On Being a Diabetes Entreprenuer Focused on Closed Loop - jonesdidepubse
IT is 2003, I am an orthopedic operating surgeon with a 2-year-old, and I can barely stretch over the table to operate happening my patients given that I am 34 weeks pregnant. My married man Dain has planned for every contingence. Lifespan is going to equalize more chaotic. But it's also going to get symmetric better with the comer of our son.
All over the weekend, our daughter Taylor is delighting in her new skill of crapulence from a cup. Atomic number 3 with any fres skill, it's withal to beryllium perfected so I am cleaning upbound a lot of spilled milk. Information technology's not discerning how much she's in reality drinking, simply as soon as the looking glass is bare she's asking for another.
Aside Sunday morning, I realize that I'm also changing wet diapers, a LOT. I'm concerned. I cry my roommate from residency who is a pediatrician, and she confirms that Deems Taylor needs to go to the ER immediately. What happened close will be familiar to many of you with type 1: blood tests, hospital stay, then back home completely overwhelmed with unpredictable and wildly fluctuating blood sugar numbers, carb counting, and uninterrupted BG checks. Even with my Graeco-Roman deity training, this is complex and unbelievably exhausting.
In our case, Deems Taylor was on such tiny doses of insulin that the only way to measure it in a syringe was to thin out the insulin. And no, you can't get diluted insulin from the pharmaceutics so we were instructed to mix our personal insulin, combining dilutent and Humalog. Dosing watery insulin is eventually one many step in a complex work: first calculate the dose based on carbs and BG; secondly, convert from insulin units to social unit markings on the syringe; tertiary, mix information technology with the right Venus's curse of NPH. This requires uninterrupted concentration that is difficult to line up with a 2-year-elderly running around and virgin baby along the mode. I couldn't trust we were expected to manage blood sugars with this imprecise and computer error-prone system for a 2-year-sure-enough! We transitioned to an insulin heart as soon as we could.
Through JDRF, Brave Buddies (an online group long before Facebook), and (the newer Palo-High-pitched based keep aggroup) CarbDM, we found an incredible T1D residential area. We joked that T1D was the superfine club that we never wanted to join. The years went by and contempt all of it, Elizabeth Taylor thrived — school, sports, friends. The awful T1D community supported us, and I am grateful every day.
Discovering CGM
Equally a D-Mom and a physician, I avidly read the diabetes medical literature. I was particularly intrigued away the promise of a closed loop, also known As the Arranged Pancreas. The data or so closed-loop system was compelling. Symmetric with early, less exact sensors, controlled objective studies showed that algorithms were effective, especially at night. However, it was equally crystallise to me that the early sensors were not ready for prime meter. Our personal experience with early sensors was an exercise in futility. The readings were inaccurate, the standardisation process was cumbrous, and the huge needle successful IT miserable to insert. For closed loop to bring up, the sensors needed to amend.
Fast brash to late 2012. The Dexcom G4 Platinum, an hi-fi and sure sensor had just been approved. Unfortunately, we learned about IT the hard way. Taylor, now 11 years old, had woken up with a blood glucose in the 60s — not terrible, but not satisfactory. She drank some succus, and started acquiring ready for school, merely I had an intuition that something wasn't right. I unbroken a close eye connected her. While she was brushing her hair, she suddenly collapsed with a seizure. It was frightening to get wind. Subsequently an emergency shot of glucagon, we headed to the hospital. We are incredibly fortunate to live close to Stanford Hospital and to have had a long and close human relationship with the awful Dr. Bruce Buckingham. He was kind enough to meet us in the ER and made sure that Taylor was going to be fine.
That's when he recommended the Dexcom G4.
From the moment that we started victimization the G4, our lives were changed. For the commencement sentence in a ten, Dain and I had heartsease. But as of import A this was, IT raised the question: why was I still getting up in the middle of the night just to enter numbers from the sensor into the pump? Sensor accuracy and dependableness had leapt forward. Pump technology was coagulated. The stoppered loop algorithms had without doubt achieved a proof of rule. Where was blocked intertwine?
Diving into the Closed Loop Tech World
I literally asked this question of everyone I met: academics, members of industry, diabetes advocates, and financial support groups. I attended conferences. Closed-loop system research was brimming with activity. It seemed to be on the cusp, but exclusive in the academic world. That's when I met Tom Peyser.
Tom is the former VP of Science for Dexcom. In 2014 we started group meeting regularly to discourse how to expedite commercialization of a winking loop system. Tom had reviewed the entire trunk of closed-loop system lit for a paper published in
Together we started a company, Manner AGC (Automated Glucose Control) in Palo Low-pitched, focused on addressing these questions and with the intent of working with heart companies to integrate the algorithm into their products. Tom had led Dexcom's participation with restricted loop studies around the world perceptive numerous studies first-hand. While there are many excellent academic groups, Tom's experience, cooperative with his comprehensive lit review, LED him to recommend that we accomplish out to the Doyle Lab at University of California, Santa Barbara. We partnered with Drs. Frank Doyle and Eyal Dassau and licensed their algorithm.
Our team now had sensor expertise, user perspective, and algorithm expertise. Uncle Tom has an exceptional understanding of the sensor and played a major role in helping Dexcom improve the accuracy of their CGM with G4 Platinum and G4AP. I understand the professional pressures on healthcare providers: EMRs (electronic medical records); constraints about documentation, coding and reimbursement; large patient panels with diverse goals, expectations and challenges, and really limited time per patient. I also understand the umteen facets of type 1 diabetes management on the continuum from bambino through teen years. Dr. Doyle and Dr. Dassau are world-renowned control theory and enclosed intertwine algorithm experts. In 2015, Dr. Doyle was appointed Dean of the School of Engineering and Applied Sciences at Harvard, where he and his team continue to work out on commercializing closed loop.
The algorithm that we licensed uses
Dr. Doyle developed the world's first MPC algorithmic program for insulin dosing over 20 years ago and has been improving information technology ever since. The on-going version of the algorithm is in a clinical study with 30 volunteers. I was well to observe the study recently and was impressed to see the algorithmic program automatically dose insulin to cover version a 65-gm pasta meal. I watched the blood glucose tracing go from around 100 atomic number 12/deciliter pre-repast punt to around 100 mg/dL post-meal without the user doing anything. It took a few hours, and the peak was about 270 mg/deciliter so it wasn't perfective, merely it was pretty awe-inspiring to watch the BG tracing come right hindmost down to the target area without a manual bolus. I marveled at the dividing line to what happens now with a incomprehensible meal bolus: 65 grams would result in a BG of 400 mg/dL.
As you probably know, first-generation drawn loop products will work a whole sle like the latest pump and sensor scheme: boluses, infusion dictated changes, and troubleshooting. But with ane big difference: blood glucose ensure. These systems automate nighttime glucose and assist the user during the day. We don't see such a system A a self-driving car – it's non just set and forget – but for the vast majority of users this will be a game-changer, offering dramatically tighter glucose control without lows.
Decades of research went into the development of the components of a closed-loop system system: algorithms, sensors, and pumps. The concluding product volition need to cautiously mix all three components. At Mode AGC, we were focused on this integrating, and translating basic science to a merchandise.
Joining Forces with Insulet
Now immediate bumptious another few eld to 2016, and Mode AGC found a fantastic partner with Insulet and are helping develop the Omnipod HORIZON system expected to set in motion in 2020. HORIZON is an exceptional product that testament offer the much-loved tubeless tire Omnipod pump with the additional gain of glucose control from automated insulin delivery.
The algorithmic program that controls insulin rescue is embedded in the pod so the system is always working regular when you're away from your phone or PDM. This "on body" configuration will be an incredible vantage for children and athletes A well as a simple and convenient diabetes direction system for anyone along insulin therapy. This feature is particularly important to me since my daughter plays sports and uniforms don't come through with a pocket for a phone!
Along a attribute note, I'm no more on the job for Mode AGC, but I'm proud to have contributed to Omnipod HORIZON encouraging the Insulet squad on product requirements, clinical trial design, data analysis, and UX. Insulet has accomplished various clinical trials that include over 100 adults and children, and the Omnipod Visible horizon is well on its way to a final pivotal study. I'll be eagerly watching for Insulet's announcements A the cartesian product advances through FDA commendation and to the much-hoped-for commercial launch. In the meantime, I'm staying busy advising commence-ups and volunteering with JDRF and Beyond Type 1 to ultimately curative T1D.
Thigh-slapper Jennifer, thank you for sharing! This — aboard the efforts from many other industry players — gives United States of import Bob Hope for more closed-loop system systems on the market sooner instead than later.
Source: https://www.healthline.com/diabetesmine/jennifer-schneider-guest-post
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