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Diabetes technology radically changed, still changing

Wednesday, October 15 2008 | Comments

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What's This? By Patrice LaVigne

The landscape of diabetes therapy has changed dramatically during the past 50 years, but especially during the past decade, and even more change is expected for the next decade, according to Dr. Stuart Weinzimer, associate professor of pediatrics at Yale University.

The disease itself has moved from being characterized as a fatal disease to a chronic one, he explained, while diabetes care has changed from blood sugar testing through urine or blood and the use of animal-derived insulins to continuous blood glucose monitoring (CBGM) systems in addition to finger-stick testing and highly purified recombinant insulins.

"Devices have gotten smaller and better over time," Dr. Weinzimer said. The technology also offers much more flexibility, although effort is still required from the patients, he noted.

"Right now the hottest thing in diabetes therapeutics is the use of continuous glucose sensors combined with an insulin pump," he told VerusMed.

Most of the studies regarding insulin delivery through a pump are in the pre/post format that compares diabetes control using individual insulin shots versus the insulin pump, Dr. Weinzimer said. However, randomized controlled trials are beginning to come out and show that the pump provides sustained improvements in blood sugar control.

As for CBGM systems, there are only a few available on the market, including Medtronic Inc.'s Paradigm Real-Time, Abbott Diabetes Care's FreeStyle Navigator, and DexCom Inc.'s Seven, he noted. The Paradigm is approved for use up to 3 days, Navigator up to 5 days, and Seven up to 7 days.

All of the sensors need to be calibrated for use and Dr. Weinzimer stressed that none of them completely eliminates the need to manually check blood sugar. They are meant to be an adjunct to finger-stick testing. All of the monitors set off alarms when blood sugar rises too high or low according to the threshold set by the patient. However, he noted that the alarms do not prevent all hypoglycemic events and this is an unrealistic expectation for patients to have.

The GuardControl trial was the first study to review the efficacy of sensors compared with no sensor and intermittent sensor use. The results, which were published in 2006, demonstrated that all the groups lowered their hemoglobin A1C levels, but the group that used sensors all the time did a little better.

Dr. Weinzimer noted that all the clinical trials indicate that sensor-augmented therapy is efficacious and tolerable. However, there are some deficiencies with the current sensors, including the lack of user-friendly algorithms to encourage adoption, accuracy and quality control issues, and no evidence of long-term efficacy and cost effectiveness.

As a pediatrician, Dr. Weinzimer said the best approach to take with patients when introducing the new technologies is that you "can't overpromise and underdeliver."

The next step anticipated in diabetes technology, he said, is to automate these processes with the "artificial pancreas." This idea is essentially the use of sensors to deliver minute-to-minute blood sugar level information to the pump, which will calculate the insulin needed based on changes in the blood sugar levels.

"The most promising thing would be to have this kind of technology run in a completely automated fashion where you don't have to intervene at all," he told VerusMed.

Although this technology may be still years off, Dr. Weinzimer said there will be incremental steps to get there. He believes the first advancement will be to create an insulin pump that automatically shuts off when a patient's blood sugar level drops.

Still, he, along with others, have been conducting early testing with the artificial pancreas. In his recently published study, 17 teenagers who used the technology during 36 hours in the hospital setting showed a decrease in blood sugar levels after meals. He said he expects that future studies will be longer-term, will be conducted outside of the hospital setting, and will involve more advanced technology.

"There's a tremendous amount that's going to start happening in the next 5 years," he said. "Technology happens and we should embrace it."

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