Could the development of a platform that could automatically monitor and deliver insulin to patients based on their physiological reactions to environment and activity be far behind? According to presentations at the 69th annual American Diabetes Association (ADA; Alexandria, Virginia) in New Orleans that day might be well on the horizon.
Medtronic Diabetes (Northridge, California), which has successfully combine its own glucose monitoring system and an insulin delivery pump into a single platform device for patients, took huge steps toward automatic insulin delivery with a device that is a closed-loop diabetes system to mimic the insulin delivery of a normal pancreas.
"The device is now able to make decisions based on the data from the patient it receives via glucose monitoring," Steve Sabicer a spokesman for Medtronic Diabetes, told Medical Device Daily. "For example, whenever the patient's glucose levels become too low, the device will automatically stop any insulin production. "It's certainly not an automatic device but an airbag if you will . . . that softens the damage when a person becomes hypoglycemic."
The device includes a Low Glucose Suspend (LGS) feature that regularly checks a patient's glucose levels 24-hours a day and automatically suspends insulin delivery when glucose levels become too low, protecting against the risk of hypoglycemia (low blood sugar) even when a person is asleep and unable to react – a key selling point of the device, Sabicer says.
"It's an external device often worn on the belt or in the pocket," he told MDD. A small tube which is part of an infusion set fits under the skin. A glucose monitoring sensor fits on the patient."
The company boosted the development of the device with its recent purchase of all continuous glucose monitoring (CGM) assets from PreciSense (Horsholm, Denmark), a company focused on CGM technology.
To date a version of the device has been released in the UK, with plans for launches throughout Europe this summer. Plans call for the platform – which could have some differences from its UK counterpart to be available within in 18 to 24 months. But that depends on FDA regulation and clearance.
Sabicer said the company has pretty strong evidence to support the platform's effectiveness already.
In a study titled REAL Trend, which evaluated the device, findings proved that patients who used Personal CGM more than 70% of the time achieved nearly a full percentage point reduction in A1C (average blood glucose levels).
This study also reinforced the superiority of insulin pump therapy over multiple daily injections for poorly-controlled Type 1 diabetes patients. Across study populations, A1C levels improved significantly after treatment was changed from multiple daily injections to a conventional insulin pump or an insulin pump augmented with personal CGM. Studies have shown that reducing A1C can result in reduced risk of long-term side effects associated with diabetes, including blindness and kidney disease.
But Medtronic isn't the only company with such a program. University of California Santa Barbara and Sansum Diabetes Research Institute (both Santa Barbara, California) scientists have demonstrated for the first time that an automated artificial pancreas system (APS) can safely and effectively maintain desired blood glucose levels in patients with Type 1 diabetes.
"The missing component is having these devices [glucose monitor and insulin pumps] talking to each other to create an automatic infusion of insulin," Howard Zisser, study investigator and director of clinical research and diabetes technology at Sansum Diabetes Research Institute, told MDD.
To achieve this end, researchers tested an automated insulin delivery system comprising Insulet's (Bedford, Massachusetts) OmniPod System and DexCom's (San Diego) STS7 continuous glucose monitor, linked and controlled through UCSB's artificial pancreas software.
The software's insulin delivery algorithm, optimized for each patient, includes a unique safety feature, based on clinical parameters, which prevents insulin-induced low blood glucose levels.
The algorithm is based on Model Predictive Control – and is similar to a game of chess – predicting the adverse reactions a patient has from complications of diabetes, according to principal investigator Frank Doyle, professor of chemical engineering at UCSB.
Without any outside intervention, the system restored normal blood glucose levels following both induced high levels (hyperglycemia) and unanticipated meals, while avoiding hypoglycemia. This was achieved through the automatic delivery of insulin to correct for the induced high blood glucose levels, and an insulin infusion rate moderated to ensure a smooth return to normal levels and avoid low blood glucose levels.
But Doyle said the team isn't out of the woods yet.
"I think our next step now is getting more patients tested in these studies," he said. "After that, we have to look at how the body and insulin levels are affected by exercise or physical activity. We still have a lot of work cut out for us."