What’s the diabetes medtech community up to?

What milestones have recently been achieved?

How are new devices working for users in the real world?

What challenges have these PWDs (people with diabetes) encountered? And what new challenges may be on the horizon?

These are the questions we aim to address at our biannual DiabetesMine D-Data ExChange forum, which brings together a unique mix of innovators from the #WeAreNotWaiting DIY community, pharma and diabetes device companies, and the regulatory and clinical worlds.

The aim is to spark momentum and collaboration, by shining a spotlight on PWDs’ wins, desires and challenges in the real world – vis-à-vis rapidly advancing diabetes tech and data tools.

Today we’re excited to provide an overview of the hot topics covered at the Summer 2018 #DData event (marking our 10th in the series!), that took place in Orlando in late June, just prior to the big annual ADA conference.

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The DIY Diabetes Shakeup

First off, let’s set the stage... We’ve been hosting this forum twice a year since Fall 2013, when the very first #DData was held in a Stanford classroom. That was the birthplace of the #WeAreNotWaiting movement.

We’ve witnessed incredible change since then – and are proud to know that these #Ddata gatherings have been a catalyst for progress (sparking collaborations, partnerships, hirings, etc.)

Today we find ourselves in the middle of a huge upsurge of innovation in data-driven diabetes tools, improved BG sensor technology, and closed-loop/Artificial Pancreas systems developing at breakneck speed – not to mention the FDA’s newest efforts to accelerate the path to market (!)

All this has happened due to a progression of three things:

  1. The worldwide expansion of the Diabetes DIY Community (thank you to the inventors of Nightscout, OpenAPS, Looping, etc.)
  2. The amazing progress that diabetes tech companies have been making of late (looking at you, Medtronic 670G, Abbott Libre FreeStyle, Dexcom G6, Insulet DASH, etc.)
  3. A maturing ecosystem coming together to support those efforts – by FDA regulators and entrepreneurs

To summarize, you could say that over the last five years: DIYers started shaking things up, the industry responded ratcheting up innovation, and now a new infrastructure is emerging to support these advancements.

Meanwhile, Harvard Business Review recently published an article describing how medtech companies developing their solutions along with patients are the real winners in today’s marketplace. When they start by identifying basic needs and desires of end users, they are by far the most likely to achieve “adoption” and “adherence.” Right?!

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This really validates our DiabetesMine Innovation Project approach that patient-led design is key to medical devices of the future!

That’s how we kicked off our program on June 22. And here’s how the rest of the afternoon went down…

{see the event photos here}

{access the agenda / program here}

 

A T1D's Push for Open-Source Design

Our opening speaker was Justin Walker from New Zealand, International Sales Manager for SOOIL Development Co. in Seoul, Korea – makers of DANA insulin pumps.

He’s lived with T1D himself for 31+ years, been a pumper for 20+ years, a CGM user for 12+ years, and an OpenAPS user for ~2 years now.

Justin is the individual responsible for encouraging SOOIL to build the first-ever insulin pump designed specifically to be open-source ready.

With that, he has essentially built a bridge from commercial diabetes product manufacturers to the Open Source development community… A bridge that others will hopefully cross soon.

It’s PRETTY HUGE that he was able to play a leading role in building a pump based on the needs and wants of the Open Source Community.

We were excited to hear this story, illustrated in Justin’s slides here.

 

Learnings from the FDA Precertification Pilot

Next up was #DData co-organizer Howard Look, CEO & Founder of Tidepool – the non-profit on a mission to “liberate data from diabetes devices and provide useful free software to the diabetes community.”

In case you’re not familiar, Howard previously did pivotal work at Tivo, Pixar and Amazon. After his daughter was diagnosed with T1 diabetes some eight years ago, he decided to devote himself to data-driven D-care.  He took it all the way to the White House, winning a Presidential Champions for Change award in 2015.

Tidepool is of course one of just nine companies in the country to be chosen for the FDA mHealth Software Precertification Pilot Program, designed to accelerate the review process of digital health tools.

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Howard presented our group of innovators with an incredible deep dive into the differences between Laws, Regulations and Guidance Documents; the opportunities for “alternate approaches”; ways to challenge the status quo; and specific components of the PreCert approach tied to real-world performance.

Some attendees remarked that his presentation was “one of the best regulatory talks ever seen.”

See Howard’s slides here.

 

Direct from FDA: Diabetes Innovation Pathways

Likewise, Courtney Lias of the FDA’s Center for Devices and Radiological Health turned heads with her talk this June as she outlined new FDA Innovation Pathways, especially the new iCGM (interoperable CGM) classification created to better handle connected systems.

Courtney, along with Stayce Beck and others on her team at FDA, have made award-winning efforts to foster diabetes patient community relations and push for innovation in automated systems and digital tools.

There seems to be so much happening so fast at FDA right now (not something we thought we’d ever say!)

At #DData18 June, Courtney presented a clear and detailed overview of iCGM performance standards, communication protocols, accuracy and transparency requirements. She even looked specifically at new products DreaMed Advisor Pro, Medtronic 670G, Senseonics Eversense, and Tandem’s new Predictive Low Glucose Suspend (PLGS) feature.             

See Courtney’s slides here.

 

Predicting Glucose Levels in Advance: The Next Frontier

Speaking of predictive alerts, one of the most exciting things on the horizon in the #DData world is the emerging ability to continually and reliably predict where BG levels are going in the next few hours of a person’s life.

One Drop is just now launching some powerful new tech in this area, and their new VP of Data Science Operations Dan Goldner was on hand to tell us about it.

The company is hoping to fundamentally change people’s care with that ability to see a bit into the future.

They’re referring to their solution as Automated Decision Support, and are starting by targeting people with T2 diabetes who are not on insulin, as a baseline with fewer BG data points to crunch.

They tell us their sophisticated analytics will eventually provide insights and recommendations to all PWDs, using a variety of meds and devices.  

See Dan’s slides here.

 

Evaluating the Impact of mHealth Apps 

As you all know, we’re still fighting the good fight to get these software tools and apps recognized, legitimized and supported by the Medical Establishment.

Ever wonder who is researching the real impact of these tools on people’s health outcomes? And how are those results being shared with providers and health plans?

We explored this a little at our last Innovation Summit at Stanford last Fall, and were excited in June to have with us Brian Clancy of the IQVIA Institute for Human Data Science.

Brian is Co-Lead for something called AppScript, “the world’s leading curation, prescribing, and studies platform for digital patient engagement tools.”

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The goal is to help elevate all these digital health tools for diabetes and beyond from some “nice to have” ancillary components to to being established as the Standard of Care. To facilitate this, mHealth tools are being referred to as “digital therapeutics.”

See Brian’s slides here.

 

Access and Learning - Major Barriers to Diabetes Tech Use

The heart of our DiabetesMine Innovation programs always lies with the Patient Experience with all these new technologies out in the REAL WORLD. In Orlando, we had a multi-part panel that featured two experts discussing Access and Learning topics, followed by three PWD representing different products and POVs.

First off, we were privileged to have renowned Los Angeles endocrinologist Dr. Anne Peters give a passionate talk about access barriers. She works closely with people who are “under-privileged” in the LA area, and has been personally involved in how they can – or mostly cannot -- take advantage of digital tools.

Anne did not use slides, but rather shared the tale of a T2D patient of hers who lost his livelihood, family and even a limb due to diabetes – and how she toiled for two years straight trying to get him a CGM, which in the end was too little, too late. She brought the house down! She was given a standing ovation (only the second one in our #DData series since Mark Wilson’s “It’s the Drive” talk). As Hamish said, thank you for your whole career Anne!

Who is Hamish? That would be Hamish Crocket, the poor researcher from New Zealand who had to follow Anne on stage – but he did an admirable job of representing the other end of the spectrum: mainstream patients who are grappling with how to learn and optimize the sophisticated technology available to them.

Hamish is a social scientist at the University of Waikato, NZ, whose research centers on how people learn. He started out studying how sports coaches learn how to coach.

As a T1D himself diagnosed in 2013, he turned his attention to this community and recently examined the learning experiences and challenges of novice users of DIY Artificial Pancreas systems.

His study on “Learning to Close the Loop” provided some great insights on context, community dynamics, and traits necessary for success (think persistence!).

See Hamish’s slides here.

 

Diabetes End-Users Speak Out

After the above talks, we turned our attention to users… Because it’s all about users and we always want to hear directly from them on:

  • Pro’s and Con’s of existing products/features
  • What might improve the user experience
  • How these devices are, or are not, improving their lives

Our user panelists were:

Alan Monroe, T2 from Southern Illinois, who’s using Abbott Libre

Joanne Welsh, T1 from Philadelphia, using the Medtronic Minimed 670G, and

Katie DiSimone, T1 from Southern CA, a leader in the Looping community helping to onboard new users (who was also a Demoer later in the day)

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If I had to summarize the oft-nuanced discussion in Tweet format, I’d most likely say:

@AlanMonroe – loves the Libre, motivates him to check much more often, has learned to understand effects of food, thinks everyone should push their Dr to get one

@JoanneWelsh – has improved time in range w/ Minimed 607G, but using it involves compromises, many system quirks to overcome

@KatieDiSimone – passion to help everyone take advantage of DIY tech by making it easier to assemble & use, step-by-step instructions needed, vibrant “always on” community helps much

 

Preview of AADE’s New Technology Portal  

A couple of exciting things were unveiled at #DData18 in Orlando!

First, we got a sneak peak of the AADE’s new technology portal.

That is, the AADE (American Association of Diabetes Educators) has been making a concerted effort to embrace technology, and help their CDE members be informed.

I’ve been privileged to be part of those efforts on a DOC Relationship Committee and also their Tech Workgroup Committee weighing in on what resonates with patients.

Headed by their new-ish Chief Technology & Innovation Officer Crystal Broj, they’ve been hard at work developing a technology portal called DANA that allows their members to browse and learn about available devices and apps.

DANA includes a detailed product database with app reviews; educational resources on new types of tech tools; news articles and discussions; and also polls and focus groups to gather data on CDEs' existing knowledge and clinical practice.

This comprehensive platform is set to go live for AADE's members on Aug. 6.

View Crystal's preview slides here.

 

Ascensia Diabetes Challenge Winner: Hello Whisk

Also announced – and demo’d for the first time! – was the winner of Ascenia’s Diabetes Challenge, a global competition seeking innovative digital solutions to genuinely change behavior and improve the lives of people with T2D diabetes.

Earlier this year, Ascensia partnered with Yet2 to launch this contest, and six finalists were announced in early April. At #DData18 June, we were treated to an exclusive preview of the grand prize winner, Whisk.

Whisk is a start-up focused on food using AI to power a “Digital Dietician” currently available for consumers in the UK and US.

Ascensia plans to work with Whisk to build a version of their platform that links to BGM data, to make tailored recipe recommendations for PWDs optimized to their BG readings. They’ll call this the Whisk Ascensia Culinary Coach.

See the Whisk demo here.

 

Hot New Diabetes Tech Demos!

To top off the afternoon, we had a lineup of extremely cool demos of new solutions that spanned the gamut from “microlearning” videos to a whole new level of DIY CGM optimization to a revolutionary new implantable CGM system.

An we once again had a panel of three excellent patient/expert judges (all living with T1D themselves), who got to ask the pointed questions Top Chef-style:

Aimée José – an RN, CDE & Certified Diabetes Technology Clinician at Palo Alto Medical Foundation. She also has a degree in Psychology. Her passion and specialty is teaching intensive diabetes management using insulin pump therapy and CGM. 

Jeremy Pettus - an Assistant Professor of Medicine in the Division of Endocrinology at UC San Diego. He was diagnosed himself at the age of 15. Many may know him from leadership role with the TCOYD conference series, heading the T1D Track.

Cherise Shockley – a leader in the diabetes online community, founder of the Diabetes Social Media Advocacy (#DSMA) Twitter chat and community, who’s currently launching a new group to unite women of color with diabetes.

Thanks to this excellent “reactor panel,” for bringing the real.

Here’s a quick description of each demo they reviewed, with a link to their #DData presentation slides:

Mytonomy demo - a leader in video-based microlearning. Their T2-focused platform connects PWDs to a virtual care team through any mobile device or laptop, anytime, anywhere.

Cornerstones4care demo - Novo Nordisk has partnered with Glooko on this new T2-focused free diabetes management app that can track BG, medicine, meals and activity all in one place. It also offers educational content on healthy eating and lifestyle

Metronom Health demo - developing and commercializing a new CGM system they say is “deeply rooted in users’ individual needs.” Its proprietary Smart Sensing technology is expected to provide a variety of benefits, including superior accuracy and reliability.

Eversense Senseonics demo - the world’s first long-term implantable CGM sensor that uses cutting-edge fluorescence technology to provide real-time accurate glucose readings, trend information, and high and low alerts. Eversense was literally FDA approved the night before #DData18, so we were treated to the latest and greatest info, plus a live demo of the insertion using a prosthetic arm.

Spike app demo - an app created by the #WeAreNotWaiting open source community to allow PWDs to get the most out of their CGM transmitters. Features include seamless data-sharing with Nightscout, Apple HealthKit and other systems; customizable alerts and charts; spoken audio readings; touchscreen support and a whole lot more. We imported co-creator Miguel Kennedy from Portugal to present on this incredible app, and his brother, who works for Apple in California, actually designed his slides. A must-view!

LoopDocs demo - a comprehensive customer support site, all built by the community of users. D-Mom Katie DiSimone has done an incredible job curating this site and creating easy-to-use instructions (often in video format) for the setup, operation and troubleshooting of these DIY looping systems.

 

Kudos, and “DiabetesMine University” This Fall

Our DiabetesMine Innovation events have been described as “an amazing mix of patients, pharma, med tech, providers, payers, tech, and regulators.”  

And regarding #DData18 June in particular, one CTO in attendance says: “Congratulations on an outstanding event in Orlando… Highly informative and well planned to keep everyone engaged.”

So great to hear, as we pour our hearts into these programs, as our main platform for advocacy.

We’re excited for the Fall kickoff of DIABETESMINE UNIVERSITY (DMU) – our new innovation program that encompasses our annual Innovation Summit and D-Data ExChange forums, with a fresh learning twist. Class is in session at the UC San Francisco Mission Bay center on Nov. 1-2.

 

Demoers Wanted: Got a great new app, sensor, platform or tool for improved diabetes management? APPLY NOW to present to #WeAreNotWaiting & industry influencers at our #DData18 day (part of DMU) this Fall:

 https://tinyurl.com/DData-DMU-DemoAPP