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.