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Vol. 3 No. 47

Expert sees ‘no magic pill’ for dealing
with kidney issues of weight and diet

ST. PETERSBURG, FLA. – While the results of a recent study indicating the importance of diet in kidney-disease management don’t surprise one expert on the disease, its conclusions strike a chord in efforts to improve both treatment and approach.

Research published in May in the Clinical Journal of American Society of Nephrology reflecting data involving nearly 15,000 middle-aged adults enrolled in the Atherosclerosis Risk in Communities study concludes that high adherence to healthy plant-based directives like the Mediterranean diet is linked to favorable kidney-disease outcomes.

Kim Zuber, PA-C, executive director of the American Academy of Nephrology PAs and past chair of the National Kidney Foundation/Council of Advanced Practitioners, raises two vital aspects of kidney-disease treatment brought to mind by this study:

  • challenges many patients encounter in buying and preparing healthy foods
  • medical practitioners, including physician assistants (PAs) and nurse practitioners (NPs), are all-too-often paid when their patients continue to be sick, rather than when they become or remain healthy

Zuber, of St Petersburg, Fla., a faculty member of the Metabolic & Endocrine Disease Summit (MEDS), echoes the study’s point that associations between a healthy and less-healthy plant-based diet are significant only among normal-weight participants (“not many of my patients are thin and eating a healthy diet”) and underscores the importance of weight management.

“As an example,” Zuber says, “my brother-in-law is a pediatrician in California. He works with an adolescent obesity clinic, and he sees that both kids and parents lose weight when diet changes are made by the family. We need to treat the whole patient, not just the medical aspect.” “It’s a matter of getting the message across, in office visits, in handouts, in paperwork,” she adds. “The study shows that a plant-based, Mediterranean diet is good, which is not news. However, insisting on plant-only diets have issues, because, by the time someone is on dialysis, their protein levels are so low that they are malnourished. They need protein, too---it’s a pull-push kind of thing with this diet, Mediterranean, plus protein (in any form) is best.”

“There is no magic pill,” Zuber says. “The study notes that a Mediterranean diet slows progression to kidney failure, deals with healthy-weight patients eating diets that are plant-based---careful eaters who don’t wind up on dialysis. But that isn’t the population most of us deal with. And one problem is that much of the population can’t get this food; they live in food deserts.”

“We know that a Mediterranean diet is good, but it’s hard to get fresh fruits and vegetables for many patients, and there’s the issue with cost or how to cook it---I’ve found that patients aren’t aware that they shouldn’t fry vegetables, or make them with cheese, or that they are better off with frozen vegetables than with canned. Dietary habits are often based on what you grow up with.”

One oasis in the food desert is the Produce Rx voucher program. Launched in 2019 in Washington, D.C., by Giant food, AmeriHealth Caritas District of Columbia, and the D.C. Department of Health, the program allows medical professionals to prescribe (with a written prescription) fresh fruit and vegetables to patients with chronic illnesses.

The program, which also offers clinics for those living in poverty, as well as professional dietary advice, “can get people off of medication,” says Zuber, who cautions that “this kind of food, unfortunately, is more available in the D.C. suburbs than in the city.”

Another government-sponsored effort to improve health care that Zuber touts is an effort by Medicare and Medicaid to encourage health-care practitioners to keep patients healthy.

“We get paid for taking care of patients,” Zuber says, “but keeping them healthy works against us. We should make more by keeping people healthy---which isn’t often the case. Medicare, though, has a comprehensive-care plan in which we are paid more to keep people healthy.”

Currently, she says, “I’m paid more each time a patient is hospitalized. I’d rather be paid to keep patients healthy and out of the hospital. Better to get part of the savings if patients are healthy. Now, we make more money if we do a crappy job; better to pay practitioners to keep their patients healthy. In this Medicare model, we keep the patient healthy, they live longer, and the money saved is split between the Accountable Care Organization (ACO) and the medical professional.”

CITATION: Hyunju Kim, Laura E. Caulfield, et. al. Plant-Based Diets and Incident CKD and Kidney Function. Clinical Journal of the American Society of Nephrology. CJASN May 2019, 14 (5) 682-691. Food as medicine: doctors are prescribing broccoli and bananas alongside beta blockers. Washington Post. May 17, 2019. Wholesome RX: Fruit and Vegetable Prescription

Innovation Models/Center for Medicare & Medicaid Information.


Research pinpoints children’s risks
of asthma-related ICU re-admissions

RABAT, MOROCCO – A recent study indicates that, compared to children not admitted to intensive-care units (ICUs), those admitted to ICUs for asthma are at increased risk of asthma-related re-admission, with certain risk factors conferring an even higher risk.

The retrospective-cohort study published in September in the Journal of Asthma was designed to compare the time to asthma-related re-admission between children admitted to ICUs for asthma and those with non-ICU hospitalization in the United States and to explore risk factors associated with re-admission among children admitted to ICUs.

Its authors---including Imane Jroundi, University of Mohammed V of Rabat, Rabat, Morocco, and Sze Man Tse, Montreal University, Montreal---assessed information on subjects aged two-to-17 years in the State Inpatient Database (2005-to-2014) from four U.S. states who were hospitalized for asthma.

They compared the time to asthma-related re-admissions and emergency department (ED) visits between children admitted and not admitted to the ICU using the log-rank test.

A total of 66,835 children were hospitalized for asthma, with 14.0% admitted to the ICU, and 12,844 were re-admitted for asthma, while 22,915 had asthma-related ED visits.

The time to asthma-related re-admission was shorter in the ICU group compared to the non-ICU group, but the time to asthma-related ED visit did not differ between the two groups.

Being pre-school-aged, female, black, and having lower household income and a longer length of stay during the initial hospitalization conferred a higher risk of asthma-related re-admission among children admitted to the ICU.

Pre-school age and Medicaid were Florida-specific risk factors while Hispanic ethnicity was New York-specific.

CITATION: Imane Jroundi, MD, MPH, Ph.D, Sze Man Tse , MDCM, MPH, et. al. Long-term asthma-related readmissions: comparison between children admitted and not admitted to the intensive care unit for critical asthma. Journal of Asthma. Received 29 April 2019. Accepted 31 Aug. 2019. Accepted author version posted online: 06 Sept. 2019. Published online: 20 Sept. 2019.


Study: Obese neuromuscular patients
getting PSFs likelier to face infection

COLUMBUS, OHIO – A recent study indicates that obese neuromuscular patients undergoing posterior spinal fusion (PSF) have higher odds of experiencing adverse outcomes, particularly surgical-site infections, urinary-tract infections, and re-admissions.

The retrospective, evidence-level three study published in October in Spine also indicates that providers should promote prevention strategies, such as dietary modification and/or early physical activity, in these high-risk patients to minimize the risks of complications in the acute post-operative period.

Its authors---including Azeem Tariq Malik, The Ohio State University Wexner Medical Center, Columbus, Ohio---assessed the impact of varying severity of body mass index (BMI) on 30-day outcomes following PSFs in neuromuscular scoliosis.

The 2012-to-2016 American College of Surgeons National Surgical Quality Improvement (ACS-NSQIP) data-base was queried using Current Procedural Terminology codes 22800, 22802, and 22804 to identify patients undergoing PSF for neuromuscular scoliosis only.

BMI was classified into four groups based on the Centers for Disease Control (CDC) BMI-for-age percentile chart: normal weight, underweight, overweight, and obese.

Multivariate regression models were built to understand the impact of varying BMI severity classes on 30-day outcomes.

A total of 1,291 patients underwent PSF for neuromuscular scoliosis; 695 were normal weight, 286 were underweight, 145 were overweight, and 165 were obese.

Obese-versus-normal weight patients were at a significantly higher risk of:

  • surgical-site infections
  • wound dehiscence
  • urinary-tract infections
  • 30-day re-admissions

Overweight-versus-normal weight subjects had higher odds of cardiopulmonary complications; no significant associations were seen for varying BMI and other 30-day outcomes.

CITATION: Malik AT, Tamer R, et. al. The Impact of Body Mass Index (BMI) on 30-day Outcomes Following Posterior Spinal Fusion in Neuromuscular Scoliosis. Spine (Phila. Pa. 1976). 2019 Oct 1;44(19):1348-1355. PMID: 3121270.


Assessment boosts use of FLS context
in leading to a lower rate of mortality

MALAGA, SPAIN – Recent research indicates that patients treated with anti- osteoporotic drugs in a Fracture Liaison Service (FLS) context have a lower mortality rate than patients managed before FLS implementation.

Authors of the study published in September in Osteoporosis International---including David Gonzalez-Quevedo, Regional University Hospital of Malaga, Malaga, Spain---did not observe significant one-year-mortality differences after hip fracture between patients treated before FLS implementation and those treated post-implementation.

Nor did they find that the FLS application affected the risk of suffering a second osteoporotic fracture.

The researchers analyzed the effect of the FLS model over the first-year mortality rates following a hip fracture by conducting a prospective-cohort study on patients over 60 years of age who suffered hip fractures during two consecutive years, before-and- after the implementation of the FLS between January, 2016 and December, 2017.

Patients'39; information was drawn from a local data-base. Patients were followed for one year after the hip fracture. Mortality and re-fracture rates were compared between the two groups using a multivariate Cox proportional hazard model.

Seven-hundred-twenty-four individuals were included in this study (357 before FLS implementation and 367 after).

Anti-osteoporotic drugs were more frequently prescribed after FLS implementation; 74 patients after FLS implementation and 92 before implementation died during the follow-up period.

Second fractures occurred in 17 patients after FLS implementation and 13 before FLS implementation.

Patients treated with anti-osteoporotic drugs after FLS implementation had a lower one-year mortality compared with patients managed before implementation of the FLS protocol (treated or not treated with anti-osteoporotic drugs).

CITATION: D. Gonzalez-Quevedo, D. Bautista-Enrique, et. al. Fracture liaison service and mortality in elderly hip fracture patients: a prospective cohort study. Osteoporosis International. First online: 11 September 2019.


Coverage for insulin, test strips targeted
in tracking progress for diabetes patients

SYDNEY – No less-resourced country had even near-complete coverage for insulin, and coverage was worse for test strips, according to a study demonstrating the utility of this framework which could be developed as a means of tracking progress in meeting the needs of diabetes patients.

Authors of the study published in September in Diabetes Research and Clinical Practice---including Emma Louise Klatman, Life for a Child Program, Sydney, and Martin McKee, London School of Hygiene & Tropical Medicine, London---note that global governments have committed to achieve Universal Health Coverage (UHC), ensuring access to quality and affordable health care for all.

Such care, they note, is fundamental for those with type 1 diabetes mellitus, who require daily access to both insulin and blood-glucose test strips to survive. This group, the researchers state, risks being left behind by global initiatives that fail to consider these needs.

A questionnaire was distributed to key informants in 37 less-resourced countries. Seven high-income countries were also included.

The authors drew on a World Health Organization (WHO) framework developed to assess progress towards UHC to create scales on three dimensions: population covered, services provided and direct costs. A fourth dimension, availability, was added.

The study indicates that 65% of the less-resourced national-health systems provided insulin, with medians of 67% for service provision, 55% direct costs covered, and 75% availability. Test strips were only provided in 14% of the less-resourced systems, with medians 42% (less than two strips per day), 76%, and 88% respectively.

Six patterns of provision were identified. Progress correlated with income level, yet some low-income countries are achieving provision for insulin and test strips for those enrolled in health insurance.

CITATION: Emma Louise Klatman, Martin McKee, et. al. Documenting and visualising progress towards Universal Health Coverage of insulin and blood glucose test strips for people with diabetes. Diabetes Research and Clinical Practice. Published online: Sept. 20, 2019. Accepted: Sept.13, 2019. Received in revised form: Sept. 5, 2019. Received: July 17, 2019.


Difference between proteinuria, albuminuria
is explained in an article in Clinician Reviews

A Q&A posted in October in Clinician Reviews details the difference between proteinuria and albuminuria. Written by Cynthia A. Smith, DNP, CNN-NP, FNP-C, APRN, FNKF, of Renal Consultants, PLLC, South Charleston, W.Va., the article notes the importance of assessing for proteinuria, a marker for chronic kidney disease (CKD). Proteinuria indicates an elevated presence of protein in urine, while albuminuria is an abnormal loss of albumin in urine---and is common in CKD patients. The article also notes that if non-albumin proteinuria is suspected, testing for specific-urine proteins is recommended. It can be accessed at


Vol. 3 No. 46

‘Exciting finding’ indicates T2D benefits
from long-term testosterone therapy

LAGUNA NIGUEL, CALIF. – Long-term testosterone therapy (Tth) completely prevents pre-diabetes progression to type 2 diabetes (T2D) among men with hypogonadism, according to a recent study that also indicates that it improves glycemia, lipids, and Aging Males’ Symptoms (AMS) scale scores.

The research published in March in Diabetes Care is deemed “an exciting finding” by
Ji Hyun Chun, PA-C, BC-ADM, president of the American Society of Endocrine Physician Assistants (ASEPA).

Chun---who is affiliated with OptumCare Medical Group, Laguna Niguel, Calif., and is a faculty member of Metabolic & Disease Summit (MEDS)---notes that the observational study concludes that Tth offers potential for men with pre-diabetes and hypogonadism, and looks for validations from future research.

“I would love to see the study replicated in other studies and settings to draw conclusions which can further guide us on this topic matter,” he says. “We would especially need a well-designed randomized-controlled trial so we have a better matched placebo group.”

As the study, which involved 316 men with pre-diabetes and symptoms of hypogonadism, notes that pre-diabetes represents a window of opportunity for intervention to prevent T2D, Chun suggests that this “window” can best be utilized through careful screening for potential hypogonadism, and appropriate work-ups.

“Keep in mind,” he urges, “that ‘active’ testosterone (free and/or bio-available testosterone) levels need to be checked in this setting. Many patients with dysglycemia are overweight or obese, which lowers sex-hormone binding globulin (SHBG), and thereby have lower total testosterone, but might have normal ‘active’ testosterone levels.”

Chun adds that “another important point mentioned in the study is the presence of symptoms of hypogonadism in treatment decision-making.”

“If patients with pre-diabetes have true hypogonadism (biochemical and symptomatic), and other reversible causes are ruled out,” he says, “Tth may improve their metabolic health and help them from progressing to overt diabetes.”

While Chun calls this research and its conclusion “an exciting finding from an observational study,” he also urges caution.

“As in any study results,” Chun says, “one should carefully review the study setting (in this case, an observational study that was non-blinded, non-randomized, not propensity matched, and funded by industry) and acknowledge its strength (i.e., real-world data) and weakness before drawing a conclusion.”

One aspect of the study is its mention of the importance of weight loss, as pre-diabetics are urged to aim at 10% weight loss, with Tth yielding nearly that (9%).

“As we have seen the overlap of obesity and diabetes,” Chun says, “we know that weight management is the cornerstone in managing metabolic syndrome regardless of its stage (euglycemia, prediabetes, diabetes). It is very intriguing to see this significant improvement in weight, and more importantly, its sustainability in this particular registry. I am curious on what is different in this population other than the Tth that led to this significant weight benefit.”

“We all know,” he adds, “that just going on testosterone would not drop someone's weight. We have to give adequate guidance on the needed lifestyle intervention to achieve that. It is plausible to think that Tth would make patients with symptomatic hypogonadism feel better, and have more energy to increase their physical-activity levels, and would be more likely to keep and build lean muscles with exercise and thereby improve their metabolic health.”

Chun also asserts that “discussing this needed lifestyle intervention and setting the right expectation by nurse practitioners (NPs) and physician assistants (PAs) is very important.”

He concludes, too, that, in wake of this study, “there certainly will be an increase in interest and requests from patients in both checking testosterone and using testosterone. Unlike other chronic disease states (i.e., diabetes, hypertension, dyslipidemia, osteoporosis) where patients’ perceived risks outweigh benefits, it is exactly the opposite in hypogonadism---patients are more willing to get on treatment. It is left to us to carefully listen to our patients’ symptoms, concerns, and expectations and guide them to what's best for their overall health.”

CITATION: Aksam Yassin, Ahmad Haider, et. al. Testosterone Therapy in Men With Hypogonadism Prevents Progression From Prediabetes to Type 2 Diabetes: Eight-Year Data From a Registry Study. Diabetes Care. Published online March 18, 2019.


Osteoporosis study notes good calibration
in FRAX-predicted versus MOF probability

LOS ANGELES – A study published in August in the Journal of Bone and Mineral Research indicates good calibration in Fracture Risk Assessment Tool (FRAX)-predicted versus observed 10-year major osteoporotic fracture (MOF) and hip-fracture probability.

The study’s authors---including Carolyn J. Crandall, David Geffen School of Medicine at University of California, Los Angeles, and John T. Schousboe, University of Minnesota, Minneapolis---examined, among women 40-and-older, the performance of the FRAX and FRAX-based osteoporosis-treatment thresholds under the U.S. National Osteoporosis Foundation (NOF) and UK National Osteoporosis Guideline Group (NOGG) guidelines.

They used registry data for all women aged 40-and-over in Manitoba, Canada, with baseline bone mineral density (BMD) testing (54,459 patients). Incident MOF, hip fracture, and clinical fracture were assessed from population-based health-services data, with a mean follow-up of 10.5 years.

Age-stratified hazard ratios (HRs) were estimated from Cox regression models. The researchers assessed the sensitivity, specificity, positive predictive value (PPV), number needed to screen (NNS), and number needed to treat (NNT) to prevent a fracture for osteoporosis-treatment thresholds under the NOF and NOGG guidelines.

Femoral neck T-score and FRAX (with-and-without BMD) predicted all fracture outcomes at all ages.

The gradient of risk for fracture prediction from femoral neck T-score and FRAX (with- and-without-BMD) as continuous measures was strong across the age spectrum. The sensitivity and PPV of the strategies based on dichotomous cut-offs were low, especially among women aged 40-to-49 years (who have lowest incidence rates).

The researchers conclude that threshold-based approaches should be reassessed, particularly among younger women.

CITATION: Crandall CJ, Schousboe JT, et. al. Performance of FRAX and FRAX-Based Treatment Thresholds in Women Aged 40 Years and Older: The Manitoba BMD Registry. Journal of Bone and Mineral Research. 2019 Aug;34(8):1419-1427.


Mid-life obesity linked to higher mortality
even when BMI normal in early adulthood

MELBOURNE, AUSTRALIA – Mid-life obesity is associated with higher mortality even when body mass index (BMI) is normal in early adulthood, according to recent research highlighting the importance of weight management throughout adulthood.

The prospective-cohort study published in August in BMJ Open also indicates that prolonged borderline obesity is associated with elevated risk of death from all-causes and obesity-related cancers relative to maintaining lower-normal BMI across adulthood.

Its authors---including Yi Yang and Pierre-Antoine Dugué, University of Melbourne, Melbourne, Australia---report that since chronic obesity will probably be a major health issue for future generations, policies and prevention programs are needed to target obesity beginning early in life.

The researchers assessed data on 29,881 adults enrolled in the Melbourne Collaborative Cohort Study aged from 40-to-70 between 1990-and-1994, with BMI data for at least three time points. Outcomes included deaths from any cause before March 31, 2017, and deaths from obesity-related cancers, cardiovascular diseases (CVDs) and other causes before Dec. 31, 2013.

The authors identified six group-based BMI trajectories:

  • lower-normal stable (TR1)
  • higher-normal stable (TR2)
  • normal-to-overweight (TR3)
  • chronic-borderline obesity (TR4)
  • normal-to-class I obesity (TR5)
  • overweight-to-class II obesity (TR6)

Generally, compared with maintaining lower-normal BMI throughout adulthood, the lowest mortality was experienced by participants who maintained higher-normal BMI; obesity during mid-life was associated with higher all-cause mortality even when BMI was normal in early adulthood, and prolonged borderline obesity from early adulthood was also associated with elevated mortality.

These associations were stronger for never-smokers and for death due to obesity-related cancers. Being overweight in early adulthood and becoming class II obese was associated with higher CVD mortality relative to maintaining lower-normal BMI.

CITATION: Yi Yang, Pierre-Antoine Dugué, et. al. Trajectories of body mass index in adulthood and all-cause and cause-specific mortality in the Melbourne Collaborative Cohort Study. BMJ Open. Received February 26, 2019. Revised June 7, 2019. Accepted July 8, 2019. First published August 10, 2019. Online issue publication August 10, 2019.


Research into heart failure, CKD issues
ties C‐terminal FGF23 levels, mortality

GRONINGEN, NETHERLANDS – Recent research indicates that exogenous erythropoietin increases C‐terminal FGF23 levels markedly over a period of 50 weeks---elevated levels of which, even at baseline, are significantly associated with an increased mortality risk.

Results of the study published in August in the Journal of the American Heart Association underline, in a randomized-trial setting, a strong relationship between erythropoietin and FGF23 physiology in patients with chronic heart failure and chronic kidney disease (CKD).

The authors---including Michele F. Eisenga, University of Groningen, Groningen, Netherlands, and Mireille E. Emans, Ikazia Hospital, Rotterdam, Netherlands---report that baseline cFGF23 levels are strongly associated with an increased risk of mortality. They also state that the currently-identified association between exogenous EPO and cFGF23 levels could be the potential link between exogenous EPO and detrimental outcomes in this patient setting.

The authors recommend further research to establish whether adverse outcomes associated with EPO treatment are truly attributable to a direct effect of exogenous EPO on cFGF23 levels.

Using the Erythropoietin in CardioRenal Syndrome (EPOCARES) study, the researchers randomized 56 anemic patients with both chronic heart failure and CKD into three groups, of which two received epoetin beta 50 IU/kg per week for 50 weeks;  the third group served as control.

Measurements were performed at baseline, and after two, 26, and 50 weeks. Data were analyzed using linear mixed‐model analysis. After 50 weeks of erythropoietin‐stimulating agent treatment, hematocrit and hemoglobin levels increased.

Similarly, C‐terminal FGF23 levels, in contrast to intact FGF23 levels, rose significantly due to erythropoietin‐stimulating agents as compared with controls.

During median follow‐up for 5.7 years, baseline C‐terminal FGF23 levels were independently associated with increased risk of mortality.

CITATION: Michele F. Eisenga, Mireille E. Emans, et. al. Epoetin Beta and C‐Terminal Fibroblast Growth Factor 23 in Patients With Chronic Heart Failure and Chronic Kidney Disease. Journal of the American Heart Association. Originally published 17 Aug. 2019.


Severe-asthma patient assessment backs
multi-disciplinary pulmonary rehabilitation

TRADATE, ITALY – Authors of a study published in August in the Journal of Asthma indicate that their research on a large sample of severe-asthma patients provides evidence that a multi-disciplinary pulmonary rehabilitation (PR) program is effective in terms of exercise capacity and symptoms.

The researchers---including Elisabetta Zampogna and Rosella Centis, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy---also report that exercise capacity improves in the presence of bronchiectasis and/or obstructive sleep apnea (OSA).

The authors, noting that PR is a multi-modal treatment that is poorly investigated in severe asthma where respiratory symptoms remain uncontrolled despite intensive pharmacological therapy, investigated the effectiveness of PR on functional exercise, dyspnea, and muscle fatigue in severe-asthma patients.

They assessed 317 patients affected with severe asthma according to Global Initiative for Asthma (GINA) guidelines who underwent a multi-disciplinary three-week rehabilitation program with an adherence of more-than-80% to PR, and who could complete a Six Minute Walking Test (6MWT).

PR included:

  • endurance training
  • educational meetings
  • chest physiotherapy
  • breathing exercises
  • psychological support

Six-minute walking distance and Borg scale for dyspnea and muscle fatigue were recorded before-and-after rehabilitation.

Of the 371 patients analyzed, 39 had bronchiectasis, 163 OSA, and 17 had both. PR significantly improved 6MWT distance, Borg dyspnea and muscle fatigue, and mean peripheral capillary oxygen saturation (SpO2) recorded during 6MWT.

CITATION: Elisabetta Zampogna MSc, Rosella Centis, BScEcon, et. al. Effectiveness of pulmonary rehabilitation in severe asthma: a retrospective data analysis. Journal of Asthma. Received 25 Feb. 2019. Accepted 16 July 2019. Accepted author version posted online: 18 July 2019. Published online: 13 Aug. 2019.


Clinician Reviews article offers advice
on ways to cut patients’ insulin costs

A Q-and-A posted recently in Clinician Reviews offers suggestions to reduce patients’ insulin costs. Written by Alyssa Kanagaki Greenleaf, BA, MHS, PA-C, Hartford Healthcare Medical Group Endocrinology in Southington and New Britain, Connecticut, the article offers such advice as: trying older insulins, switching to a syringe and vial, patient-assistance programs, co-pay cards, and shopping for the best deal. The writer cautions that patients “must be advised that not taking their prescribed insulin, or taking less insulin than prescribed, is not a safe alternative.” The article can be accessed at



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