There were so many fascinating and thought provoking statements, facts and conversations I was exposed to at #2019dtm, that it’s difficult to include all the lessons learned.

For my third and final article from this congress, I’ve cherry picked some topics, statements and facts that have stuck in my mind and or had me googling to learn more.

Panelists Who Made Me Want To Stand Up And Cheer

When a group of panelists were asked the following questions re: CGM use in both hospital settings and for people living with Type 2 Diabetes, their responses were spot-on and evoked applause from the audience - both IRL and via twitter.

Q. When do you think we will be using CGM for inpatient care in ICU?

Dr. David Price: We need the right clinical data
Dr. Bruce Buckingham: If you have diabetes, it’s already there and in use.
Dr. Francine Kaufmann: Wouldn’t it be nice if a patient coming into ICU can continue to wear CGM and then extend that to closed loop. 

Q. What about the role of CGM for people living with Type 2 Diabetes?

Dr. Robert Vigersky: People with Type 2 Diabetes are the greatest unmet need re: CGM .
T2s being able to see CGM results in real time allows them to want to make changes. 

Dr. Andreas Stuhr: The power of CGM is that seeing is believing.
If people only measure fasting glucose in the a.m., they don’t see the need for changes.
A CGM allows them to see the changes throughout the day and bring about behavioral changes.
It’s not about proving that the technology works - we know it works  - the road block is the value people see in tech - managing expectations that technology doesn’t cure, but it’s a tremendous aid in managing diabetes.

Diabetes Road Blocks

Stability Health’s Doctor David Harlan discussed diabetes roadblocks in the US for people in all dimensions, including, but not limited to: 

The number of Diabetes Specialists in the US is woefully inadequate. 

80% of people living with the diabetes in the US receive treatment from their Primary Care Physician. In order for diabetes technology to be adopted and accepted, Primary Care Physicians must get on board with it.

This means Primary Care Physicians receiving proper training and education re: tech, medications, proper terminology (ditch the term Brittle Diabetic because #LanguageMatters) and IMO, how to recognize the psychological impacts of living with diabetes has on the person.  And that’s a tall order.

Dr. Harlan stated that people living with diabetes are disengaged and hate the term non —compliant.

Sidebar: DAMN STRAIGHT WE DO. Non-Compliant is a defeatist and antiquated term that perpetuates the diabetes blame and shame game and stigmatizes the person with diabetes because #LanguageMatters. He then informed the audience that disengaged people with diabetes reach out for help from their healthcare professional and often don’t receive it.

Dr. Harlan explained that insurance companies often pay for up to 10 hours of Diabetes Education, which is great. But that doesn’t always pay for diabetes coaching. 

Diabetes Education: More dictatorial. Things that have people with diabetes must know and must do.

Diabetes Coaching: More engaging and encouraging - requires the diabetes HCP to find out what the person with diabetes needs and then help THE PWD meet those needs.

Both techniques are paramount in treating people with diabetes.

Smart Insulin & The Animal Kingdom

For the longest time when it came to diabetes and the Animal Kingdom, cows, pigs, and a ridiculous amount of mice cured of their diabetes have reigned supreme.

New research spotlights other diabetes connections to the Animal Kingdom - including  the cone snail and African leopard tortoise.

Also and I just now realized this: Both have shells. Coincidence?

Dr. Sanjoy Dutta’s Smart Insulin talk began by discussing the cone snail’s ability to use rapid-acting insulin venom as part of a deadly cocktail to induce severe hyperglycemia in prey fish they are trying to catch.

Also: The structure of cone snails’ insulin may be the key to designing more rapid-acting smart insulins - and possibly the key to increasing thermal stability (the shelf life) of manufactured insulin once a bottle is opened.

He went on to define smart insulin as ultimately having the following components: Glucose responsiveness; ultra-rapid acting, targets the liver, able to be used as both an injectable and via pump, treats all diabetes types, and both thermostable and affordable.

Dr. Dutta went on to discuss smart insulin gaps, including: not yet closing the loop, hyperinsulinization and insulin resistance being “under addressed issues,” and obesity.

All of the above gaps are exacerbated by long term use of insulin.

Example: A large number of people living with type 1 diabetes after the 30 year mark develop insulin resistance.

Dr. Dutta’s closing thoughts highlighted the need for healthcare professionals to understand both the physiology and pathology components when it comes to insulin innovations, while continually considering the cost and burden to people with diabetes  re: the development of new insulins.

An Insulin Device Pill That Delivers Micro-injections To The Gut - Dr. Alex Abramson, PhD Stanford University, Palo Alto, California

SOMA: Self-Orientating Millimeter-scale Applicator, which delivers insulin systematically in vivo.

In Vivo: A process performed or taking place in a living organism. In this case, humans.

According to Dr. Abramson, the advantages of insulin delivered via pill include:

1. Reducing stigma and improving a person with diabetes quality of life
2. Eliminating biohazard needle waste disposal
3. Reducing plastic waste foot print by 90% compared to auto-injector pens
4. Enabling chemical stability in high temperature environments
5. Eliminating the need for subcutaneous injections and scar tissue.

OK, but what exactly is it?

SOMA is a self-orienting applicator for ingestible drug delivery - a.k.a., insulin.

The African leopard tortoise comes into play via the shape and density distribution which facilitates self-orientation.

The pill’s self orienting design (“Weebles wobble but they don’t fall down” immediately entered my head) means once the pill is swallowed and hits the stomach, it orients itself upright (and stays upright) attaching onto the stomach wall by anchoring itself via injection. 

Then the insulin inside the SOMA dissolves and is delivered.

The insulin pill and milli-injector also dissolve and are not passed.

The spring and shell are not bio-degradable and are excreted without any complications.

OK, that last bit makes me stop and practice the pause… but I’m keeping an open mind.

There was much talk about glucose data at DTM from all aspects - as in developing ways to capture it, creating platforms for integrating it, sharing it and expanding access to it, and companies creating their own diabetes data sharing platforms to compete with those already on the market.

And just as important, the challenges related to data sharing re: diabetes hardware (pumps, glucose meters and CGMs) were also discussed in detail.

Data security must be guaranteed in all aspects (see previous article below).

Data sharing needs to be fully automated for the user - as in no manual uploads - and open systems are required - as in no proprietary solutions.

In Simple Terms: All diabetes robot parts must be able to communicate with one another seamlessly, no matter who the manufacturer is.

On A Personal Note: All of our diabetes computer parts communicating seamlessly means allowing for calculations of insulin units given when manual correction injections are required by those of us wearing insulin pumps/pods. This is an issue for anyone wearing an insulin pump/pod, including myself.

Manual insulin corrections administered via shots/pens for people wearing insulin pumps/pods occur more often than industry thinks and or acknowledges. A correction injection is required:

1. When blood glucose goes above a certain number, a manual injection is the quickest way to bring extremely elevated blood glucose down, and helps to prevent ketones from spilling and DKA from occurring.
2. When blood glucose stays elevated after multiple correction boluses and for no apparent reason, a correction shot becomes a process of elimination tool for a PWD. Is the slow drop in glucose due to diabetes taking its time utilizing the insulin correction boluses, or has a faulty cannula or scar tissue issues come into play? A correction shot of insulin helps us make that determination.  
3. Subtracting units injected from additional pump corrections/carb calculations requires tracking a ridiculous amount of “diabetes math” in an already stressful situation(s). Allowing diabetes end-users to input insulin units of correction shots into their pump/pod’s IOB (Insulin Onboard) feature, would simplify tracking and would be an enormous help.

Diabetes Data’s Impact On The Language of Diabetes

The influx of Diabetes Data gathering technology over the past decade has impacted the language of diabetes, leading to new terms and metrics in diabetes management.

People will already be well aware of:

CGM: Continuous Glucose Monitor.

SMBG: Self-Monitoring Blood Glucose via finger-sticks.

Some of the newish terms that are being used more frequently are:

TiR (Time in Range): the percentage of time a person with diabetes’ glucose level spends in target range and is a measurement that is now included in the ADA’s standards of care.

TiR captures variables, allows for real time decisions and corrective actions, and enables people to set targets to guide therapy - striving for higher TiR and fewer hypos with a slightly older metric of management, AGP.

AGP: Ambulatory Glucose Profile is a standardized report for interpreting a patient's daily glucose/insulin patterns. It’s not a super new term, but one that has become further enhanced by the development of CGMs.

Healthcare professionals prefer an AGP that is FNIR - flat, narrow, in range.

CGMs using real time trend arrows help to track the effects of food, exercise, stress, and the other 40+ things that can impact our blood sugars, allowing for personalizing glycemic management using GMI of both TiR and AGP.

GMI: Glucose Management Indicators denote the average A1C level expected of a PWD based on mean glucose measured via CGM over a period of time.

Some physicians favor TiR via CGM because they feel patients understand the parameters much better than HbA1c.

Both A1c and CGMs have multiple measurement methods and both have detractors.

For instance, there’s a “learning element” in the first 24/48 hours of a new CGM sensor and 27% of people stop wearing CGM technology after the first year.

Genetic factors can be a detractor in A1c tests - but A1c tests have more standardized quality control compared to CGMs.

Meaningful Monitoring: The use of diabetes tech that improves the life of PWD.

All of the above info had me circling back to another diabetes acronym discussion on day 1 on Glycemic Variability Metrics for TiR when it came to diabetes and cardiovascular health.

GVC - Glycemic Variability Metrics (extreme swings in glucose management) are incredibly important re: the long term heart health of people with diabetes.

Glycemic variability increases as both blood glucose and A1c increases - and here’s where PWD heart health comes into play.

Studies show a direct correlation between glycemic variability and time spent outside of range, leading to cardiovascular events.

FTR: People with diabetes tend to have more severe heart disease and at a younger age than people sans diabetes. 

Long term high blood glucose swings damage the heart muscle and blood vessels, and the nerves that keep our heart and blood vessels functioning properly. Paraphrasing Dr. David Rodbard

The above sentence provides easy to understand facts and a strong visual that resonates for anyone living with diabetes.

And IMO, it’s as game changer.

The cardiovascular implications of blood glucose management for people with t2 diabetes is often mentioned - ADA’s Know Diabetes by Heart™ is a joint collaboration with the American Heart Association focusing on t2 diabetes and heart disease.

And that’s great! But those same cardiac implications exist for people with t1.

FYI: If you have diabetes, and heart issues and  strokes run in your family - your risks increase exponentially.

Healthcare professionals always tell people with diabetes the importance of keeping blood sugars in range re: kidney disease; blindness, eye issues, neuropathy, and amputations.

People with diabetes are also told that we are at greater risk for both heart attacks and strokes than people sans diabetes. But the reasons behind the higher risks aren’t always fully explained in detail…until after the fact.

And that needs to change because knowledge is power and allows us to incorporate preventative actions.

IMO: HCPs need to spell out “the hows and whys” re: cardiovascular implications of blood glucose management and TiR to people with diabetes, and no matter the type - before a PWD experiences a cardiac event or is diagnosed with cardiovascular issues - not after - so they can help us prevent them from occurring.

The first day of DTM 2019 (Diabetes Technology Meeting) was crazy - so many incredible sessions and speakers to take in!

Takeaways on Day 1 (for me) primarily focused on CGMs, CGM adhesives, finger-sticks, and diabetes cyber security - no matter the tech.

Day one kicked off at 8 a.m. with a panel discussion on Continuous Glucose Monitoring systems consisting of company reps from Dexcom, Medtronic, POCTech, Eversense, and LifeCare (not yet on the market) discussing CGM usage and technologies to improve to performance.

Key Panel Points - In Order of Speaker Line-up

Dexcom’s new generation G7 promises a smaller sensor, a possible decrease in cost, and a target launch date of 2020.

No need for finger checks was also mentioned. More on that later.

Dexcom referred to their CGM as being a platform technology.

Sidebar: On Wednesday, November 13, Dexcom CEO Kevin Sayer told CNBC’s Jim Cramer, “This whole integration of health care data is really going to be the next frontier.” Interesting and concerning.

Medtronic is looking to focus on better and more skin friendly adhesives to integrate with new sensor technology that extends beyond 10 days.

POCTech’s CT-100 C #CGM System has a flexible sensor filament.

In Non-tech Speak: The sensor is flexible and allows for adjustment to sensor placement and depth control post insertion. YES.

FYI: A CGM sensor placed in the wrong spot not only hurts, it is also a waste of both money and the sensor. 

The transmitter memory holds 15 days’ worth of data, glucose response time is fast — as in 20 seconds, and is water resistant.

Full Disclosure: POCTech is a Chinese medical device company formed in 2010, initiated CGM research in 2013, entered clinical trials in 2015, and hit selected Asian markets in 2017. In January 2019, Ascensia announced its global partnership with POCTech to distribute and co-develop CGMs.

Eversense discussed the possibility of including an activity tracker in the form of an Accelerometer and stated that their CGM will soon be available to people with diabetes on Medicare.

LifeCare’s Injectable Sencell Glucose Sensor is a Novel Osmotic, pressure-based implantable Glucose Sensor. FTR, it’s super tiny. A human pilot study starts in December 2019, with additional miniaturization and wireless data transfer capability in 2020.

Circling Back To Questioning The Need For Finger-Sticks

None of us in the US knows what our insurance will cover from year to year, and the rules change with Medicare and Medicaid frequently.

People with diabetes also deal with device alarm fatigue (the struggle is real) and require breaks from being “attached," because the fact is we’re all human and there are times when being part Diabetes Cyborg isn’t all it’s cracked up to be.

PWDs need access to the medications and devices that work for us.

It also takes up to 48 hours for CGMs (including Dexcom) to recognize an individual's glucose algorithms. So yes, in my opinion, (and many others) finger-sticks are still needed.

And I say this as a PWD who wears both a Dexcom G6 and an Omnipod.

Every CGM company has acknowledged and tried to address skin adhesive issues.

The skin of people with diabetes takes a beating with all the tech (pumps, pods, CGMs), general wear and tear, and adhesives, all of which are not user friendly. 

We need to protect our "real estate” and I’m glad to hear that the industry is acknowledging and helping. THANKS.

One of the panelists mentioned that an invite should be extended to a Dermatologist for next year’s panel because of these skin/adhesive issues.

YES, that would be great. As would having multiple people with diabetes wearing different diabetes technologies, but I digress.

Post CGM Panel Discussion, other morning standouts include:

CGM sensor studies (implanted in pig skin) show that skin develops inflammatory reactions after 7 days, and vessel damage and scar tissue after 21 days. Not surprising and good to know.

Inquiring minds want to know: Is it possible to make sensors reusable so we can switch them out, preserving both our skin and the planet?

3,000 bio markers can be found in interstitial fluids. So can lots of drugs. Who knew?

Speaking of interstitial fluids… be on the lookout for sampling interstitial fluid via micro-needling patches.

Diabetes Devices Cybersecurity Talk By Robert Hurtz, MS - Director of Product Design & Engineering, Ascensia Diabetes Care

Major Takeaways

Robert began his talk by stating that: Blood glucose management has changed a lot in the last few years — moving from stand alone to interconnected diabetes management systems.

And then pointed out that diabetes device systems across the board are inherently more complex — now including cloud systems, phones and apps.

Cloud and app interconnectivity increases security risk for all connected D devices (insulin pumps, CGMs, meters) and lurkers are constantly trying to find alternative ways into systems.

All of the above demand new sets of security language to master (because language does indeed matter). Hurtz then stressed the importance of medical device companies having defense in depth via multiple layers of security, in order to provide a secure root of trust (the root of trust is a source that can always be trusted within a system).

It is clear that companies now require both security risk assessments and safety risk assessments of their devices and products, and need to remember both.

Incorporating security of a system in the beginning of the build is a must, beginning with standard based protocols first, followed by adding additional layers of defense.

Why? Because hackers think differently and have an amazing set of tools at their disposal to infiltrate systems in order to steal data or cause harm.

Sidebar: The plot line for the November 17th Episode of NCIS Los Angeles was about a Navy Officer’s insulin pump being hacked, causing him to go low in order for the hacker to access confidential information the officer was working on.

Did someone tell them that DTM 2019 was November 14th through the 16th?

Talk about a perfect intro!

A strong defense is the best offense. It’s therefore imperative that companies use external sources to get their security systems certified for safety.

Security certification is key because it proves that a company has done their due diligence from start to finish. 

Bottom Line: Nobody want to be the one that’s on the front page with a security breach.

“In a connected world you want to be trusted member of the community - and you want your system and product to be a trusted!” Robert Hurtz