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Posts tagged ‘science’

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.

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!”

JDRF Seattle Sweden Diabetes Day – Sept. 24

This sounds bland but is a really fantastic opportunity to hear about the latest in T1 research nationally and internationally. If you live in Puget Sound, sign up now!

JDRF puts this on every year and pulls in top researchers, CDEs, pump and CGM reps, and other experts. Last year’s line-up included updates on the artificial pancreas; best practices for diabetes management by Ragnar Hanas (author of Type 1 Diabetes – best book I’ve read on T1 management); a joint US/Sweden epidemiological analysis of T1 increase, prevalence, etc.; future Medtronic plans; a keynote by Jeffrey Brewer (the man is an incredible speaker) on JDRF’s future direction; and I’ll just stop here. It was amazing.

There’s time for Q&A with each talk as well. My favorite question was from a woman who noted that beta cell count increases during pregnancy, so – aside from encouraging her 18 year old daughter to get pregnant, what other options were out there for increasing beta cells…?

Register here.

JDRF NW got a larger room this year so more can attend (it filled up immediately last year) – it’s again at the Microsoft Commons on the Microsoft campus in Redmond.   There will be on-site care (Kids Zone): contact the JDRF Northwest Chapter office at jdrfnorthwest@jdrf.org or call 206-838-5153.

Stem/Islet Cell Implants

Two news items just popped up about implanted, encapsulated beta cells – one of the potential cures lurking tantilizingly on the horizon. Implants would would effectively solve the autoimmune part of T1 (the trickiest part to solve) by shielding the cells from T-cell attack.

And perhaps not so distant – Joshua Levy just posted that this year, 28 people in Argentina will take part in LCT’s second Phase II human trials of implanted, encapsulated pig islet cells. The first phase was moderately successful – people needed little or no insulin for a few weeks to a few months.  (Joshua’s blog is a great resource r.e. potential treatments in human trials – as he points out, mice have been cured over and over again.)

A bit further out (target date – 2013) ViaCyte is proposing Phase 1 trials of an implanted pouch of stem cells that become functioning beta cells. (The article is vague about exactly how and when the stem cells in the pouch get turned into beta cells once implanted.) Yes, they have cured hundreds of mice with this technique. 🙂 But what gives me hope is actually the cautious phrasing of CIRM’s (California Institute of Regenerative Medicine) president: “What people want is a single, one-time cure. I don’t see that happening in the foreseeable future.” But, he adds, this might be a step in the right direction.

For some personal accounts from people who’ve had islet cell transplants, check out My New Islets, Hope – I still have it…for stem cells, My Life and My Islets, and Nicole’s Pancreatic Transplant blog.