June 2, 2015

Of Spinal Tap, One Louder and Advocacy

Diabetes advocacy can learn from the great philosopher, Nigel Tufnel, who offered this sage observation, “Well, it's one louder, isn't it?


We need to turn up the volume and to keep it up. Why? The diabetes caucus is the largest in the US Congress, yet many pieces of diabetes legislation lack the support of those very caucus members.
Worse, in the current policy environment the squeaky wheel is going to get cut less, the other are going to get slaughtered. Diabetes needs to turn it up. We can't let them just move on after checking the diabetes box. So we to turn up the advocacy volume to help keep attention and accountability on diabetes.

But, I hear you say, “Just taking care of diabetes is a time major attention already, advocacy is just more.” 

No kidding. So advocacy needs to be easy. Click simple. OK, it will be. I am proud to partner with Christel in creating the Diabetes Patient Advocacy Coalition (DPAC.) Join us.


DPAC is a non-profit and non-partisan organization founded to provide united, simple, and effective advocacy opportunities for people impacted by diabetes for safety, quality and accessibility of care.
DPAC will keep track of issues, opportunities, and how to contact officials and make it easy to advocate.


Be one louder. 

Dexcom on Android


From press release: 

Dexcom® Announces Follow App is Now Available for Android Devices

Caregivers and Loved Ones of People with Diabetes Now Have Access to Life-Saving Glucose Data on their Android Devices

SAN DIEGO--()--Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the Dexcom Follow app is now compatible with Android devices. The app is a component of the Dexcom G4® PLATINUM Continuous Glucose Monitor System with Share™, the industry’s first mobile-connected CGM system. Already available to iOS-enabled devices, the Follow app allows family members, friends and caregivers (“Followers”) to remotely view a loved one’s glucose data and trends on their smart device, giving them peace of mind and reassurance when they are apart. CGM users (“Sharers”) can invite up to five Followers to view their glucose information via the Follow app. The Followers can view the Sharer’s glucose data and trends, as well as choose to receive alerts and notifications when the Sharer’s glucose levels are outside specified ranges.
More

This is the Follow app, not the Share tool, it is still on iOS. But it is a step in the right direction. 

May 27, 2015

Lilly Humalog U-200 KwikPen Approved.

Lilly announced FDA approval of U-200 Humalog in a release today

U.S. Food and Drug Administration Approves Humalog® 200 units/mL KwikPen® 
Marks approval of first concentrated mealtime insulin analog in the U.S. and expands Lilly's portfolio of medicines for people with type 1 and type 2 diabetes 
INDIANAPOLISMay 27, 2015 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company (NYSE: LLY) announced today. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog 
Humalog U-200 KwikPen holds twice as many units of insulin (600 units vs. 300 units) as the U-100 formulation in the same three-milliliter cartridge. This offers patients a pen that lasts longer between pen changes, allowing for fewer changes every month.* Humalog U-200 KwikPen delivers the same dose in half the volume of Humalog U-100 KwikPen with no dose conversions required, and can be dialed in one-unit increments to a maximum of 60 units per injection.

May 26, 2015

DSMALive - 'Rents talks Bionic Pancreas June 1

Join Lorraine and I as DSMALive 'Rents talks with Scott K Scolnick, M.Ed. 
Scott has had type 1 diabetes for nearly 40 years.  In his professional life, he has worn many different hats.  He has his Masters in Counseling Psychology with a focus on marriage and family therapy.  He worked in that area for 18 years.  He has worked for two pump companies for over 12 years.  During this time, he did talks around the country on dealing with the Emotional Impact of Diabetes.  In 2013, Scott had the opportunity to be a subject in the Beacon Hill Study, in Boston, using the Bionic Pancreas.  Most recently, he joined Boston University and is working in the College of Biomedical Engineering where is working with Ed Damiano and his team on the Bionic Pancreas.  Scott with present the results of past as well as current clinical studies with this dual hormone system.  He will also share the plans for the final pivitol studies and submission to the FDA.  

http://www.blogtalkradio.com/diabetessocmed/2015/06/02/dsmalive-rents-bionic-pancreas--scott-scolnick

May 13, 2015

A conversation with the DOC and FDA

A conversation on device labels with friends identified by three letter abbreviations.

I have enjoyed being a go-between connecting friends in the DOC with friends at FDA for a conversation about device labeling. FDA reached out for some informal feedback. I in turn asked the DOC to share thoughts to help balance what I share. 

This essay is a summary of that conversation. My goal is simply to foster wider, open, and respectful conversation between all. 

Labels = Instructions
Labels are being used here to means the instructions for devices. Currently, it is an everyone creates their own kind of label world when it comes to the format of instructions.  So the question is would some standardization help? I was fairly sure I am not the best person to ask. Fortunately, I’m only one of a number of folks they called, and the hope was I would ask around. I am a fan of patient voices in the process. I think that FDA is a reaching out, for users views, is fantastic.  

My 2¢
My thoughts, based on no particular expertise, are that some flexible suggestions to design instructions may help. Particularly if it is more a template, which could ease developing, reviewing, and using device labels. 

Obviously focusing on simpler to write, review and use is better than harder to write, more time-consuming to regulate and difficult to sort through. I’m for well indexed, simple, effective language and clear illustrations. I don’t think anyone is looking for more onerous regulation.

I suspect that more complex tools need more detailed instructions, and simple stuff needs less. The risk of using the devices incorrectly matters, more risk needs better instructions (and better design up front.)  Syringes are fairly simple, pumps require a more complex set of user actions and artificial pancreas when it get here, I hope will bring sophistication AND simplicity of use - we will see.

What do people in the community think?

I informally polled the Diabetes Online Community (DOC) in three broad areas:
The process of considering instruction policy 
What is important in the label
How should the instruction be accessible

My hope was that asking these would also generate some thoughtful, open ended comments. The DOC did not let me down. Over a hundred folks took the survey and many shared detailed views. WoHoo! Still this is not a scientific survey. There are some obvious biases like it was done online, in English, it was quickly tossed together, etcetera. 

Still - It does help sift through ideas - what floats to the top and what sinks to the bottom. To do that, I used a weighted average.  I have listed all in the tables below. 

The top response had to do with what is in the label, specifically clear instructions for use and risk. Three of the remaining to 5 spots 3 were about how to get information suggesting folks see value in multiple ways to do that, phone support, a copy online and online support center. Lastly, the top five includes one item on the process: Keep the process simple enough to avoid fueling cost increases to comply with rules. The top 5 response are in various shades of green below.  

Clear easy, to access and don’t fuel costs with instruction processes. 

Next are, include patients, have image based instructions and have clear uniform instructions for reporting device errors to FDA.  Followed by including a printed copy with the device and standard format elements. 

The final five still all score in the range between important and more important than average, suggesting tall this stuff matters. Standardizing the formats of instructions with tables of contents, etc. is second to the bottom. Risk adjusting and FAQ seem less important to this group as well. Multi-language ranked last, and the comments maybe provide some insight why.

A number of comments spoke to the volume of labeling that consumers thrown away. One spoke directly to languages and paper use.

Comments
Each comment received is included below, unedited, because each individuals’ view matters. I have group individual comments into broad themes.

The most common theme of individual comments relates to accessing information:  
  • The very first item of these questions is most important - get input from end users - and not just college graduate level people - not everyone has a college degree or extensive knowledge even about Diabetes (like the people working for the manufacturers. They may know the product upside and backwards and how it works could be deep in their brain, but think about who your end users are - it may include children, and granted parents will likely be there helping them, but sometimes it's a school nurse who does not have extensive Diabetes device expertise. Almost anyone should be able to pick up the instructions and "get it" with relative ease.
  • An 'at a glance' version, like the one that came with our Dexcom is extremely helpful for devices which come with large instruction manuals. This is something that reviews the very basic instructions for use and the most common troubleshooting issues.
  • I wonder if this shouldn't apply to software, too. As apps become more common, users need ready access to manufacturers for comments, complaints and issues.
  • Yes I do. It's important people get educated on pumps and cgms. I know it seems low risk but you are pumping drugs into your body that could kill you if you don't check your blood sugar often!
  • Where is the line between the labeling and the user manual? The user guide needs to be pretty thorough. But they are never written well enough or thorough enough to cover every situation. Having access to online and, if possible, phone help is key for more complicated devices like insulin pumps. I am very much in favor of adjusting documentation requirements with device complexity, risk level, and even price point. Requiring a consistent table of contents sounds like specious precision that might actually inhibit the transmission of useful info.
  • You tube videos are a nice to have - I just do not have time to look at them. I completely rely on the manufacturer's documentation that accompanies the product. Instructive product videos generally should be clear - not someone blabbing and making jokes about the product (although humor always helps people learn better and gives the user a better memory of something that may not be so fun to deal with. (Last year Delta did a really cute pre-flight instruction video - everyone actually watched it. It was fun.) 
  • Visuals must be intuitive - photo pictures are better than drawings and it's ok to also include Words with the photos to explain the process. (e.g. I just looked at a visual guide for the Medtronic Mio and Quick Set pump tubing- they were so confusing (these entire products are confusing!) Quick start up guides and FAQs are also great. They should be based on actual user experience (e.g. obtained during clinical trials or general issues that people often encounter.)
  • Consistency helps us understand.
  • the data is ours and we should have a right to use it how we please
  • Publish "ingredients"-like list of materials that may have adverse interactions (i.e. adhesives -- what type is used? certain types are irritating for certain people. if wireless technology is used, what is the RF frequency (transmit and receive) and power level? also, don't make labeling so restrictive/subject to approval that it can't be modified over time with minimal effort to provide more details, troubleshooting FAQs, etc, that are discovered to be helpful after the device is on the market

The volume of printed material and ongoing use of devices and supplies.
  • I know it is impractical, but after the first few months of using the devices, I don't look at the printed information. Can there be a way to cut out the cost of printing labels on " refills"?
  • Please don't use this as an excuse to increase packaging.
  • I get very frustrated when i have pump sets coming with HUGE manuals every time i buy them. i have been using the same exact sets for a decade now, and they still give me the manual. it would be helpful and also more friendly for the environment if an educated patient (by the pump company or whatever) would not need to receive this every time. please also note that i am not from the U.S.
  • Minimize the paperwork that comes with the devices to essentials and include URLs to more in depth info. I never read all of the info that comes with my devices because there's too much of it. Ain't got no time for that!
  • Other languages are important for people speaking those languages but I'm in the US and I speak English and I think it's a waste of paper to include 10 different languages on instructions for me & my kid. But I realize it could be very challenging from a manufacturing and packaging perspective to differentiate which language to provide - maybe just include English ad Spanish in the US and perhaps a scanning code to quickly view other languages online? However, some people may not have the ability to to access this.) 

Cost and burden
  • I gave a slightly lower "importance level" on reporting device issues to the FDA on the actual product thinking that people can go to the FDA website for that information but even that can enormously confusing for an end user who is not familiar with all of the different areas of the FDA. So the FDA should have user-friendly standardized language including the appropriate website that all device manufacturer's use on their product labels.
  • Keep costs low so that more Type 1 diabetics have a chance at a somewhat "normal" life, with less testing and better BG control!!! It's all about dignity and the right to a healthy life! 
  • This isn't a real problem at present. Adding requirements here is a mistaken burdening of resources.
  • These are great as long as they don't further slow down the process of getting our devices. Hurry up with the artificial pancreas already!!!!!!!!!!!!

Usability
  • Minimum size, contrast of font color to make it easier to read. Size, quantity must be specified in metric units also.
  • Key word searchable DFUs should be available online.

Support
  • I have an Omnipod pump and Dexcom. I love the support from Dexcom, Omnipod is easy, but their online support has been condescending. Keeping it simple, with online info and support works for me.
  • Customer service reps - must have experience with the device (even better if they actually live with the disease and use the product but this may not always be feasible.) (E.g. On numerous occassions, I have called Omnipod (Insulet) Customer Service and most of the time they are clueless and it's like a battle getting information from them. Customers calling a manufacturer for help may be very upset, they not be feeling well or have a sick child to deal with. They should be trained on compassion skills.

Survey Results
The First table list the survey questions in the groups and order asked. People were asked to respond to each as Unimportant, Matters a Little, Important, More than Average, Very Important. 

The top 5 based on a weighted average are in descending shades of green. The rest are shade from yellow shifting to shades of to orange. All that color may make it confusing and a second table ranks all regardless of the group in descending average rank order. 




Group & Questions
Average Score
Rank
About the Process Making Device Label Rules - How important is it to:


Include patients in the process of creating label regulations.
4.16
6
Have standard formats for elements of device labels, like tables of contents.
3.94
10
Adjust label requirements for risk, less rules for low risk devices.
3.86
13
Keep process simple enough to avoid fueling cost increases to comply with rules.
4.46
4
About What is in Device Labels: How important are:


Clear instructions for use and risk.
4.64
1
Have standard formats for elements of device labels, like tables of contents.
3.85
14
Frequently Asked Questions.
3.87
12
Have clear uniform instructions for reporting device errors to FDA.
4.10
8
Outlining the information needed for a meaningful device event report.
3.93
11
About Accessing Device Labels: How important are:


There is a printed copy that comes with the devices.
3.94
9
Access to a customer support phone number
4.60
2
Make a copy available online
4.51
3
Provide online support center
4.39
5
Image based instructions
4.11
7
Multilingual resources
3.56
15




Question 
Average
Clear instructions for use and risk.
4.64
Access to a customer support phone number
4.60
Make a copy available online
4.51
Keep process simple enough to avoid fueling cost increases to comply with rules.
4.46
Provide online support center
4.39
Include patients in the process of creating label regulations.
4.16
Image based instructions
4.11
Have clear uniform instructions for reporting device errors to FDA.
4.10
There is a printed copy that comes with the devices.
3.94
Have standard formats for elements of device labels, like tables of contents.
3.94
Outlining the information needed for a meaningful device event report.
3.93
Frequently Asked Questions.
3.87
Adjust label requirements for risk, less rules for low risk devices.
3.86
Have standard formats for elements of device labels, like tables of contents.
3.85
Multilingual resources
3.56


April 27, 2015

What matters to you about device instructions?


Friends at the FDA called. 


Yes, I have friends there. 


They were looking for thoughts on device labeling and wondered if I could ask around. 

Sure, what are friends for? 

I would love to help funnel back thoughts to them from the DOC, not just my 2¢. It is all very informal but I hope, maybe, we can help them organize their thinking if they get to more formal asking. 

Willing to help?


Background:
Here is the little of what I know, labels are the instructions on how to use a device, what it is intended to do and what to do if there is a problem.  

RAPS aka Regulatory Affairs Professionals Society notes that unlike drugs devices do not have standardized labeling. “Under 21 CFR 801, medical device manufacturers are required to label their products with certain information, but the format and layout of that information is for the most part left up to the discretion of the manufacturer.” 1

Given that devices range from fairly simple to very complex it may make sense not to have a one size fits all standard. My BG meter is not the same level of sophistication as the CAT scanner at hospital, even if both are medial devices.

In this case FDA is asking about home-use devices. In the diabetes world that is a wide range of things from meters, insulin pens, pumps, CGMs, uploading software and more.

In a recent document FDA said this about home-use device labels:
Medical device labeling provides safety information, instructions for use, and/or other necessary information to the user. This labeling can be essential for home-use devices, which are much more likely to be used by lay users, who frequently have not been trained to use such medical devices and who are especially reliant on the instructions for use and other information provided by the device label and package insert.  2

AdvaMed the medical device association in 2013 said, "The development of a standardized Table of Contents (TOC) for device Instructions for Use (IFU) may be a useful tool if adequate allowances are made for the broad range of device types, users and environments."  3

So there we have the RAPS, FDA and AdvaMed, A.K.A. a bowl of Alphabits of regulatory professionals, regulators and industry. 



Notice a key group missing? Me too - Users, AKA patients. Maybe that is why they called. 


Here is my ask - take this quick survey. I made it up - none of it is their's. I’ll summarize the results for my friends at FDA and if you would like to see those too, share your contact information at the end of the survey and I send you what I send them. 

https://www.surveymonkey.com/s/MQ9BKQQ



Thanks



Sources:




Help a Dad asking for better education.

Tom Karlya, aka Diabetes Dad reached out and asked for help getting the word out on a North Carolina diabetes education ask.

I'm happy to help share.

The effort is to help provide education about the symptoms of diabetes so that kids are not sent home entering DKA with a suspected flu or other childhood bug. Tom outlines the issue better than I. Like so many advocacy issues this popped up at the last second. All the more reason we need a strong advocacy database.

http://diabetesdad.org/2015/04/27/today-the-world-changes-but-we-must-act-by-2pm-est-please-help/