Cinnamon Beats Placebo in Prediabetes

Cinnamon supplements kept a lid on fasting plasma glucose (FPG) and other measures of glucose dysregulation in patients with prediabetes, a small randomized clinical trial found.

In 51 patients with prediabetes followed for 12 weeks, FPG increased by an average of 4.5 ± 6 mg/dL in the placebo group but remained the same in the group who received cinnamon supplements, resulting in a between-group mean difference of approximately 5 mg/dL (114 ± 8 vs 108 ± 11, P<0.01), reported Giulio Romeo, MD, of the Joslin Diabetes Center in Boston, and colleagues.

In addition, as shown in the study online in the Journal of the Endocrine Society, use of cinnamon supplements resulted in a smaller area under the curve for plasma glucose compared with placebo (19,946 vs 21,389 mg/dL/120 min, P<0.05).

Cinnamon supplements, but not placebo, were also associated with a significant decrease in plasma glucose at the 2-hour time point of the oral glucose tolerance test (-20 ± 27 mg/dL, P<0.01).

“This randomized controlled trial of individuals with prediabetes showed that treatment with cinnamon 500 mg thrice daily resulted in a statistically significant between-group mean difference in FPG of approximately 5 mg/dl at 12 weeks, which was the primary outcome measure of the study. No change in FPG was noted at 6 weeks, which was one of the three pre-specified secondary end-points,” the researchers wrote.

“Our 12-week study showed beneficial effects of adding cinnamon to the diet on keeping blood sugar levels stable in participants with prediabetes,” Romeo said in a news release. “These findings provide the rationale for longer and larger studies to address if cinnamon can reduce the risk of developing type 2 diabetes over time.”

According to criteria used by the American Diabetes Association, approximately 38% of the U.S. population has prediabetes. Of these, approximately 3%-11% will progress to type 2 diabetes each year. Lifestyle interventions and anti-diabetic drugs are used to prevent the progression, but as many as half of individuals who receive some form of treatment still progress. “Therefore, identification of efficacious, durable, safe, and cost-effective strategies for type 2 diabetes prevention remains a clinically relevant unmet need, especially in low- and middle-income countries,” the researchers said.

Over the years, randomized clinical trials have tested various forms of cinnamon in adults with type 2 diabetes; doses ranged from 500 to 6,000 mg, and the duration of the studies ranged from 4 weeks to 4 months. The majority of trials demonstrated reductions of 10%-15% in FPG from baseline. However, changes in glycated hemoglobin (HbA1c) were inconsistent among the trials.

Mechanisms proposed for the glucose-lowering activity of cinnamon include increased glucose transporter type 4 membrane translocation, stimulation of post-prandial levels of glucagon-like peptide-1, inhibition of alpha-glucosidase activity, and antioxidant properties, Romeo’s group explained.

“In individuals with prediabetes, the evidence from randomized clinical trials addressing the impact of cinnamon on glucose homeostasis is more limited,” the researchers added. “Specifically, it remains unclear if in this population: (a) cinnamon affects FPG, glucose tolerance, or both; and (b) the response to cinnamon is conserved across ethnic groups.”

The new double-blind trial included two ethnic groups: 39 individuals recruited at the Kyung Hee University Medical Center in Seoul, Korea; and 12 recruited at the Joslin Diabetes Center. All participants were adults ages 20 to 70 with prediabetes.

Inclusion criteria were:

• Impaired fasting glucose, defined as FPG of 100 to 125 mg/dL

• Impaired glucose tolerance as demonstrated by a 2-hour plasma glucose level of 140-199 mg/dL based on a 75-g oral glucose tolerance test

• HbA1c of 5.7% to 6.4%

Patients were excluded if they had evidence of diabetes or other significant endocrine, cardiovascular, pulmonary, renal, or liver disease.

Participants were randomized 1:1 to receive cinnamon capsules, which contained 300 mg of cinnamon extract (Cinnamomum spp.) and 200 mg of Cinnamomum burmannii powder, or a look-alike placebo capsule containing cellulose, food coloring, and cinnamon incense. Participants took the capsules three times a day for 12 weeks, and laboratory tests were performed at baseline and at 6 and 12 weeks.

Study limitations, the researchers said, included that the short duration did not allow them to assess progression from prediabetes to type 2 diabetes, and it was not powered to discriminate between participants with impaired fasting glucose compared with those with impaired glucose tolerance.

Nevertheless, “treatment with cinnamon for 12 weeks, compared to placebo, resulted in favorable changes on measures of glucose homeostasis in a representative population of participants with prediabetes,” Romeo and co-authors concluded. “These findings should set the foundation for a longer and larger randomized clinical trial that directly addresses the impact of cinnamon on incident type 2 diabetes and/or remission of prediabetes.”

Disclosures

The study was supported by the Ministry of Health and Welfare in South Korea.

Romeo and co-authors reported having nothing to disclose.

Primary Source

Journal of the Endocrine Society

Source Reference: Romeo GR, et al “Influence of cinnamon on glycemic control in subjects with prediabetes: a randomized controlled trial” J Endocrin Soc 2020; DOI: 10.1210/jendso/bvaa094.

https://www.medpagetoday.com/endocrinology/diabetes/87692

No Hanky-Panky at HHS’s New COVID Data Hub, Contractor Says

No one in the Trump administration has attempted to manipulate national COVID-19 data or unduly influence the operations of the new Department of Health and Human Services (HHS) Coronavirus Data Hub, said the head of the company contracted to develop and maintain the database.

“Unequivocally zero,” Christopher Johnson, president of TeleTracking Technologies in Pittsburgh, said in an exclusive interview with MedPage Today. “It’s been very, very clear since the beginning that the goal has always been transparency…. A lot of the raw data is being published and it’s clearly traceable. There’s been no indication, no intent, no inkling of that, at least from my perspective. I have zero question about the integrity, ethics, or moral fiber of the people I’ve encountered.”

Moment in the Spotlight

TeleTracking has come into the spotlight now that HHS has debuted the data hub. It replaces the CDC’s National Healthcare Safety Network (NHSN), to which states and hospitals had previously been submitting COVID-19 data such as intensive care unit capacity, ventilator use, personal protective equipment (PPE) levels, and staffing shortages. But in guidance to hospitals, updated July 10 and published with little fanfare, HHS ordered hospitals to stop submitting such data to the NHSN and instead submit it either to HHS or to their state health department, which would then submit it to HHS. The data is now posted on the dashboard via the department’s new HHS Protect data system, which was developed by TeleTracking.

The company was founded in 1991 with businessman Michael Zamagias as its main investor; he is the company’s chairman and CEO. “He had a vision and saw the problem,” which is that healthcare is “horribly inefficient,” Johnson said. “Of the $4 trillion spent on U.S. healthcare, roughly half of that is in labor, and that labor is terribly inefficient — it’s a very complex system, and you’re dealing with human beings that are at their weakest in many cases.” The company “saw it as an opportunity to create better visibility into what is happening, starting with a ‘bed board’ that shows you what’s happening with beds and the patients in the hospital.” That expanded to include workflows around transporters, workers who clean the rooms, and biomedical engineers who make sure equipment is in the right place at the right time.

Over the years, the company has invested more than $1 billion into “a technology platform, a team of operational experts, and a set of best practices that we can apply to help healthcare organizations perform better operationally — more productively, more efficiently,” said Johnson. The company now serves more than 1,100 hospitals in the U.S., Canada, and Great Britain, with offices in North Carolina, Tennessee, and London.

The interaction with the federal government came about gradually, beginning about 5 years ago, he said. “We had the opportunity to meet with the House Ways & Means Committee” and testify at a 2016 hearing on the use of technology to improve cost and efficiency in healthcare, Johnson explained. Company officials also met with people at the Centers for Medicare & Medicaid Services and across government, “really as a way to create awareness that there’s an opportunity here to make an improvement in the cost of healthcare.”

CDC Involved in Move to HHS Protect

And then COVID hit. “It became clear to everyone very, very quickly that there was a need for situational awareness across the U.S.,” said Johnson. “We had an opportunity to speak with HHS around what they were trying to achieve — to create data so policymakers and emergency responders could make decisions on allocation of resources.”

Contrary to some media reports, the bidding for the contract seemed to be competitive, he said. “There were definitely conversations where they would reference other reviews that were happening. We were working with them on our stuff, and they would say they were speaking to others as well.” TeleTracking was awarded the 6-month, $10.2-million HHS Protect contract in April and began executing it “almost immediately,” Johnson said.

When TeleTracking started its work, “there were multiple ways” in which the government was collecting hospital data — “the NHSN that the CDC ran, TeleTracking, and there were others, like direct feeds into HHS from the states,” he explained. “From the outside looking in, that may not seem like the best way to do it but I understood the thought process behind it; we needed as much data as we could get.”

Johnson said the company wasn’t involved in any discussions of bypassing the CDC, and at first that wasn’t part of the plan. “What we knew was, there was a desire to streamline the process and relieve the burden on hospitals to the best of their ability.” At that point, he added, “some people were using NHSN, some were not. If you were still using NHSN you could still use it; we just gave them the ability to do it in a different way.”

But then it was decided to have hospitals send their data only to HHS. “The decision to move to TeleTracking in a primary way and no longer collect data through NHSN was a decision that [CDC Director] Dr. [Robert] Redfield was a participant in,” he said. Johnson said he feels that decision was misunderstood.

“The CDC has the same access to data they had before,” he continued. “It was portrayed as the CDC being ‘cut out’ of the COVID response. I never saw that as the case at all. We interact daily with people from HHS, CDC, and other agencies; that has continued uninterrupted as we move through this process.” The goal for the project “has always been to have the most complete and transparent data set, so we can understand collectively as a nation, at the federal, state, and local level, what’s happening.”

The Ultimate Customers

Johnson sees healthcare providers as his ultimate customers. “We’re committed to helping caregivers do their God-given calling,” he said. “It amazes me — healthcare, unlike any other field, is a calling; they are drawn to it. Those are the people we serve; that’s who we’ve been focused on.”

Claims that TeleTracking was awarded the contract because its executives are donors to President Trump are untrue, said Johnson. “I personally have never donated to really any campaign,” he said, adding that company chairman Michael Zamagias hasn’t donated to Trump either as far as Johnson knows (public campaign contribution databases confirm it, although Zamagias has donated to Republican congressional candidates).

Johnson also debunked rumors that TeleTracking retained access to the data being collected. “People had some belief that TeleTracking was some private industry in Pittsburgh and all the data is stored in our building; that’s not true,” he said. Instead, TeleTracking helps HHS acquire the data for use in their system, which “is very modern, very robust, very well done — all the things you’d expect from a modern data platform.”

On average, hospitals are reporting to the system once a day, and although most of the reporting is currently being done manually, Johnson is hopeful much of it can be automated. “The technology exists for us to automate these processes and increase the speed of transfer,” he said. Part of the reason that hasn’t happened yet is that “the types of data required in order to make better-informed decisions continues to evolve … As we settle on a core set of attributes necessary for management of this and any other crisis, the opportunities for automation are readily available.”

Johnson said he is proud of the work that his company has done, and that the feedback he has gotten from hospitals has been overwhelmingly positive. “We would hope publication of this data will continue to get more robust, more high-fidelity over time, and we hope to alleviate some of the unfounded fears of what was happening. I think we’re making great progress.”

https://www.medpagetoday.com/infectiousdisease/covid19/87700

Exact Sciences may gain from Humana at-home screening kit initiative – Evercore

According to Evercore ISI, Exact Sciences (EXAS +3.3%) may get a boost from Humana’s initiative to send ~1M at-home preventative care screening kits to its members to identify early complications associated with diabetes and colon cancer.

Exact’s top revenue producer is its Cologuard screening test for colon cancer.

https://seekingalpha.com/news/3594343-exact-sciences-may-benefit-from-humana-home-screening-kit-initiative-evercore

Intuitive Surgical’s Outlook ‘Has Never Been Stronger’ – Canaccord After Q2

Intuitive Surgical, Inc.’s ISRG 2.07% second-quarter report Tuesday was “surprisingly positive,” according to Canaccord Genuity.

The Intuitive Analyst: Cecilia Furlong maintained a Buy rating on Intuitive and raised the price target from $562 to $725.

The Intuitive Thesis: Intuitive faced headwinds from the coronavirus pandemic in the quarter, but the company’s system sales and procedural volume were both “well ahead of consensus projections” and showcased a “faster-than-anticipated recovery,” Furlong said in a Wednesday note. (See her track record here.)

The analyst named the following as Intuitive’s strengths:

Geographic Diversity: The company’s geographic diversity will help “offset potential future rolling weakness in specific regions,” she said. In the second quarter, Intuitive had strong sales in Asia, which complemented its sales in the U.S., Furlong said.

Strong Value Proposition: In a COVID-19 world, minimally invasive robotic procedures will help address “the focus on streamlining patient care and minimizing hospital LOS,” the analyst said.

New Extended Use Program: Intuitive announced its Extended Use Program to commercialize select instruments that have longer usage lifetimes than current instruments. This program will “further entrench [Intuitive] within its customer base ahead of impending competition” and help it become more competitive, she said.

The long-term outlook for Intuitive “has never been stronger,” Furlong said.

https://www.benzinga.com/news/earnings/20/07/16742391/intuitive-surgicals-outlook-has-never-been-stronger-analyst-says-after-q2-report

U.S. sets global benchmark for COVID-19 vaccine price at around cost of a flu shot

The U.S. government has set a benchmark for COVID-19 vaccine pricing in a $2 billion deal announced on Wednesday with Pfizer Inc and German biotech BioNTech SE that will likely pressure other manufacturers to set similar prices, industry analysts told Reuters.

The deal, which is contingent on an approvable product, secures enough vaccine to inoculate 50 million Americans for about $40 a person, or about the cost of annual flu shots, and is the first to provide a direct window into likely pricing of successful COVID-19 vaccines.

It also allows for some drugmakers to profit from their efforts to protect people from the virus that has killed some 620,000 people worldwide, almost a quarter of those in the United States.

Unlike other vaccine deals signed by the government, Pfizer and BioNTech will not collect a payment until their vaccine proves to be safe and effective in a large pivotal clinical trial expected to start this month.

The U.S. and other governments have previously struck deals to support COVID-19 vaccine development, some of which included guaranteed deliveries of doses. But this is the first deal to outline a specific price for finished products.

“The average price for a flu vaccine is around $40,” said Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest. “It looks good with that comparison. It’s well within the ballpark of reasonableness.”

So far, the other major experimental vaccines have all displayed relatively similar data on safety and efficacy, suggesting that no one drugmaker would be able to charge dramatically more than its peers, said Mizuho biotechnology analyst Vamil Divan.

The U.S. government agreed to purchase 100 million doses of the Pfizer/BioNTech vaccine at a price that amounts to $39 for what is likely to be a two-dose course of treatment, or $19.50 per dose.

Health experts believe effective vaccines are needed to break the pandemic that has battered economies worldwide. But they would need to be available to billions of people, and drugmakers are under considerable pressure to avoid making big profits during a global health crisis.

At $40 per person, “manufacturers will certainly generate profits” and gross margins could be in the range of 60% to 80% in some geographic areas, said SVB Leerink analyst Geoffrey Porges. Gross margins do not include research and development costs, which Pfizer has said could run as high as $1 billion for its vaccine.

Still, analysts and pricing experts said the price tag is on par with other common vaccines and a good deal for governments, given the desperate need.

The deal “would provide important benchmarks for COVID vaccine pricing,” Porges said, adding that vaccine makers are likely to aim for a single price around the word.

Pfizer, Moderna Inc and Merck & Co have all said they plan to sell their vaccines at a profit.

Governments and non-profits are in a race to secure supply from companies with promising COVID-19 vaccine candidates, although there are no guarantees any will ultimately succeed.

Last week, Johnson & Johnson told Reuters it is in talks for vaccine deals with the European Union, Japan and the Bill and Melinda Gates Foundation.

Some drugmakers, including J&J, have announced plans to price their vaccines on a not-for-profit basis while the pandemic is ongoing, although J&J has not provided specifics on pricing.

AstraZeneca Plc agreed to provide the United States 300 million doses of the vaccine it is developing with Oxford University researchers in exchange for $1.2 billion in upfront funding.

Although the cost per dose comes out to around $4 – far less than what Pfizer and BioNTech would receive – AstraZeneca can use some of that funding to offset research and development costs even if its vaccine ultimately fails.

https://www.marketscreener.com/ASTRAZENECA-PLC-4000930/news/U-S-sets-global-benchmark-for-COVID-19-vaccine-price-at-around-the-cost-of-a-flu-shot-30976418/

Genocea Bio up on positive GEN-009 data

Genocea Biosciences (GNCA) Q2 results:

Revenues: $0.9M.

Net loss: ($11.3M) (-73.8%); loss/share: ($0.39) (+7.1%); Quick Assets: $22.1M (-44.9%).

GNCA presented long-term follow-up data from Part A of the ongoing Phase 1/2a clinical trial of GEN-009 at ASCO20 Virtual Scientific Program that evaluates eight participants.

Seven out of eight patients treated on Part A of the study are without disease progression at one-year median follow-up.

ATLAS-identified neoantigens generate broad, sustained T cell responses starting after only 4 weeks and lasting for up to 1 year after the last vaccination.

Genocea will present a clinical update on GEN-009 on July 30, at 8:00 a.m. EDT.

The company has filed an IND application to initiate a Phase 1/2a study of GEN-011 evaluating patient safety, T cell proliferation and persistence, and clinical activity. The trial expects to enroll up to 24 patients.

https://seekingalpha.com/news/3594237-genocea-bioplus-16-on-positive-genminus-009-data

Humana to send 1M in-home screening kits to members during pandemic

Aimed at helping members identify early complications associated with diabetes and colon cancer, Humana (NYSE:HUM) will mail more than 1M in-home preventative care screening kits to members, many who are seniors, who have postponed health procedures during the COVID-19 pandemic.

The initiative, at no cost to Medicare Advantage members, will run until September.

https://seekingalpha.com/news/3594246-humana-to-send-1m-in-home-screening-kits-to-members-during-pandemic