Effect of Lower Extremity Nerve Decompression in Patients With Painful Diabetic Peripheral Neuropathy: The Diabetic Neuropathy Nerve Decompression Randomized, Observation Group and Placebo Surgery-Controlled Clinical Trial.

OBJECTIVE: To evaluate the effect of nerve decompression on pain in patients with lower extremity painful diabetic peripheral neuropathy (DPN). BACKGROUND: Currently, no treatment provides lasting relief for patients with DPN. The benefits of nerve decompression remain inconclusive. METHODS: This double-blinded, observation and same-patient sham surgery-controlled randomized trial enrolled patients aged 18 to 80 years with lower extremity painful DPN who failed 1 year of medical treatment. Patients were randomized to nerve decompression or observation group (2:1). Decompression-group patients were further randomized and blinded to nerve decompression in either the right or left leg and sham surgery in the opposite leg. Pain (11-point Likert score) was compared between decompression and observation groups and between decompressed versus sham legs at 12 and 56 months. RESULTS: Of 2987 screened patients, 78 were randomized. At 12 months, compared with controls (n=37), both the right-decompression group (n=22) and left-decompression group (n=18) reported lower pain (mean difference for both: -4.46; 95% CI: -6.34 to -2.58 and -6.48 to -2.45, respectively; P < 0.0001). Decompressed and sham legs equally improved. At 56 months, compared with controls (n=m 14), pain was lower in both the right-decompression group (n=20; mean difference: -7.65; 95% CI: -9.87 to -5.44; P < 0.0001) and left-decompression group (n=16; mean difference: -7.26; 95% CI: -9.60 to -4.91; P < 0.0001). The mean pain score was lower in decompressed versus sham legs (mean difference: 1.57 95% CI: 0.46 to 2.67; P =0.0002). CONCLUSIONS: Although nerve decompression was associated with reduced pain, the benefit of surgical decompression needs further investigation as a placebo effect may be responsible for part or all of these effects.

The Impact of a Diabetes Transitions of Care Clinic on Hospital Utilization and Patient Care.

BACKGROUND: There is currently limited guidance from the American Diabetes Association regarding transitions of care for patients with diabetes. OBJECTIVE: This study's aim was to determine the impact of a diabetes-specific transitions of care clinic (TOCC) on hospital utilization and patient outcomes in recently discharged patients with diabetes. METHODS: This retrospective study evaluated patients seen by TOCC as compared with similar patients discharged from the study institution the year prior. The primary outcome was a composite of the number of unique patients with readmissions/emergency department (ED) visits within 30 days of discharge. Secondary outcomes included a subcomponent analysis of readmissions/ED visits, index hospital length of stay (LOS), and to describe clinical interventions made in clinic. This study was approved by the institutional review board of the Office of Responsible Research Practice at the Ohio State University Wexner Medical Center. RESULTS: There were 165 patients in the TOCC group and 157 in the control group based on the matching criteria. There was a statistically significant decrease in the primary outcome in the TOCC group versus the control group (18% vs 36%, P < 0.001). In evaluation of its subcomponents, there was a statically significant decrease in patients with readmissions (11% vs 26%, P < 0.001) but not ED visits (10% vs 17%, P = 0.096). The LOS for the TOCC group was shorter at 4 days versus 5 days in the control group (P = 0.055). CONCLUSIONS AND RELEVANCE: The implementation of a diabetes-specific TOCC can decrease both readmissions and ED visits and may impact hospital LOS. In addition, a TOCC can be used to identify gaps in preventive care. The results from this study may help support the creation of similar TOCC at other institutions.

Applying National Diabetic Care Standards for the Management of a Hispanic Population Attending a Free Clinic.

BACKGROUND: National quality measures set goals for diabetes management. Hispanic populations are higher risk for diabetes and associated complications, especially low-income communities. Research suggests free clinics provide suboptimal diabetes management. Our quality improvement project aims to improve diabetes management in the Hispanic free clinic population. METHODS: Clínica Latina's volunteer medical students and physicians serve predominantly uninsured Spanish-speaking patients. Established diabetes patients that attended clinic during the study were included. Data was collected regarding patients' diabetes care for two months, then analyzed compared to quality metrics. We implemented paper checklists and electronic medical record (EMR) smart phrases for volunteers to utilize in managing diabetes. RESULTS: 32 patients were included in the study. At baseline, 78% had an A1C check in the past 3 months, 81% were on a statin. In the past year, 81% had a lipid panel, 19% had an eye exam, 63% had a diabetic foot exam, 53% had a urine microalbumin-creatinine screening. After interventions, 97% had an A1C check, 93% were on a statin, 91% had a lipid panel, 31% had an eye exam, 75% had a foot exam, 63% had a urine microalbumin-creatinine. Patients with an LDL < 100 increased from 62 to 66%. The mean A1C did not statistically significantly change. Volunteer smart phrase utilization increased from 37 to 59.1%. CONCLUSION: We implemented a checklist and EMR smart phrase to optimize diabetes management in a student-run Hispanic free clinic, which improved quality metrics. Low-resource clinics serving Spanish-speaking populations may benefit from similar interventions to improve diabetic care.

COVID-19 Vaccination Rates and Vaccine Hesitancy Among Spanish-Speaking Free Clinic Patients.

We sought to assess COVID-19 vaccination rates, as well as attitudes and beliefs towards the vaccine, of patients in a Spanish-speaking student-run free clinic in Columbus, Ohio. A cross-sectional study was performed. Surveys were distributed to all individuals over 18 years who presented to La Clínica Latina between July, 2022 and September, 2022. A convenience sample was used: patients in the waiting room and their accompanying family members or friends were invited to participate. Subjects were excluded if under the age of 18 or over the age of 75, or if non-Spanish speaking. Of the 158 individuals who agreed to participate in our study, 146 responded to the question regarding vaccination status, revealing 90.4% of respondents had received a COVID-19 vaccination. Most respondents learned about the vaccine from social media (26.4%) or television (22.7%). The majority of participants sought answers to questions surrounding the vaccine by asking their doctor (49.1%). The most common reason among unvaccinated participants for not undergoing vaccination was fear of an adverse reaction to the vaccine (n = 11). We found that a large proportion (90.4%) of individuals seeking care at a Spanish-speaking free clinic were vaccinated against COVID-19. Our study also provides perspective on the means of health knowledge acquisition and behaviors in this predominantly Latinx patient population in central Ohio. We can utilize our results to optimize and tailor clinic services and initiatives for COVID-19 boosters to meet the needs of this community.

Predictors of change in hypoglycemia unawareness among patients with type 1 diabetes.

AIMS: To analyse predictors of hypoglycemia unawareness (HU) and improvement in Clarke score in clinical practice. MATERIALS AND METHODS: We retrospectively identified patients with type 1 diabetes (T1D) at an academic T1D clinic who completed HU surveys 6-12 months apart. HU (Clarke score ≥4) and improvement in Clarke score (decrease by ≥1 point or more clinically relevant ≥2 point) were assessed in univariable relationships and using multivariable logistic regression. RESULTS: Of the 300 participants, median diabetes duration was 19 years, 47 had HU at baseline, and 91 had an improvement by 1 point while 21 had an improvement by 2 points. Patients with baseline Clarke score ≥4 who had ≥1 or ≥2 point improvement had lower filtration rate (eGFR) than those who did not. After adjustment for other variables, gender (male OR 0.33, 95% CI 0.15, 0.74), log diabetes duration (OR 6.40, 95% CI 2.84, 14.5), and eGFR <60 ml/min/1.73 m2 (5.56, 95% CI 1.98, 15.6) were independent predictors of baseline HU. Continuous glucose monitoring use (OR 2.04, 95% CI 1.20, 3.48) and log diabetes duration (OR 1.78, 95% CI 1.22, 2.60) were independent predictors of 1 point improvement and eGFR <60 ml/min/1.73 m2 (OR 10.5, 95% CI 3.64, 30.0) and an education visit (OR 2.64, 95% CI 1.01, 6.89) were independent predictors of 2 point improvement in Clarke score. CONCLUSIONS: Diabetes duration, gender, and eGFR were independent predictors of HU. Improvement in Clarke score is possible in patients with long-standing T1D, underscoring the need for additional study.

Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Management of Dyslipidemia and Prevention of Cardiovascular Disease Algorithm - 2020 Executive Summary.

The treatment of lipid disorders begins with lifestyle therapy to improve nutrition, physical activity, weight, and other factors that affect lipids. Secondary causes of lipid disorders should be addressed, and pharmacologic therapy initiated based on a patient's risk for atherosclerotic cardiovascular disease (ASCVD). Patients at extreme ASCVD risk should be treated with high-intensity statin therapy to achieve a goal low-density lipoprotein cholesterol (LDL-C) of <55 mg/dL, and those at very high ASCVD risk should be treated to achieve LDL-C <70 mg/dL. Treatment for moderate and high ASCVD risk patients may begin with a moderate-intensity statin to achieve an LDL-C <100 mg/dL, while the LDL-C goal is <130 mg/dL for those at low risk. In all cases, treatment should be intensified, including the addition of other LDL-C-lowering agents (i.e., proprotein convertase subtilisin/kexin type 9 inhibitors, ezetimibe, colesevelam, or bempedoic acid) as needed to achieve treatment goals. When targeting triglyceride levels, the desirable goal is <150 mg/dL. Statin therapy should be combined with a fibrate, prescription-grade omega-3 fatty acid, and/or niacin to reduce triglycerides in all patients with triglycerides ≥500 mg/dL, and icosapent ethyl should be added to a statin in any patient with established ASCVD or diabetes with ≥2 ASCVD risk factors and triglycerides between 135 and 499 mg/dL to prevent ASCVD events. Management of additional risk factors such as elevated lipoprotein(a) and statin intolerance is also described.

GONADOPENIA AND AGING IN MEN.

OBJECTIVE: The decrease in testosterone levels that occurs with aging has become an important clinical issue both due to the growth of the geriatric population and patient interest in testosterone therapy. The decision to assess for testosterone deficiency and the ability to determine whether the benefits exceed the risks require a comprehensive evaluation of the aging patient. This article is part of a series of papers focused on the endocrinology of aging. This review addresses common issues needed for clinical decision making, including how to interpret test results, differential diagnosis, potential impact of testosterone treatment on insulin resistance and cardiovascular disease, and options for therapy. METHODS: Papers reviewed were identified through literature searches conducted on PubMed. RESULTS: Assessment of testosterone levels in the geriatric male requires an understanding of the limitations of the assay that is used, the symptoms associated with low testosterone, the impact of comorbid conditions on levels, and risks of therapy. Successful treatment requires setting realistic expectations of the benefits of replacement therapy. CONCLUSION: While the prevalence of low testosterone concentrations is increased with aging, the common comorbidities such as obesity and diabetes may contribute to changes in testosterone levels. Clinical trial evidence shows modest benefit for treatment of low testosterone in the presence of symptoms. Assessment of the geriatric male should include evaluation of their testosterone level in the context of their functional status and comorbidities. ABBREVIATIONS: CDC = Centers for Disease Control and Prevention; CI = confidence interval; CVD = cardiovascular disease; DXA = dual-energy X-ray absorptiometry; EMAS = European Male Aging Study; FDA = U.S. Food and Drug Administration; FHS = Framingham Heart Study; HDL = high-density lipoprotein; HOMA-IR = homeostasis model assessment of insulin resistance; LH = luteinizing hormone; OR = odds ratio; PSA = prostate-specific antigen; SHBG = sex hormone-binding globulin; T2DM = type 2 diabetes mellitus; vBMD = volumetric bone mineral density.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY GUIDELINES FOR MANAGEMENT OF DYSLIPIDEMIA AND PREVENTION OF CARDIOVASCULAR DISEASE.

OBJECTIVE: The development of these guidelines is mandated by the American Association of Clinical Endocrinologists (AACE) Board of Directors and American College of Endocrinology (ACE) Board of Trustees and adheres with published AACE protocols for the standardized production of clinical practice guidelines (CPGs). METHODS: Recommendations are based on diligent reviews of the clinical evidence with transparent incorporation of subjective factors, according to established AACE/ACE guidelines for guidelines protocols. RESULTS: The Executive Summary of this document contains 87 recommendations of which 45 are Grade A (51.7%), 18 are Grade B (20.7%), 15 are Grade C (17.2%), and 9 (10.3%) are Grade D. These detailed, evidence-based recommendations allow for nuance-based clinical decision-making that addresses multiple aspects of real-world medical care. The evidence base presented in the subsequent Appendix provides relevant supporting information for Executive Summary Recommendations. This update contains 695 citations of which 203 (29.2 %) are EL 1 (strong), 137 (19.7%) are EL 2 (intermediate), 119 (17.1%) are EL 3 (weak), and 236 (34.0%) are EL 4 (no clinical evidence). CONCLUSION: This CPG is a practical tool that endocrinologists, other health care professionals, health-related organizations, and regulatory bodies can use to reduce the risks and consequences of dyslipidemia. It provides guidance on screening, risk assessment, and treatment recommendations for a range of individuals with various lipid disorders. The recommendations emphasize the importance of treating low-density lipoprotein cholesterol (LDL-C) in some individuals to lower goals than previously endorsed and support the measurement of coronary artery calcium scores and inflammatory markers to help stratify risk. Special consideration is given to individuals with diabetes, familial hypercholesterolemia, women, and youth with dyslipidemia. Both clinical and cost-effectiveness data are provided to support treatment decisions. ABBREVIATIONS: 4S = Scandinavian Simvastatin Survival Study A1C = glycated hemoglobin AACE = American Association of Clinical Endocrinologists AAP = American Academy of Pediatrics ACC = American College of Cardiology ACE = American College of Endocrinology ACS = acute coronary syndrome ADMIT = Arterial Disease Multiple Intervention Trial ADVENT = Assessment of Diabetes Control and Evaluation of the Efficacy of Niaspan Trial AFCAPS/TexCAPS = Air Force/Texas Coronary Atherosclerosis Prevention Study AHA = American Heart Association AHRQ = Agency for Healthcare Research and Quality AIM-HIGH = Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides trial ASCVD = atherosclerotic cardiovascular disease ATP = Adult Treatment Panel apo = apolipoprotein BEL = best evidence level BIP = Bezafibrate Infarction Prevention trial BMI = body mass index CABG = coronary artery bypass graft CAC = coronary artery calcification CARDS = Collaborative Atorvastatin Diabetes Study CDP = Coronary Drug Project trial CI = confidence interval CIMT = carotid intimal media thickness CKD = chronic kidney disease CPG(s) = clinical practice guideline(s) CRP = C-reactive protein CTT = Cholesterol Treatment Trialists CV = cerebrovascular CVA = cerebrovascular accident EL = evidence level FH = familial hypercholesterolemia FIELD = Secondary Endpoints from the Fenofibrate Intervention and Event Lowering in Diabetes trial FOURIER = Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk trial HATS = HDL-Atherosclerosis Treatment Study HDL-C = high-density lipoprotein cholesterol HeFH = heterozygous familial hypercholesterolemia HHS = Helsinki Heart Study HIV = human immunodeficiency virus HoFH = homozygous familial hypercholesterolemia HPS = Heart Protection Study HPS2-THRIVE = Treatment of HDL to Reduce the Incidence of Vascular Events trial HR = hazard ratio HRT = hormone replacement therapy hsCRP = high-sensitivity CRP IMPROVE-IT = Improved Reduction of Outcomes: Vytorin Efficacy International Trial IRAS = Insulin Resistance Atherosclerosis Study JUPITER = Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin LDL-C = low-density lipoprotein cholesterol Lp-PLA2 = lipoprotein-associated phospholipase A2 MACE = major cardiovascular events MESA = Multi-Ethnic Study of Atherosclerosis MetS = metabolic syndrome MI = myocardial infarction MRFIT = Multiple Risk Factor Intervention Trial NCEP = National Cholesterol Education Program NHLBI = National Heart, Lung, and Blood Institute PCOS = polycystic ovary syndrome PCSK9 = proprotein convertase subtilisin/kexin type 9 Post CABG = Post Coronary Artery Bypass Graft trial PROSPER = Prospective Study of Pravastatin in the Elderly at Risk trial QALY = quality-adjusted life-year ROC = receiver-operator characteristic SOC = standard of care SHARP = Study of Heart and Renal Protection T1DM = type 1 diabetes mellitus T2DM = type 2 diabetes mellitus TG = triglycerides TNT = Treating to New Targets trial VA-HIT = Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial VLDL-C = very low-density lipoprotein cholesterol WHI = Women's Health Initiative.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY GUIDELINES FOR MANAGEMENT OF DYSLIPIDEMIA AND PREVENTION OF CARDIOVASCULAR DISEASE - EXECUTIVE SUMMARYComplete Appendix to Guidelines available at http://journals.aace.com.

OBJECTIVE: The development of these guidelines is mandated by the American Association of Clinical Endocrinologists (AACE) Board of Directors and American College of Endocrinology (ACE) Board of Trustees and adheres with published AACE protocols for the standardized production of clinical practice guidelines (CPGs). METHODS: Each Recommendation is based on a diligent review of the clinical evidence with transparent incorporation of subjective factors. RESULTS: The Executive Summary of this document contains 87 Recommendations of which 45 are Grade A (51.7%), 18 are Grade B (20.7%), 15 are Grade C (17.2%), and 9 (10.3%) are Grade D. These detailed, evidence-based recommendations allow for nuance-based clinical decision making that addresses multiple aspects of real-world medical care. The evidence base presented in the subsequent Appendix provides relevant supporting information for Executive Summary Recommendations. This update contains 695 citations of which 202 (29.1 %) are evidence level (EL) 1 (strong), 137 (19.7%) are EL 2 (intermediate), 119 (17.1%) are EL 3 (weak), and 237 (34.1%) are EL 4 (no clinical evidence). CONCLUSION: This CPG is a practical tool that endocrinologists, other healthcare professionals, regulatory bodies and health-related organizations can use to reduce the risks and consequences of dyslipidemia. It provides guidance on screening, risk assessment, and treatment recommendations for a range of patients with various lipid disorders. These recommendations emphasize the importance of treating low-density lipoprotein cholesterol (LDL-C) in some individuals to lower goals than previously recommended and support the measurement of coronary artery calcium scores and inflammatory markers to help stratify risk. Special consideration is given to patients with diabetes, familial hypercholesterolemia, women, and pediatric patients with dyslipidemia. Both clinical and cost-effectiveness data are provided to support treatment decisions. ABBREVIATIONS: A1C = hemoglobin A1C ACE = American College of Endocrinology ACS = acute coronary syndrome AHA = American Heart Association ASCVD = atherosclerotic cardiovascular disease ATP = Adult Treatment Panel apo = apolipoprotein BEL = best evidence level CKD = chronic kidney disease CPG = clinical practice guidelines CVA = cerebrovascular accident EL = evidence level FH = familial hypercholesterolemia HDL-C = high-density lipoprotein cholesterol HeFH = heterozygous familial hypercholesterolemia HIV = human immunodeficiency virus HoFH = homozygous familial hypercholesterolemia hsCRP = high-sensitivity C-reactive protein LDL-C = low-density lipoprotein cholesterol Lp-PLA2 = lipoprotein-associated phospholipase A2 MESA = Multi-Ethnic Study of Atherosclerosis MetS = metabolic syndrome MI = myocardial infarction NCEP = National Cholesterol Education Program PCOS = polycystic ovary syndrome PCSK9 = proprotein convertase subtilisin/kexin type 9 T1DM = type 1 diabetes mellitus T2DM = type 2 diabetes mellitus TG = triglycerides VLDL-C = very low-density lipoprotein cholesterol.

Comparative Effectiveness of Hybrid Closed-Loop Automated Insulin Delivery Systems Among Patients with Type 1 Diabetes.

BACKGROUND: Clinical trials have demonstrated the efficacy and safety of hybrid closed-loop (HCL) systems, yet few studies have compared outcomes in the real-world setting. METHOD: This retrospective study analyzed patients from an academic endocrinology practice between January 1, 2018, and November 18, 2022. The inclusion criteria were diagnosis code for type I diabetes (T1D), >18 years of age, new to any HCL system [Medtronic 670G/770G (MT), Tandem Control IQ (CIQ), or Omnipod 5 (OP5)], and availability of a pump download within three months. The outcomes included %time in range (TIR) of 70 to 180 mg/dL, %time below range (TBR) <70 mg/dL at 90 days, and HbA1c for 91 to 180 days. RESULT: Of the 176 participants, 47 were MT, 74 CIQ, and 55 OP5. Median (25%, 75%) change in HbA1c was -0.1 (-0.8, 0.3), -0.6 (-1.1, -0.15), and -0.55 (-0.98, 0)% for MT, CIQ, and OP5, respectively, (P = .04). TIR was 70 (57, 76), 67 (59, 75), and 68 (60, 76)% (P = .95) at 90 days while TBR was 2 (1, 3), 1 (0, 2), and 1 (0, 1)%, respectively, (P = .002). The %time in automated delivery was associated with TIR and change in HbA1c. After controlling other factors including %time in automated delivery, HCL type was not an independent predictor of change in HbA1c nor TIR but remained a significant predictor of TBR. CONCLUSION: There were significant reductions in HbA1c in CIQ and OP5. TIR was similar across pumps, but TBR was highest with MT. The %time in automated delivery likely explains differences in change in HbA1c but not TBR between HCL systems.

JCL Roundtable. Obesity, Diabetes, and Liver Disease in Relation to Cardiovascular Risk.

Metabolic risk for cardiovascular and other systems includes much more than just LDL cholesterol. This JCL Roundtable brings together 3 experts to address new opportunities to reduce the risks posed by obesity, diabetes, and fatty liver disease. Successful nutritional approaches to weight loss are diverse and need to be matched with individual preferences. Topiramate plus extended-release phentermine has been shown to promote meaningful weight loss in randomized trials, but the patented drug combination is expensive. Clinical experience suggests that generic topiramate and phentermine may also be effective. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and sodium-glucose cotransporter 2 inhibitors (SGLT2is) have shown favorable tolerability and efficacy for cardiovascular disease in randomized trials, an achievement without precedent among earlier diabetes medications. These 2 drug classes differ in their effects. GLP-1 RAs decrease atherosclerotic cardiovascular events and also decrease hemoglobin A1c, body weight, blood pressure, and possibly diabetic renal disease. SGLT2 inhibitors are effective in reducing heart failure events even among nondiabetic patients. They also decrease progression of diabetic renal disease. The presence of nonalcoholic fatty liver disease signifies risk for atherosclerotic cardiovascular disease as well as cirrhosis and serious hepatic decompensation, including hepatocellular carcinoma. The key to identifying cirrhosis risk is to assess pre-emptively liver fibrosis, which can be predicted initially with blood test risk scores (e.g., FIB-4 index) and more definitively by transient elastography and other imaging techniques and/or liver biopsy. Some medications approved for the treatment of type 2 diabetes may reduce liver fat (SGLT2 inhibitors, insulin) or even reverse steatohepatitis in paired liver biopsy studies (GLP-1 RAs or pioglitazone) Overall the field of preventive metabolic medicine is expanding. Clinical lipidologists should become familiar with recent advances.

Influence of Literacy, Self-Efficacy, and Social Support on Diabetes-Related Outcomes Following Hospital Discharge.

Objective: To evaluate the relationship between health literacy, social support, and self-efficacy as predictors of change in A1c and readmission among hospitalized patients with type 2 diabetes (T2D). Methods: This is a secondary analysis of patients with T2D (A1c >8.5%) enrolled in a randomized trial in which health literacy (Newest Vital Sign), social support (Multidimensional Scale of Perceived Social Support), and empowerment (Diabetes Empowerment Scale-Short Form) was assessed at baseline. Multivariable models evaluated whether these concepts were associated with A1c reduction at 12 weeks (absolute change, % with >1% reduction, % reaching individualized target) and readmission (14 and 30 days). Results: A1c (N=108) decreased >1% in 60%, while individualized A1c target was achieved in 31%. After adjustment for baseline A1c and potential confounders, health literacy was associated with significant reduction in A1c (Estimate -0.21, 95% CI -0.40, -0.01, p=0.041) and >1% decrease in A1c (OR 1.37, 95% CI 1.08, 1.73, p=0.009). However, higher social support was associated with greater adjusted odds of reaching the individualized A1c target (OR 1.63, 95% CI 1.04, 2.55, p=0.32). Both higher empowerment (OR 0.23, 95% CI 0.08, 0.64, p=0.005) and social support (OR 0.57, 95% CI 0.36, 0.91, p=0.018) were associated with fewer readmissions by 14 days, but not 30 days. Conclusion: The study indicates that health literacy and social support may be important predictors of A1c reduction post-discharge among hospitalized patients with T2D. Social support and diabetes self-management skills should be addressed and early follow-up may be critical for avoiding readmissions. Clinical Trial: NCT03455985.

Hypothyroidism Prevalence in the United States: A Retrospective Study Combining National Health and Nutrition Examination Survey and Claims Data, 2009-2019.

Previous estimates determined prevalence of hypothyroidism (HT) to be 4.6% of the US population. This study aimed to update estimates of HT prevalence in the United States by retrospective analysis of 2 datasets. Data on HT type (overt or subclinical HT) and treatment were collected from the 2009-2010 and 2011-2012 National Health and Nutrition Examination Survey (NHANES) cycles. From the Optum administrative claims database, medical and pharmacy claims were collected between January 1, 2012, and December 31, 2019. Patients were defined as having HT if, per given year, they had >1 prescription for HT treatment, >1 claim indicating an HT diagnosis, or thyroid-stimulating hormone levels >4.0 mIU/L (NHANES arm). For both studies, treatment was defined as any evidence of synthetic or natural thyroid hormone replacement, identified by pharmacy claims or patient surveys. Data are reported as percentage of patients with HT and treatments received. Between 2009 and 2012, HT prevalence remained around 9.6% of the US population. The administrative claims dataset showed that HT prevalence grew from 9.5% in 2012 to 11.7% in 2019 and that >78% of patients received thyroxine (T4) monotherapy. Similarly, the NHANES dataset showed that T4 replacement therapy was the most common treatment for HT. From 2012-2019, patients with untreated HT grew from 11.8% to 14.4%. The prevalence of HT in the United States has steadily increased since 2009. Likewise, the percentage of hypothyroid-diagnosed patients not receiving treatment also increased, suggesting that the increased prevalence may be due to increased cases of subclinical HT.

Effectiveness of a Diabetes-Focused Electronic Discharge Order Set and Postdischarge Nursing Support Among Poorly Controlled Hospitalized Patients: Randomized Controlled Trial.

BACKGROUND: Although the use of electronic order sets has become standard practice for inpatient diabetes management, there is limited decision support at discharge. OBJECTIVE: In this study, we assessed whether an electronic discharge order set (DOS) plus nurse follow-up calls improve discharge orders and postdischarge outcomes among hospitalized patients with type 2 diabetes mellitus. METHODS: This was a randomized, open-label, single center study that compared an electronic DOS and nurse phone calls to enhanced standard care (ESC) in hospitalized insulin-requiring patients with type 2 diabetes mellitus. The primary outcome was change in glycated hemoglobin (HbA1c) level at 24 weeks after discharge. The secondary outcomes included the completeness and accuracy of discharge prescriptions related to diabetes. RESULTS: This study was stopped early because of feasibility concerns related to the long-term follow-up. However, 158 participants were enrolled (DOS: n=82; ESC: n=76), of whom 155 had discharge data. The DOS group had a greater frequency of prescriptions for bolus insulin (78% vs 44%; P=.01), needles or syringes (95% vs 63%; P=.03), and glucometers (86% vs 36%; P<.001). The clarity of the orders was similar. HbA1c data were available for 54 participants in each arm at 12 weeks and for 44 and 45 participants in the DOS and ESC arms, respectively, at 24 weeks. The unadjusted difference in change in HbA1c level (DOS - ESC) was -0.6% (SD 0.4%; P=.18) at 12 weeks and -1.1% (SD 0.4%; P=.01) at 24 weeks. The adjusted difference in change in HbA1c level was -0.5% (SD 0.4%; P=.20) at 12 weeks and -0.7% (SD 0.4%; P=.09) at 24 weeks. The achievement of the individualized HbA1c target was greater in the DOS group at 12 weeks but not at 24 weeks. CONCLUSIONS: An intervention that included a DOS plus a postdischarge nurse phone call resulted in more complete discharge prescriptions. The assessment of postdischarge outcomes was limited, owing to the loss of the long-term follow-up, but it suggested a possible benefit in glucose control. TRIAL REGISTRATION: ClinicalTrials.gov NCT03455985; https://clinicaltrials.gov/ct2/show/NCT03455985.

Interferon gamma mediates the reduction of adipose tissue regulatory T cells in human obesity.

Decreased adipose tissue regulatory T cells contribute to insulin resistance in obese mice, however, little is known about the mechanisms regulating adipose tissue regulatory T cells numbers in humans. Here we obtain adipose tissue from obese and lean volunteers. Regulatory T cell abundance is lower in obese vs. lean visceral and subcutaneous adipose tissue and associates with reduced insulin sensitivity and altered adipocyte metabolic gene expression. Regulatory T cells numbers decline following high-fat diet induction in lean volunteers. We see alteration in major histocompatibility complex II pathway in adipocytes from obese patients and after high fat ingestion, which increases T helper 1 cell numbers and decreases regulatory T cell differentiation. We also observe increased expression of inhibitory co-receptors including programmed cell death protein 1 and OX40 in visceral adipose tissue regulatory T cells from patients with obesity. In human obesity, these global effects of interferon gamma to reduce regulatory T cells and diminish their function appear to instigate adipose inflammation and suppress adipocyte metabolism, leading to insulin resistance.

Diabetes following acute pancreatitis.

Diabetes represents a group of diseases involving persistent hyperglycaemia. Exocrine disorders of the pancreas are increasingly recognised to cause or precede the onset of diabetes, which in this context is referred to as pancreatogenic or type 3c diabetes. Diabetes, as a sequela of acute pancreatitis, is observed across the spectrum of severity in acute pancreatitis and can be associated with other clinical complications. The pathophysiology of acute pancreatitis-related diabetes is poorly understood, and observations suggest that it is probably multifactorial. In this Review, we discuss the epidemiology, pathophysiology, and management considerations of diabetes following acute pancreatitis, and highlight knowledge gaps in this topic.

Differentiating Basal Insulin Preparations: Understanding How They Work Explains Why They Are Different.

Since the introduction of insulin as a life-saving agent for patients with type 1 diabetes, insulin preparations have evolved to approximate physiologic insulin delivery profiles to meet prandial and basal insulin needs. While prandial insulins are designed to have quick time-action profiles that minimize postprandial glucose excursions, basal insulins are designed to have a protracted time-action profile to facilitate basal glucose control over 24 h. Given that all insulins have the same mechanism of action at the target tissue level, the differences in time-action profiles are achieved through different mechanisms of protraction, resulting in different behaviors in the subcutaneous space and different rates of absorption into the circulation. Herein, we evaluate the differences in basal insulin preparations based on their differential mechanisms of protraction, and the resulting clinical action profiles. Multiple randomized control trials and real-world evidence studies have demonstrated that the newer second-generation basal insulin analogs, insulin glargine 300 units/mL and insulin degludec 100 or 200 units/mL, provide stable glycemic control with once-daily dosing and are associated with a reduced risk of hypoglycemia compared with previous-generation basal insulin analogs insulin glargine 100 units/mL and insulin detemir. These advantages can lead to decreased healthcare resource utilization and cost. With this collective knowledge, healthcare providers and payers can make educated and well-informed decisions when determining which treatment regimen best meets the needs of each individual patient.Funding: Sanofi US, Inc.

Information technology for the treatment of diabetes: improving outcomes and controlling costs.

BACKGROUND: Diabetes in particular presents an ideal opportunity for the incorporation of information technology (IT) in the provision of care. The disease is highly prevalent in managed care populations, is frequently associated with comorbid conditions, and requires multiple medications in its management. Furthermore, effective diabetes care involves the monitoring of several measures of disease control, such as hemoglobin A1c (A1c) and lipid levels, by several different levels of providers, such as physicians, nurse practitioners, physician assistants, pharmacists, and dieticians. All of these factors combined make diabetes an opportune disease state for a case study of the implementation of health information technology (HIT) in managed care. OBJECTIVE: To review practical applications of HIT for improving the delivery of care in diabetes management. SUMMARY: Between 1990 and 2002, the incidence of type 2 diabetes increased by 61% in the United States. The total costs associated with diabetes have been increasing since the late 1970s as well, with a more dramatic rise over the last 10 years. In fact, the total cost of diabetes in the United States will approach $200 billion per year by the year 2020. In order to improve diabetes management efforts nation wide, the goal of glucose lowering therapy has been recommended to lower the hemoglobin A1c (A1c) to < 7% and keep it below that level long term. Other measures beyond A1c levels have also been identified as being important components to effective diabetes management and incorporated into national treatment recommendations, providing an ideal opportunity for the incorporation of HIT interventions. These interventions have been aimed at 3 different groups of stakeholders in managed care: payers, providers, and patients. CONCLUSIONS: While uncontrolled diabetes remains a major concern in managed care from both a health and a cost perspective, implementation of information technology enabled diabetes management (ITDM) has demonstrated significant potential for improving processes of care, preventing the development of diabetic complications, and generating cost savings. ITDM improves the synthesis of information, the delivery of knowledge, and the efficiency of communication, allowing for coordination of care across delivery teams. Of the existing technologies targeting providers, patients, and payers, provider centered interventions, such as diabetes registries currently show the most potential for benefit in improving outcomes and reducing costs.