What’s Coming from Beta Bionics and Bigfoot? Exciting Next-Gen Automated Insulin Delivery was reported by Emma Ryan and Adam Brown on diaTribe.org, 31 August 2018. This is GOOD NEWS!
This year’s Friends for Life conference showcased upcoming automated insulin delivery (AID) systems from Beta Bionics and Bigfoot. Both companies aim to begin pivotal studies in 2019 testing their insulin-only systems, iLet and Loop. Assuming things go well, this means both could launch sometime in 2020.
Rather than just adding a CGM and control algorithm to an existing pump, both players are rethinking insulin delivery from the ground up, designing simpler, end-to-end, more seamless user experiences – easier system startup, easier meal dosing, adaptation over time, prefilled insulin cartridges, and much more.
A pivotal trial (to support an FDA submission) is expected to start in the second half of 2019, with a hoped-for approval in adults and children in the second half of 2020. A second pivotal trial testing insulin and glucagon aims to begin in late 2019/early 2020, with approval targeted for 2022. This timeline is longer since Beta Bionics has also to secure approval for Zealand’s pumpable glucagon – a longer study and submission process.
In exciting news, the FDA has given Beta Bionics permission to use Senseonics’ 90-day Eversense as an additional CGM in its system.
iLet pump updates:
- A slimmer, lighter design than the previous Gen 3 version, with a nice touchscreen, a rechargeable battery, and an excellent user interface design by the Tidepool team.
- A simple system startup process: apply and connect the CGM sensor, insert the insulin cartridge (and glucagon if desired), apply and connect the infusion set, and enter body weight. From there, a user will “GO BIONIC” and remain in closed loop – no need to juggle “Manual” vs. “Auto” modes like in the 670G.
- A “no numbers” meal entry system. Users answer only two questions to take insulin for a meal: “Where in your day are you?” (Begin, Middle, End, or Sleeping) and a rough estimate of meal size (tiny, small, typical for me, or large). Beta Bionics’ system will not require meal announcement, meaning it will dose insulin automatically if a mealtime dose is missed.
- The iLet’s control algorithm adapts over time based on performance – e.g., if it is not bringing a user to target, it will change its dosing accordingly. The insulin-only iLet targets 120 mg/dl, while the insulin/glucagon system targets a slightly lower 110 mg/dl
BIGFOOT BIOMEDICAL LOOP and INJECT:
Bigfoot’s Loop system includes a next-gen version of the FreeStyle Libre 14-day no-fingersticks CGM, a screenless pump (acquired from Asante), and a slick smartphone app that serves as the primary user interface. There is continuous communication between the Libre CGM and the pump, meaning that the system will remain in closed loop even when the smartphone is out of range. A user will enter meals on the phone app, which will recommend a dose and allow delivery without having to touch the pump.
For users preferring multiple daily injections (MDI) ove r an insulin pump, Bigfoot also hopes to launch its Inject system in 2020. Inject will use smart insulin pen caps that read how much insulin is in basal (long-acting) and bolus (fast-acting) disposable insulin pens. Data will be sent to a smartphone app, and the app will then recommend insulin dose changes based on FreeStyle Libre CGM patterns.
Read more: What’s Coming from Beta Bionics and Bigfoot?
and a Data Crunch Podcast about machine learning in diabetes management and an interview with Brian Mazlish of Bigfoot Biomedical: Machine Learning Takes on Diabetes
Tandem Started 2018 Worth $26 Million. Now, It’s Worth $2.3 Billion was reported by Bailey Lipschultz on Bloomberg.com, 30 August 2018.
Sell-side analysts keep bumping up their price targets for Tandem Diabetes Care Inc. , which has skyrocketed beyond all expectations. The now-$2.3 billion company has been one of the hottest stories in MedTech after entering 2018 with a market value of $26 million.
Read more: Tandem Started 2018 Worth $26 Million. Now, It’s Worth $2.3 Billion
Type 1 Diabetes and Sleep – An Exciting New Technology Study with Tidepool and Evidation was presented by Jeemin Kwon and Adam Brown of diaTribe.org, 31 August 2018.
Want to participate in this study?
Sleep is frequently overlooked when it comes to identifying lifestyle factors that affect diabetes – food and exercise often command much of the discussion. However, sleep has an enormous impact on life with diabetes: too little sleep is associated with higher blood glucose levels, more carb cravings, weight gain, insulin resistance, and more. Additionally, blood sugars can impact sleep, especially overnight lows that can interrupt sound sleep. This study will hopefully generate new insights into the link between sleep, blood sugars, and diabetes, particularly when overnight lows are a factor.
Read more and find out if you qualify: Type 1 Diabetes and Sleep – An Exciting New Technology Study with Tidepool and Evidation
Metformin for Protection Against Alzheimer’s, Cancer and Heart Disease? was reported by Kathleen Doheny on Endocrineweb.com, 20 August 2018. SAY WHAT? Yup, Metformin and reverse aging and more!!!
Metformin may influence fundamental aging factors that underlie many age-related conditions, including cancer, heart disease and Alzheimer’s, says Nir Barzilai, MD, director of the Institute for Aging Research at Albert Einstein College of Medicine, the Bronx.
“Metformin is generic, and it’s cheap,” Dr. Barzilai says. And accumulating data suggests that ”it interferes with the biology of aging.”
Read more: Metformin for Protection Against Alzheimer’s, Cancer and Heart Disease?
Xeris Submits Glucagon Rescue Pen to FDA: A Dramatically Easier and Faster Treatment for Severe Hypoglycemia, as reported by Jimmy McDermott on diaTribe Learn, 31 August.
Xeris has submitted its Glucagon Rescue Pen – the “G-Pen” – for the emergency treatment of extremely low blood sugar (severe hypoglycemia) to the FDA. Unlike current glucagon kits, Xeris’ glucagon is a room-temperature stable liquid; because it does not require mixing prior to use, it will be “ready to inject” (like an EpiPen for allergies) in two simple steps: (1) remove the cap from the pen; and (2) press the pen against the skin (presumably arm or leg or wherever is available). Upon contact with the skin, the automatic injector will deliver a rescue dose of glucagon. This will make glucagon administration during emergencies easier and faster than current options. Assuming a standard review process, we hope for an approval decision from the FDA in roughly mid-2019.
Read more: Xeris Submits Glucagon Rescue Pen to FDA: A Dramatically Easier and Faster Treatment for Severe Hypoglycemia
all good stuff!!