FDA OKs Tandem Diabetes Control-IQ! was reported by Mike Hoskins for DiabetesMine.com, 13 December 2019.
Control-IQ combines Tandem’s touchscreen insulin pump with the popular Dexcom CGM (continuous glucose monitor) and a smart algorithm that not only auto-adjusts basal rates for both high and low blood sugars, but also allows for automatic corrections for unexpected highs to get the user back in range.
On Dec. 13, the FDA announced its approval of Control-IQ, just about six months after the California company had submitted it to regulators.
This will be the most advanced commercial “closed loop” system available, leap-frogging Medtronic Diabetes’ first-to-market Minimed 670G Hybrid Closed Loop that only adjusts background basal rates but doesn’t support automatic food or correction boluses. This advanced Control-IQ feature comes just about a year after Tandem launched its Basal-IQ tech, which predictively suspends insulin if it foresees an impeding low blood sugar.
Read more: FDA OKs Tandem Diabetes Control-IQ!
Dexcom suffered a system Share failure last week … causing a lot of angst in the T1 community.
The Dexcom CGM Outage: What Really Needs Fixing was written by Amy Tenderich for DiabetesMine.com, 2 December 2019.
CGM is still a relatively new tool! Dexcom has brought us this ability to have accurate continuous glucose readings — a privilege that we can all be grateful for — while being mindful that cloud computing is not perfect and there WILL be gaps in data-sharing at times. But as we noted during Dexcom’s first outage over New Year’s 2019, it’s important for all of us with diabetes to have a backup plan for when technology fails. It is not, unfortunately, our God-given right to have perfect CGM data-sharing service every moment of every day.
What needs fixing more than anything in this case is the process by which customers are notified when service goes down – precisely because the service in question is medical, and considered life-critical by so many users. Clearly, many parents of T1D children keep their smartphones by their bedsides these days, relying on the CGM Share function to keep their children safe.
Knowing this, companies like Dexcom simply MUST have better business processes in place to communicate and deal with gaps in service.
Dexcom CEO Kevin Sayer Addresses Dexcom Customers After Follow Function Outage was posted 13 December 2019 on YouTube.
We want to thank you for your patience during the recent outage of the Dexcom Follow function, and apologize on behalf of the entire organization. Please watch this video with a personal message from Dexcom CEO, Kevin Sayer.
Pacific Diabetes Tech Debuts Combo Insulin Infusion Set + CGM Sensor was reported by Mike Hoskins for DiabetesMine.com, 11 December 2019.
Pacific Diabetes Technologies presented a combined CGM sensor+insulin infusion set to market. “The reason we got into this was ‘device burden,’ where people have to use several devices and it’s cumbersome,” says Dr. Ken Ward, a bioscience engineer who’s been involved in glucose sensing at companies like Bayer and iSense before co-founding PDT. “Despite the science showing these devices are very effective, many people don’t wear their pumps and sensor all the time. Our belief is ‘device burden’ has a lot to do with that, so we want to create a single device where the cannula and glucose sensing is all-in-one.”
PDT says the insulin delivery will not interfere with CGM readings — enabled by their hollow sensor with “redox mediator” technology that’s different than what existing CGM manufacturers use today.
The company has a working prototype and is currently seeking investors and research partners, according to CEO and co-founder Robert Cargill.
CEO Cargill tells us PDT needs about 24 months from now to get to an initial filing t start their pivotal trials, assuming they can find adequate funding to bring their R&D team up to the needed 18-20 people. He estimates needing $1.5-3.0 million per year for the next two years to make this happen. Then about a year to conduct those pivotal trials and prepare for FDA filing… so roughly 2023.
Watch this video for further details: http://pacificdt.com/about/cgm-infusionset/
Sanofi to restructure its Onduo, Verily partnership alongside diabetes exit was written by Conor Hale for FierceBiotech.com, 10 December 2019.
As its new CEO begins to move Sanofi away from new diabetes research, the drugmaker—and producer of one of the world’s top-selling insulins—will also look to pull back from its three-year-old relationship with Verily and their virtual diabetes clinic, Onduo.
Now, newly installed chief Paul Hudson aims to refocus the company on its strongest products in immunology and vaccines, while discontinuing its R&D programs in diabetes and cardiovascular diseases following struggling sales.