Dr. Bruce Bode talks with Diabetes in Control Publisher Steve Freed during the ADA 77th Scientific Session in San Diego about the focus on safety during the trial.
Dr. Bruce Bode, MD, FACE is a professor of medicine at Emory University School of Medicine in Atlanta, GA. He has a strong affinity for working with children and young adults with diabetes and is considered one of the leading experts in the world on insulin delivery and glucose sensing. He is very active in clinical research on new diabetes products including pharmacological agents to prevent diabetes and control glucose and new insulins and glucose sensors.
Transcript of this video segment:
Steve Freed: One of the questions that I’m sure you get all the time is: I don’t want to be attached to a machine that can kill me.
Dr. Bode: I certainly don’t want to be attached to a machine either that can kill me. This is why this was a safety trial. We didn’t have a randomized control group because the FDA’s all about safety. We wanted to make sure it was safe. The FDA did one other thing during this trial. They made us, for 6 days and 5 nights, take everybody and put them in a hotel. They have to exercise four hours a day. Some people never exercise one minute a day. We would have to have a physician there. Every night. We had to check their glucose before each meal, bedtime, midnight, and 3am. We showed that there was no hypo during that period either. So we did stress it for one week. So as a result of that data and since it was safe and appears to lower glucose in more time and range, they allowed it to come on the market.
Steve Freed: How many patients was that?
Dr. Bode: So, it’s 124 in the adult patients, adults being, sorry, 14 up to 75. So we had about 30 or so adolescents and the remaining 90 plus were adults.
Steve Freed: So that’s when you have 200 patients. What about when you have 2 million patients? The risk kind of goes up as far as finding there could be a greater chance to have serious issues with hypoglycemia. It’s very unlikely but it’s certainly a possibility whenever you deal with technology, something called Murphy’s Law, something always goes wrong. How do you respond to that?
Dr. Bode: So, when you really look and people say when you get a million people out there on this device. Are you going kill somebody from low sugar? Hopefully not, there are so many safe guard rails. People all the time with type 1 die of hypoglycemia. Typically the data is 6 to 10% of people will die of hypoglycemia right now. This hopefully will prevent that. We can’t guarantee it until we have lots of data but what we do have since the launch of this we have started the pediatric trial, 7 to 13, it’s still ongoing. It’s another 110 plus patients. We have people who have gotten early access. They bought the 630G so we have another 1,000 plus out there. If you look at the data in Care Link, because people upload weekly all the time, were told to upload weekly. The data from our Pivotal trial is mirroring, or the data from Real Time, another 1300 people plus, is mirroring what we saw in the Pivotal Trial. We have very rare time, less than .3% under 50, less than 3% under 70. We’re approaching a mean glucose right around 145 to 150. We don’t have any severe hypos.