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.