Quest for the Artificial Pancreas
It is the closest thing to an artificial pancreas the diabetes community has ever seen and the first automated insulin system to be approved by the FDA: the Medtronic MiniMed 670G hybrid closed-loop system. Capable of automatically detecting and preventing dangerous high and low glucose levels, Medtronic’s new insulin system is being hailed as a monumental breakthrough for people with type 1 diabetes.
“This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency news release.
Medtronic’s MiniMed 670G uses a continuous glucose monitor (CGM) to track blood glucose levels and an insulin pump to administer insulin. While both of these devices have been around for years, it has traditionally fallen on the user to calculate how much insulin to dose based on blood glucose readings from the CGM.
The Medtronic MiniMed 670G introduces a new component to diabetes management that the FDA has long been cautious about: allowing computer software to handle insulin delivery. Too much or too little insulin can have serious and potentially fatal consequences. Users are still required to enter mealtime carbs and periodically calibrate the device, says Medtronic, but this is the first FDA approved device to automatically adjust delivery of basal insulin based on CGM sensor glucose values.
How the MiniMed 670G gained FDA approval
Proven failsafe mechanisms and encouraging results from a three-month, 123-person pivotal trial gave the FDA the confidence it needed approve the Medtronic MiniMed 670G. Specific findings from the trial published in the Journal of the American Medical Association include:
- A 44% decline in time spent with blood glucose below 70 mg/dL.
- A 40% decline in time spent with dangerous hypoglycemia (below 50 mg/dL).
- A 0.5% reduction in A1C, from a baseline of 7.4% to 6.9%.
- No serious adverse events, diabetic ketoacidosis, or severe hypoglycemia were reported.
We caught up with Dr. Michael Greenfield, endocrinologist and Glooko’s Chief Medical Officer, to get his take on the trial. Although Dr. Greenfield expressed some concern over the relatively small size of the study and how these findings will translate to the real world, he quickly acknowledged the benefits of this new treatment option for many diabetes patients.
“The 670G will help patients the most who have problems with overnight control of their blood glucose (BG), especially individuals who have hypoglycemia unawareness and night time hypoglycemia. In the pivotal trials, A1c was improved without an increase in hypoglycemia. This device could be used by anyone with type 1 diabetes committed to using pump and CGM treatment,” said Dr. Greenfield.
Medtronic paves the way for competitors
Medtronic was able to beat competitors to market partly due to the fact that they already manufacture their own CGM and insulin pump technologies. But according to JDRF, there are currently 18 artificial pancreas systems in various stages of development. Here are a few key programs to keep an eye on:
- Bigfoot Biomedical (planned release date – 2018): Right on the heels of Medtronic’s announcement, Bigfoot Biomedical announced they have also started a clinical trial for their own artificial pancreas system.
- Beta Bionics (estimated release date – late 2018): Planning a large pivotal study in mid-2017, BetaBionics is testing both insulin+glucagon and insulin-only versions of the iLet automated system.
- Insulet (release date – unknown): One of the largest insulin pump manufacturers in the world, Insulet is reported to currently be conducting a trial with 20 people using its own closed-loop system.
- Verily (release date – unknown): Not much is known about Verily’s artificial pancreas/closed-loop development. However, the Alphabet company is reportedly amassing diabetes experts including Insulet’s Howard Zissler, who helped spearhead Insulet’s artificial pancreas program.
Medtronic’s remaining challenges
With trustable failsafe mechanisms now in place, Medtronic can begin focusing on how to better optimize control algorithms to give patients tighter control of their blood glucose.
When the device becomes commercially available in Spring 2017, it will be important for Medtronic to evaluate how well their new algorithms respond to factors such as exercise and mealtime BGs, noted Dr. Greenfield. “This will be challenging based on insulin delivery under the skin, how fast insulin acts, and the delay in measuring BG in the fluid under the skin rather than in the blood. New faster acting insulins are being developed, which should help better control BG levels after meals.”
For now, the MiniMed 670G is the only FDA approved closed-loop system for people ages 14 and older. Medtronic is currently studying the device with children ages 7 to 13 in hopes of gaining approval for this age group as well.
Utilizing real-world data for better algorithms and better outcomes
Getting enough data (that is also accurate) has long been a battle for endocrinologists to help make informed suggestions for patient care. With enough data about a patient’s blood glucose levels, doctors can identify trends and help their patients reign in their blood glucose levels by solving for the events causing deviations from targeted ranges.
Recently developed CGMs and insulin pumps have provided clinicians with more data than ever before and the Glooko data management platform is helping caregivers analyze what is happening — with unprecedented detail.
Because Medtronic devices already integrate with the Glooko data platform, by linking to Medtronic users’ CareLink Personal account and extracting data as it is available, Medtronic users are able to get a unified view and actionable insights using Glooko. We look forward to taking this data analysis to the next level with even richer data from devices like the MiniMed 670G, which we will support in the near future.