There were a number of encouraging news announcements this week here in Florida about progress on the JDRF’s Artificial Pancreas Project. The most prominent of those is today’s unveiling of the results of the STAR 3 Trial (Sensor-Augmented Pump Therapy for A1C Reduction) that showed adults, teens and children achieving a 4x reduction in A1C levels using this tech-heavy therapy versus patients on injections.
The STAR study, sponsored by Medtronic, was conducted at 30 clinics in the US and Canada. A total of 485 patients participated, ranging from age 7 to 70 (329 adult and 156 children). The study group used a pump and Medtronic CGM, while the control group used daily injections. After a full year of observation, researchers found that more than 81% of those using the “sensor-augmented pump therapy” were able to reduce their A1C levels by an average of a full percent point.
Also, of the kids and teens in the study, nearly 44% of those using the pump/CGM regularly achieved their daily glucose targets, versus only 20% of those using shots.
Personally, I would argue that in the aggregate, people get better results on
a pump than on shots anyway — but adding the CGM sensor was a bit like outfitting one set of spies with old-school binoculars and another with a full Agent 007 spy gear set. Who do you think will perform better?
Nevertheless, the STAR 3 study is important because it’s the first solid data collected to confirm that a “pre-closed-loop” system (pump + CGM) provides superior glucose control, especially for kids and adolescents, “an age group that is particularly challenging to treat due to the social and psychological changes… of growth and maturation.”
Meanwhile, another study from the University of Cambridge presented at the ADA this weekend showed that a complete artificial pancreas system (sensor and pump + algorithms to automate dosing) can improve overnight glucose control without increasing risk of hypoglycemia “across a range of real-life situations.” This study was conducted in a clinic setting, where patients were hooked up to an array of technology mimicking what a healthy pancreas does. In one case, they had patients eat a large meal and drink a glass of wine — and guess what? The system got the dosing right!
A Joslin researcher named Marilyn Ritholz presented a third study that made me smile. She’s a psychologist focusing on the “human experience” part of diabetes management. She conducted in-depth interviews with 20 patients using CGM systems to understand their feelings and concerns. Guess what she learned?
* People had a variety of negative responses to the annoyance of alarms, sensor insertion, and sensor time lag
* People’s coping skills varied: those with a problem-solving approach did better than those with an emotional approach, as the latter got frustrated and gave up
* People’s learning approach varied quite a bit too. The “problem-solvers” were much more likely to download their data and attempt to analyze it
* The level of success had a lot to do with the level of support patients got from their spouse or significant other – the less support, the more the patient struggled
* Body image concerns – how self-conscious was the patient about wearing CGM or other diabetes gear on their body? It made some people feel different, “even robotic”
The researcher concludes: “success or failure of this system is as dependent on the human experience as it is on the technology.”
Hmmm, I LOVE that academics are looking at these issues. But I could have told you all that! Re-read the list above. Is this not a basic checklist of the factors that determine how well someone will do coping with diabetes at pretty much any level?
Anyhow, all these announcements have served to raise awareness of the Artificial Pancreas project and hopefully show the world what a high priority it is for JDRF (and ADA) to develop a system that will help patients live better asap.
“There’s a big clinical need for this in insulin-dependent people,” says JDRF’s AP project director Aaron Kowalski. “The average Type 1 spends about 90 minutes a day hypoglycemic. They also spend a significant amount of time above target. Our goal is to help ‘shave off’ time there, and help people spend more time within healthy target ranges.”
The next step, he says, is to conduct “home studies” that will get the AP system out of the lab. JDRF is already organizing panel to help the FDA decide what’s required for these home studies.
What this will likely look like is an overnight study in which patients will be hooked up to a home-based AP system while they sleep. This is the time that about 50% of adults and 75% of kids have the most hypos, 
Kowalski says. The home system will consist of 4 components: the pump, CGM (Abbott Navigator – which just introduced an upgraded system in Europe, btw, with just a one-hour warm-up time versus 10 hours previously!), a remote control, and a ‘bedside box’ that contains algorithm to automate insulin delivery, and also shut-off if the patient goes low. For the initial study, the system will be used overnight only.
“The possible danger of a closed-loop system is of course over-delivery,” Kowalski says. This study will be designed to show that automatic shut-off provides a sufficient safety mechanism to avoid that. “This is the easiest path forward,” he said.
I don’t know about easy. None of this is easy. But I for one am excited to see so many smart people pushing so hard for the advancement of these integrated BG control systems.
For some great background info: see Manny Hernandez’s video interview with key players in the Artificial Pancreas project.
Great article- thanks for sharing! Today I’m working on paperwork to get my DD (age 7) on a pump, so reading the stats about pump vs. shots was very encouraging to me. I love to dream about the possibility (however remote) that when she’s an adult, this artificial pancreas could possibly be the normal treatment.
Thanks for posting this – I just stumbled upon your blog. I’m a 30 year old woman and was recently diagnosed with Type 1.5 diabetes about a month ago. I’m in my “honeymoon” phase now, which makes life a little easier temporarily, I guess, but I still have so many questions and need to learn so much. I am very much interested in getting on a pump once my honeymoon is over and am trying to learn all about my options.
Kate
I was on the STAR 3 study here in San Diego. My A1C before starting the pump and CGM was 8.4 and 3 months later was 6.7!!
Joan
Have you heard anything from Animas and Dexcom about their pump/CGM? Just wondering….
For a long time, hearing about the artificial pancreas project annoyed me, because I didn’t really think of it as a cure. I still don’t think it is, but after reading Dan Hurley’s review of it in his book, and seeing him say that, when he was on the AP, he took only a fraction of the insulin he was used to taking, I got really excited about it. I think taking less insulin has all kinds of benefits, not the least of which would be losing a few pesky pounds!!
I think that data showing more children on the pump doing better than those not on the pump is slightly inaccurate due to several factors:
children on the pump typically come from families with more financial resources
children on the pump are more closely monitored by parents because they are hooked up to a computer/machine/gadget
children on the pump often do better at the beginning (during which studies are often conducted) and later have troubles absorbing insulin due to scar tissue growth
There are other factors but, the point I wanted to make is that we value technology over most everything and to me it seems that proper diabetes education is more valuable than the latest gizmo.
I think pumps and CGMS are great but, not necessarily a better replacement over shot therapy because of the complications they add. It depends on the individual wether they should be on a pump or on shots. It isn’t fair that most out there openly favor one over the other just because they don’t feel they could do well without a pump.
I switched from the pump back to shots a few years ago. My A1c is now between 4-5% on shot therapy which is awesome because I like being free of stuff attached to my body and free of the beeping and free of the extra prescriptions and free of the potential for a computer error to occur…the list goes on.
I hope everyone will acknowledge it is possible to have great control with or without a pump.
Nice article Amy, I thoroughly enjoy your reporting on all of the latest.
[...] Amy Tenderich reports on her site DiabetesMine that researchers plan to conduct “home studies” next. She says the [...]
Wow. An A1c of 4-5% translates to an average blood sugar of 65-100.
@Bob – nobody had an A1c that low, as far as I know. (They said 44% of the study group lowered their levels, is all)
I don’t understand your binoculars analogy. I currently wear the CGM with my pump and have had great success. I would much rather have my set of “spyware” vs having no surveillance (binoculars) as you call it. Just because you choose not to wear a CGM, why criticize it. According to the article you are citing, the CGM is a key component of the system.
Clarke
Diagnosed 13 years ago
Medtronic 722 with CGM for 4 years
Hello
I think that the JDRF funded artificial pancreas is a waste of time and money. My 10 yr old son has type 1 the last thing he wants is more things plugged in to his growing body. Insulin was discovered almost 90 yrs ago and this is the stage we are at?
Why isn’t JDRF using all this money for a cure or a non invasive glucose monitor?
I find it hard to believe that in 2010 not one company in the world can test a blood sugar without pricking a finger. WE need to stop curing mice and start curing the beautiful people fighting this disease.
Jamie
Sorry, Amy. My comment was meant for @Sysy Morales statement, not your article.
@Clarke – I think you misunderstood me. I meant that one group had very basic treatment (shots), while the other group had all the latest and greatest diabetes tech, including CGM — so they were at an obvious advantage.
I look at this “new tech” this way. Right now I have a tube in my stomach to do dialysis with, which is a “nice cuss word” bigger hassle than an infusion set on an insulin pump.
I see this technology as great, awesome, and much needed. As well, I see some solutions to problems mentioned that seem to be very simple if they implemented the solution into the pump design. That is, when a bg goes low enough in an emergency situation such as when a person is asleep or can’t get to a piece of candy, the machine would have a seperate reservoir full of “sugar” in fluid form to get the bg up, administered by the pump to do just that. With all that on the device, it would be “completely closed circuit” with the exception of the time taken to change out reservoirs and maintenance, battery changes, etc.
I’m a pump user, I use the current Revel by Minimed, and the closed monitoring system I can use although at the moment the insurance will not pay for it, even though it would and will cut down on the overall long term cost of diabetes. Considering now it costs me 150,000 minimum in US Dollars to SURVIVE on dialysis, a six grand insulin pump and the CMS set up would have bought all that cost many times over now that many years later I’m having to do dialysis.
The bottom line in the USA is they don’t want to cure diabetes, the FDA gets kick backs and money to keep people sick so the medical system can earn more off the disabilities the disease creates in dialysis and other medical area’s they love the money they make in. I see it like it is, the USA is full of crooks in the FDA and other high places, and I call them out, come over to my house and I’ll love to punch you idiots in the nose as well for being so “nice cuss word” smart about solving medical problems you are stupid.
This system is the best solution for diabetes type one, and a lot easier to deal with while living life than having to live with a PD tube for dialysis many years later, and all the other damages health wise that come along with having diabetes that is super difficult to keep in control. As the idiots believe, “control” being so “easy” to accomplish with out a pancreas.
This is the best thing yet to be invented to solve a problem, and it can be reduced in size even more as time progresses, and even the size now is a lot better than the future complications that are very real. How do I know they are real? I live with them all, I’ve had type one diabetes 36 years and the complications happen whether you want to believe or not.
Do the right thing, approve this stuff, get it on the market, let people have a healthier life and a better future. You people in the USA who love you money more than our health, come to my house and I’ll gladly give you a shiner or a bloody nose today. You I highly hate and have no “love” for, nor do I “love” diabetes or ever will “love” the “nice cuss word” disease.
Straighten up FDA before some real Americans come visit you and kick you in the “nice cuss word for a rear end”.
Sincerely,
Dwight J. Emery
I’m in Spring Lake, NC if you want to visit for a nice fight, those I offend… I could use some idiots as a punching bag! LOL! And would be nice to see diabetes cured instead of treated for a change…
[...] July 6, 2010 by Lorraine Leave a Comment You may have heard the announcement of the results of the STAR 3 study last week. Amy of Diabetes Mine had a hot-off-the-press post about it here. [...]