September 27, 2013 was a big day in the diabetes technology world: the FDA approved the first prototype of the “artificial pancreas” in which a continuous glucose sensor communicates with an insulin pump. I have recently written about the artificial pancreas (also known as the ASPIRE) study several entries ago and now we have a real product that should be released in several weeks. I was first alerted by a colleague from the FDA and Francine Kaufman, MD, Chief Medical Officer and Vice President, Global Medical, Clinical & Health Affairs of Metronic Minimed that the MiniMed® 530G with Enlite® was approved and will become available shortly!
The new pump is similar to the “Veo” that was recently introduced in Europe. The Veo pump, based on information from the sensor, will respond to the programmed hypoglycemia alerts. The new version 1.0 “artificial pancreas system will automatically stop insulin delivery when sensor glucose values reach a preset level and when the patient doesn't respond to the Threshold Suspend alarm.”. There is new sensor hardware called the “enlite” sensor that according to the Metronic Minimed literature is a “31% improvement in overall accuracy from the previous generation.” According to Dr. Kaufman, the “Enlite sensor detects up to 93% of hypoglycemia episodes when predictive and threshold alerts are on.” Not only does the new sensor appear to be more effective, it also has decreased in size by 69%, a benefit for children with decreased available surface area. Keep in mind that the Minimed 530 G system was approved for use in people with diabetes over 16 years; however, many diabetes care providers are comfortable using medications and hardware off –label in certain circumstances with extremely close followup.
How does it work?
According to the literature, the “threshold suspend automation” will automatically prevent the pump from delivering insulin once glucose levels reach a pre-determined threshold. The healthcare team will have the ability to set the level between 60-90 mg/dl. As in previous sensor/pump combinations, once the threshold is reached, the new system will sound alerts to the user with an alarm. What makes the MiniMed 530G system unique is that the system will stop delivering insulin for two hours if the user is asleep, unconscious or unable to respond and react to the alarms. This important feature will enable parents and caregivers to have a degree of comfort overnight and allow them to sleep!
Furthermore, according to Metronic Minimed, during the suspension period, no insulin boluses can be delivered and the user can resume basal insulin delivery at any point. Another important caveat is that “if the sensor glucose value is below threshold at four hours after resuming from a full two-hour suspend, the pump re-suspends insulin delivery after the set Low Repeat time has been reached.”
What are the new “Enlite” sensor features?
According to the literature, there is a 31% improvement in overall accuracy from the previous sensor, a hypoglycemia detection rate over 93.2% and up to six days of use without changing the sensor. In addition, it appears that the sensor is thinner and 1/3 the size of the previous glucose sensor and 38% shorter under the skin.
The contour next link meter will still work with new Minimed 530G system by wirelessly transmitting blood sugars to the insulin pump.
Keep in mind that the new Minimed 530G system is not yet available at the time of this writing, but should be a major upgrade to the current operating system of sensors and pumps which up till now did not communicate with each other!
This is version 1.0 of the artificial pancreas. There will be many versions in the near future. The ultimate goal, of course, is for the sensor and pump to seamlessly communicate with each other and automatically deliver insulin based on the continuous monitoring of blood sugars with minimal input from the person with diabetes. In addition, be on the alert for systems that titrate both insulin and glucagon as a means to maintain blood sugar in an optimal narrow range.
Finally….the first prototype of the artificial has arrived!
Published On: October 04, 2013