.70). After adjusting for baseline MCS values, MCS 1 year after screening was also similar between the two groups (P = 0.77)., Conclusions: For patients with a new diagnosis of diabetes discovered through systematic screening, HRQoL is similar to patients found not to have diabetes. Furthermore, HRQoL scores remain stable over the year after screening. This suggests that screening for diabetes has minimal, if any, "labeling" effect with respect to HRQoL.

Background: Opportunistic disease screening is the routine, asymptomatic disease screening of patients at the time of a physician encounter for other reasons. While the prevalence of unrecognized diabetes in community populations is well known, the prevalence in clinical populations is unknown., Objective: To describe the prevalence, predictors, and clinical severity of unrecognized diabetes among outpatients at a major medical center., Design and Setting: A cross-sectional observational study at the Durham Veterans Affairs Medical Center., Subjects: Outpatients without recognized diabetes (N=1,253)., Methods: We screened patients for diabetes by using an initial random Hemoglobin A1c (HbA1c) measurement, and then obtaining follow-up fasting plasma glucose (FPG) for all subjects with HbA1c > or =6.0%. A case of unrecognized diabetes was defined as either HbA1c > or =7.0% or FPG > or =7 mmol/L (126 mg/dL). Height and weight were obtained for all subjects. We also obtained resting blood pressure, fasting lipids, and urine protein in subjects with HbA1c > or =6.0%., Results: The prevalence of unrecognized diabetes was 4.5% (95% confidence interval [CI], 3.4 to 5.7). Factors associated with unrecognized diabetes were the diagnosis of hypertension (adjusted odds ratio [OR], 2.5; P=.004), weight >120% of ideal (adjusted OR, 2.2; P=.02), and history of a parent or sibling with diabetes (adjusted OR, 1.7; P=.06). Having a primary care provider did not raise or lower the risk for unrecognized diabetes (P=.73). Based on the new diagnosis, most patients (61%) found to have diabetes required a change in treatment either of their blood sugar or comorbid hypertension or hyperlipidemia in order to achieve targets recommended in published treatment guidelines. Patients reporting a primary care provider were no less likely to require a change in treatment (P=.20)., Conclusions: If diabetes screening is an effective intervention, opportunistic screening for diabetes may be the preferred method for screening, because there is substantial potential for case-finding in a medical center outpatient setting. A majority of patients with diabetes diagnosed at opportunistic screening will require a change in treatment of blood sugar, blood pressure, or lipids to receive optimal care.

Context: To estimate the prevalence of unrecognized diabetes in a large managed care organization (MCO)., Design: Retrospective data analysis., Patients and Setting: All patients over age 30 enrolled in the (staff-model) MCO of Duke University Medical Center between April 1996 and March 1999., Data Sources: Merged database of MCO administrative, billing, and laboratory files and selected medical records. CASE DEFINITIONS: We identified all patients with abnormal test results suggestive of diabetes (i.e., hemoglobin [Hb] A1c > or = 7.0% or plasma glucose > or = 200 mg/dL) on one or more occasions. Patients were considered to have recognized diabetes if they had an ICD-9 diagnostic code for diabetes in the administrative database or a diagnosis mentioned in their medical record (on the basis of medical record review of a random sample of 30% of patients with abnormal test results and no ICD-9 code). Patients with unrecognized diabetes did not have an ICD-9 code or a medical record diagnosis., Results: 1426 patients had laboratory tests suggestive of diabetes. Of these patients, 1122 (79%) had an ICD-9 diagnostic code for diabetes in the administrative database. Forty-six of the remaining 304 patients without ICD-9 codes had mention of diabetes on medical record review; thus, we estimate that as many as 258 (18% of patients with laboratory tests suggestive of diabetes) had unrecognized diabetes. When this estimate was restricted to findings that are most suggestive of diabetes (high HbA1c or two high plasma glucose tests), 124 (9%) patients had unrecognized diabetes., Conclusions: A substantial proportion of patients in an MCO have laboratory values suggestive of diabetes with no evidence that their providers have recognized this condition.

Objective: Patients with persistent poorly-controlled diabetes mellitus (PPDM) despite engagement in clinic-based care are at particularly high risk for diabetes complications and costs. Understanding this population’s demographics, comorbidities and care utilization could guide strategies to address PPDM. We characterized factors associated with PPDM in a large sample of Veterans with type 2 diabetes. Methods: We identified a cohort of Veterans with medically treated type 2 diabetes, who received Veterans Health Administration primary care during fiscal years 2012 and 2013. PPDM was defined by hemoglobin A1c levels uniformly >8.5% during fiscal year (FY) 2012, despite engagement with care during this period. We used FY 2012 demographic, comorbidity and medication data to describe PPDM in relation to better-controlled diabetes patients and created multivariable models to examine associations between clinical factors and PPDM. We also constructed multivariable models to explore the association between PPDM and FY 2013 care utilization. Results: In our cohort of diabetes patients (n = 435,820), 12% met criteria for PPDM. Patients with PPDM were younger than better-controlled patients, less often married, and more often Black/African-American and Hispanic or Latino/Latina. Of included comorbidities, only retinopathy (OR 1.68, 95% confidence interval (CI): 1.63,1.73) and nephropathy (OR 1.26, 95% CI: 1.19,1.34) demonstrated clinically significant associations with PPDM. Complex insulin regimens such as premixed (OR 10.80, 95% CI: 10.11,11.54) and prandial-containing regimens (OR 18.74, 95% CI: 17.73,19.81) were strongly associated with PPDM. Patients with PPDM had higher care utilization, particularly endocrinology care (RR 3.56, 95% CI: 3.47,3.66); although only 26.4% of patients saw endocrinology overall. Conclusion: PPDM is strongly associated with complex diabetes regimens, although heterogeneity in care utilization exists. While there is evidence of underutilization, inadequacy of available care may also contribute to PPDM. Our findings should inform tailored approaches to meet the needs of PPDM, who are among the highest-risk, highest-cost patients with diabetes. [ABSTRACT FROM AUTHOR]

Background: In the Atherosclerosis Risk in Communities (ARIC) Study and Jackson Heart Study (JHS) cohorts, serum potassium (K) is an independent predictor of diabetes risk, particularly among African-American participants. Experimental studies show that serum K levels affects insulin secretion. The KCNJ11 gene encodes for a K channel that regulates insulin secretion and whose function is affected by serum K levels. Variants in KCNJ11 are associated with increased diabetes risk. We hypothesized that there could be a gene-by-environment interaction between KCNJ11 variation and serum K on diabetes risk. Methods: Evaluating a combined cohort of ARIC and JHS participants, we sought to determine if KCNJ11 variants are risk factors for diabetes; and if KCNJ11 variants modify the association between serum K and diabetes risk. Among participants without diabetes at baseline, we performed multivariable logistic regression to determine the effect of serum K, KCNJ11 variants, and their interactions on the odds of incident diabetes mellitus over 8–9 years in the entire cohort and by race. Results: Of 11,812 participants, 3220 (27%) participants developed diabetes. 48% and 47% had 1 or 2 diabetes risk alleles of rs5215 and rs5219, respectively. Caucasians had higher proportions of these risk alleles compared to African Americans (60% vs 17% for rs5215 and 60% vs 13% for rs5219, p<0.01). Serum K was a significant independent predictor of incident diabetes. Neither rs5215 nor rs5219 was associated with incident diabetes. In multivariable models, we found no statistically significant interactions between race and either rs5215 or rs5219 (P-values 0.493 and 0.496, respectively); nor between serum K and either rs5215 or rs5219 on odds of incident diabetes (P-values 0.534 and 0.687, respectively). Conclusion: In this cohort, rs5215 and rs5219 of KCNJ11 were not significant predictors of incident diabetes nor effect modifiers of the association between serum K and incident diabetes. [ABSTRACT FROM AUTHOR]

Objectives To determine whether a home-based multicomponent physical activity counseling ( PAC) intervention is effective in reducing glycemic measures in older outpatients with prediabetes mellitus. Design Controlled clinical trial. Setting Primary care clinics of the Durham Veterans Affairs ( VA) Medical Center between September 29, 2008, and March 25, 2010. Participants Three hundred two overweight (body mass index 25-45 kg/m2), older (60-89) outpatients with impaired glucose tolerance (fasting blood glucose 100-125 mg/ dL, glycosylated hemoglobin (HbA1c) <7%) randomly assigned to a PAC intervention group (n = 180) or a usual care control group (n = 122). Intervention A 12-month, home-based multicomponent PAC program including one in-person baseline counseling session, regular telephone counseling, physician endorsement in clinic with monthly automated encouragement, and customized mailed materials. All study participants, including controls, received a consultation in a VA weight management program. Measurements The primary outcome was a homeostasis model assessment of insulin resistance ( HOMA- IR), calculated from fasting insulin and glucose levels at baseline and 3 and 12 months. HbA1c was the secondary indicator of glycemic control. Other secondary outcomes were anthropometric measures and self-reported physical activity, health-related quality of life, and physical function. Results There were no significant differences between the PAC and control groups over time for any of the glycemic indicators. Both groups had small declines over time of approximately 6% in fasting blood glucose ( P < .001), and other glycemic indicators remained stable. The declines in glucose were not sufficient to affect the change in HOMA- IR scores due to fluctuations in insulin over time. Endurance physical activity increased significantly in the PAC group ( P < .001) and not in the usual care group. Conclusion Home-based telephone counseling increased physical activity levels but was insufficient to improve glycemic indicators in older outpatients with prediabetes mellitus. [ABSTRACT FROM AUTHOR]

In this single-arm pilot study, we demonstrated feasibility and acceptability of an insulin simplification intervention in patients with persistent, poorly-controlled type 2 diabetes on complex insulin regimens. While not powered to assess clinical outcomes, we observed neither worsened glycemic control nor increased hypoglycemia. • Insulin simplification is rarely studied outside of the context of older adult care. • Patients that maintain poor glucose control on complex insulin therapy can benefit. • Simplification in this population is feasible, acceptable and may improve HbA1c. [ABSTRACT FROM AUTHOR]

Introduction: Non-communicable diseases (NCDs) are the leading cause of mortality in the world, with 80% of burden in low-and middle-income countries (LMICs). Studies have found microfinance (MF) programs can reduce poverty and improve health outcomes. The group medical visit (GMV), an encounter between clinician(s) and a patient group, has also been shown to improve health outcomes in high-income countries. Contextual factors, facilitators, and barriers to implementation of an integrated MF/GMV program for NCDs in LMICs are not well known. Methods: This qualitative study is situated within the larger BIGPIC (Bridging Income Generation with grouP Integrated Care) trial combining MF and GMV for cardiovascular risk reduction among individuals with, and at increased risk of, diabetes in western Kenya. We conducted mabaraza (community gatherings) and focus group discussions (FGDs) among rural clinicians, patients, and MF members. Five mabaraza (113 male, 92 female participants) and 16 FGDs (57 male, 105 female) were conducted. Sessions were audio-recorded, transcribed and translated to English. Content analysis of English transcripts was performed in NVIVO. Results: Patients expressed interest in participating in MF/GMV programs, but cited potential challenges (Table). First, stigma associated with chronic diseases may lead to fear of joining groups. Second, previous negative experiences lead to earned skepticism of the health system. Third, the impact of stigma and skepticism is exacerbated because patients have few options for care and experience socio-economic fragility. MF/GMVs are a possible way to decrease cost and stigma, while increasing efficiency, social support, clinician accountability and quality of care. Conclusions: Participants report interest in MF/GMVs despite potential challenges of stigma, skepticism and fragility. An integrated MF/GMV program may overcome challenges and improve access to healthcare in low-resource settings. [ABSTRACT FROM AUTHOR]