A Slice of Life with Diabetes

Diabetes Outcomes Measures Beyond Hemoglobin A1c (HbA1c).

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The FDA will be holding a public workshop regarding the above title.  This public workshop will be held on August 29, 2016.  Listed below is my letter to the FDA regarding this particular matter.

I am writing to express my comments and opinions to the Food and Drug Administration (“FDA” or “Agency”) regarding the August 29th meeting to discuss “Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c).

 

One particular question is the direct relevance and the importance to all patients living with diabetes. Improved timely outcomes need measured data to confirm that given causal actions are having on improved outcomes. We have reached a new period where we are facing a multi-generational issue. The possibility now exists for great-grand-parent(s) with seventy-five (75) years as type 1 diabetics, grandparent(s) with fifty (50) years as type 1 diabetics, parent(s) with twenty-five (25) years as type 1 diabetic(s) with a type 1 diabetic child. The number one desire is to live the healthiest life and minimize complications for all generations!

One size from the age of 2 months to 90 years makes no sense.

Are the choices for the management of diabetes Patient-Centered with consultation of our medical professionals still valid?

How many of us use a ninety day average for your local temperature to determine what to wear today?

Our baby shoes cannot be worn for our lifetime

What data needs to be collected?  When should the data be collected and how should the data be collected? This is only the start. What is missing are analytical tools and analysis to discover and observe subtle changes. One way to build confidence is to identify improvements in patients’ personal health.  Mike Hoskins wrote an excellent article entitled’ “Manipulating My A1c and Looking Beyond that Number”.   (http://www.healthline.com/diabetesmine/looking-beyond-my-A1C). His conclusions were to add the criteria of Time In-Range, Hypos, and Glucose Variability. My salient point to each of you is the following: Blood flows through the body like a moving river. A river will ebb and flow over time. We need current succinct data to make micro adjustments and maintain a “normal glucose range”.   How quickly can a directional signal of an approaching hypoglycemic state be stopped, blocked and turned around to return to a normal blood glucose level as quickly as possible, ASAP! In May 2014, I complied with Medicare and signed up. As a Dexcom CGM user. I found myself in a fight to overcome the position that a CGM was precautionary. My experiences are documented in the following article. (http://www.ajmc.com/journals/evidence-based-diabetes-management/2016/may-2016/a-medicare-appeal-for-cgm-coverage-one-patients-never-ending-story). At the end of the article on page 3, go to the pdf and review the five (5) Figures. Figures 4 and 5 are the critical graphs prepared from the earlier supporting data contained in Figures 1-3. Two of the graphs are at the end of the article. One item that did not appear in the article is the fact that my A1c on 2-24-2016 was 7.0%.Based upon my fifty-year history. It is the lack of collection of what I refer to as soft data. The operative questions in need of analysis are: What, When and How have given me a personal insight in the challenges to live a healthy life with diabetes. As one example, I have found that exercise in the early morning, late morning, early afternoon, late afternoon, early evening and late evening can have very different impacts on my insulin needs and the ability to maintain a normal range.   This is just one example of the variability of life. The real objective is the need to make timely micro adjustments with new tools to maintain or return to a normal glucose level in the same manner as a non-diabetic.      The size of the data base has exploded. How many of you have observed the comprehensive statistical reports from Diasend. Individual data reports or individual diabetic equipment which measures only a certain set of variables can present a major challenge in attempting to coordinate and quantify patient data.

Diabetes is a highly burdensome, 24/7 disease with no time off. It is my position that having multiple backup systems should any one of the units fail for whatever reason. Failure of equipment is unacceptable. The coordination of tools should be focused on the best possible outcomes for the individual patient and determined in conjunction with one’s physician.

It is my position that my endocrinologist is the head coach of my medical team. When I step on the field of life, it is my desire to be prepared with the best equipment and life plan to successfully navigate the personal daily, hourly and each and every minute which I confront as a type 1 diabetic. I will do and I (along with my medical team) will understand. Meaning as a diabetic patient, I need to take the best, appropriate action at a given moment in time. My action precedes the understanding which comes with documentation over time and can be best managed with a doctor patient relationship regardless of the age of the diabetic patient.

The operative question before the FDA should be patient based. How can patients in consultation with their doctors determine a choice of action that has the highest probability of success? Again one size does not fit all the time for all the diabetic people.

The FDA decisions should not be centered on the choice of an either or, binary choice. Meaning, it is not a choice between new single item(s). Coordination and sharing of data, information, will reduce time and facilitate the review of the data.

 

The operative question before the FDA should be patient based. How can patients in consultation with their doctors determine a choice of action that has the highest probability of success? Again one size does not fit all the time for all the diabetic people.

It is my position that my endocrinologist is the head coach of my medical team. When I step on the field of life, it is my desire to be prepared with the best equipment and life plan to successfully navigate the personal daily, hourly and each and every minute which I confront as a type 1 diabetic. I will do and I (along with my medical team) will understand. Meaning as a diabetic patient, I need to take the best, appropriate action at a given moment in time. My action precedes the understanding which comes with documentation over time and can be best managed with a doctor patient relationship regardless of the age of the diabetic patient.

Diabetes is a highly burdensome, 24/7 disease with no time off. It is my position that having multiple backup systems should any one of the units fail for whatever reason. Failure of equipment is unacceptable. The coordination of tools should be focused on the best possible outcomes for the individual patient and determined in conjunction with one’s physician.

Respectfully submitted,

 

The post below is from the http://diatribe.org/BeyondA1c . It has the links for following this meeting on August 29th.  A special thanks to all the members of the Diabetes Online Community for their support on this important matter.  As always have a great day.

To learn more about the FDA Public Workshop on Diabetes Outcome Measures Beyond Hemoglobin A1c, click here for a blog post by the diaTribe team. Stay tuned for event updates on Monday evening, and check out diaTribe’s Facebook Livestream feed, direct from the FDA, on August 29. We’ll also be live-tweeting the day, along with numerous other diabetes advocates from all over the country – keep an eye on #beyondA1c and #DOCasksFDA. We’ll be very excited to see so many patient opinions shared through a video, patient impressions, and a patient survey – stay tuned and be sure to let us know of any questions or comments you have! – See more at: http://diatribe.org/BeyondA1c#sthash.6xMAl80N.dpuf

 

 

 

 

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