March 18, 2024

Where is My Huge Production Number?

It has been a while since I last wrote a blog post. Since then my diabetes may’ve varied. 


You would think that there would be a web site or something that could have warned me. 




Meanwhile I have seen is a parade of type 2 medication ads on TV.  Some outstanding production numbers -  serious displays of spontaneous song and dance. 


My T2 has never been an big song and dance number. It is more just slogs along and slowly change, mostly out of sight and ignored if not totally out of mind. Eventually it moved in a way that was less than ideal. Lacking the big attention grabbing song and dance, I kinda blew it off.


I can blame some on events. I severely pulled a hamstring while being an idiot trying to waterski like I was five decades younger I am. That injury pretty much eliminated physical activity other than using the TV remote for a while. The meds that were maybe enough with activity, certainly weren’t enough without it. 


But the truth was I just didn’t care. 


There got to be a little more of me particularly in the flabby side handles department, as I hobbled around to PT trying recover from the water skiing idiocy. Not so great an effort on diabetes care on my part and it showed up in the old bloodwork. It was defiantly not production number worthy. 


I decided to care a little more. I went to see the doc and we decided on some new meds. I have transitioned back to bike rides and the occasional pickleball lesson. My ‘diet’ is probably ‘better’ than the average American’s but not totally without things my diabetes likes less than I do. 


I’ll write about this some stuff in more detail future posts. 


In the meantime, I guess if there is a lesson in all this is it, and this is a shocker I know, diabetes doesn’t go away. It just varies. I gotta care just a little even if there is still no huge song and dance number. But in all honesty, I am not a singer or a dancer and I don't want a big production. I really would just like to get about everything else and keep the diabetes mostly ignored in the background. 







September 29, 2020

MDMV



I haven't written at YDMV in a while. There are a variety of reasons and key among them is that this was started as a blog by, about, and for families (parents) with kids with diabetes. It was inspired by my kids, and in fact, blogging suggested by one of the non-T1 kids because she thought my perspective on being a parent of kids with diabetes was "different." 


From what I don't know. I do know it was a compliment. Part of different was joking about diabetes, part was not seeking perfection. Here’s one of my thoughts at the time. (2007)


We hold these truths to be self-evident, that all diabetics’ families are created equally screwed up, that they are endowed by their diabetes with certain unalienable Rights, that among these are venting about Life, Liberty, and the pursuit of Insulin. That to secure these rights, web blogs are instituted among Women and Men, deriving their just powers from the consent of the diabetic posters. That whenever dealing with the overly “helpful” non-diabetic becomes restrictive to these ends, it is the Right of the People to institute a new blog, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to affect their Safety and Happiness.


I have tried to separate parenting from the kid’s diabetes. As they became adults my roll in their diabetes has diminished. From time to time I help, if asked, often with the GAWD AWFUL logistics of getting all the crap diabetes self-management requires. So less to write about.


Meanwhile, my type 2 has continued to “progress.” A word that here means slowly requires more attention. Not sure if that means worse.  


At any rate, I guess Your Diabetes May Vary means My Diabetes May Vary too.  

December 28, 2018

Should Patients Engage in the Design of Device Trials? FDA Wants Your Views.



The device group at the Food and Drug Administration is seeking comments on Patient Engagement in Clinical Trials. Not just as trial subjects but as participants in the development of studies.


So far there are no comments. I'm willing to bet that people with diabetes have views on patients being involved in designing the trials for the devices that we use to manage our health. Now is the chance. Particularly as automated insulin delivery devices are poised to revolutionize diabetes care.

What do you think? Should FDA encourage device sponsors to include patients in the early process of defining trials? Where should devise sponsors be looking for patients with who to engage?  -  advocacy groups?

A full discussion of what they are seeking comments on can be found in the DOC or PDF files here. (1) The document runs around nine pages. But here are the reader's digest version of the discussion questions asked in the document.
• Define “patient engagement” in medical device clinical trials.
• Explain the value and positive impact of engaging patients in the design, conduct, and
communication of clinical trials.
• Describe barriers and challenges in engaging patients for clinical trials.
• Outline how and when sponsors can engage patients in the design and conduct of clinical trials.
You don't have to answer all the questions. All feedback is welcome.

Please comment into the docket at this link. (2)

Disclosure:
I am a voting member of these Patient Engagement Advisory Committee (PEAC) to which FDA posed these questions in November. FDA has subsequently asked members of PEAC to share this docket. It is open to January 8.

They are listening, so say your 2¢ now!




(1)  Links to documents: https://www.regulations.gov/document?D=FDA-2018-N-4171-0001or download a PDF here: https://www.regulations.gov/contentStreamer?documentId=FDA-2018-N-4171-0001&contentType=pdf

(2) https://www.regulations.gov/comment?D=FDA-2018-N-4171-0001  

December 13, 2018

Give Diabetes Gifts? Yeah of a kind.




My friend Will at Diabetes Mine asked about diabetes stuff and holiday gift giving. He broke possible D-gifts down into Medical gifts (tools and meds), practical gifts (diabetes-related gear, life, or kitchen supplies that aren’t purely medical), and diabetes humor gifts.

In general medical supplies including tools, possibly short of a new iPhone because it really isn't a medical device, aren't gifts. They fail the does this bring joy outside of diabetes test. That test probably should be a guide in all cases short of humor where diabetes should be the butt of the joke. While there are aspects of life with diabetes that are gifts, friendships, discovering personal strength and the like, a disease isn't grounds for a gift  - short of, I guess, an instantaneous cure.  

Practical life stuff is tough as a gift, diabetes or not. Try giving your spouse a frying pan. That is risky territory as you are likely to get hit upside the head with said pan. Practical gifts should be avoided by all but experts.  There is some nuance I would suggest the "Who Benefits?" test. If the frying pan is to make you - the giver - tasty burgers, hold off. So If the item is chore related, it is hard to see it as a gift. 

On the other hand if it something the recipient will see as fun in their scope of life then - maybe. Proceed With Caution. For example, I would like a good fry pan, but it would have to be one cool fry pan in my eyes, better for something I want to PLAY with cooking than my existing pans.  Since the key word there is play, not practical, possibly this test may invalidate Will's practical gift catagory. I think there are two important considerations in this situation. 1) Did the recipient specifically ask for the item and/or 2) is the item more hobby/joy than chore/work related. 

Other stuff disclaimer: There better be other non-chore stuff under the tree and in the stocking. 

Can you define any diabetes tool or meds as hobby/joy related? Not a chore? If so you are a ninja and don't need my advice because I can't see it. 

Humor is fair game as long as the health condition is the joke not the person with the condition. Just be sure everyone's sense of humor is aligned and see the other stuff disclaimer above. For example, my son gave me a stuffed plush toy prostate after cancer surgery. That was hysterical. 

I don't think the rules are much different with kids or adults. Maybe the sensitivity is different. Remember kids are kids. The holidays are BIG for them, and diabetes probably isn't their focus. Why bring it in? On the other hand, you can hurt an adult's feelings too. 

As a parent, any diabetes stuff needs to be outside the sibling
balance of gifts, with the possible exceptions of humor. Maybe diabetes humor should be in a balance of other fun poking humor with other kids. Cause if you poke fun at one kid's diabetes and don't poke fun at the other kids' challenges you could have more significant problems than holiday gift giving - you may be a dick.  

On the flip side of non-diabetes stocking stuffing, I was never a restrict holiday treats kind of a parent. I was always the guy packing in the Hershey's Miniatures and Reese cups; in my view - it isn't a holiday without them. It is the only time of the year I eat MrGoodbars, and I crave them Christmas morning. 

Be sure that there is parity in treat access. If the non-D kids get Hershey's kisses so do the D- kids, with the same freedom of access. Also if Reeses are low cures, from time to time they were here, then the other kids get'm too up to the last 15 carbs worth.

I don't recall any D-gifts. Years ago I put used insulin bottles on a chain of lights. They go in the tree every year.  Then I put the bacon ornament right next to them - that is our tradition.  

So, Will, my advice is that gifts are for the unique celebration of your family, tradition, and faith. Diabetes chronically sucks. Why bring suckage from any source into your individual celebration? As Bert and Earnie taught us, one of these things is not like the other. 

Of course, your diabetes may vary and it can bring gifts - the every cloud has a silver lining type. I see these a the friends that come from connection with the community. We have many, That is the kind of diabetes gift to give. 

So to all the lovely friends who help us get through the suckage of diabetes, we wish much joy with your families, revel in your traditions and find peace through your faith. While our holidays may vary, here is hoping our happiness does not. 

November 16, 2018

Verily (Google) Halts Glucose Sense Contact Lens

It made a lot of news stories since it was first announced but Verily aka Google has put the breaks on the glucose-sensing contact lens. You can read their statement here.

In part they say:
Our clinical work on the glucose-sensing lens demonstrated that there was insufficient consistency in our measurements of the correlation between tear glucose and blood glucose concentrations to support the requirements of a medical device.

Meanwhile, regular old school continuous glucose monitoring has advanced in accuracy, coverage, and its place in automated insulin delivery systems. 

The Patient Engagement Meeting Was Different




The Center for Devices and Radiological Health, the Food and Drug Administration device group, held their second Patient Engagement Advisory Committee on November 15, 2018.*

I am a voting member. I attended. Here are some of my impressions on the meeting process, which was different, in a good way.

To be clear - these are my views, not in anyway an official report of proceedings. The appropriate people will do that in due course.

What struck me is that the agency wants to engage patients. They worked hard to fit working with patients into their mandated process of public meetings. Maybe the most visible sign of that desire is the time commitment the director of the boss, Dr. Jeffrey E. Shuren gave to the meeting. He was the opening speaker and was there all day.

Less visible was the time that staff put into preparing for the meeting. They cleverly adapted existing meeting processes to patient engagement. One change was there were more opportunities for people in the audience to engage. Yes, there was the typical public comment period. Same as at other advisory committee hearings. But there were also calls from the Chairman for public comment throughout the day. That is good. What was different were roundtable discussions of questions asked of the audience.

All the people attending were invited to break up to randomly assigned tables to address questions pertinent to the day’s topic. The tables are moderated by agency staff who then summarised and reported out each tables conversations. While participation was voluntary the idea of having everyone in the audience join together and be part of the proceedings was pretty unique.

These breakout conversations were a bit of struggle to fit into the advisory meeting process. A process was in part designed to ensure that advisors on any given panel are kept separate from inappropriate influence. Like from industry or other parties. You know, no private meetings in the hallway.

That what we the panel saw and heard was through the open public process. Good meeting design - Particularly for meetings where the regulators seek advice on a device approval. The panel isn't meant to be talking privately with pharma sponsors or anyone else. In this case, since every comment at every table wasn’t publically reported out, as panel members, we couldn’t participate in those roundtable conversations. 

I would have loved to hear those conversations. I respect that Center for Devices and Radiological Health found a way to have everyone engage and that the price of that was that committee members couldn't just jump in. 



All voices = better.

Devices are critical in diabetes care. So I suggest that people with diabetes take the time to join in these meetings. You will be heard, even if I can't chat you up in the hallway.



* Two cents on acronyms. I'm finding them wearying, and I tried to edit them out.

My friend Ginger writes on early work on T2 Treatment to increase insulin production.

Interesting piece by my friend Ginger Viera at Healthline about stimulating insulin production in type 2. She writes the procedure stimulates regrowth of cells on the surface of the small intentions that are responsible to trigger insulin production. While the work is in the early stages it is potentially an interesting path for future care. The article interviews Dr. George Grunberger about the process and similarities to gastric bypass in the timing of the return of insulin production.

Good read.

I encourage you to read Ginger's piece here and the full article in Diabetes Care

November 9, 2018

Pay Attention to the Man Behind the Curtain on Drug Prices


I'm enough of a nerd that I'm a fan of the blog Drug Channels.  It is written by Adam J. Fein, Ph.D. and consistently brings smart analysis to the drug marketplace. By smart, I mean pealing back the layers of the onion and getting to the root causes of market distortions, like spiraling list prices while manufacturers face stagnant net revenue.

I found this recent piece a particularly good example of why I like it. Drug Prices After the Midterms: Five Crucial Implications of Pharmacy Benefit Design


Going beyond complaining about drug prices, Fien seeks to explain some of what is going on behind the curtain in the mostly invisible drug middle market. This is where the big companies that manage drug benefits (not make medicine or dispense it) do their thing.  The whole post is a good read but here are a few highlights.

This quote should send chills down the spine (bold text added):

Coinsurance amounts are typically based on the negotiated rate between a pharmacy and payer. These amounts typically approximate a drug’s undiscounted, pre-rebate list price. Though patients pay the list price, their employer can still collect a rebate that is not reflected in that pharmacy pricing. For some high-list/high-rebate drugs, the patient’s out-of-pocket costs can even exceed the net cost of the drug to the employer.  
That’s right: Employers can actually profit from certain drugs. Plan sponsors can hoard rebates rather than share the savings with the employees whose prescriptions generated the rebate funds.

Who is likely getting screwed over in these cases?
Employers and their PBMs typically place therapies for such chronic, complex illnesses as cancer, rheumatoid arthritis, multiple sclerosis, and HIV on the fourth and specialty tiers of benefit plans.

So IMHO, PBM reform that applies rebates at the point of sale seems like a really good place to start the conversaton on drug price reform. If anyone is serious about it. 

November 8, 2018

OmniPod & Samsung Working Together

OmniPod announced they are working with Samsung to control the Pod with select Galaxy phones.* It is an announcement of working to that end not an approval, yet. But that is good news none the less.

The announcement says they will be using Samsung security at hardware and operating system levels. Sounds positive. I'm no expert.

No word on other phones.

For the announcement details see: http://investor.insulet.com/news-releases/news-release-details/insulet-collaborates-samsung-deliver-galaxy-smartphone

From the release:
*Capabilities will be limited to select Samsung Galaxy smartphone models. Information on exact model availability will be shared at a later date.

November 2, 2018

Omnipod Announces Tidepool Loop Agreement



This very cool news from the Omnipod earnings call:



“As a first step in our support of interoperability, we are pleased to share that Insulet is the first pump partner for Tidepool’s Loop Program. For those who aren’t familiar, Tidepool is a non-profit organization that is working to get an open source, iOS-based Looped app and algorithm, approved by the FDA. Together, we are developing an interoperable, automated insulin delivery system that allows Omnipod DASH to be controlled by the Tidepool Loop algorithm from an iPhone. This partnership is additive to our internal Omnipod Horizon program and offers a potentially faster avenue to market, an automated insulin delivery system with iPhone control for our Podders, and a terrific way for us to support the DIY diabetes community.” (About 23 minutes into earnings call starts getting more interesting for PWD aka less businessy at about 20:00)


At first blush, it seemed to me that the Bluetooth Omnipod DASH offered little more than an evolutionary step for the Pod, particularly without smartphone control. Nicer new controller but still something extra to carry.


Well, now revolutionary is more accurate. They announced the path to phone control and interoperability aka multiple Automated Insulin Deliver algorithms.


WoHoo!



See 
(listen to) the earnings call https://edge.media-server.com/m6/p/c5dg8rkq