How Recent Developments Impact Insulin Affordability

Insulin for All?

Patrick Campbell is the senior editor of Endocrinology Network, as well as its sister publication Practical Cardiology. Prior to joining these brands, he led coverage of cardiology and diabetes with HCPLive. Before joining parent company MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a freelance multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. In his free time, he enjoys traveling, sports, and exploring the great outdoors. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

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Results of the FIGARO-DKD trial are providing clinicians with further insight into the effects of the nonsteroidal, selective mineralocorticoid receptor antagonist finerenone in patients with type 2 diabetes. 

While the FIDELIO-DKD trial and subanalyses have established the efficacy of finerenone in patients with stage 3-4 CKD, the FIGARO-DKD trial enrolled patients with a wider range of CKD and provides evidence supporting use of finerenone in patients with a wider range of CKD.

“Finerenone improved cardiovascular outcomes in patients with mild-to-moderate kidney disease and type 2 diabetes treated with optimized RAS blockade and with well-controlled blood pressure and diabetes,” said principal investigator Bertram Pitt, MD, professor of medicine emeritus at the University of Michigan School of Medicine, 

. “The benefits of finerenone were consistent across eGFR and urine albumin-to-creatinine ratio (UACR) categories. Together with FIDELIO-DKD, the results support the use of finerenone to improve cardiorenal outcomes across the spectrum of kidney disease and type 2 diabetes.”

Although the rise of finerenone has not received the same attention as other diabetes medications, namely SGLT2 inhibitors, in recent years, the results of FIDELIO-DKD and the July 2021 approval for reducing the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in patients with CKD signaled the official arrival of a new agent with potential to alter treatment course of patients with diabetes.

Briefly, FIDELIO-DKD compared finerenone versus placebo therapy and found use was associated with an 18% reduction in risk for progression of chronic kidney disease and a 16% reduction in risk of the composite cardiovascular endpoint. More recently, a trio of prespecified analyses presented at ADA 2021 demonstrated the agent provided consistent effectiveness, irrespective of baseline insulin, GLP-1 RA, and SGLT2 inhibitor use.

FIGARO-DKD was a double-blind trial randomizing 7437 patients from study sites in 48 countries in a 1:1 ratio to placebo therapy or finerenone. The primary outcome, which was assessed in a time-to-event analysis, was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. The first secondary outcome of interest was a composite of kidney failure, a sustained decrease from baseline of at least 40% in eGFR, or death from renal causes.

To be considered eligible for the trial, patients needed a UACR of 30 to less than 300 and an eGFR of at least 60 ml/min/1.73m2. Investigators noted patients included in the trial were treated with RAS blockage that had been adjusted before randomization to the maximum dose on the manufacturer’s label.

Ultimately, 7352 patients were included in the final analyses, including 3686 randomized to finerenone and 3666 randomized to placebo. This patient population had a mean age of 64.1±9.8 years, 69.4% were men, the mean eGFR was 67.8±21.7 ml/min/1.73m2, and 45.3% had a history of cardiovascular disease.

Upon analysis, which included a median of 3.4 years of follow-up, a primary outcome event had occurred among 12.4% (n=458) receiving finerenone and 14.2% (n=519) receiving placebo therapy (HR, 0.87 [95% CI, 0.76-0.98]; 

=.03). Further analysis this effect was mainly driven by a 29% relative reduction in risk of hospitalization for heart failure (HR, 0.71; 95% CI, 0.56-0.90). When assessing the secondary composite outcome, investigators identified an outcome event in 9.5% (n=350) of patients receiving finerenone and 10.8% (n=395) of patients in the placebo group (HR, 0.87; 95% CI, 0.76-1.01).

In safety analyses, investigators found the overall frequency of adverse events did not differ substantially between those receiving finerenone and those receiving placebo therapy. Investigators pointed out the incidence of hyperkalemia-related discontinuation was greater with finerenone (1.2%) than with placebo (0.4%).

This study was presented as “FIGARO-DKD: finerenone in patients with chronic kidney disease and type 2 diabetes,” at ESC Congress 2021 and simultaneously published as “

Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes,

Articles

Results of FIGARO-DKD were presented at ESC Congress 2021 and, combined with FIDELIO-DKD data, demonstrate the ability of finerenone to provide benefit across the spectrum of eGFR. 

FIGARO-DKD: Finerenone Proves Benefit in Mild CKD

FDA Approves SKYTROFA, First Once-Weekly Treatment for Growth Hormone Deficiency in Children

With approval awarded to Ascendis Pharma on August 25, lonapegsomatropin-tcgd (SKYTROFA) becomes the first once-weekly injection approved by the FDA to deliver somatropin by sustained release over a 1-week period.

FreeStyle Libre 2 App Receives Clearance from US FDA for Diabetes Management

Abbott announced the FDA's clearance of their FreeStyle Libre 2 iOS app, which the company suggests is the only sensor-based glucose monitoring app that allows users to check their glucose with a compatible iPhone every minute with optional real-time glucose alarms.

Insulin for All? How Recent Developments Impact Insulin Affordability

This 3-part video series from Diana Isaacs, PharmD, and Lucia Novak, CRNP, explores how news from Walmart and Novo Nordisk and a historic approval from the US FDA impacts insulin affordability.

How Walmart and Novo Nordisk's Insulin Initiative Impacts Insulin Affordability, with Diana Isaacs, PharmD, and Lucia Novak, CRNP

Experts discuss how the launch of ReliOn NovoLog and the involvement of corporate entities could impact insulin affordability in both short- and long-term diabetes management.

How the Approval of Semglee Impacts Insulin Affordability, With Diana Isaacs, PharmD, and Lucia Novak, CRNP

Experts offer perspective on how the interchangeable biosimilar approval of Semglee impacts the cost of insulin and what they think is important for patients, providers, and pharmacists to know about the historic FDA approval.

Insulin for All or Insulin for Some? Turning Points for Insulin Affordability, With Diana Isaacs, PharmD, and Lucia Novak, CRNP

The final installment in our series, Isaacs and Novak

discuss how recent developments impact the cost of insulin and whether "Insulin for All" is a meaningful phrase or wishful thinking.

USPSTF Releases Updated Guidance for Screening for T2D, Gestational Diabetes

USPSTF Lowers Recommended Screening Age for Type 2 Diabetes


The US Preventive Services Task Force has issued a B-graded recommendation statement lowering their recommended age for screening for type 2 diabetes from 40 to 35 years.

USPSTF Reaffirms 2014 Guidance on Screening for Gestational Diabetes

The latest recommendation statement reaffirms the USPSTF's 2014 guidance, which included a B recommendation for screening for gestational diabetes at 24 weeks of gestation or after.

Study Draws Link Between Vitamin D Levels and Blood Glucose, BMI and COVID-19 Severity

A substudy of a prospective observational study performed at a hospital in Italy details potential associations of vitamin D levels with BMI and blood glucose and severity of COVID-19.

August's month in review features a pair of FDA approvals, new guidance on screening for gestational diabetes and T2D, a 3-part video series, and news on COVID-19, glucose control, and vitamin D levels.

Endocrine Month in Review: August 2021

In what investigators call the largest and longest study of its kind, new research details how gender-affirming hormone therapy can influence body weight and rates of obesity among transgender and gender-diverse individuals.

A longitudinal, observational study with at least 2 years of follow-up for each of the 470 patients, results provide evidence demonstrating body weight and body mass index (BMI) should be closely monitored by clinicians before and after initiation of gender-affirming hormone therapy and also suggest transmasculine individuals experienced greater rates of obesity and obesity both before and during hormone therapy than transfeminine individuals.

“Our study is the first to describe the associations between gender-affirming hormone therapy and body weight changes for at least 2 years, and to compare the rates of underweight, normal weight, overweight, obesity and severe obesity using measurements taken before and after hormone treatment,” said Michael S. Irwig, MD, an endocrinologist and director of Transgender Medicine at Beth Israel Deaconess Medical Center (BIDMIC), 

. “Because high body weight and obesity are so common in our society, clinicians may forget to address this important issue with their patients and miss opportunities to lower their risk for cardiovascular disease and cancer.”

As investigators point out in their study, the increased prevalence of obesity often leads to this comorbidity being an overlooked aspect of management, particularly among those receiving gender-affirming hormone therapy. With the current study, Irwig and colleagues from BIDMC investigators hoped to expand the current knowledge base surrounding obesity rates and weight changes in adults treated with gender-affirming hormone therapy. Through a chart review of transgender and gender diverse patients who were treated with gender-affirming hormone therapy at the George Washington University or the medical staff at Whitman-Walker Health, investigators identified a cohort of 470 individuals for inclusion in their study.

This patient cohort included 247 transfeminine and 223 transmasculine individuals and this group had a mean age of 27.8 years. For inclusion in the study, individuals needed to be 17 years or older, have a non-cisgender gender identity, and have information related to body weight and BMI at baseline and multiple follow-up visits. Investigators pointed out follow-up clinical visits occurred up to 57 months after initiation of gender-affirming hormone therapy. The primary outcomes of interest were changes to body weight and obesity rates after receiving therapy.

Upon analysis, investigators found the mean body weight in the transmasculine group had increased by 2.35 (IQR, 1.15-3.55) kg within 2-4 months of starting gender-affirming hormone therapy. This continued to increase beyond 34 months. In contrast, mean body weight was stable for the first 21 months of hormone therapy among the transfeminine group. However, investigators pointed out mean body weight began to increase following 21 months, with this increase most apparent among transfeminine individuals less than 30 years old.

At baseline, the prevalence of obesity was 39% in the transmasculine group and 25% in the transfeminine group. When assessing prevalence following initiation of hormone therapy, results indicated the prevalence of obesity ranged from 42-52% among the trans masculine group and 21-30% among the transfeminine group. Additionally, weight gains of 5 kg or more were observed among 30% of transmasculine individuals and 21% of transfeminine individuals following 11-21 months of gender-affirming hormone therapy.

“The weight gain in transmasculine individuals is consistent with previous studies, and testosterone is the most likely reason for the weight gain, as it occurred so soon after initiating therapy,” said Irwig. “Among transfeminine individuals, the onset of weight gain so long after initiating therapy indicates that gender-affirming hormone therapy is playing less of a role in weight gain.”

Weight gain and obesity rates in transgender and gender diverse adults before and during hormone therapy,

Hailed by investigators as the largest and longest study of its kind, new research is providing clinicians with an overview of the potential for weight change and obesity among patients receiving gender-affirming hormone therapy.

Gender-Affirming Hormone Therapy Associated with Changes in Body Weight

The US Food and Drug Administration has approved lonapegsomatropin-tcgd (SKYTROFA) for the treatment of pediatric patients 1 year and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH), according to a 

Announced on August 25, the once-weekly injection becomes the first product approved by the FDA that delivered somatropin by sustained release over a 1-week period. The indication is for use in pediatric patients 1 year and older who weigh at least 25.4 lb.

“Today’s approval represents an important new choice for children with GHD and their families, who will now have a once-weekly treatment option. In the pivotal head-to-head clinical trial, once-weekly SKYTROFA demonstrated higher annualized height velocity at week 52 compared to somatropin,” said Paul Thornton, MBBCh, MRCPI, a clinical investigator and pediatric endocrinologist in Fort Worth, Texas, in the 

. “This once-weekly treatment could reduce treatment burden and potentially replace the daily somatropin therapies, which have been the standard of care for over 30 years.”

Ascendis Pharma pointed out the approval also includes the SKYTROFA Auto-Injector and cartridges, which can be stored at room temperature for up to 6 months after removal from a refrigerator. The company also noted pre-filled cartridges would be available in 9 dosage strengths to allow for dosing flexibility and the commercial launch of lonapegsomatropin-tcgd will include a full suite of patient support programs, including patient education protocols.

According to Ascendis Pharma, approval of lonapegsomatropin-tcgd was based on the results of the heiGHt trial. A phase 3 global, randomized, open-label, active-controlled, parallel-group trial lasting 52 weeks that enrolled 161 treatment-naive children with growth hormone deficiency, the trial was designed with a primary endpoint of annualized height velocity at 52 weeks in those treated with lonapegsomatropin-tcgd and daily hGH treatments. Results of the trial suggested use of lonapegsomatropin-tcgd was associated with greater annualized height velocity at week 52, with a treatment difference of 0.9 cm/year (11.2 cm/year vs 10.3 cm/year)

“It is wonderful that patients and their families now have the option of a once-weekly growth hormone therapy,” said Mary Andrews, Chief Executive Officer and co-founder of the MAGIC Foundation, in the release from Ascendis Pharma. “GHD is often overlooked and undertreated in our children and managing it can be challenging for families. We are excited about this news as treating GHD is important, and children have a short time to grow.”

Lonapegsomatropin-tcgd is contraindicated in multiple patient populations, including those with acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin, those with hypersensitivity to somatropin or any of the excipients in SKYTROFA, and those with any active malignancy.

Editor’s note: More information about contraindications can be found in the 

prescribing information for Lonapegsomatropin-tcgd (SKYTROFA)

In response to ballooning rates of prediabetes and type 2 diabetes, the US Preventive Services Task Force (USPSTF) has lowered the recommended starting age of screening for 

The latest recommendation statement from the organization, which was published in the 

Journal of the American Medical Association, 

lowers the recommended screening age from 40 to 35 years for type 2 diabetes and the recommend screening age for prediabetes and type 2 diabetes in asymptomatic adults with overweight or obesity from ages 35-70 years.

“Clinicians can prevent serious health complications by screening adults with overweight or obesity for prediabetes and diabetes," said Task Force member Chien-Wen Tseng, MD, MPH, MSEE, in a 

 "With appropriate screening, diabetes can be detected and treated earlier to improve overall health."

With the last USPSTF recommendation on the topic coming in 2015, the USPTF conducted a review of available data to evaluate screening for prediabetes and type 2 diabetes in asymptomatic, nonpregnant adults and preventive interventions for those with prediabetes. In their 2015 recommendation, the USPSTF recommended screening for abnormal blood glucose levels as part of a cardiovascular risk assessment in patients 40-70 years who have overweight or obesity. In the updated recommendation statement, the USPSTF recommends screening for prediabetes and type 2 diabetes adults 35-70 who have overweight or obesity as well as recommending clinicians refer patients with prediabetes to effective preventive interventions. Additionally, the latest recommendation also recommends beginning screening for type 2 diabetes at 35 years.

Related: Recent study examines rising rates of type 1 and type 2 diabetes in US youth.

The review used to make these recommendations included 89 publications with a patient population of 68,882 participants. Publications were selected for inclusion if investigators determined they answered any of the 9 key questions posed within the review. These 9 questions included inquiries related to direct evidence of screening on improving health outcomes, potential harms of screening, benefits of interventions, potential influence of age, race, sex, and ethnicity, and more.

Data points highlighted in the published review article included reductions in all-cause mortality seen with screening at a younger age, improvements in health outcomes seen among overweight persons with intensive glucose control, and improvements associated with lifestyle interventions, such as weight loss, reduced BMI, and blood pressure reductions. In the recommendation statement, authors also underlined the increased risks of cardiovascular disease, NAFLD, and nonalcoholic steatohepatitis associated with diabetes.

“Fortunately, there are interventions that are effective for preventing prediabetes from progressing to diabetes and in helping people with prediabetes improve their health,” says Task Force vice chair Michael Barry, MD. “The Task Force encourages clinicians to screen adults over age 35 with overweight or obesity and work with them to determine if an intervention is needed.”

This recommendation statement, titled “

Screening for Prediabetes and Type 2 Diabetes

Screening for Prediabetes and Type 2 Diabetes Updated Evidence Report and Systematic Review for the US Preventive Services Task Force,

The US Preventive Services Task Force has issued a B-graded recommendation statement lowering their recommended age for screening for type 2 diabetes from 40 to 35 years.

New research detailing the increasing rates of both 

 among children and adolescents across the US is underlining the need for increased screening and preventive services.

Results of the cross-sectional observational study, which included data from 4 geographic areas, 1 health plan, and select American Indian reservations, provides insight into the degree of rising rates of diabetes among adolescents in the US—suggesting the prevalence of type 1 diabetes increased by 45.3% from 2001 to 2017 while prevalence of type 2 diabetes increased by 95.3% during that same time period.

“In 6 regions in the US, significant increases in the estimated prevalence of type 1 diabetes and type 2 diabetes were observed from 2001 to 2017. Although the percentage increase in prevalence was greater for type 2 diabetes, the absolute prevalence increase was greater for type 1 diabetes, which remains more common than type 2 diabetes in youth,” wrote investigators.

Carried out by a team of investigators from the SEARCH for Diabetes in Youth Study group, which was national multi-center study funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the current study was designed to provide an updated overview of trends in prevalence of type 1 diabetes and type e 2 diabetes among individuals younger than 20 years in the US. With this in mind, investigators designed their study as a cross-sectional observational study using data collected from clinical centers included in the SEARCH for Diabetes in Youth Study cohort, which included clinical centers based in California, Colorado, Ohio, South Carolina, and Washington State as well as Indian Health Services centers in Arizona and New Mexico.

The specific aim of the study was to assess changes in estimated prevalence of type 1 and type 2 diabetes from 2001, 2009, and 2017. Investigators also hoped to assess these potential changes according to race and ethnicity. For the purpose of analysis, investigators included all physician-diagnosed cases of type 1 diabetes among youths aged 19 or younger and all cases of type 2 diabetes among youths aged 10-19 years.

Among patient 19 years or younger, 4958 of 3.35 million had type 1 diabetes in 2001. This figure increased to 6672 of 3.46 million in 2009 and 7759 of 3.61 million in 2017. Among patients aged 10-19 years, 588 of 1.73 million had type 2 diabetes in 2001. This figure increased to 814 of 1.85 million in 2009 and 1230 of 1.85 million in 2017.

Results of the analysis suggested the estimated prevalence of type 1 diabetes per 1000 among individuals aged 19 years or younger was 1.48 (95% CI, 1.44-1.52) in 2001, 1.93 (95% CI, 1.88-1.98) in 20019, and 2.15 (95% CI, 2.10-2.20) in 2017, which correlates to an absolute increase of 0.67 (5% CI, 0.64-0.70) per 1000 youth and a relative increase of 45.1% (95% CI, 40.0-50.4%) during the 16-year study period. Further analysis indicated the greatest absolute increases occurred among non-Hispanic White (0.93 per 1000 [95% CI, 0.88-0.98]) and non-Hispanic Black (0.89 per 1000 [95% CI, 0.88-0.98]) youths.

Among individuals aged 10-19 years, the estimated prevalence of type 2 diabetes per 1000 was 0.34 (95% CI, 0.31-0.37) in 2001, 0.46 (95% CI, 0.43-0.49) in 2009, and 0.67 (95% CI, 0.63-0.70) in 2017, which correlates to an absolute increase of 0.32 (95% CI, 0.30-0.35) per 1000 and a relative increase of 95.3% during the 16-year study period. Further analysis revealed the greatest absolute increases were observed among non-Hispanic Black (0.85 per 1000 [95% CI, 0.74-0.97]) and Hispanic (0.57 per 1000 [95% CI, 0.51-0.64]) youths.

“The absolute increases in the estimated prevalence of type 1 diabetes were greatest among Black and White youths. Type 2 diabetes remained more common among racial and ethnic minority youths, with the absolute increases in estimated type 2 diabetes prevalence being greatest among Black youth and Hispanic youth,” investigators noted.

Trends in Prevalence of Type 1 and Type 2 Diabetes in Children and Adolescents in the US, 2001-2017

Data from the SEARCH for Diabetes in Youth Study suggests the prevalence of type 1 diabetes among youths have increased by nearly 50% from 2001-2017 and prevalence of type 2 diabetes increased by more than 95% during the same period. 

Rates of Type 1 and Type 2 Diabetes in Children Increasing Across the US

This article was originally published on HCPLive.com. 

A recent study is providing clinicians with an overview of the relationship between pre-existing diabetes, hypertension, or cardiovascular disease (CVD) and the severity of intermittent hypoxemia (IH) based on oxygen desaturation index (ODI) and novel desaturation parameters.

As a result, investigators, led by Tuomas Karhu, Department of Applied Physics, University of Eastern Finland, found IH to be more severe in patients with pre-existing CVD at baseline and both pre-existing diabetes and CVD has associations with expedited worsening of IH.

The team used data from the Sleep Heart Health Study (SHHS), a multi-center community-based cohort study of patients enrolled between 1995 - 2006 in the United States.

The design of the SHHS was to determine association between sleep-disordered breathing and related health consequences, including CVDs.

Both baseline and follow-up data was available on polysomnography (PSG), to determine from the apnea—hypopnea index (AHI), for 2,647 participants. Following exclusion for incomplete background information (n = 112), a total of 2535 participants were included in the analysis.

The study defined CVD as myocardial infarction, heart failure, coronary angioplasty, coronary artery bypass graft, and stroke, which were determined based on medical history interview. In addition, hypertension was defined as systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or hypertension medication was used. Diabetes was determined through patient-report or usage or insulin.

Investigators noted all patients underwent 2 polysomnographic recordings at 5.2 years apart.

Further, covariate-adjusted linear regression analysis investigated the difference in severity of intermittent hypoxemia at baseline between each comorbid group and participants free from all comorbidities (n = 1264).

Of the total patient population included in the study, 1164 patients had hypertension, 170 patients had diabetes, and 265 patients had CVD at baseline.

Data show diabetes-presence or CVD-presence groups were generally older, with a higher BMI and NC-H (

 <.05), in comparison to the corresponding absence groups and no-comorbidity group.

Further, the team noted that the oxygen desaturation index (ODI), desaturation severity, and desaturation duration were significantly higher at the baseline in all presence groups compared to the no-comorbidities group.

After linear regression analysis, investigators found a higher ODI (β = 1.77; 95% CI, 0.41 – 3.13, 

 = .011), desaturation severity (β = 0.07, 95% CI, 0.00 – 0.14, 

 = .048), and desaturation duration (β = 1.50, 95% CI, 0.31 – 2.69, 

 = .013) in patients with preexisting CVD at baseline.

In addition, investigators observed an increase in ODI (β = 3.59, 95% CI, 1.78 – 5.39], 

 < .001), desaturation severity (β = 0.08, 95% CI, 0.02 – 0.14, 

 = .015), and desaturation duration (β = 2.60; 95% CI: 1.22 – 3.98, 

 < .001) in patients with diabetes during follow-up.

Finally, the data show an increase in ODI (β = 2.73, 95% CI, 1.15 – 4.32, 

 = 0.001) and desaturation duration (β = 1.85, 95% CI: 0.62 – 3.08, 

Investigators concluded that due to IH being an essential consequence of sleep apnea, patients would benefit from screening and follow-up monitoring.

“The detection of SA would enable preventative actions for its further worsening, such as lifestyle counseling or initiation of treatment,” investigators wrote. “These actions could mitigate the development of future SA-related comorbidities and adverse health consequences.”

Diabetes and cardiovascular diseases are associated with the worsening of intermittent hypoxaemia

New data suggests patients with a history of diabetes, hypertension, or cardiovascular disease were at increased risk of worsening hypoxemia compared to their counterparts without these conditions. 

History of Diabetes, CVD Could Increase Risk of Worsening Hypoxemia

A new study is underlining the importance of testing albuminuria levels in patients with 

Despite inclusion improving early detection of 

, the meta-analysis of patient data from the global CKD Prognosis Consortium suggests just 35% of patients with diabetes and 4% of patients with hypertension underwent UACR testing.

“We’re really missing a huge number of chronic kidney disease cases that should be detected and treated, and apart from all the other downsides of letting it go untreated, there is the fact that COVID-19 outcomes are often much worse for people with kidney disease,” said senior investigator Josef Coresh, MD, the George W. Comstock Professor in the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health, 

With conflicting guideline recommendations surrounding UACR measurements, Coresh and a team of colleagues from Johns Hopkins sought to evaluate trends in testing among adult patients with diabetes or patients with hypertension but without diabetes from within the CKD Prognosis Consortium, which has collected data from than 80 unique patient cohorts from 40 different countries since 2009. Using the CKD Prognosis Consortium, which has patient-level data from more than 11 million participants, investigators were able to identify 31 subcohorts including 1,344,594 adults with diabetes and 25 subcohorts including 2,334,461 nondiabetic patients with hypertension for inclusion in their analysis.

For the purpose of analysis, investigators planned to examine rates of UACR testing. Additionally, Investigators designed their analysis with the intent of estimating the prevalence and incidence of UACR of 30 mg/g or less as well as development of risk models for those with UACR of 30 mg/g or greater.

Initial analysis indicated screening rates of 35.1% (12.3-74.5%) of patients with diabetes and 4.1% (1.3-20.7%) of patients with hypertension. Investigators found incidence of UAACR testing was unrelated to the predicted risk of prevalent albuminuria. Results also suggested the median prevalence of UACR of 30 mg/g or greater was 32.1% across the diabetes cohorts and 21.8% across the hypertensive cohorts.

When assessing factors associated with increased prevalence of albuminuria, higher systolic blood pressure was associated with a 50% increase in odds per 20 mmHg in patients with diabetes (HR, 1.50; 95% CI, 1.42-1.60) and a 36% increase in odds per 20 mmHg in patients with hypertension (HR, 1.36; 95% CI, 1.28-1.45). Investigators highlighted the estimated ratio of undetected to detected UACR of 30 mg/g or greater was 1.8-to-1 in patients with diabetes and 19.5-to-1 in patients with hypertension.

Among those with a UACR below 30 mg/g, the median 5-year incidence of UACR reaching or exceeding 30 mg/g was 23.9% in patients with diabetes and 21.7% in patients with hypertension. Additional analysis revealed incident albuminuria was associated with increased initiation of RAAS inhibitors, with incidence-rate ratios of 3.09 (95% CI, 2.71-3.53) in patients with diabetes and 2.87 (95% CI 2.29-3.59) in patients with hypertension.

“Our findings suggest that albuminuria screening should be used much more often for detecting chronic kidney disease early, so that patients can benefit from earlier treatment,” said Jung-Im Shin, MD, an assistant professor in the Department of Epidemiology at the Bloomberg School, in a statement.

Albuminuria Testing in Hypertension and Diabetes: An Individual-Participant Data Meta-Analysis in a Global Consortium

A new meta-analysis by investigators from Johns Hopkins details the prevalence of UACR testing in patient populations at increased risk of albuminuria, suggesting less than 40% of patients with diabetes underwent UACR testing and this figure dropped to less than 5% among patients with hypertension.

Skipped UACR Testing Often Leads to Missed Albuminuria in Patients with Diabetes, Hypertension 

A recent review is underlining the prevalence of sleep disorders among patients with 

 and the impact it can have on health outcomes in this patient population.

A review of the PubMed database from inception through January 2021, results suggest patients with type 2 diabetes had greater prevalence of sleep disorders, including insomnia OSA, and restless legs syndrome, than the general population and multiple studies demonstrated presence of these disorders negatively impacted health outcomes.

“With this review, we aim to highlight the importance of targeted diagnosis and treatment of sleep disorders in people with type 2 diabetes,” wrote investigators.

To further inform clinicians on the role of sleep disorders in progression of type 2 diabetes and development of diabetic complications, a team of investigators from the Netherlands conducted a literature review to describe current treatment options and provide an updated overview of associations with diabetic complications from available data. An 11-page document with almost 80 references, the review highlights current data as well as detailing pharmacological and non-pharmacological treatments, implications for diabetes management, and priorities for future research.

For their review, investigators performed a search of PubMed form inception through January 2021 using type 2 diabetes and the following terms: sleep disorders, sleep wake disorders, sleep deprivation, circadian, sleep arousal, insomnia, obstructive sleep apnea, and restless legs syndrome. For the purpose of the review, investigators included all relevant English or Dutch language original and review studies. Investigators pointed out observational and experimental studies were included in the review and no quality or risk of bias assessments were made.

Analysis of data from studies included in the review suggested insomnia (34-44%), OSA (55-86%), and restless legs syndrome (8-45%) appeared to be more prevalent in patients with type 2 diabetes than among the general population, which was based on data from the ICSD-3 third edition. Investigators pointed out they were unable to identify any studies reporting on prevalence of circadian rhythm sleep–wake disorders, central disorders of hypersomnolence, or parasomnias.

Multiple cross-sectional and prospective studies suggested presence of sleep disorders was associated with negative health outcomes, specifically in glycemic control. Investigators highlighted insomnia was associated with increased HbA1c levels (2.51 mmol/mol [95% CI, 1.1-4.4]; 0.23% [95% CI, 0.1-0.4]) and fasting glucose (0.4 mmol/l [95% CI, 0.2-0.7]). Investigators also pointed out presence of insomnia was associated with increased risk of depressive symptoms (OR, 1.31; 95% CI, 1.16-1.47) in patients with type 2 diabetes.

“Sleep disorders are highly prevalent in people with type 2 diabetes, negatively affecting health outcomes. Since treatment of the sleep disorder could prevent diabetes progression, efforts should be made to diagnose and treat sleep disorders in people with type 2 diabetes in order to ultimately improve health and therefore quality of life,” wrote investigators.

After providing a summary of guideline-directed treatments for sleep disorders in patients with type 2 diabetes, investigators drew attention to the apparent lack of randomized controlled trials assessing the effect of treating sleep disorders in this patient population.

“Special research focus is warranted on the effects of both pharmacological and non-pharmacological treatment options on health outcomes in type 2 diabetes,” wrote investigators.

Sleep disorders in people with type 2 diabetes and associated health outcomes: a review of the literature,

A review article details the prevalence and impact of sleep disorders in patients with type 2 diabetes as well as providing an overview current treatment options and research needs.

Patients with Diabetes at Increased Risk of Sleep Disorders, Could Increase Complications Risk

A new study is underlining the increased risk of vision problems among children born to mothers with diabetes.

With data from nearly 2.5 million individuals born from 1977-2016, investigators determined children born to mothers with diabetes were at a 39% greater risk of high refractive error before the age of 25 years.

“In this nationwide population-based cohort study, we observed that children born to mothers with either pre-gestational or gestational diabetes were at an increased risk of developing high refractive error in general, as well as specific types of high refractive error, persisting from the neonatal period to early adulthood. Children born to mothers with diabetic complications had the highest risk of high refractive error,” wrote investigators.

Using data from multiple Danish health registries, a team of investigators from China and Denmark designed the current study as a cohort study of 2,470,580 individuals born in Denmark from 1977-2016. With follow-up lasting as long as 25 years, investigators planned to use Cox regression to assess associations between maternal diabetes and the risk of high RE in offspring from birth until the age of 25 years.

Investigators noted Cox regressions models were adjusted for multiple confounding factors, including sociodemographic information and other clinical factors.

Of the 2,470,580 live births included in the study, 2.3% (n=56,419) were born to mothers with diabetes. Overall, 0.9% (n=22,235) were born to mothers with type 1 diabetes, 0.3% (n=7412) were born to mothers with type 2 pre-gestational diabetes, and 1.1% (n=27,176) were north to mothers with gestational diabetes. Initial analysis indicated 20,248 offspring were diagnosed with high refractive error during the follow-up period, including 553 offspring of mothers with diabetes and 19, 695 offspring of mothers without diabetes.

Upon analysis, results indicated prenatal exposure to maternal diabetes was associated with a 39% greater risk of high refractive error before the age of 25 (HR, 1.39 [95% CI, 1.28-1.51], 

 <.001). Investigators pointed out an increased risk was observed for incidence of hypermetropia (HR, 1.37 [95% CI 1.24-1.51], 

 <.001), myopia (HR, 1.34 [95% CI 1.08-1.66], 

=.007), and astigmatism (HR, 1.58 [95% CI 1.29-1.92], 

 <.001). Additionally, results suggested the increased risk associated with exposure to maternal diabetes was more apparent in offspring born to mothers with diabetic complications, with a more than 2-fold (HR, 2.05 [95% CI, 1.60-2.64], 

 <.001) increase in risk compared to those born to mothers without diabetes and an 18% greater risk when compared to those born to mothers with diabetes but no complications (HR, 1.18 [95% CI, 1.02-1.37], 

“Although the 39% increased risk is a relatively low effect size, from a public health perspective, considering the high global prevalence of REs, any tiny improvement in this low-risk preventable factor will contribute to a huge reduction in absolute numbers of these eye conditions,” wrote investigators.

This study, “Association of maternal diabetes during pregnancy with high refractive error in offspring: a nationwide population-based cohort study,” was published in 

An analysis of registry data from more than 2.4 million births in Denmark suggests those born to mothers with diabetes were 39% more likely to experience high refractive error before turning 25 years old. 

Children Born to Mothers with Diabetes More Likely to Experience Vision Problems

The North American Menopause Society (NAMS) has released a new position statement outlining the organization’s guidance for the management of 

With their most recent position statement released more than a decade prior in 2010, the latest update reflects advances in management and assessment tools as well as providing guidance related to role of nutrition in maintaining bone health in postmenopausal women.

“Education regarding a woman’s skeletal health risks is critical during the menopause transition. The recommendations made in the updated position statement include strategies designed to minimize bone loss as a way to prevent fractures and help women maintain mobility and independence,” said Michael McClung, a member of the NAMS board and co-lead of the Editorial Panel for the 2021 Osteoporosis Position Statement and founding director of the Oregon Osteoporosis Center in Portland, Oregon, 

A 25-page document with 225 references, the position statement was composed by a 6-person editorial panel led by McClung and JoAnn Pinkerton, MD, division director of Midlife Health with the University of Virginia Health System, who were tasked with reviewing and updating the 2010 statement as well as reviewing new evidence for inclusion. To mold the current position statement, the panel reviewed studies published in English related to osteoporosis management in postmenopausal women, with priority given to randomized clinical trials and meta-analyses of these trials. The statement authors noted the focus of their review, in regard to therapies, was listed to those available for use in North America.

Much of the document, which was published on September 1, highlights known risk factors and underscores the importance of education related to osteoporosis for both clinicians and patients. Highlights of the new statement include the endorsement of hormone therapy for preventing bone loss at the time of menopause for healthy women, particularly those with menopause symptoms.

Additionally, the latest statement recommends use of T-score at the hip as an appropriate target for guiding therapy choices as current evidence suggests bone mineral density measured on-treatment correlates with the patient’s risk of fracture. The statement also outlines differing treatment approaches for women at very high risk of fracture, which calls for beginning treatment with a bone-building agent following by an antiremodeling agent, such as bisphosphonates and denosumab.

“This new position statement on osteoporosis provides clinicians with a practical guide to assessing and managing bone health in postmenopausal women and emphasizes an individualized approach with regular follow-up and adjustment based on changing clinical needs and patient preference,” said Stephanie Faubion, MD, MBA, NAMS medical director, in a statement.

Management of osteoporosis in postmenopausal women: the 2021 position statement of The North American Menopause Society

Menopause: The Journal of The North American Menopause Society.

The organization's first update since their 2010 position statement, the osteoporosis position statement reflects more than a decade of advances in knowledge related to diagnosis and management of osteoporosis.

North American Menopause Society Releases Updated Osteoporosis Guidance

New research suggests sexual dysfunction may often go undiagnosed in patients with diabetes. 

A recent study focused on the prevalence of sexual dysfunction in both men and women with type 1 diabetes (T1D) or type 2 diabetes (T2D) and is providing clinicians with an overview of associations between clinical and psychological variables with increased risk. 

A team of investigators, led by Jolijn Van Cauwenberghe, Department of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital, observed sexual dysfunction in men was related to clinical factors, while women reported low emotional well-being and symptoms of anxiety compared to women without sexual dysfunction.

The study was performed as part of the Diabetes Management and Impact for Long-term Empowerment and Success (MILES), an observational study investigating the psychosocial aspects of diabetes. Enrolled patients completed an online survey that included questions on sociodemographic, clinical and health care use, as well as validated psychological questionnaires.

Investigators measured sexual functioning in patients using questions obtained from the Short Sexual Functioning Scale (SSFS). It included 13-items covering different difficulties and amounts of distress caused by the dysfunction.

Participants would rate their sexual dysfunction and stress they experienced on a scale of mild, moderate, or severe. Then, investigators would determine sexual dysfunction if moderate or severe dysfunction caused moderate or severe distress.

In addition, the WHO-5 well being index (WHO-5) collected information on general emotional well-being, with a score <13 showing impaired well-being. Further, the Generalized Anxiety Disorder 7-item scale (GAD-7) screened for symptoms of anxiety, with a score ≥10 indicating moderate to severe symptoms of anxiety. 

The Problem Areas in Diabetes (PAID) scale was used to assess diabetes distress, with a score ≥40 as cut-off for elevated diabetes distress.

Of the 1935 participants in the study, the analysis included those who were sexually active in the past 4 weeks and completed the SSF (n = 756). Overall, 140 of 411 men (36%) and 114 of 345 women (33%) reported sexual dysfunction.

For men, the most reported sexual dysfunctions were erectile dysfunction (T1D: 20%, T2D: 33%), and orgasmic dysfunction (T1D: 22%, T2D: 27%). 

Data show sexual dysfunction in men had associations with older age (OR = 1.05, 

 = .022), higher waist circumference (OR = 1.04; 

 <.001) and longer duration of diabetes (OR = 1.04; 

 = .007). In addition, more men with sexual dysfunction reported diabetes distress (20% versus 12%, 

Further, women reported decreased sexual desire (T1D:22%, T2D:15%), lubrication problems (T1D:19%, T2D:14%), and orgasmic dysfunction (T1D:16%, T2D:15%). 

Data also show women with sexual dysfunction reported impaired emotional well-being (36% versus 25%, 

 = .036), diabetes distress (36% versus 21%, 

 = .003), and anxiety symptoms (20% versus 11%, 

Investigators concluded that diabetes patients commonly experience sexual dysfunction, with significantly more men and women with sexual dysfunction reporting high levels of diabetes distress.

They noted further research is needed to understand the biological, psychological and social mechanisms behind sexual dysfunction in these patients, as well as objectively measured clinical data.

“Protocols should further include validated instruments that do not only measure the presence of SD’s but that also take into account the distress they create,” investigators wrote. “By combining these elements in large studies, more high quality information about the link between diabetes and various sexual dysfunctions could be obtained.

Prevalence of and risk factors for sexual dysfunctions in adults with type 1 or type 2 diabetes: Results from Diabetes MILES - Flanders

New data describes risk factors associated with increased prevalence of sexual dysfunction among patients with type 1 and type 2 diabetes.

Patients with Diabetes More Likely to Experience Sexual Dysfunction

I studied the August 5, 2021, New England Journal of Medicine report of a trial comparing semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), versus tirzepatide, a drug that has both GLP-1a and glucose-dependent insulinotropic polypeptide activity.

 GLP-1 RA’s stimulate insulin secretion during hyperglycemia and decrease glucagon secretion during euglycemia and hypoglycemia.GLP-1 RA’s also decrease gastric emptying thereby decreasing appetite and body weight. Tirzepatide has GLP-1 RA activity, but also stimulates insulin release and decreases glucagon levels during euglycemia and hypoglycemia via its glucose-dependent insulinotropic activity. This dual-action has theoretical advantages. The study compared semaglutide 1 mg SQ weekly, versus tirzepatide 5, 10, or 15 mg SQ weekly. Tirzepatide has not yet been FDA approved.

All 3 tirzepatide doses decreased mean hemoglobin A1c (A1c) by 2.01 to 2.3% versus 1.86% for semaglutide. Bodyweight decreased 1.9 to 5.5 kg more with tirzepatide than with semaglutide over the 40-week study. But this was not a fair comparison because STEP 2 or the Semaglutide Treatment Effect in People with Obesity study used a semaglutide dose of 2.4 mg weekly,

 and higher semaglutide doses probably would have reduced hemoglobin A1c and body weight more.

Dr. Paul Thompson reflects on how advances in diabetes management have bled over into the field of cardiology and offers perspective on why he believes staying abreast of these advances is an integral part of being a cardiologist today. 

North American Menopause Society Releases Updated Osteoporosis Guidance

Patients with Diabetes More Likely to Experience Sexual Dysfunction

Why Cardiologists Should Become Diabetologists, With Paul D. Thompson, MD

Bertram Pitt, MD: Interpreting Data from FIDELIO-DKD and FIGARO-DKD

TWILIGHT CKD-DM: Ticagrelor Monotherapy Preferable in Concomitant CKD and Diabetes