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.”