My quest for the Holy Grail — wearing the closed-loop, artificial pancreas technology at UVA — hit a small speed bump on the road this week. My search results: U.S. Food and Drug Administration’s health guidelines 1, Mike Anderson clinical trial participant 0.
Last Monday, I made a new pilgrimage on I-64 West to Charlottesville to take my health screen, step 1 of my hoped-for-admittance into a Mother’s Day weekend outpatient trial at the UVA Center for Diabetes Technology. If I passed the screen I would be rewarded with 2 overnight stays in an economy hotel adjacent to the university and the opportunity to actually “Wear” a working prototype of the closed loop artificial pancreas technology!
At the heart of the system is a novel hand-held device developed by a UVA research team, led by Patrick Keith-Hynes, PhD, and Boris Kovatchev, PhD. The device uses a “smart” algorithm that automatically delivers insulin and regulates a person’s blood sugar levels — taking much of the burden of constant monitoring off the patient. Inside the normal looking droid phone would be the “brain,” that would be smart enough to take over my glucose management for 24 hours and achieve nearly perfect control without my assistance. In this hospital test, a “straight line” means life NOT death for Type 1 diabetics. To say I was excited to see the APP in action, would be the understatement of the year.
To make a long story fit into a blogger’s attention span, however, I did not pass the FDA-required screen because my Hematocrit came back with a score of 39.5. The FDA minimum threshold for acceptance — 40.0.
Yes, I missed it by “that” much. So, I wondered, am I sick if I couldn’t score a 40? And why is my Hematocrit costing me a date with the APP? Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells. This measurement depends on the number of red blood cells and the size of red blood cells. Normal results vary, but in general are as follows:
- Male: 40.7 – 50.3%
- Female: 36.1 – 44.3%
Normal value ranges vary slightly among different laboratories, and you should always consult with your doctor on lab results before making changes to diet.
When Daniel Cherñavvsky, MD, called me with my UVA lab results I could not believe it. However, this was not a score that could be “managed” or “finessed” or worked around, Dr. Danny said. The FDA requirements are in place for the health and safety of clinical trial participants like me. The “irony is,” I’ve passed this same Hematocrit screen twice before and participated safely in two clinical trials where blood was drawn continuously for 12 hours! The new outpatient AP trial is only taking blood via finger sticks, so, I’m confident I’m “Iron Man” enough for this new study.
The good news about the bad new is that the May trial is the “proof of concept,” the first of what should be many more outpatient clinical trials in the coming months at UVA and four other universities in the USA and Europe.
So, I’ve got some work to do in the coming months if I wish to qualify.
- Eat more red meat. Eat more leafy green vegetables.
- Check with my Endo and start taking a low-dose, slow release iron supplement once a day.
- Exercise as much as possible, drinks lots of water and get more rest.
I wonder if that’s how all great explorers prepared for their quest? So check back here very soon for a real-time, live blog report of the closed-loop AP in action. The future is coming thanks to the awesome team at UVa. Together, We R the Cure.