July 7, 2017

Vote for FDA's AP Efforts as Excellent Public Service

FDA has given us, diabetes community, excellent efforts on artificial pancreas regulation. They have worked with innovators and patients to help the regulatory process work for people with diabetes. We should say thanks. Here is an easy way to do that.


Vote to recognize FDA's Artificial
(https://servicetoamericamedals.org/peoples-choice/index.php)

Scroll down and click next to
"Courtney Lias, Stayce Beck and the FDA Artificial Pancreas Team"

Here are the details:
The FDA's Artificial Pancreas team was selected as a finalist for the Samuel J. Heyman Service for America Medal in the Management Excellence category for our contribution to the first-in-the-world approval of the 670G hybrid closed loop system last fall. These Medals are awarded by the Partnership for Public Service, a non-profit organization whose mission is to "help government serve the needs of all Americans by strengthening the civil service and the systems that support it." In part the nomination says:

Before Lias and Beck got involved, both the industry and patient advocacy groups publicly voiced concerns that FDA’s review process caused unnecessary roadblocks and was standing in the way of developing this technology and delivering it to those in need. 
Lias and Beck changed this dynamic by treating all those involved—the device companies doing the research, the doctors, the hospitals and the advocacy groups—as partners, not adversaries, as they worked to improve and speed up the process. 
“They used to see the FDA as a barrier and now I believe they see us as an ally,” Lias said.
Read the full details of the nomination.

More information about the award program can be found here https://servicetoamericamedals.org

June 27, 2017

Meter Accuracy Study - DTS

Diabetes self-care is driven by data from glucose meters. The accuracy of meters matters because it is the cornerstone living successfully with diabetes. The Diabetes Technology Society just published a blinded study of meters. Have a look: https://www.diabetestechnology.org/surveillance.shtml

February 9, 2017

Pills better than insulin for t2?

Physicians Briefing reports a Swedish study that shows a lower risk of mortality (I vote that is a better outcome) with oral type 2 medications than with insulin. Good to see the study considered hypos. Given that diabetes is underestimated as a cause of death, it is good to see research looking at the big picture of all-cause mortality.

WEDNESDAY, Feb. 8, 2017 (HealthDay News) -- For patients with type 2 diabetes, novel oral glucose lowering drugs (GLDs) are associated with reduced risks of all-cause mortality, cardiovascular disease (CVD), and hypoglycemia, compared with insulin use, according to a study published online Jan. 24 in Diabetes, Obesity and Metabolism. 

Still - YDMV. The best course of treatment is the one the patient and physician agree meets the individual needs.

I think this "all-cause" approach should be taken when considering access to care beyond medications. One size doesn't fit all. Disrupting access to diabetes tool from strips, to the appropriate pump should be considered on a similar basis. 

February 2, 2017

Diabetes is Underestimated

Sometimes I think diabetes it is the Rodney Dangerfield of health. Unfortunately, it isn't a joke.

A recent study highlighted in this piece at Medscape says diabetes is underestimated as a cause of death in the US. The study puts diabetes, "the third leading cause of death in the United States in 2010, after diseases of the heart and malignant neoplasms and ahead of chronic lower respiratory diseases and cerebrovascular diseases." 

People with diabetes can thrive. By engaging early, we minimize complications, costs, and deaths. We need the appropriate tools and medications to be successful. 

Join me in calling on Congress to maintain the prohibition on pre-existing conditions, like diabetes, being grounds to exclude people from health care coverage. 

It is easy. 
  • The Diabetes Patient Advocacy Coalition has an easy to send letter to Congress. I'm sending it often. You can too.  
  • I'm sending Tweets from their Twitter Scorecard. Join me.
  • Getting through to our Senator's by phone has been iffy recently. So I 'm sending snail mail. 
Not only do we need to work with our doctors to care for diabetes. We need to work with our elected officials to maintain access to coverage. We need respect.




January 25, 2017

My Diabetes May Vary


Variations are inevitable and frustrating. 

Following treatment for cancer, I started medications as part of recovery including an emotional health medication. They seem to help. But the emotional health drug has a side effect - it bumps up my glucose levels. This feeds a feeling of fasting glucose frustration.

My go-to response is to try "to eat better." But when I don't see immediate results, the myth that I can control the rat bastard with diet, makes me feel a temptation to just eat less, to produce less glucose. The risk (and some days the reality) then becomes to eat less AND worse.

I aggravate everything doing that. It is a losing proposition.

So type 2 diabetes becomes more front of mind. I am checking glucose more. (Boy, I would love a sensor that filled in the gaps in my glucose profile. Come on Libre)

I think on balance the numbers are OK-ish. But they show that type 2 diabetes doesn't play well with others health issues, including emotional health.

As it changes, it demands additional adjustments. I know that is the deal. Knowing it doesn't make it less frustrating.


Type 2 is inevitably frustrating.


MDMV


January 16, 2017

CMS Ruling on CGM

The Centers for Medicare & Medicaid Services has concluded that Continuous Glucose Monitor Systems can be covered as durable medical equipment.* Specifically, those with an FDA label for the purpose of adjusting the treatment diabetes.

In practical terms currently, means the Dexcom G5. The CMS finding also established criteria for coverage that is an innovation target for other devices to achieve. Codes and coverage still need to be worked out. Still, this is great news. As one piece on the ruling observed. "Nearly 25% of patients with type I diabetes fall under Medicare."

A lot of effort, by many, contributed to this success. The industry has maintained a rapid pace of innovation. FDA has responded with timely reviews of CGM applications, most recently with a non-adjunctive label for the G5. A majority of both houses of Congress supported legislation in the last Congress supporting coverage. Courts ruled in individual cases for coverage. We, the people with diabetes, advocated in every avenue open to us to ask for coverage.

Positive diabetes health news is great. Savor this.


*You read the CMS Ruling at https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/Downloads/CMS1682R.pdf