Type 2 diabetes drug metformin recalled over contamination with possible carcinogen

Nostrum Laboratories Inc., based in Kansas City, Missouri, announced Monday that it is voluntarily recalling its metformin HCl extended release tablets, USP 750 mg, according to a recall posted by the US Drug & Food Administration.
Testing revealed levels of nitrosamine, or NDMA, above acceptable limits in the recalled tablets.
The chemical NDMA is considered a possible carcinogen by the US Environmental Protection Agency. It’s an organic chemical used to make liquid rocket fuel and it can be a byproduct of manufacturing, including pharmaceutical manufacturing. It’s also found in water and foods, including meats, dairy and vegetables.

NDMA has also been found in certain blood pressure drugs and antacid.

This is the latest in a series of metformin recalls linked to potentially cancer-causing contaminants in the drugs.

Nostrum said it has not received any reports of adverse events related to the recall. The company also said it was notifying its distributors and arranging for the return of the recalled product.

The impacted product is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg lots are under NDC 29033-056-01, lot numbers MET200101 and MET200301 which expiration date 05/2022. It can be identified as an off-white oblong tablet debossed with “NM7.”

More than 34 million people in the US have diabetes — about 1 in 10 — with approximately 90 to 95% of them being diagnosed with type 2 diabetes, according to the US Centers for Disease Control and Prevention.

Source Article

Read more

UK Diabetes Clinicians Urged to Embrace ‘Time in Range’

A new ‘best practice guide’ urges UK healthcare professionals to embrace the ‘time in range’ metric for patients with diabetes who use continuous glucose monitoring (CGM), particularly in light of the COVID-19 pandemic.

Time in range: a best practice guide for UK diabetes healthcare professionals in the context of the COVID-19 global pandemic, was published October 19 2020 in Diabetic Medicine by Dr Emma Wilmot of the diabetes department, Royal Derby Hospital, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, and colleagues. The document is a publication of the Diabetes Technology Network (DTN) UK, part of the Association of British Clinical Diabetologists (ABCD). 

Real-time CGM

In June 2019, an international consensus report established the ‘time in range’ concept – the proportion of time a person’s blood glucose falls within a prescribed range – as a clinical metric for patients with type 1 or type 2 diabetes who use either real-time CGM (rtCGM) or intermittently scanned CGM (isCGM), also called ‘flash glucose monitoring’. The latter, the Abbott FreeStyle Libre, is the one most commonly used in the UK, although the NHS in England has recently authorised the Dexcom G6 rtCGM for use during pregnancy.  

The new guidance aims to clarify the intent and purpose of the international consensus recommendations and provide practical clinical and technical advice for use of time in range in UK diabetes care, particularly in the context of the COVID-19 pandemic, co-author Pratik Choudhary, professor of diabetes at the University of Leicester, told Medscape Medical News.

“Even though FreeStyle Libre has been widely rolled out and people are seeing the reports, we felt that a locally-published paper by local leaders of the DTN was needed to get people to start thinking about time in range. People are still fixated on haemoglobin A1c (HbA1c) and glucose of 5 [mmol/L],” Prof Choudhary said.

International Guidelines

The paper reviews and provides rationale for the international guidelines, which recommend generally that more than 70% of glucose readings should fall within a blood glucose range of 3.9-10.0 mmol/L, with modifications for children, older adults, and pregnant women.  

“It’s a huge mindset [change] from saying your target is 5 [mmol/l] to saying you’ve got a target range. It’s saying you’ve got an allowance of 30%, so if you screw up a little bit it’s not a disaster. It will balance out. That’s the narrative we want to put out there,” Prof Choudhary explained.

A UK-based audit on the use of FreeStyle Libre conducted by ABCD showed significant improvements in HbA1c, reduced hospital admissions, and lower levels of diabetes-related distress in patients with type 1 diabetes. Updated data from that study were published in the September 2020 issue of Diabetes Care.

Remote Monitoring

The new document emphasises that time in range is meant as an adjunct to HbA1c rather than a surrogate, and discusses the correlations between the two values and their respective association with diabetes-related outcomes. However, because the COVID-19 pandemic has reduced the capacity for in-person visits including blood tests,

Read more

Rhythm Pharmaceuticals Announces Publication of Results from Phase 3 Clinical Trials of Setmelanotide in The Lancet Diabetes & Endocrinology

Largest studies in POMC and LEPR deficiency obesities demonstrate that treatment with setmelanotide reduced body weight and hunger

BOSTON, Oct. 30, 2020 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, announced today that results from two pivotal Phase 3 studies evaluating setmelanotide in proopiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity were published in The Lancet Diabetes & Endocrinology. As previously reported, data from the studies demonstrate that treatment with setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, led to statistically significant and clinically meaningful reductions of weight and hunger.

“Results from Rhythm’s pivotal Phase 3 studies, which are the largest studies to date in POMC and LEPR deficiency obesities, provide evidence regarding the safety and efficacy of setmelanotide and we believe they validate its potential long-term use as a novel treatment for severe obesity and hyperphagia,” said co-author Peter Kühnen, M.D., Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin, Germany. “It is important to recognize the signs of these rare genetic disorders because we may soon have a targeted treatment option available for the first time for obesity disorders caused by impairments of the MC4R pathway.”

Rhythm initially reported positive topline data from the Phase 3 studies in August 2019 and subsequently presented updated data in a late-breaking research forum during the 37th Annual Meeting of The Obesity Society at ObesityWeek® 2019.

Eight of 10 participants with POMC deficiency obesity (80%; P<0.0001 compared with historical data) and five of 11 participants with LEPR deficiency obesity (45%; P=0.0001 compared with historical data) achieved at least 10 percent weight loss at approximately one year. The mean percent change in “most hunger” score in participants aged 12 years and older was -27.1 percent (n=7; P=0.0005) in POMC deficiency obesity and -43.7 percent (n=7; P<0.0001) in LEPR deficiency obesity. Consistent with prior clinical experience, setmelanotide was generally well-tolerated in both trials. The most common adverse events were injection site reaction, skin hyperpigmentation, and nausea.

“These results are significant because, as we know from natural history data, individuals living with POMC or LEPR deficiency obesity consistently experience substantial weight gain each year beginning in early childhood, and we would not expect any of these patients to be able to achieve 10 percent weight loss over the course of a year without continued treatment,” said co-author Karine Clément, professor of nutrition at Pitié-Salpêtrière hospital and Sorbonne University in Paris. “These data and the significant unmet need to address the obesity and hyperphagia caused by rare genetic disorders of obesity underscore the importance of testing for genetic variants that may impair MC4R activation and lead to severe obesity.”

In May 2020, Rhythm announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for setmelanotide for the treatment of POMC deficiency obesity and LEPR deficiency obesity, granted Priority Review of the NDA and assigned a Prescription Drug

Read more

Lessons From COVID-19 Need to Be Learned for Diabetes Care



While the COVID-19 pandemic has highlighted a number of pre-existing challenges in delivering diabetes care in the NHS, some of the innovative approaches taken to continue patient management during the pandemic need to be retained to improve ongoing care, say UK experts.

The research was presented during the Diabetes UK Professional Conference: Online Series on October 27, in a session dedicated to the remodelling of diabetes services during the COVID-19 pandemic.

Challenges

Nicola Milne, a community diabetes specialist nurse with Manchester University NHS Foundation Trust said that, prior to the COVID-19 pandemic, diabetes care “very much focused on face-to-face consultations”, with the majority “really rigid” 30- to 40-minute appointments every 3 to 6 months.

“But was that working? We knew we were starting to face a number of challenges,” she said.

These included increasing numbers of patients, the increasing complexity of diabetes care, poor uptake of structured diabetes education, and the need for access to advances in technology.

Alongside, there were challenges around healthcare service capacity, as well as with workforce recruitment and retainment, with Milne saying that a recent survey found there was a 10% vacancy rate for diabetes specialist nurses.

Variation in Care

The arrival of the COVID-19 pandemic only served to heighten these challenges.

Initial guidance issued on 23 March – around the time of the UK-wide lockdown – recommended that inpatient diabetes services should continue and may need to be increased to a 7-day service.

However, secondary care services, including diabetes foot, and pregnancy and diabetes services, were to be kept to a safe minimum, while group-based face-to-face contact was to be avoided.

Nicola Milne said that a survey by Diabetes UK in August revealed there was consequently “considerable variation” in diabetes inpatient care during the first peak of the pandemic.

Some trusts were able to adapt to the circumstances and provide a proactive, flexible service that relied on increased use of technology and maximised the number of days worked, while others saw their care comprised, particularly when their diabetes teams were disbanded and redeployed.

The result for Milne’s community service was that it had a 55% reduction in capacity due to staff shortages, but was required to perform an additional 580 type 2 diabetes reviews as a result of early hospital discharge, admission avoidance, and a reduction in outpatient services.

COVID-19 Mortality

However, data from a study published in The Lancet showed that a disproportionate number of diabetes patients died from COVID-19 infection, and that both type 1 and type 2 diabetes were significant independent predictors of COVID-19 mortality.

Nicola Milne said that this underlined how frontline diabetes services need an effective ‘back line’ of community and outpatient services and remote consultations.

Moreover, there is a “need” for patient triage and risk stratification to ration overstretched and restricted services.

“This is really uncomfortable for us as healthcare professionals because we always want to give 100% to 100% of the people we’re caring for,” she said, “but we have got to accept that we are going

Read more

How One Fitness Enthusiast Is Tackling the Navajo Diabetes Crisis

From Men’s Health

LOREN ANTHONY’S BACKYARD gym keeps growing. Early this year, he had a few wooden beams. When summer ended, he had railroad ties, chains, and crates, MacGyver-ing them together for deadlifts and shoulder presses.

The 37-year-old grits out a workout session nearly every day, often uploading clips to his Instagram or Facebook account. It’s how he inspires his Diné people to find ways to train—and he desperately wants them to do that. “I want more people to understand that fitness is a lifestyle that isn’t a trend,” he says.

It’s a lifestyle that Anthony hopes more in the Navajo Nation can embrace, because it may be the key to overcoming the health issue that’s plagued them since the early 1970s: diabetes. Roughly one in every five Navajo has prediabetes, the highest ratio of any racial or ethnic group in the U. S.

Dietary issues are part of the problem. When the Diné were forced off their homeland and moved to Bosque Redondo, in present-day southeast New Mexico, they relied on second-rate government rations due to crop failure and alkaline water. More than a century later, prepackaged foods sold at gas-station convenience stores are the easiest meal choice, partly because there are just 11 grocery stores on the reservation’s 27,413-square-mile expanse.

Lack of fitness facilities and instruction is the other issue. Gyms are an uncommon sight on Navajo lands. When the government started the Special Diabetes Program for Indians in 1997, the Navajo Nation built seven “wellness centers” on the reservation. Even before coronavirus concerns led those gyms to temporarily shut down, limited hours prevented many Navajo from reaching them.

Anthony understands these struggles. His grandparents were diabetic, and his father died of heart failure in 2013, the result of unaddressed heart issues. In 2009, Anthony himself weighed 298 pounds and struggled to breathe and move. Doctors told him he was prediabetic and had high blood pressure. “I really didn’t want the end of me to happen because I didn’t take care of myself,” he says.

He took up bodybuilding and powerlifting, studying both on YouTube. After several years of daily training, he was down more than a hundred pounds. (He currently weighs 181.) He did most of his training at a gym and a football field in nearby Gallup, New Mexico.

Photo credit: Steven St John

In late 2012, he started a workout group, the Iron Warriors. The group met for free workouts twice a week at Gallup’s public school stadium. It began with five people, but within a year, at least 100 were lining up for the field sprints, bear crawls, walking lunges, and pushups. Occasionally, he also held sessions in the community of Tohatchi, in the Navajo Nation, as well as in Phoenix and Albuquerque.

The pandemic forced Anthony to pause his Iron Warriors sessions in March, but he won’t let it quiet his fitness message. He knows diabetes can be beaten, because he’s done it: He’s no longer at risk of the

Read more

Consensus Guidelines Address Inpatient Diabetes Technology

A new consensus statement offers detailed guidelines for inpatient use of continuous glucose monitors (CGM) and automated insulin delivery (AID) systems.

Aimed at clinicians, researchers, and hospital administrators, the open-access document was recently published by a multidisciplinary international panel of 24 experts in the Journal of Diabetes Science and Technology.

The statement includes 77 separate recommendations under five headings: 1) continued use of CGM by patients already using them at home, 2) initiation of CGM in hospital, 3) continuation of AID systems in hospital by patients already using them at home, 4) logistics and hands-on care of hospitalized patients using CGM and AID systems, and 5) data management of CGM and AID systems in hospital.

“This is the most comprehensive and up-to-date guideline on the use of diabetes technology in the hospital now,” lead author Rodolfo J. Galindo, MD, told Medscape Medical News in an interview.

“Overall, most experts believe that CGM and AID have the potential to overcome the current limitations of glycemic monitoring in the hospital to improve patient outcomes but we need research, first to get the approval and second to get widespread use,” said Galindo, medical chair of the hospital diabetes taskforce at Emory Healthcare System, Atlanta, Georgia. 

COVID-19 Changed Everything

The guideline is an update of a 2017 statement on hospital use of CGM. The new guideine adds AID systems — sometimes referred to as an artificial pancreas, which combines a CGM and insulin pump and uses an algorithm to guide insulin delivery — and is the first to be developed during the COVID-19 era.

The update had been planned prior to the pandemic, but the actual panel meeting took place in April 2020, after the US Food and Drug Administration allowed inpatient use of CGM despite lack of official approval.

“COVID-19 changed everything…We had to be more specific about how to implement CGM in these patients. The standard of care is hourly point-of-care glucose monitoring in the [ICU], and at least every 4 hours outside the ICU. With limited [personal protective equipment] and the burden on nursing it was unachievable,” Galindo explained.

In June 2020, Galindo and other guideline authors developed a COVID-19-specific document (also open-access), which goes more into detail about CGM and how to implement in-hospital use during the pandemic.

The current consensus guideline “provides a high-level review of the evidence by experts,” Galindo added.

Recommendations Cover Different Technologies and Hospital Settings

The panel “strongly” advises that hospital providers consult with an inpatient diabetes team, if available, to help manage patients already using CGM prior to admission. Among other recommendations, they list several situations in which CGM data should not be relied upon for management decisions, including severe hyper- or hypoglycemia, diabetic ketoacidosis, or in patients with skin infections near the sensor site.

The panel also call for more research into outcomes for CGM continuation in the hospital and optimal implementation of both CGM and point-of-care glucose testing. For hospitals, strong recommendations include developing standard CGM data reports and

Read more

Mouse study shows how a virus may trigger diabetes

New research conducted in mice has shown how coxsackievirus B type 4 — an enterovirus, a virus transmitted through the intestines — may be able to trigger diabetes in people who have the virus.

A new study has shown a possible mechanism for triggering diabetes in people who have coxsackievirus B type 4 (CVB4), a type of enterovirus.

The research, published in the journal Cell Reports Medicine, may also be valuable in exploring whether SARS-CoV-2, the virus at the heart of the current pandemic, can trigger diabetes.

According to the Centers for Disease Control and Prevention (CDC), diabetes is an ongoing health condition that affects how a person’s body transforms food into energy.

As a person consumes food and drinks, their blood sugar increases. Their pancreas then produces the hormone insulin, which enables cells to access this blood sugar.

However, a person with diabetes may not be able to either make good use of insulin (type 2 diabetes) or produce enough of it (type 1 diabetes).

Type 2 diabetes is by far the most common form of diabetes, accounting for approximately 90–95% of all cases of diabetes in the adult population.

The American Diabetes Association consider both types of diabetes to be caused by a combination of genetic and environmental factors.

For type 1 diabetes, scientists believe that viruses are one aspect of these environmental factors.

In particular, research suggests that enteroviruses — a family of viruses that can cause a variety of diseases with “neurologic, respiratory, skin, and gastrointestinal” symptoms — may be key viral triggers for type 1 diabetes.

However, scientists are not yet sure exactly how this triggering function occurs.

In the present study, the researchers wanted to better understand how enteroviruses may trigger type 1 diabetes.

To do so, they used mice that had been grafted with human pancreatic cells with CVB4, as well as human and mouse insulin-producing cells that also had the virus.

After conducting various experiments with these infected cells, the researchers identified a complex chain of events that may account for the trigger of diabetes.

The researchers observed that CVB4 infection induced downregulation of URI, a protein that controls various cellular functions. This downregulation triggered a cascade of molecular events.

This in turn resulted in the silencing of the gene Pdx1, which governs the function of beta cells in the pancreas. These beta cells produce insulin.

As Dr. Nabil Djouder, a researcher at the Spanish National Cancer Research Center and the lead author of the study, explains, “Pdx1 silencing causes the loss of the identity and function of the beta cells, which become more like alpha cells, in charge of increasing blood glucose levels, and hence leading to hyperglycemia and subsequent diabetes, independently of any immune reactions.”

Helping to corroborate their findings, the researchers also noted that mice with diabetes that overexpressed the URI protein were more tolerant of blood sugar changes.

Finally, the researchers noted a correlation between the expression of URI, Pdx1, and viral particles in

Read more

Coffee, Green Tea Might Extend Life for Folks With Type 2 Diabetes | Health News

By Serena Gordon
HealthDay Reporter

(HealthDay)

THURSDAY, Oct. 22, 2020 (HealthDay News) — If you’ve got type 2 diabetes and love drinking green tea or coffee, new research suggests you may be reducing your odds of a premature death.

But you need to really love these drinks. The study found that having four or more cups of green tea along with two cups of coffee daily was linked to a 63% lower risk of death during the average five-year follow-up.

On their own, a single cup of coffee or green tea daily might lower your risk of early death by 12% to 15%, respectively.

“Familiar beverages such as green tea and coffee may have health-promoting effects. We have shown that higher consumption of green tea and coffee was associated with reduced all-cause mortality, and their combined effect appeared to be additive in people with type 2 diabetes,” said lead author Dr. Yuji Komorita, an assistant professor at Kyushu University’s Graduate School of Medical Sciences in Fukuoka, Japan.

Komorita said it’s unknown how either drink may aid health. Both contain nutrients that may reduce inflammation, among other healthful benefits. Since coffee and green tea together were linked to an even lower risk of early death, Komorita suggested that each may have different beneficial substances that act on different diseases.

But Komorita added an important caveat: This study was not designed to prove cause and effect. As an observational study, it can only find an association.

Komorita also pointed out that researchers didn’t have a lot of information about participants that could affect the findings, such as their education, income and family history.

The study included almost 5,000 Japanese adults (average age: 66) with type 2 diabetes. Almost 2,800 were men. Their health was followed for about 5 years.

Participants completed a lengthy food and drink questionnaire that asked how much green tea and coffee they had daily. They were also asked lifestyle questions, such as how much exercise they did, alcohol and smoking habits, and how much sleep they typically got.

Only about 600 participants didn’t drink green tea. About 1,000 didn’t drink coffee.

Of those who sipped green tea, more than 1,100 drank up to a cup a day, almost 1,400 had two to three and nearly 1,800 drank four or more cups each day, the findings showed. For coffee drinkers, 1,300 had up to a single cup daily, more than 960 had one cup and 1,660 had two or more a day.

During the follow-up period, just over 300 participants died.

Compared to people who didn’t drink either beverage, participants who had green tea or coffee were less likely to die during the study, the researchers found. Those who drank both had the largest reductions in death risk.

And, the more you drank, the lower your odds of dying, the study found. Folks who had more than four cups of green tea daily had a 40% lower risk — the same as those who had two or more cups

Read more

HIV Drugs Prevent Type 2 Diabetes, May Be Path to New Therapy

A class of drugs long used to treat HIV and hepatitis B viral infections appears to prevent the development of diabetes in a substantial proportion of patients who take these agents, an analysis of multiple databases has shown.

“Nucleoside reverse-transcriptase inhibitors (NRTIs), drugs approved to treat HIV-1 and hepatitis B infections, also block inflammasome activation,” Jayakrishna Ambati, MD, University of Virginia School of Medicine, Charlottesville, Virginia, and colleagues write in their article, published recently in Nature Communications.

“[We showed that] the adjusted risk of incident diabetes is 33% lower in patients with NRTI exposure…. These data suggest the possibility of repurposing an approved class of drugs for prevention of diabetes,” they say.

The researchers made a small chemical modification to NRTIs that led to their developing a new class of drugs, which they have termed “kamuvudines.” Kamuvudines are nontoxic derivatives of NRTIs, Ambati told Medscape Medical News.

“People take NRTIs because they need to live with HIV, but giving them to the general population is not a great idea because of the toxicities associated with long-term NRTI use.

“So our focus is not to go forward specifically with NRTIs but rather with these new molecules that are far less toxic, and that is how we envision a clinical trial going forward,” Ambati noted.

Researchers Screened Five Databases of >100,000 Patients

Ambati and colleagues analyzed information from five databases in which patients who had been exposed to an NRTI but who had not previously been diagnosed with type 2 diabetes were assessed for the subsequent development of diabetes over varying time intervals. In one, the Veterans Health Administration (VHA) database ― from the largest integrated healthcare system in the United States ― the analysis spanned a period of 17 years.

Of 79,744 patients with a confirmed diagnosis of HIV or hepatitis B in the VHA database, the risk for type 2 diabetes was reduced by 34% among NRTI users compared with nonusers after adjusting for potential confounders (P < .0001).

The reduction in diabetes risk was similar among HIV-positive and hepatitis B–positive patients.

These results were reaffirmed by further analyses of four other databases, the investigators report. One of these, the employer-based health insurance Truven database, had data on 23,634 patients who had been diagnosed with HIV or hepatitis B. After adjusting for potential confounders, NRTI users had a 39% lower risk of developing type 2 diabetes compared to nonusers (P < .0001).

The risk of developing type 2 diabetes was somewhat lower among NRTI users in the Pearl Diver database, which includes predominantly private health insurance claims. Of 16,045 patients diagnosed with HIV or hepatitis B included in this database, the risk for type 2 diabetes was 26% lower among NRTI users compared to nonusers (P = .004).

A similar magnitude of risk reduction was seen in the analysis of the Clinformatics dataset. Among 6341 users of NRTIs, the risk for type 2 diabetes was 27% lower than it was for nonusers (P = .009).

Read more

Substance in Tears Could Be Used for Diabetes Monitoring



Dr Masakazu Aihara

Measuring glycated albumin (glycoalbumin, GA) in tears could be a future way for those with diabetes to monitor their blood sugar levels noninvasively.

In a 100-patient trial, levels of GA in tears were found to be strongly correlated (r = .722; P < .001) with those in the blood.

“GA levels in blood are widely measured in clinical practice in Japan,” said study investigator Masakazu Aihara, MD, PhD, in an interview.

“It’s a biomarker that reflects the 2-week average blood glucose level like fructosamine,” explained the researcher from the department of diabetes and metabolic diseases in the Graduate School of Medicine at the University of Tokyo.

This could make it a better biomarker for detecting earlier changes in blood glucose than glycated hemoglobin (HbA1c), which reflects changes in blood glucose over the preceding 2-3 months.

Prior studies had shown that glucose levels can be measured in tear samples and that tear glucose levels correlated with blood glucose levels, Aihara and fellow researchers observed in a poster presentation at the virtual annual meeting of the European Association for the Study of Diabetes.

“While looking for noninvasive diabetes-related markers, we found that tears contained albumin. Based on this fact, we thought that GA could be measured in tears,” Aihara explained.

Using tears to test for biomarkers is not a new idea – tears not only protect the eye, they contain a variety of large proteins, and their composition can change with disease. Indeed, researchers have been looking at their usefulness in helping find biomarkers for Parkinson’s disease and diabetic peripheral neuropathy.

During their study, Aihara and associates collected tear and blood samples at the same time. Tear samples were assessed using liquid chromatography (LC) and mass spectrometry (MS). An enzymic method was used to measure GA levels in blood. Several diagnosis assay kits for GA are sold in Japan, Aihara said, and at least one of these has U.S. Food and Drug Administration approval.

Multiple regression analysis revealed that the correlation between GA levels in tears and in blood was maintained even after adjustment for age, gender, nephropathy stage, and obesity (P < .001). The results obtained from the tests were thought unlikely to be affected by any changes in the concentration or dilution of tear samples.

“Since GA levels in blood are clinically used in all types of diabetes, GA levels in tears is also expected to be useful in all types of diabetes,” Aihara said, noting that the effects of receiving treatment on GA levels in tears is something that he would like to look at.

The team would also like to optimize how tear samples are collected and reduce the volume of tears that are required for analysis. At the moment tears are collected via a dropper and about 100 mcL of tear fluid is required for measurement.

“At present, it is difficult to measure for dry eye patients because sufficient tears cannot be collected, but if the required amount of tears decreases

Read more