HEALTH

Analytics, connectivity help diabetes management get smart

BY David Salazar

Convenience has always been king, but another concept — connectedness — is bringing new solutions to the diabetes management space.

With the Centers for Disease Control and Prevention estimating in 2017 that 30.3 million people — roughly 9.4% of the total U.S. population — have diabetes, the space is ripe for solutions that are aimed at making managing the illness easier.

With the rise of connected health documented by such firms as Deloitte — whose recent survey on healthcare trends found that the use of digital devices to chart health and fitness goals has tripled between 2013 and 2018 — many companies are eyeing high-tech solutions to ease the burden of diabetes management. At the same time, these tools open the door for better clinical oversight and, ultimately, better patient health.

“In years gone by, the patient would get their blood glucose reading off their device and they would act accordingly,” said Brahim Zabeli, vice president of sales at Smart Meter, which makes the iGlucose diabetes care solution. “That patient was on their own doing this without any real assistance from day to day. Some of the new blood glucose systems that are out there have more data features than ever, and for those patients with diabetes, it gives them more tools to look at the readings over an extended period.”

With the iGlucose system, the use of its cell-enabled glucose monitor can be augmented by the iGlucose personal web portal for patients, where automatically transmitted readings are stored, and the virtual health coach, which offers automatic feedback on the readings. Zabeli said that the readings also can be shared with health professionals who can keep a better eye on patients. He also said that in a recent pilot with FlexCare Pharmacy in Washington, D.C., found that patients who knew their physicians might look at their results, they test more frequently.

“By having access to the data much more frequently, that healthcare professional that’s working with the patient can now monitor his or her patients on a weekly basis and take action on a weekly basis if needed,” Zabeli said.

The role that access to data plays in helping patients manage their condition also is a key component of Dexcom’s approach to the space. The company’s recently launched G6 continuous glucose monitor conducts a reading every five minutes — all without a finger stick.

“If you don’t have that real time data feed, you may miss a lot of highs and lows,” said Rick Doubleday, executive vice president – chief commercial officer at Dexcom, who added that users can share their readings with physicians and even family members. “Our system is not going to miss those, and it’s going to alert you — and if you’re using the follow function, it’s going to alert a loved one, and that loved one has the ability to then engage to help the individual.”

Retailers also can benefit from the health information that’s coming from diabetic patients, Doubleday said.

“As we collect this data, we’re creating APIs with those data streams, and retailers are going to be able to access those data streams and have software in-store where they can look at an individual patient and potentially better coach and counsel them to manage their diabetes,” he said.

Though monitors have been a primary focus of innovators in the space — many with the eventual goal of creating an artificial pancreas — one company has given a Bluetooth-enabled brain to a diabetes management mainstay — the pen injector. Companion Medical’s InPen, conceived in 2013 and being commercialized this year after several rounds of funding and Food and Drug Administration approval, was the winner of DSN/ECRM’s Buyer’s Choice Award at the recent Diabetes/Clinical Programs, Chronic Care Management & Adherence Solutions EPPS.

Accompanied by an app that displays the user’s last glucose reading — the app is interoperable with blood glucose meter, including CGMs — their last insulin dose and when the dose was administered, the pen transmits the insulin dose when the patient administers it.

Sean Saint, CEO of Companion Medical — who has Type 1 diabetes himself — said it was designed to bring the ease of monitoring of an insulin pump to the most commonly used method of administering insulin.

“We tried to take into account patients, providers and the payer when we developed this, and recently we added the pharmacist,” Saint said. “In doing that, we’ve added a lot of features and capability to the product.” He said that in the same way Dexcom offers a near-constant look at blood glucose, InPen offers a similar look at insulin doses and recommends subsequent doses based on past doses and glucose readings.

It’s worth noting that not every innovation in the diabetes management space is cell-

enabled or outfitted with hidden Bluetooth transmitters. One product that caught the eye of retailers at a recent ECRM meeting was a straightforward, if low-tech, management system for new and used pen needles. Excelsior, Minn.-based UltiMed’s UltiGuard Safe Pack offers a dual system for dispensing new pen needles and safely disposing of used ones via a built-in sharps container.

“Diabetes is a disease you not only manage daily, but hourly and sometimes by the minute,” said Sarah Hanssen, UltiMed’s vice president of sales and marketing. “It’s something people with diabetes have to constantly attend to, so anything that will make it a little bit easier is a lot.”

Hanssen said that the company works with retailers around merchandising the product, including making it a preferred choice in-store and co-branding with such retailers as H-E-B.

With all of these solutions, besides making patients’ burden of disease management lighter, there also is an opportunity to be more involved in care. Dexcom’s Doubleday said that its APIs could in the future be used to help push refill alerts to patients.

Though the main hurdle for any technology is adoption — and Smart Meter’s Zabeli said that there is potential for confusion among older-skewing patients — this underscores the aim that Saint said informed Companion Medical’s development of InPen.

“Our vision was something that was extremely familiar,” Saint said. “Our product is extremely similar to a traditional insulin pen — it’s no different. There are no buttons, no switches, no screen, no recharging — nothing.”

If companies can achieve adoption, it will mean more opportunities to drive patient outcomes. “The opportunity exists for pharmacists to be involved in this practice and not only gain revenue, but greater loyalty on the part of their patients,” Zabeli said. “Having pharmacists, particularly clinical pharmacists, involved in this practice could be a boon to the retail

pharmacy community.”

Doubleday said, “All of this is coming together to provide individuals better insight to their health than they’ve ever had before. All of that data together will help provide the individual so much greater insight than they’ve ever had before, and that’s what’s going to help drive outcomes.”

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Focus On: Garcoa Labs sees private label helping bolster sales

BY Seth Mendelson

Officials at Garcoa Laboratories feel they have all their bases covered — and that could be great news for the nation’s retailers.

The fast-growing Los Angeles-based company manufactures as many as 2,500 private-label and controlled-brand items, as well as many branded products. They include a wide range of health and beauty care categories, including hair care, skin care, body and bath care, as well as over-the-counter items and household products. While based in California, the company has manufacturing plants in Chicago, Toronto, Ottawa City, Ill., and Guatemala City, Guatemala.

On top of that, Garcoa is a company that is designed to give retailers what they need to better compete in a brutal retail environment, where getting an edge up on margins is crucial to both the short- and long-term success of the business. According to CEO Greg Rubin, who founded the company in 1983, Garcoa’s business model is fashioned on simply asking retailers what they need from the company and going out and doing what is necessary to develop the best product possible. Some retailers prefer turnkey programs to include concept, formulation, package development and procurement, while others just want manufacturing and production services, he said.

“We work with virtually every single major retailer in the country,” Rubin said. “We simply ask them what their needs are, and they give us a shopping list of products and we fulfill that list. Reverse engineering is a big part of what we do. They tell us what they want. We rebuild it to make sure it is efficacious, meets all the industry standards and is delivered on time. Our retail partners know they can come to us for all of their private-label needs. We are a one-stop shop.”

To that point, Rubin said that Garcoa offers its retail partners a broad array of services. They include global sourcing, market insight and intelligence, inventory management, packaging procurement, logistics, warehousing and distribution, research and development, and quality assurance and control.

He also was quick to add that three major firms audit Garcoa: NSF, UL and Intertek. “The diversity of our products and our reputation in the marketplace gives us a lot of range,” Rubin said. “On top of that, I think the retail community respects us for what we offer them besides the products themselves. We do the research needed to make sure the product is the best possible on the market, and we follow the trends. If a retailer has a problem, we have the solution.”

The overall private-label category is at an interesting crossroads. Private label’s market share has grown to between 20% and 25% of all sales at the nation’s mass retail outlets as product quality has dramatically improved and many retailers are looking for ways to generate more profits from many stagnant categories, as well as offer their own labels that are not available elsewhere.

Yet, some suppliers are complaining that retailers are pressuring them for even better margins and profits. That has the private-label community concerned that they might not be able to stay in business. “The private-label category is rapidly changing,” Rubin said. “The high cost of doing business is causing a large number of manufacturers to disappear. I think retailers are not giving manufacturers the opportunity to make money. They want better margins, and that is hurting the supplier’s ability to make money too.”

He said that retailers need to develop programs with their suppliers in private label that allow the supplier to make “a few cents” by developing products without interference from third parties that run costs up. “The industry has to work together to ensure that everyone can make a profit from this category,” Rubin said. “This is a lucrative marketplace and we can all benefit from it.”

Rubin, who runs the Women’s Enterprise-certified company, or WBENC, with his wife Melinda, who is president, also calls on retailers to treat private-label products in the same fashion they treat national brand items. “The promotional activity for private-label products must be increased in store,” he said. “Retailers need to do a better job promoting their private-label brands. They are giving endcaps to [national brand suppliers] for their products, but they are not giving their own brands the same support. That cannot help.”

However, Rubin is confident that retailers will soon get the message that private label can help them entice consumers into their doors and bring more profit to the bottom line, especially in the era of Amazon.com and other digital retailers.

“In five years, I think our company will be more than two times the size it is today,” he said. “At the end of the day, it will come down to the companies that are the most innovative and the most willing to bring new ideas and products to the marketplace. We think that Garcoa has stood at the front of innovation for years and will continue to be a leader well into the future.

“Yes, we cover the bases. We are trendsetters. We are knowledgeable about our total business and we know what is going to be hot tomorrow, today. We look ahead and our retailer partners benefit from this.”

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FDA to crack down on flavored e-cigs, combustible menthol products

BY David Salazar

Citing a rise in youth e-cigarette use in its 2018 National Youth Tobacco Survey, the Food and Drug Administration has unveiled efforts to curb the increase. With the report noting that more than 3.6 million middle and high schoolers used e-cigarettes in the past 30 days — up roughly 1.5 million students from last year — FDA commissioner Scott Gottlieb on Thursday outlined efforts to curb youth e-cig use, with a particular focus on flavored products.

The survey found that the past year has seen a 78% increase in reported e-cigarette use among high schoolers and a 48% increase among middle schoolers, and that of those who use e-cigarettes, 67.8% said they use flavored e-cigarettes. Gottlieb said that his recent calls for manufacturers to help prevent youth access to their products, as well as the unveiling of the FDA’s Youth Tobacco Prevention Plan and efforts to identify retailers who illegally sell e-cigs to minors, were partially in response to the survey’s raw data.

“Given the startling and disturbing youth use rates in the 2018 NYTS data being released today, it’s clear that we must do more — specifically, several policy changes to target what appear to be the central problems — youth appeal and youth access to flavored tobacco products,” Gottlieb said.

He has called on the FDA’s Center for Tobacco Products to restrict the sale of flavored products besides tobacco, mint and menthol flavors, as well as non-flavored e-cig products, in stores, with increased security around the products online as well. Additionally, Gottlieb is pushing a Notice of Proposed Rulemaking aimed at banning menthol in cigarettes and cigars, as well as a policy to ban flavors in cigars. The FDA also will seek to remove products that are marketed toward children from shelves. It is leaving mint and menthol e-cigarette offerings alone for now, though Gottlieb said that if youth use of such products doesn’t decline, he may revisit the issue.

“This policy framework reflects a re-doubling of the FDA’s efforts to protect kids from all nicotine-containing products,” Gottlieb said. “They also reflect a very careful public health balance that we’re trying to achieve. A balance between closing the on-ramp for kids to become addicted to nicotine through combustible and non-combustible products while maintaining access to potentially less harmful forms of nicotine delivery through ENDS for adult smokers seeking to transition away from combustible tobacco products.

Gottlieb’s comments followed recent efforts by Juul Labs, maker of the eponymous e-cigarette to only sell its flavored products online, where it can verify a shopper’s age and prevent bulk sales.

CVS health, which removed tobacco products from CVS Pharmacy stores in 2014, lauded the FDA’s policy goals.

“We applaud the FDA’s decision to restrict access to flavored tobacco and e-cigarette products, which have been expertly marketed and targeted at teens and young adults and has contributed to a dramatic rise in e-cigarette use among high school students,” said Troyen Brennan, CVS Health chief medical officer. “E-cigarette use among teens has also been directly correlated to a spike in cigarette smoking, after reaching historic lows. Through these new regulations, the FDA can help curb the e-cigarette epidemic and make a positive impact on public health for generations to come.”

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