Savvy Updates, 12/16/19: FDA Approves Tandem Control-IQ, On Dexcom’s Outage, Pacific Diabetes Tech CGM/Infusion Set, Sanofi Exits Diabetes Biz, CGMs 2020, T1 Females at Higher Heart Risk, Abbott Libre Limits Data Access, Gifts for Medical Professionals?

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.

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.

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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.

CGM for 2020 – will new entrants reduce costs? was discussed on Diabetech.com, 12 October 2019.

One of the highlights of the various conferences during 2019 has been the slew of new CGM providers that appear to have CE marks (European approval) and are therefore entering the previously uncompetitive market that is CGM. In addition to Dexcom and Medtronic, Medtrum has been given anecdotal thumbs up from users in central Europe, and we await their A8 with interest. Meanwhile Eversense has offered a slightly different approach to the traditional “change every 7-10 days” model, with their implantable, 90/180 days options, which still require some level of calibration.

On top of this, there’s the Abbott Freestyle Libre, and Libre 2 in some countries, that while technically not CGM, has sprouted a whole industry of add-ons and hacks to get CGM data out.

2020 – What’s coming next?

- Ascensia’s relaunch of PocTech
- Agamatrix’s Waveform Cascade
- Aidex from GlucoRX
- Infinovo’s Glunovo i3
- Nemaura’s Sugarbeat

Read more: CGM for 2020

Why Women’s Hearts Are at Greater Risk was published by Sara Seitz for InsulinNation.com, 12 December 2019. Women with type 1 diabetes have multiple factors that result in a uniquely high risk of developing cardiovascular complications.

As a whole, people living with type 1 diabetes experience heart disease far more than even those suffering from type 2 diabetes. This is true despite the fact that type 2 is a condition associated with all the major risk factors of heart disease including obesity, high blood lipids, and high blood pressure.

Stranger still, women living with type 1 experience heart disease at rates greater than men with type 1 and both men and women with type 2.

Abbott Labs kills free tool that lets you own the blood-sugar data from your glucose monitor, saying it violates copyright law was reported on BoingBoing.com, 12 December 2019.

The admin of Diabettech posted technical instructions and code for extracting your blood-sugar data from the Librelink so that you could use a different “listener” app with your data, or even connect it to an insulin pump to create an artificial pancreas loop.

In response, Abbott Labs used US copyright law to have the project deleted from Github, censoring Diabettech’s code and instructions. In its takedown notice, Abbot’s lawfirm Kirkland & Ellis LLP (a huge corporate firm) advances several alarming arguments about projects like this.

Should you give gifts to your Healthcare Providers? Here are 2 perspectives, one from a medical professional and the other from a grateful patient.

Do You Accept Gifts From Patients? From a bottle of wine to your kid’s college tuition — where do you draw the line? was written by Howard Wolinsky for MedPage.com, 5 December 2019.

Should doctors accept gifts intended as expressions of gratitude? If so, what is a reasonable monetary value? Or should you politely decline?

It depends on whom you ask.

“There are no definitive regulations regarding accepting gifts from patients, and opposing views exist. Some believe physicians should never accept gifts because it might influence the standard of care or weaken the fiduciary relationship. Others believe that accepting gifts in certain circumstances allows patients to express gratitude and strengthens the physician-patient bond,” said psychiatrist Lara Hazelton, MD, of Dalhousie University in Halifax, Nova Scotia.

Read more: Do You Accept Gifts From Patients?

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An Antique Watch for a Successful Surgery – Why patients want to give their doctors gifts was also written by Howard Wolinsky for MedPage.com, 5 December 2019.

Patients generally are oblivious to — or ignore — the fact that medical ethics attempt to regulate gift-giving to physicians and other health professionals. Gratitude is one thing, quid pro quo is another.