An Experiment in Empathy

When the new Dexcom G4 arrived earlier this week, I was excited on two counts:

First, we could pick up Luke’s blood sugar from his room (no more clunky white baby monitor to pick up alarms), from the parents’ seats at Aikido practice, and from other rooms at friends’ houses.

Second, I could try on the old Dex and see how it felt.

This seemed a little unseemly, taking D-mama empathy a bit far, but I wanted to know if Luke’s occasional complaints about the Dex hurting him were genuine or pre-schooler exaggeration, and I wanted to know what normal blood sugar looked like. When Luke was diagnosed, I left the hospital with the impression that normal blood sugar stayed strictly between 80-100 at all times. I’d learned since that there’s more variation, but I had no idea how much.

What I found was both a relief and slightly dismaying. A relief, because much of the day our blood sugars weren’t dramatically different (it was a good day – don’t get the wrong idea). A shared banana first thing in the morning spiked us both – but my pancreas kicked in to  level out blood sugar, while Luke’s synthetic insulin took a while longer to flatten out the rise. (The old Dex showing my blood sugar is on the left, and the new G4 showing Luke’s is on the right. Apparently I experienced the “dawn phenomenon” spike just before waking up – Luke’s still too young for that.)

There were moments when Luke’s blood sugar went higher or lower than I could follow – and what can you do but sigh and bolus or hand over the juice. What surprised me was how uncomfortably aware I still am, several days in, of the Dex wire under the back of my arm. It twinges when I roll over on it at night, and it’s faintly sore during the day. Maybe it’s a bad spot or I’m just not hardened yet to pokes and discomfort, but my heart sank when Luke complained this afternoon that the new Dex (which has a smaller wire) hurt his arm.

But the moment passed, and it keeps him safer at night and during the day, so we’ll stick with it. He needs something to tell stories about when he’s older – some equivalent of the old days of boiling glass syringes and sharpening needles on a whetstone. Maybe he’ll have a CGM by then that reads blood glucose via light through the skin, or maybe by then we’ll have something even closer to a cure.

MicroCHIPS – 1st successful human trial!

A friend who keeps up on the latest scientific developments (he retired from IT to a beach in Malaysia – the choices we make in life…) just sent me a link to successful human trials of  a wirelessly controlled microchip, implanted in the body, that delivers drugs more precisely than injections. Move over, Fantastic Voyage! (Note that the human trials took place in Denmark – move over, FDA.)

This was still a prototype last year, and now – ‘These programmable chips could dramatically change treatment not only for osteoporosis, but also for many other diseases…that require frequent or daily injections…” says Robert Farra, president and chief operating officer at MicroCHIPS and lead author of the paper.
“Compliance is very important in a lot of drug regimens, and it can be very difficult to get patients to accept a drug regimen where they have to give themselves injections,” says Cima, the David H. Koch Professor of Engineering at MIT. “This avoids the compliance issue completely, and points to a future where you have fully automated drug regimens.”

You thinking what I’m thinking?

I don’t think we have insulin concentrated enough yet to fit into a 1mm microchip, but if someone developed concentrated, stable glucagon, my wish would be to have a wirelessly controlled chip of the stuff synched up with our Dex and lovingly injected into our son, so I’d know that day or night, GI bug or other wackiness, his blood sugar could be instantly brought back up to safe levels. Insulin is grand – it’s the stuff that keeps him ticking like the little Energizer bunny he is – but I’m tired of driving Luke without a real emergency brake.

Go, MicroCHIPS, go! I can wait till 2014 for you to file for regulatory approval. Really. And if you get CE approval first, well – I’ve always wanted our family to live overseas at some point.

And the FDA’s heart grew three sizes that day…!

And what happened then…?

Well…in Who-ville they say

That the FDA’s small heart grew three sizes that day!

And the minute his heart didn’t feel quite so tight,

He whizzed with his load in the bright morning light!

He brought the T:slim, iBGStar, iPro2, and the Veo!

And he… HE HIMSELF…!

Gave AP draft guidance the OK-o!

No one’s getting these in their stockings yet, but the ice may be melting as approvals for new products and trials trickle through.

Jeffrey Brewer (JDRF) just posted a thank you to everyone who helped bring about the FDA’s Artificial Pancreas guidance approval (which covers requirements for in-home AP trials), and it’s quite the list: endocrinologists, diabetes organizations (AACE, ADA, AADE, Endocrine Society), Children’s Congress participants, Congressional members (see? – they did accomplish something this year!), grass-roots advocates, petition signers, and the T1D community in general. Likely that includes YOU.

JDRF’s still waiting to see how guidance requirements will really play out when trials get underway, but they’re ”cautiously optimistic.” Joshua Levy and Amy Tendrich have great analyses.

As Suess would say – with everyone making a racket, the FDA heard loud and clear,

We are here! We are here! We are here! We are here!

Tidbits from JDRF’s Seattle – Sweden Diabetes Conference

This weekend, instead of enjoying the very last day of sun in Seattle, Erik and I went to JDRF NW’s 6th annual Seattle-Sweden Diabetes Awareness Day - and were so glad we did. The event brings top researchers from the US and Sweden together to give updates on their work, much of it immediately applicable to daily life with T1D. JDRF recorded all talks and will post them online, but these pieces of information were highlights for me (most of the talks focused on kids, so apologies to adult PWDs):

Hope!

• 2-3 years after diagnosis, most kids are still producing insulin and c-peptides
• Overall A1Cs have been steadily dropping over the years
• Daily exercise lowers A1Cs on average by 1 point
• Based on genetic and antibody testing, we can now predict development of T1D with 60% accuracy  (another study had 85%), and onset can be delayed by up to 4 years.  This would hugely cut down on the # of kids who are in full DKA by the time they’re diagnosed (50% of kids under 2).
  See TrialNet on how to get screened.
•  Only half of T1 risk is genetic (at dx, only about 90% have it in their family) – the rest is environmental, which means there’s hope for prevention. One possible trigger may be illness without fever, whic increases the risk of developing antibodies by 3X! Fever actually reduced the risk. When a parent in the audience brought up that using Tylenol with vaccinations seemed to dampen the immune response and asked whether researchers would recommend not giving Tylenol for fevers, the circumspect answer was essentially “Yes.”
• There are many brilliant, humble, passionate researchers around the globe working and collaborating on detection, prevention, management, and a cure. Obvious, true, but it makes an impression to see so many in one place on one day.

Dealing with Lows (esp. after exercise)

• Night time really is different: even children without T1D have a blunted response to (mild) hypos during sleep.
• One hypo puts you at risk for another, because the liver’s glucose supply has already been tapped.
• The night after exercise, hypos usually occur betwee 12-2am.
  Suggestion (for pumps): use  -20% basal from 9pm – 3am, and suspend or drastically lower basal during exercise. And (as MDI users know), eat protein before bed – it turns to sugar overnight and helps buoy BGs.

Most interesting

I love how much data the Swedes have about T1 (the CDC has just started tracking it)! All kinds of interesting points came up:

• A1Cs by city vary widely, which shows that higher A1Cs aren’t just the individual’s fault. Heatlth care policies have huge impact (shocker).
• Most children are diagnosed during fall and winter. They didn’t suggest a reason, but there’s annecdotal evidence that abrupt temperature changes from warm to cold may trigger T1. There’s a theory that diabetes in humans may have developed during the Ice Age as an adaptation to extreme cold, with higher blood sugar preventing frostbite.
• There are gender differences that need to be understood:
  Girls have a higher a1c than boys right from the start, but the difference disappears (oddly enough) by the time boys and girls are 15 years old.
  Men are more likely to develop complications.

What’s unique about WA state

• WA and CO have the highest rates of T1 in the country (a vote for sunnier climes)
• WA state is hardest place in the country to get CGMs and even pump supplies . For whatever reason, insurance companies push back harder here, and there are many hurdles to jump through. (This year’s HTA fight was just one example.)

Something to keep an eye out for:

• Dr. Hirsch gave a very unsettling talk about “biosimilars” (generics): In the next few years, patents for most insulins now in use will expire. Insurance companies will be pushing for people to use biosimilars, but the FDA rules around production are so vague that it’s not clear in what ways biosimilars will be allowed to vary. “Would you give a biosimilar to your 3 year old or 80 year old grandmother?” Dr. Hirsch asked. “I wouldn’t.”

The latest on the Artificial Pancreas (Aaron Kowalski):

• The Medtronic Veo (which shuts off insulin delivery when blood sugar is low) is available in every single country that sells pumps except the US! 50k Veo pumps have been sold outside the US, with no incidents of DKA (as the FDA fears) and many of hypos averted by shutoffs.
• The next step in the artificial pancreas would be predictive algorithms, which research has shown prevent 75% of hypos. With A1C of 6.5, for example, you’re spending 1.5 hrs of day low – reducing that by 75% would mean just 20 minutes a day.

It Takes a Village

• An international NovoNordisk Dawn study found that family & social support are the key factor in living well with T1D (having lower A1Cs, less depression, etc.). This runs counter to the traditional view that puts the onus of responsibility on the patient, and it makes sense that the burden is more easily carried and better dealt with when shared.

There were a few laughs…

• There was a dark laugh at mention of the WA state HTA’s assessment that the impact of blood sugar testing was controversial, and that frequent testing lead to depression and hurt the fingers. I learned more about the back story: the state’s committee had actually done a comprehensive data review, but because the reviewers had no diabetes expertise and were looking primarily for cost savings, they didn’t draw the right conclusions. Fortunately, experts (and parents, PWDs, and the JDRF) had a chance to submit research and testimony that turned around the decision.
• If you’ve ever heard Aaron Kowalski talk, you know about his obsession with diet soda. Throwing his arms wide at the conference (held at Microsoft) and gesturing to the fridges stocked with free diet soda, he grinned, “I love this place!”