Friday, April 22, 2022

Goodbye, DiabetesMine

"As one chapter closes..."

A decade ago in 2012, I had the privilege of joining with my friend and fellow diabetes advocate Amy Tenderich at DiabetesMine. At that time, my journalism career evolved into one that could be combined with my passion for diabetes and my own life with type 1 diabetes. I'd been personally blogging since 2007 and had been actively involved in the DOC (Diabetes Online Community) for a handful of years at that time, attending various conferences and forums with fellow advocates looking to "do good" in the world.



I've been proud to be managing editor for so many years, covering this community and doing advocacy journalism there - before and after we became part of Healthline in 2015.The time has come, though, for my career page to turn to the next chapter.

Healthline made a decision that it's time to close down DiabetesMine. We first heard about this decision-making in early 2022, and by mid-March the final decision had been made by the higher-ups. The final details materialized from there, with April 22 becoming the final "official" day for the DiabetesMine site on HL and no more editorial content being published on the site.

This wasn't a big surprise, as the writing had been on the wall for a while.

Still, it's bittersweet for us both — especially Amy as this has been her "baby" for 17 years since February 2005. I'm proud of the work we've done together to inform, educate, impact, and advocate within the Diabetes Community and beyond.

While we won't be doing this in the same way professionally at DiabetesMine any longer, I'm excited for what comes next. Amy will continue the DiabetesMine Innovation Project events - aka D-Data ExChange and Innovation Summit. These events have been game-changers in many ways for our Diabetes Community, not the least of which was being the birthplace of where #WeAreNotWaiting crystalized into a movement.

These are some of the proudest times of my career, in being able to be a part of something for an entire decade that rarely felt like "work" but a privilege I've had in doing what I love. I've met and covered some of the most amazing people, and I'll cherish those moments and continued relationships wherever I go from here.

Mike Hoskins, Amy Tenderich, Wil Dubois

Personally, I am staying on at Healthline in a different role on a different editorial team, where I will be doing editor tasks that probably won't touch on diabetes very much.

Though I am staying in the health information field, this new role also helps re-establish that line between my "personal" and "professional" sides — so that diabetes isn't front and center, all day all the time whether I am thinking about my work or not. That is something I've said for awhile, that my next chapter would likely take the diabetes out of that professional work. For me, this is the best time for this to happen.

That being said, I am planning to continue my own diabetes writing and advocacy on a personal level in my spare time.

So that's the latest. Here's to moving forward on the next chapter.

Wednesday, February 2, 2022

Spare a Rose: Helping People with Diabetes in Need

So many people with diabetes whose lives depend on insulin are struggling to afford and get access to this life-sustaining medication, and in some cases, they're rationing and even dying as a result.

That's why every year in February, our Diabetes Community gets pretty vocal about the "Spare a Rose" initiative, a grassroots effort aimed at raising money to provide insulin and diabetes supplies for those in desperate need across the world.

The idea is simple: Instead of buying the typical "dozen roses" that are so popular on Valentine's Day, you buy just 11 and donate the value of that last flower (roughly $3 to $5) to help someone with diabetes. You still get to be romantic and give roses, while also showing some love to someone who really needs it.

Seriously, it really is that simple.

Promotional graphic for the "Spare a Rose, Save a Life" campaign to help those in need living with diabetes.

You're literally just sparing a rose — at a minimum, because there is certainly an opportunity to spare all the roses and donate much more than just the cost of a single flower.

Since the initial year in 2013, Spare a Rose has raised almost $400,000 from community donations, including support from companies in the diabetes industry.

Originally, all the money was donated to the International Diabetes Federation’s (IDF) Life for a Child (LFAC) program, which was founded in 2000 to help children with diabetes in developing countries who might otherwise die immediately or have a short life without this assistance.

But for 2022, Spare a Rose has taken on a new charity beneficiary that expands the reach to more people who need help.

Spare a Rose single flower logo

Spare a Rose donations are now being directed to the Insulin For Life Global organization, a registered charity that since 1984 has been providing insulin, supplies, education, and advocacy to children and adults alike in many under-resourced countries worldwide.

With that change, the campaign name "Spare a Rose, Save a Child" is being revised to "Spare A Rose, Save a Life" — embracing those in need of all ages, in keeping with the reality that you can be diagnosed with type 1 diabetes (T1D) at any age, and the need for insulin and supplies is universal.

"The campaign is doing something different and broadening its outlook to support people with diabetes diagnosed as adults, or who 'age out' of programs that have an upper age limit," said diabetes advocate Renza Scibilia in Australia, who blogs at Diabetogenic and volunteers with #SpareARose.

"With this in mind, #SpareARose has changed... to recognize how the campaign will be helping adults with diabetes now. It's so wonderful to know that these people will continue to receive insulin and other diabetes supplies, even once they hit 26 years of age, and beyond."

Seeding an idea

For those not familiar with this annual campaign, it's important to remember the history of how this all came to be. Spare a Rose is one of the few enduring initiatives to come from the Diabetes Online Community (DOC) at a time when many were just beginning to discover the online universe as a source of support and information, and just as the insulin pricing crisis in America was beginning to bubble up as a major point of concern.

A small group of passionate D-advocates came together in 2013 looking for a way to use social media and our ever-growing online D-community to do social good.

That small group of diabetes advocates — including Kelly Close of diaTribe and Close Concerns, Manny Hernandez who'd led the Diabetes Hands Foundation organization at the time, D-Dad Bennet DunlapKerri Sparling of Six Until Me, and Jeff Hitchcock of Children With Diabetes — met early that year to brainstorm ways to use social media to help the broader Diabetes Community offline. The Spare a Rose idea came from their discussions, which have continued organically through the years during down-time at conferences, Pharma-sponsored summits, and smaller local meetups.

The group initially considered many different avenues, from helping those on Medicaid whose insurance coverage is limited or possibly helping patients who may be uninsured. But in the end, they settled on IDF’s Life for a Child program, as the critical need for insulin to keep T1D's alive is a glaring and obvious one.

Importantly, Spare a Rose remains true to its grassroots, community spirit.

"No one person 'owns' this campaign, which makes it all the more powerful," Sparling said. "The entire Diabetes Community plays a role and stakes a claim in its success, making every voice matter and every donation more poignant. This campaign is not about big companies making big donations... but about the community coming together in small ways to make a big difference."

You can see some of the participation and connect with others following this effort by following the #SpareARose hashtag on Facebook, Instagram, and Twitter.

Expanding reach of #SpareARose efforts

Spare a Rose for people with diabetes in Ukraine

In early 2022, as the Russia and Ukraine conflict took shape, the #SpareARose effort expanded its focus beyond just the traditional timeframe of February for fundraising. Throughout the month of March 2022, money raised would be earmarked to support people with diabetes in and out of Ukraine. The money continues to go through Insulin For Life, and that group's international consortium and network in Europe — along with partners in Ukraine and neighboring countries — will help supplies be ready to go if and when and where needed.

This is pretty incredible on several levels, not only that it's helping those in need at a critical time, but that it shows just how this D-Community's #SpareARose effort is scalable on so many fronts. That isn't necessarily the plan or the goal in the longrun, but it shows so much potential. Just imagine if we saw this grassroots community campaign expand every time there was a hurricane or natural disaster globally, and there was a specific campaign aimed at helping those most at need during those situations.

Impact of Spare a Rose diabetes campaign

The impact has been heartwarming to see over the years, with companies like Ascensia Diabetes Care making global announcements of support, and patient-led initiatives like the well-received Diabetes Podcast Week helping promote the campaign.

Spare a Rose has also honed in personal stories over the years. For example, the 2018 campaign focused on the story of a T1D brother and sister from a village in India who were both diagnosed at roughly the same time a year earlier: Poovarasi, diagnosed at age 18, and her younger brother Ruhan, diagnosed at 13.

Without support, this pair would not have been able to afford insulin and supplies to manage their diabetes. Their doctor told the IDF. "They were provided with a glucometer and strips... and soon excelled in self-monitoring and their A1C dropped to near-normal levels. The boy soon returned to school and the girl has started to learn tailoring to complement the parents' income. Nearly a year following the diagnoses, the family has regained some of the original happiness that they had."

With that, we just have to echo how hugely important insulin affordability is here in the United States and across the world; withholding access is an outrage.

As we all mark the 100th anniversary of insulin's discovery in 1921 and that historic milestone in January 1922 when insulin was first given to a human with diabetes who would've died without it, we can't echo enough how important it is to raise the level of conversation globally about making insulin affordable and accessible to every single person who needs it.

Really, with the "Hallmark Holiday" of Valentine’s Day that encourages a celebration of love, it's a great moment for our Diabetes Community to step up.

'Tis the season to celebrate both Love and Life. Enough said.

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Originally published on DiabetesMine

Sunday, January 9, 2022

Non-invasive Diabetes Tech: The Never-ending Dream

 The invention of a "noninvasive" device that can measure blood glucose for people with diabetes with no need to poke the skin and draw blood has been the dream for decades.

After all, why wouldn't people with diabetes (PWDs) flock to a skin patch that can detect blood sugar levels through sweat, or a wrist band that uses radio frequency technology to continuously beam glucose data directly to an app?

Numerous companies are pushing forward in this noninvasive continuous glucose monitoring (CGM) space, even in the midst of a pandemic.

To date, it's been mostly hype versus hope, as attempts to create those products have fallen flat.

The Diabetes Technology Society (DTS) published a scientific analysis on this topic in October 2021, noting "the amount of interest in seeing the development of an accurate [noninvasive glucose sensor] and the amount of hyperbole by companies promising an accurate [product] both far outstrip the amount of publicly available data actually generated by these potential products."

Yet, diabetes technology experts still believe potential exists for noninvasive devices to make it big, and industry analysts are predicting a booming market in the next 5 years.

How does it work?

Analysts note that there are systems under development for both home use and in-clinic and hospital settings. The former are wearables, and the latter will be non-wearable or tabletop systems.

They segment the systems under development by the type of technology used to take blood glucose readings — mainly, different types of spectroscopy, a technique that identifies chemicals based on the interaction of molecules with electromagnetic radiation.

Spectroscopy, which uses lasers that don’t pierce the skin, has been under study for decades. Researchers at MIT and elsewhere are finding that when used properly, it can produce highly accurate continuous data on blood glucose levels.

In a June 2021 academic review article, the DTS — led by Dr. David Klonoff of the University of California, San Francisco and medical director of the Diabetes Research Institute at Mills-Peninsula Medical Center — highlighted the many barriers that exist, but still predicted that noninvasive devices are poised for success in the coming years.

Notably, the article authors classified for the first time bloodless glucose monitoring products into three categories:

  • Noninvasive optical glucose monitoring (NIO-GM): when a noninvasive measurement involves passing a type of radiation into a vascular region of the body
  • Noninvasive fluid sampling (NIFS-GM): analyzes a fluid sample (tears, sweat, saliva, urine, etc.) that's collected without an invasive procedure
  • Minimally invasive devices (MI-GM): involves insertion of a sensor into the subcutaneous tissue underneath the skin, such as existing continuous glucose monitoring technology that exists today

"Bloodless glucose monitoring products... are expected to become key components of novel wearable digital health tools for monitoring glucose concentrations in the diabetes market and the fitness market," the DTS authors wrote.

Who’s developing noninvasive CGM?

Let's take a look at some companies making progress. Keep in mind, there are ambitious new companies emerging in this space regularly, despite decades of others trying unsuccessfully.

Scanbo

Scanbo noninvasive glucose monitoring

At the big Consumer Electronics Show (CES) in early January 2022, an artificial intelligence company based in British Columbia named Scanbo gave a glimpse of its technology that would use a 60-second noninvasive finger measurement instead of a traditional blood drop required to measure glucose. The company has developed a prototype that combines a 3-lead ECG measurement and a Photoplethysmogram (PPG) used to detect blood volume. You just put your fingers on the flat white sensors and the system uses a set of algorithms to analyze and offer insight on glucose values.

Hagar Technology's GWave

Another new company making headlines is Hagar Technology, based in Israel, which received Food and Drug Administration (FDA) fast track designation last year after a series of investor fundraising. The company's developing what it calls the GWave, which is a sensor inserted into a "ceramic, lightweight, comfortable bracelet worn on the wrist" that uses radio frequencies to detect glucose levels. The device will be the size of a smartwatch and connect to a mobile app, enabling users to get glucose readings on their smartphones and share that data with their diabetes care team.

Clinical trials are in progress, according to the company's public comments.

SugarBEAT

SugarBEAT, from U.K.-based Nemaura Medical, is already approved for use in Europe. It's a small peel-and-place patch that sticks onto your skin for 24 hours before needing replacement. The adhesive-backed rectangular transmitter sends wireless readings to a companion smartphone app via Bluetooth every 5 minutes.

SugarBeat noninvasive glucose monitor

According to the company, it works by “passing a mild, nonperceptible electric current across the skin, (which) draws a small amount of selected molecules, such as glucose, into a patch placed on the skin. These molecules are drawn out of the interstitial fluid, which naturally sits just below the top layer of skin.”

Nemaura had originally submitted this to the FDA in mid-2019, but the company had to refile the following year with additional study data. Then, the pandemic began. The company tells DiabetesMine they hope to continue conversations with regulators as soon as possible in order to move forward, but there's no expected timeline available.

In the meantime, they're launching a nonregulated product called proBEAT in the United States, which is a professional CGM version developed for use in those with type 2 diabetes and others who don't need continuous glucose data. Their program incorporates the device into a meal replacement plan, originally developed by the Joslin Diabetes Center in Boston, Massachusetts, and overseen by healthcare providers.

Know Labs

Seattle, Washington-based Know Labs is developing two devices that employ Body-Radio Frequency Identification (Bio-RFID) technology, which uses radio waves to measure specific molecular signatures in the blood through the skin. Formerly known as Visualant, this tech company changed its name in 2018 and is developing both a wristband-style device as well as a finger-scanning device that eliminate the need to pierce the skin to get glucose readings.

  • UBand is a wristband with a built-in biosensor designed to continuously monitor glucose levels. It won’t have a display screen, but instead, the readings will be sent directly to a smartphone app. They’re expecting it to have a battery life of 7 days before you would need to recharge it. This product is aimed at people with diabetes who are interested in a noninvasive CGM.
  • KnowU is a device that sort of resembles a traditional fingerstick glucose meter in that it's small enough to fit into your pocket — but it doesn’t require test strips. Instead, you’d take the sensor off the base and scan it over your palm to generate readings that would then display on the base device itself or be beamed wirelessly to a smartphone app. This is aimed mainly at PWDs who aren’t interested in a full CGM, but want more of an easy on-the-go use option for glucose monitoring without the finger pokes.

Know Labs previously told DiabetesMine it hoped to begin the FDA pre-approval process in 2022.

DiaMonTech

Out of Germany, DiaMonTech has developed a system that uses molecular spectroscopy — the science of absorption of light by molecules — to detect glucose molecules through the skin. They're currently working on three versions:

  • a phone-like "D-Pocket" handheld receiver that you press your finger on to get a glucose reading, which isn't expected before 2023 at the earliest
  • a small "D-sensor" embedded into watches or fitness bands, which is anticipated for 2024 for later
  • a more stationary, shoebox-sized device that would sit on a table and could be used in clinical settings, which is ready for use now
DiaMonTech noninvasive glucose monitoring technology

"Finger pricking is messy and inconvenient, and that’s why so many diabetics are not measuring enough to successfully manage their blood sugar," DiaMonTech CEO Thorsten Lubinski told DiabetesMine. "Noninvasive measurements lower this hurdle, as measuring your blood sugar is as easy as using the fingerprint sensor on your mobile phone."

Lubinski recognizes that others before have failed to develop noninvasive D-tech, but emphasizes that his company's technology is more accurate and focuses specifically on the glucose molecule itself (rather than other things).

Created by startup co-founder Dr. Werner Mäntele, this technology has shown in research from 2020 that it has comparable accuracy to the minimally invasive FreeStyle Libre Flash glucose monitor from Abbott Diabetes.

NovioSense

The Dutch startup known as NovioSense is working on a glucose sensor that is placed under the lower eyelid, from where it can wirelessly send glucose measurements directly to a smartphone.

The NovioSense device consists of a flexible metal coil just 2 centimeters long that contains nanosensors inside. The coil is covered by a protective layer of soft hydrogel, and it could measure constant changes in glucose levels from tear fluid using the same enzyme technology employed in conventional glucose test strips.

Clinical trial research published in late 2020 shows promising results for the technology and accuracy similar to the FreeStyle Libre, but there are few details available beyond that.

LifePlus

This Silicon Valley, California-based startup is developing a noninvasive wearable wristwatch called LifeLeaf. The company says it can detect blood glucose levels, blood pressure, heart rate, sleep apnea, and more by using sensors already on the market and an additional light sensor to enhance accuracy.

According to this demo presentation at DiabetesMine's D-Data ExChange forum in June 2020, it uses a "novel approach based on spectroscopic principles... to determine an accurate spectral signature for glucose."

Their phase 1 product is aimed at consumers and people with prediabetes, and phase 2 will be for type 2 PWDs and eventually also those with type 1, with high and low alerts and guidance.

The company has conducted clinical trials around the world, and at last count, was aiming for FDA clearance by June 2022.

Afon Technology

Afon noninvasive glucose monitoring smartwatch

Out of Wales, a startup called Afon Technology is developing a sensor that would fit inside a smartwatch band to monitor glucose levels. Per the company's website, it will provide real-time data and alert PWDs to high and low sugars, as well as track other health data. The company is working on clinical trials outside the United States, with plans for a launch starting in mid-2022.

Afon shares feedback from Dr. Hans de Vries, medical director at diabetes research organization Profil in Germany and a principal investigator at the University of Amsterdam's Faculty of Medicine, who says: “We evaluated the Afon device under both hyper- and hypoglycemic conditions during the clinical trials and we were surprised and excited by the possibilities of this technology.”

Apple and Samsung

Both Apple and Samsung are rumored to be developing noninvasive CGM sensors of their own.

In fact, for years, many have confused the Apple Watch's capability to display Dexcom’s CGM data with the notion that Apple itself offers CGM technology. But that buzz may finally be coming true soon.

According to a January 2021 report, Apple may be working on their own glucose monitoring tech that would use an integrated optical glucose sensor. The report has some fascinating visuals on what the Apple Watch display could look like.

Samsung may have its sights on this tech, too. This January 2021 news report states:

“Samsung Electronics will be equipped with a blood glucose measurement function in the new smartwatch ‘Galaxy Watch 4’ [tentative name] to be introduced in the second half of this year. It is a no-blood sampling method that detects the level of glucose in the blood without blood collection using an optical sensor, and is expected to contribute to the health management of the general public as well as diabetics.”

There had been talk years back about a Samsung and Medtronic Diabetes partnership aimed at integrating glucose data into Android watches, but that relationship faded without any product materializing beyond prototypes.

There are numerous other small companies and universities currently working on noninvasive glucose monitoring technology, too.

Gone but not forgotten

DiabetesMine has been covering attempts at noninvasive diabetes tech since 2005, and a couple of the gadgets that captured headlines at the time remain legendary.

GlucoWatch

The first and best-known example is the infamous GlucoWatch. This product made it to market briefly in the early 2000s, but it ended up being totally unreliable and actually started burning some patients' skin while they were wearing it! It was later recalled by the FDA.

Contact lenses

Google and Novartis were once developing a contact lens that could use fluorescent light to monitor sugars through the eye, but that research was eventually scrapped because the company determined it wouldn't work. That hasn't stopped others from pursuing that same path in recent years.

C-8 MediSensors

Another notable name in noninvasive CGM tech for several years was C-8 MediSensors based in San Jose, California. This gadget promised to use light to identify and analyze glucose molecules under the skin via interstitial fluid, just like other traditional CGMs.

This company even obtained European CE Mark approval in 2012, but a launch never materialized and, eventually, the company went bankrupt a year later. Many of the C-8 scientists moved on to other companies like Apple and Google, before the company eventually rebranded and relaunched as C-Eight without any focus on noninvasive glucose monitoring.

What the skeptics say

Some industry experts who've watched this field for many years still insist that it will never happen.

"It's the easiest slide-deck pitch to make, but it never seems to go anywhere," said JDRF CEO Dr. Aaron Kowalski, who has been knee-deep in the world of emerging diabetes technology for decades. "There are major technology challenges that are so big, and you have to wonder if there is even a need anymore with what we have in diabetes technology today."

"Noninvasive still has a lot of challenges," said Dr. Barry Ginsberg, who runs Diabetes Technology Consultants in New Jersey and is considered a premier expert on noninvasive diabetes tech after analyzing this trend for more than a decade. He predicts the market will be dominated by products that are simply "less invasive" and smaller than what we have now, such as the Dexcom G7 model expected in 2022.

Semiretired industry consultant John L. Smith is another of the foremost experts on this front, author of the seminal paper “The Pursuit of Noninvasive Glucose: Hunting the Deceitful Turkey” article first published in 2006 and last updated in a 2020-seventh edition.

He writes that one of the most disturbing aspects in this field has been the “perennial” announcements by young companies that believe they’ve reached a solution for PWDs to no longer have to prick their fingers. Without exception, Smith says these announcements have been premature and are meant to generate hype, raising false hopes.

He estimates that it would take a minimum of 5 years and as much as $25 to $30 million in funding just to get a product to market, so it's no wonder that most have pretty much failed to date.

He points to the wearables technology trend in recent years as growing strong beyond diabetes, but notes that the economic impact of the COVID-19 pandemic will likely push out many wannabe noninvasive tech developers.

Diabetes industry analyst David Kliff, an insulin-using PWD himself and notorious devil’s advocate, has maintained longstanding skepticism over noninvasive tech during his 20-plus years of writing for Diabetic Investor.

“It’s one of the better scams I’ve ever seen in the diabetes world,” he told DiabetesMine. “It sounds so appealing with all kinds of 'Star Trek'-y elements. They sell the hype and there’s just enough science to back it up so it looks great. The mainstream media give it more play and people buy the dream.”

Kliff decries the millions of dollars that investors are tempted to "throw at this tech."

The base problem, he says, is not so much having an easier way to get a glucose reading, but knowing what to do with that reading in order to improve your health outcomes.

“I’ve contended from day one, that whether it’s invasive or not, if the person doesn’t understand the number, it doesn’t matter if it’s given to them by God. I’m more impressed with practical technology that works and you can trust. For any patient, that’s the bottom line.”

Nevertheless, researcher Smith writes about noninvasive glucose monitoring: “In spite of all the failures (and quite likely because I have been close to so many of them), it is still my fond wish that someday, somewhere, someone will find the solution to this intensely recalcitrant problem and realize the benefits for all people with diabetes worldwide.”

Sunday, January 2, 2022

New Diabetes Technology: What to Expect in 2022


As we look to what's ahead in new diabetes technology for 2022, many may experience a sense of déjà vu. After all, much of what we'd anticipated for 2021 was delayed because of the continuing global pandemic (much like the year before). That means a lot of the forecast for the year ahead resembles what had initially been on tap a year earlier.

Still, it's exciting to look at new innovations anticipated to literally change the face of daily diabetes management — from new insulin pens and pumps, to CGMs, and smart closed loop tech, or Automated Insulin Delivery (AID) systems.

Our DiabetesMine team has been listening to industry earnings calls, and talking with company insiders and other experts to compile this roundup of what’s expected to materialize in 2022, with some of our own insights and observations sprinkled in.

Tandem Diabetes Care

For the first time, people with diabetes (PWDs) will likely see technology giving us the ability to control our medical devices via mobile smartphone apps — including remote insulin dosing! This functionality has been hinted at for many years but hasn’t yet been approved by the Food and Drug Administration (FDA) for use in diabetes devices. That's about to change.

Mobile bolusing by phone

Notably, Tandem Diabetes Care will likely be the first to cross the finish line in getting FDA clearance on a smartphone app that can be used to control an insulin delivery device.

With that added function, the newly designed t:connect app — launched in mid-2020 alongside Tandem’s Control-IQ system — will allow for remote bolusing (aka insulin dosing) via mobile app for the existing t:slim X2 insulin pump platform and beyond.

The company had filed its expanded mobile app functionality with the FDA in late 2020, but the pandemic delays meant we didn't see that approval come in 2021 as many had hoped. [Tandem announced on Feb. 16, 2022 that it had received FDA clearance for the remote bolusing by mobile app for iOS and Android smartphones, with an expected launch in Summer 2022.]

This also paves the way for Tandem’s future insulin pump technology, which promises the first new form factor since its original t:slim model first launched in 2012.

Tandem Mobi (formerly t:sport)

The new mini-pump with smartphone control that was known initially by the prototype name "t:sport" is now publicly known as Tandem Mobi. Here's what we know about the design based on the company's first-ever R&D Day in December 2021:

  • roughly 50 percent of the t:slim X2 size
  • a hybrid mini-pump that has both a short, 4-inch tubing with the trademark “pigtail” connector that goes to an infusion set as well as adhesive on the back to stick onto the body — so it can be worn either way
  • will hold 200 units of insulin in the cartridge
  • has no display screen at all
  • will be operated solely by an iOS or Android smartphone app
  • allows for wireless charging
  • has a bolus button on the side of the device
  • waterproof
  • compatible with the latest “iCGM” devices like the Dexcom G6
  • has an embedded Automated Insulin Delivery (AID) algorithm to be compatible with Tandem Control-IQ features
  • compatible with current Tandem infusion sets as well as a future 4-inch set in development

DiabetesMine got a first glimpse of an early prototype at the company’s San Diego headquarters in 2017. Tandem had planned to submit this device to the FDA in 2020, but the pandemic delayed the clinical trial, and it’s now waiting on the new mobile app with remote bolusing feature.

Tandem expects once it gets the FDA's OK on the mobile bolusing functionality, it will then finalize its Tandem Mobi plan and file that with regulators later in 2022. We may possibly see that approval and launch in '22, but it could be pushed to the following year.

Omnipod 5 tubeless system

Another holdover from the year before is the new Omnipod 5 tubeless insulin pump system, formerly known as Omnipod Horizon, from Massachusetts-based Insulet Corp. This will be the company's first closed loop system that automates insulin delivery based on CGM data.

Like Tandem’s Control-IQ, Horizon is a closed loop system, aka Artificial Pancreas technology. It connects the Omnipod tubeless patch pump to a CGM via a smart algorithm, allowing for automatic insulin dosing adjustments.

It’s based on the Omnipod DASH platform launched in 2019 and uses the same insulin pods and mobile app. It will first be available to connect with the Dexcom CGM and later with Abbott’s FreeStyle Libre.

Omnipod 5 is also set to bring mobile app control and insulin dosing, eliminating the need to carry a separate Personal Diabetes Manager (PDM) around to control the Omnipod if you gave a compatible smartphone.

Omnipod 5 is another one that had been originally planned for 2020 but was delayed because of COVID-19. Insulet filed it with the agency on Dec. 23, 2020, but it didn't materialize by the end of 2021. However, many believe it will get FDA approval in the first half of 2022. [Omnipod 5's FDA clearance came on Jan. 27, 2022.]

Medtronic Diabetes technology

Minimed 780 and Guardian 4 CGM sensor

Many are also waiting for Medtronic's next-generation combo insulin pump and CGM sensor system, which will be the 780G — also known as the Advanced Hybrid Closed Loop (AHCL) system. This system will expand upon the foundation of Medtronic's first two iterations: the 670G and 770G; the latter already offers built-in Bluetooth for remote updating of the technology in the future.

This new tech will keep the basic form factor of the company’s 6-series pump models with a vertical "modern" look, compared to the older models with a horizontal design that resembled 1980s pagers.

The 780G has many new features:

  • works with Medtronic’s next-generation CGM sensor (the Guardian 4), which will require just one calibration on the first day of wear and no further fingerstick tests beyond that (this sensor is also made for 7-day wear, same as their current model)
  • provides automatic correction bolus delivery every 5 minutes to help keep users in an optimal blood glucose range and to automatically adjust for missed meal doses
  • has an adjustable glucose target between 100 to 120 mg/dL (compared to the 670G's fixed target of 120 mg/dL)
  • offers different insulin action duration times, unlike other commercial closed loop systems available
  • offers built-in Bluetooth necessary for data sharing and remote monitoring, as well as remote software updates so users won’t be required to buy a whole new device every time new features are launched (currently, only the Tandem t:slim X2 offers this remote updating capability)

Notably, right from the start, Medtronic has asked FDA regulators to OK this new system for adults and kids as young as 2 years old.

The company had planned to file the 780G for review soon after its investor update in late 2020, but that ended up being delayed until Feb. 23, 2021. Due to concerning FDA warnings about Medtronic's facilities and product development, the approval timeline and launch remains TBD.

Extended 7-day wear infusion set

Of course, Medtronic did get FDA clearance in July 2021 for its new extended-wear infusion set, designed to last more than twice as long as existing infusion sets that connect traditional tubed pumps to the body for insulin delivery. That means it can be worn on the body for up to 7 days — compared to existing sets that must be changed out every 2 or 3 days.

Medtronic Diabetes new 7-day wear insulin infusion set.

This new extended infusion set introduces changes to the tubing material and a redesigned connector to reduce the loss of preservatives, prevent tube occlusions (insulin clogs in pump tubing) and keep the insulin chemically and physically stable over time. Medtronic specifically points to a “novel and proprietary approach” that addresses insulin degradation, preservative loss, and occlusions — all things that can result in disrupted insulin delivery and therefore higher blood sugars.

The extended-wear set also has a more skin-friendly adhesive designed to allow longer, more comfortable wear on the body. The company reports that participants in a 100-person European study commented on the new infusion set being more comfortable compared to their previous infusion sets and saw this as a meaningful improvement that reduced the overall burden of insulin pump therapy.

Clinical data also shows that people using this new set might save 5 to 10 vials of insulin per year because it eliminates the many units of insulin currently wasted by the requirement to change out an infusion set every few days. Less frequent set changes also allow skin site locations to rest and heal, Medtronic points out.

Medtronic hasn't specified when this new extended-wear set will actually launch, but it will be in 2022, and the pricing details will be offered at that time.

Dexcom G7

Dexcom G7 combined sensor and transmitter

This latest model of the Dexcom CGM is set to bring a significant form-factor change: a combined sensor and transmitter design.

Here are the G7 details:

  • Fully disposable. Unlike Dexcom CGM models to date, the G7 will be fully disposable. This means there will no longer be a separate transmitter with a 3-month battery life. Instead, the sensor and transmitter will be integrated, and once the sensor’s run is finished, you’ll dispose of the whole combined unit.
  • Wear time. While it will start off at 10-day wear like the current G6 version, the G7 is designed to eventually support longer wear for up to 14 to 15 days. No fingerstick calibrations will be required, but that will remain optional.
  • Thinner. The G7 will be 60 smaller, as the thinnest generation of Dexcom's CGM sensors yet.
  • Shorter warm-up. Instead of taking two hours to warm up before displaying glucose data, the G7 will only have a 30-minute warm-up period.
  • Different mobile app. With the G7, Dexcom will roll out a completely new app. The company's a bit vague on what this new version will entail, but they've pointed to different alarms and alerts as well as more Clarity data integrated directly onto the G7 app compared to past app designs. The company points out this new software platform will also allow it to more easily update apps as features are changed, and that Dexcom plans to automate more services like customer assistance and tech support.
  • Decision support. Dexcom has talked a lot about wanting to integrate software features like dosing assistance and information and prompts that help users make better health choices based on their CGM readings. Given Dexcom’s acquisition of TypeZero Technologies in 2018, they seem to be on the path to providing a smart algorithm for this kind of user support. This should also help the company in its goal to expand CGM use for more people with type 2 diabetes, as well as for users without diabetes.
  • Follow app. As to data-sharing, Dexcom notes that its Follow app will work with the G7 at the time of launch. Dexcom also plans to update the Follow app at a later time.

At the big JP Morgan healthcare conference in January 2022, Dexcom CEO Kevin Sayer presented pivotal data that it had submitted to the FDA. Notably, this latest technology outperformed the regulatory iCGM standards with better time-in-range performance of 93.3 percent compared to the FDA's standard of 87 percent. The way CGM technology is measured for accuracy is by a standard known as MARD, or Mean Absolute Relative Difference, and the G7 registered an 8.1 percent in children and 8/2 percent in adults.

"The results are much superior to G6 and any competitive product in the market," Sayer said at the JPM investor update. "We think it’s going to be a fabulous product across the board. It was very rewarding when we launched G6 to see how that changed the world. This product is going to do it again."

In recent investor updates, Sayer explained that the company plans to eventually have different versions of the G7 for different groups of users. For example, non-insulin—using type 2s or general health consumers may prefer a much simpler interface than insulin-using type 1s who have experience with CGM tech and want all the advanced alarms and tracking features.

Dexcom filed the G7 with the FDA by the end of 2021. So most likely, we will see that approved before too long in 2022 and Dexcom will conduct an initial limited launch before eventually rolling the G7 out more broadly across the United States later in the year.

Eversense 180-day implantable

Made by Senseonics and sold by Ascensia Diabetes Care, the Eversense implantable CGM is a first of its kind that has been available in the United States since 2018.

The next-generation version under development would allow for the same tiny sensor to be implanted for 180 days (or 6 months rather than 3). This version will also reduce the number of fingerstick calibrations needed down from two to just one per day, according to the company.

In September 2020, Senseonics asked the FDA to approve the 180-day wear version, but it's still TBD on getting approval. We may very well see this appear in 2022. [FDA approved the Eversense E3 on Feb. 11, 2022.]

Lilly’s Smart Tempo connected pen

The pharma giant Eli Lilly had planned to launch its new connected Tempo Smart Pen system during the second half of 2021, but that didn't happen and now it's expected in 2022.

Lilly is collaborating with Welldoc to integrate a new version of Welldoc's BlueStar app into what's known as Lilly's Tempo Personalized Diabetes Management Platform. The first version of that platform will be a data transfer module known as "Tempo Smart Button," which attaches to the top of a prefilled disposal insulin pen (Tempo Pen) initially approved in 2019.

The company submitted the Tempo Smart Button to the FDA in 2021, as did Welldoc with its new app. Those are still under FDA review and pending 510(k) clearance. The expectation is the system will get approval and launch in 2022.

FreeStyle Libre 3

The FreeStyle Libre from Abbott Diabetes is known as a Flash Glucose Monitoring (FGM) system because it offers a “flash” of a glucose reading whenever you scan the sensor with the handheld receiver or smartphone app.

Since hitting the U.S. market in 2017, this system has allowed PWDs to get a glucose reading whenever they want just by scanning the little white round sensor worn on the arm. The Libre 2 became available in 2020, offering optional alerts for low and high blood sugars. The mobile app was released in 2021, which eliminated the need to scan the sensor with the handheld reader.

Abbott confirmed with DiabetesMine that it filed the Libre 3 with the FDA in 2021, so it's certainly possible we might see the agency approve this latest version at some point in 2022.

But Libre 3 promises to elevate the tech to full-CGM functionality because it will no longer require any sensor scanning to provide real-time glucose readings. Instead, Libre 3 generates a real-time glucose reading every minute, displaying that result on the compatible mobile app on iPhone or Android. This continuous stream of data allows optional alerts for high and low blood sugars, along with glucose results. This is a big leap forward compared to Libre 2 that still requires a confirmation scan to get a numeric reading.

Libre 3's round, fully disposable sensor is also much smaller and thinner, the thickness of just two pennies (rather than two stacked quarters in earlier versions). Per Abbott, that is a more than 70 percent size reduction that uses 41 percent less plastic.

The Libre 3 received international approval in September 2020, and with a pivotal clinical trial completed and the technology now filed with FDA, we'll likely see the Libre 3 hit the market before too long.


Originally published at DiabetesMine in January 2022

Thursday, December 9, 2021

Tandem Diabetes Care Plans for Future with Technology Choices

In the coming years, Tandem Diabetes Care has ambitious plans to introduce the next version of its tubed t:slim insulin pump, a series of three smaller devices to reduce and eventually eliminate tubes completely, and features allowing users to fully control their insulin pump and even deliver bolus insulin with their smartphones.

The San Diego, California-based company revealed all of this at its first-ever R&D Day on Dec. 6, 2021, mapping out its 5-year pipeline plan for new technology.

While medtech timelines often slip, given corporate priorities and the Food and Drug Administration (FDA) review process, Tandem expects that it will be able to develop and launch most — if not all — of these new products on a rolling scale between 2022 and 2027.

"As a diabetes care company, we realize there is not a one-size-fits-all solution to managing this complex condition," Tandem CEO John Sheridan said. "'Positively different' is a sum total of our brand... As we look to the future of our hardware strategy, we are moving away from offering a single platform and will be emphasizing choice."

It's likely that as these new devices and mobile data options are launched, they will be compatible with Tandem's existing products including its Basal-IQ and Control-IQ algorithms, and will continue to integrate with the latest Dexcom continuous glucose monitor system.

Here's a look at the new products in development:

Smartphone insulin dosing and device control

Pieces of Tandem's tech plan are already in the works, with a key first step already submitted to the FDA.

There are two parts to their mobile data pipeline:

Bolus-by-phone. Tandem asked regulators in late 2020 to OK its mobile bolusing by phone app function, which would allow Tandem customers to use their iPhone or Android smartphone apps to dose insulin without needing to take out the pump itself. The company had hoped for approval and launch in 2021, but delays related to the COVID-19 pandemic have caused an FDA backlog, so review is taking longer than expected. [UPDATE: Tandem announced on Feb. 16, 2022 that it had received FDA clearance for its mobile bolusing feature for both iOS and Android, and it's expected to launch in summer 2022.]

Full device control by phone. This would come down the road, going beyond just bolusing insulin remotely. It would allow for other features that include changing basal (background insulin) rates, turning alerts and alarms on or off, suspending and resuming insulin delivery, and more directly from your phone. The company has not yet named a specific timeline for this to be submitted to regulators.

Tandem believes FDA clearance for the mobile bolusing function could come "any day now," and is planning for an early 2022 launch. There is no official word yet on whether existing Tandem pumpers will need to update or download an entirely new mobile app for their iOS or Android devices, to accommodate this new capability. That key detail will be shared once FDA's requirements are known.

Tandem Mobi (formerly t:sport mini-pump)


The company has been developing a hybrid micro-pump of sorts, roughly half the size of the current t:slim X2 pump and without any display screen at all. Initially referred to as the t:sport and now branded as Tandem Mobi, this mini-pump has both a short, 4-inch tubing with the trademark "pigtail" connector that goes to an infusion set as well as adhesive on the back to stick onto the body — so it can be worn either way.

Here is a rundown of the Tandem Mobi outlined at the recent R&D Day:

  • roughly 50 percent of the t:slim X2 size
  • will hold 200 units of insulin in the cartridge
  • operated solely by an iOS or Android smartphone
  • allows for wireless charging
  • has a bolus button on the side of the device
  • waterproof
  • compatible with the latest "iCGM" devices like the Dexcom G6
  • has an embedded Automated Insulin Delivery (AID) algorithm to be compatible with Tandem Control-IQ features
  • compatible with current Tandem infusion sets as well as a future 4-inch set in development

DiabetesMine got a first glimpses of the t:sport prototype at the company’s San Diego headquarters in 2017. Tandem had planned to submit this device to the FDA in 2020, but the pandemic delayed the clinical trial, and it's now waiting on the new mobile app with remote bolusing feature.


Tandem now plans to file Mobi with the FDA after it secures regulatory approval for the mobile bolusing app feature, and finalizes any necessary revisions or clinical work needed from there. That could be as early as the second half of 2022, but there's no solid timeline yet.

Enhancements to Tandem's Control IQ

Aside from brand new product offerings, Tandem is also planning to improve its existing software with new features. Specifically, that may involve lower glucose targets (ie 100 mg/dL instead of the current 110/112 mg/dL), which is something many Tandem tech users want to see.

"We are driving innovation in our algorithms, emphasizing automation, personalization, and simplification, all intended to continue to improve therapeutic outcomes and provide a positive patient experience characterized by simplicity and ease of use," the Tandem product pipeline says. "Examples of our efforts to provide enhanced personalization include alternative targets, settings optimizations, and enhanced exercise options. Examples of our efforts to provide greater ease of use include adaptations, smarter alerts, and new signal integrations."

Tandem also plans to pursue expanded Control IQ indications for kids as young as 2 years old, as well as those with type 2 diabetes.

There is no public timeline on these enhancements, but it seems likely that they'll be happening concurrently with other clinical trial research and regulatory discussion on everything else in Tandem's near-term pipeline. Hopefully, we can see some of these improvements by early 2023.

Tandem t:slim X3

This is Tandem's third generation of its t:slim pump, which soon marks its 10-year launch anniversary from August 2012. The second version came in 2016 with the t:slim X2, the first to be compatible with a CGM.

There is not currently much detail on what will change with the X3, but we were informed that it will have the same basic form factor with a color touchscreen as the current generation. Features will include:

  • holds 300 units of insulin
  • enhanced technology
  • refreshed user interface
  • increased battery life
  • wireless software updates

This new model will follow approval of the first-generation of Tandem Mobi, expected at some point in 2022 or early 2023.

Tandem Mobi Tubeless pump


This new device is the second of a three-part plan moving toward a full patch pump without any tubes. While the first version of Tandem Mobi will be a hybrid with short tubing, the second iteration will go tubeless.

Instead of pump tubing and the t:connect "pigtail" connector attaching to an infusion set, this Mobi Tubeless will replace that infusion set with a "disposable on-body kit." Conceptual designs appear to show the Tandem Mobi Tubeless adhering directly onto the body, with a black rectangle shape and removable insulin cartridge. As it uses the same Mobi pump design, it will likely also hold 200 units.

Fully disposable pump patch

Finally, Tandem will develop what it describes as a fully-disposable pump patch. There wasn't much detail provided on this future product, as Tandem says it's very early in the development process. A conceptual image shows a thin white patch-like device adhered to the upper arm, but that may only be a prototype placeholder until the concept is more fully developed in the coming years.

No doubt, with these tubeless patch pump devices, Tandem has in mind going up against its competitor — the tubeless Omnipod made by Insulet. That's not surprising, given the excitement over the sophisticated new Omnipod 5 system expected to become available in 2022 as the first tubeless closed loop system.

Infusion sets and more

Tandem is also expecting to launch new pump infusion sets as it moves forward with these next-generation devices. In addition, the company says it's working to allow its devices to use higher concentration insulin, as well as more personalized settings and management options for those with diabetes.

Options are certainly the key, coupled with affordability and access. Way to go on bringing more flexibility and choice for people whose lives depend on insulin, Tandem!


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Originally reported by Mike Hoskins at DiabetesMine