Disclaimer: This is my individual perspective on using automated insulin delivery. It does not make any product claims about Tidepool Loop, an in-development app for iPhone that is not FDA cleared (as of the time of this blog post).
This is a story of my diabetes journey, using DIY Loop, and why I joined Tidepool with a focus on access.
My diabetes story
I was diagnosed with type 1 diabetes in 2001. Looking back, I’m grateful that I was 12 years old — old enough to take on my own care pretty much immediately, but not so old that I had lived many decades of life and had to rethink everything.
This wasn’t the dark ages of urine testing and barbaric lancing tools like “The Guillotine,” but devices were still not ideal 19 years ago. I relied on about four fingersticks and a few injections per day for the first year, but also lived a normal teen life. “Reviewing my data” consisted of manually handwriting a paper logbook a few times each year before appointments. Getting an insulin pump made bolusing more convenient, but my management was still manual. Every night I went to bed with the same basal rate — no matter what I ate, or how stressed I was, or how much basketball I had played. My pump settings ended in zeroes or fives, because round numbers are easier, and adjusting settings was never explained to me or my mom.
I ran an A1C in the 8–9% range for most of my teens — much of that due to the above, combined with typical teenage eating. I had one severe hypoglycemia event at the school library, which required a visit from the paramedics and was also totally embarrassing.
Fast forward to college, when a few turning points transformed my diabetes and life trajectory. I began taking nutrition classes, lifting weights, and thinking about my health more scientifically. In 2010, I began an awesome summer internship at diaTribe and Close Concerns, where I first heard about continuous glucose monitoring (CGM) at the Keystone conference in Colorado. I was so convinced after hearing a single panel of CGM users, that I called up Dexcom from the hotel lobby and got on the Seven Plus CGM. While it now looks antiquated (TI-83 calculator, anyone?), it was so advanced at the time!
Getting on a CGM changed everything, as it provided a stream of data I never had access to and a feedback loop to try things, see if they worked (or didn’t), and improve. Thanks to the generosity of Kelly Close, that internship turned into a full-time job writing about diabetes technology for nearly a decade.
I’ve worn a CGM for over 70,000 hours now, worn an automated insulin dosing system continuously for the past three years, and tested just about every diabetes device and app I can get my hands on. As a journalist, I followed products, companies, leaders, FDA, and industry trends. I went to hundreds of conferences and wrote/edited thousands of articles. I came to appreciate the nuances of making products, the challenges of selling them, and how all the pieces fit (or don’t fit) together.
Five months ago, I embarked on a new journey to become a licensed therapist, with an ultimate aim to focus on the mental, emotional, and behavioral health needs of people with diabetes and chronic conditions. In addition to becoming a healthcare provider, I also want to bring more principles of psychology into diabetes technology. You can read more in this just-published diaTribe column.
My DIY Looping story
I tend to measure success of any diabetes product by its ability to do two things:
- Improve time in range (I aim for 70–140 mg/dL)
- Reduce burden, hassle, and thinking about diabetes (i.e. more time for life)
Many things in diabetes can do the first, but it’s the combination of both that is a real revolution for living with this chronic condition. I believe that automated insulin dosing can do both.
I shared my time in range experience on a do-it-yourself automated insulin dosing system called Loop in diaTribe about a year ago, which I’ve updated with an additional year of data in the graph below. Over 56 months of total data, my time in 70–140 mg/dL has improved from 73% on manual insulin dosing (pump and CGM; blue) to 81% on automated dosing (orange). That’s 2.1 more hours per day in range. In total, that adds up to a staggering one extra month per year in range.
(I’ve always felt it is important to share personal data, though I want to caution: Individual results will vary widely. The biggest single driver of my overall time in range is food choices. Indeed, my time in the wider range of 70–180 mg/dl is unchanged over this time period.)
What does automation mean on a daily basis? Two pictures I often show in presentations illustrate the power. Each slide below is from one night, both of which were taken within the same week.
My night-time CGM data is shown on top, and the automated basal insulin dosing is on the bottom. The orange boxes represent algorithm decisions: Extra basal insulin was delivered wherever there is a box that rises upwards (max. of four units per hour for me), while insulin was reduced or completely suspended when the box goes downwards. No orange box indicates my normal basal rate was delivered.
Night A: 6 units of insulin delivered
Night B: 16 units of insulin delivered
You’ll notice that in these two cases, each night started and ended around the same blood sugar — approximately 100 mg/dL. What was insane was the difference it took to get from the same starting line to the same finish line. The first night (A) required just 6 units of insulin, while the second night (B) required 16 units — a 166% difference in insulin requirements on two nights within the same week!
This sort of variability happens all the time in diabetes, because there are at least 42 factors that affect blood glucose — two days are rarely the exact same! It’s possible that I ate a late dinner on Night B. Or that I was on the third day of my infusion set. Or that I was more sedentary than usual. Or that I had a particularly stressful day. Or (more likely) some unknown combination of those variables!
Automated insulin dosing is designed to better cope with unpredictability, since an algorithm is making decisions about insulin delivery up to every five minutes. While an algorithm works intelligently, I can sleep with fewer interruptions.
I also now understand some of the reasons why my teenage self struggled so mightily with diabetes — a single, fixed insulin regimen can struggle to adapt to this ever-changing condition, particularly with so few fingerstick data points. We didn’t know what we didn’t know.
On top of more time in range, I have seen a powerful quality of life impact from automated insulin dosing:
- Not needing to run a guessing game before bed every night, wondering if I’ve eaten enough (to avoid lows) but not too much (to avoid highs).
- Not having sleep disrupted every hour with a CGM alarm.
- Not having to think about diabetes immediately when I wake up. Sometimes, I get a couple hours into the morning before I have a single diabetes or blood sugar thought.
- Not having to play catch-up every single morning, frustrated that I’m not in target, and beginning the day 100 yards behind the starting line. A more predictable morning makes the whole day smoother.
- Not feeling handcuffed to eat on a set schedule.
My Tidepool story
Tidepool is working hard to bring the DIY Loop system I’ve been using, to market as an FDA-regulated app for iPhone: Tidepool Loop. In January, I was elated to join the amazing group here working to make that happen!
I joined Tidepool because I believe far more people should have access to the benefits of automated insulin dosing that I’ve experienced. We want to deliver this technology in a modern, 21st century user experience — one that runs on a smartphone, can be downloaded from the App Store, and could be continuously updated and improved based on user feedback.
I joined Tidepool because I believe in interoperability and user choice. Historically, choosing a device has required making guesses about different companies: Insulin pumps have a four-year warranty cycle, and everything requires a prescription. It’s not that easy to just switch to a different company or product, or to combine two different products. It’s quite far from a consumer-friendly market!
Our vision at Tidepool is building one automated insulin dosing app that could work with many companies’ devices — you choose the compatible pump and CGM that work for you, and we make it as easy as we can to connect them to Tidepool Loop. We hope to get to a point where automated insulin dosing looks more like consumer electronics — one company’s USB or wireless headphones can work with another company’s laptop. (It’s obviously harder in diabetes, since these are medical products that require prescriptions and must safely work together.)
This “interoperable ecosystem” could enable faster innovation of the individual system components, rather than requiring one company to own and be accountable for the entire system. The FDA has done an incredible job of making this vision a reality through creation of the iCGM, ACE Pump, and iAGC pathways.
As users, we should not have to predict the future (“When is ___ coming out?”), or be at the mercy of insurance companies (“Sorry, we’ve switched your coverage to ____.”). Hopefully, Tidepool’s focus on interoperability will help set people up to navigate a system that so often takes away their choices.
I joined Tidepool because I believe in transparency. For example, you can read all of Tidepool’s communication with the FDA, financial filings, and legal documents. Look at the code we’re working on. Or read our employee handbook. I’ve never seen another company this committed to open, honest, transparent communication.
I joined Tidepool because I don’t believe in, “Well, that’s the way we’ve always done it.” “Is there another way we can do this?” is a question that we constantly ask at Tidepool. One example is how we’re using real-world data as one of our methods to show the safety of automated insulin dosing that runs on an iPhone. The FDA submission of Tidepool Loop will actually use data from a real-world observational study of DIY Loop, examining its safety in a staggering 873 people with diabetes. (You can see the first public presentation of that data here.)
I’ve been a participant in this study (long before I joined Tidepool), and what’s amazing is that I have never had to drive somewhere, or see someone in person, in order to participate in this research. All my insulin and CGM data uploads directly from my phone in the background. I’m reminded each week via text message to fill out a patient-reported outcomes survey. And I’m mailed an A1C kit that is sent to a lab. The result is that this data set has 2–10 times the number of participants typically enrolled in studies of automated insulin dosing. As a participant, it’s far easier to be in this study than other closed-loop studies, which require driving somewhere for lengthy in-person visits. I’m incredibly excited about remote, virtual approaches to collecting real-world evidence — the more people we can enroll in a diversity of locations and groups, the more we can prove the value of automated insulin dosing to insurance companies.
Another example of doing things differently is our participation in the FDA's PreCert program, which is ambitiously rethinking how medical software is regulated.
I joined Tidepool because I believe in partnership. We absolutely cannot do this alone, which is why our approach is focused on building great diabetes software and partnering with companies who make pumps and CGMs. So far, Insulet, Dexcom, and Medtronic have signed on, and I’m hopeful that many more will join. As a nonprofit, Tidepool is uniquely positioned to partner with a wide variety of diabetes device companies in pursuit of our mission. We are stronger together!
I joined Tidepool because I believe in the collective wisdom of people living with diabetes. Our team has over 429 combined years of personal diabetes experience in-house, and we stand on the shoulders of giants — the incredible ingenuity of the #WeAreNotWaiting diabetes community. The perspective of people with diabetes infuses everything that we do.
I joined Tidepool because I believe in humility. We understand what living with this disease is like, but we also recognize that we can never know each person’s individual experience, successes, and struggles, and that our own experiences are not indicative of our broader community. We are committed to continuous learning and never-ending improvement, rather than reaching some end point of “competence.” You can always send us feedback.
I joined Tidepool because I believe in access. Great technology does not matter if people cannot get it in their hands. We have a long way to go, but we’re ready to take on the challenge. We hope you’ll follow our progress along the way!