World’s First Artificial Pancreas Awaiting Approval from FDA
Dublin based Medtronic Plc. developed ‘artificial pancreas’, Minimed 670G for continuous monitoring of blood glucose level and delivery of insulin accordingly.
The company has applied for US Food and Drug Administration (FDA) approval and expects to reach the market by 2018. If approved it will be the world’s first ‘artificial pancreas‘ for management of type-1 diabetes.
Minimed 670G device itself remains outside the body of the patient. It works by measuring the blood glucose level of the patient every five minutes and then administering micro-doses of insulin or withholding production of insulin, as required, in order to maintain blood glucose within optimum levels.
Figure 1. Minimed 670G (photo credit: diatribe.org)
Medtronic Plc has applied to the FDA of the United States of America, seeking approval for the device, on the grounds of its pivotal study, carried out with 124 patients.
The results demonstrated that the system proved to be useful in lowering the A1c levels and in maintaining the blood glucose sensor values more consistently.
Called a ‘hybrid closed-loop system’, the device itself consists of three major components:
- Glucose sensor: This component is a wearable device which can be worn for 7 days till it needs recharge.It is attached to the body in order to measure blood sugar levels.
- Insulin pump: Responsible for the administration of the required dosage of insulin. It requires to be refilled every three days.
- Infusion patch: The patch and needle, connected to the insulin pump with the help of a catheter, delivers insulin to the patient’s system.
Video: Medtronic MiniMed – How does the MiniMed 640G insulin pump work? (Credit: Medtronic Diabetes Europe, Middle East, Africa).
Trials carried out with the patients showed that the automatic system was far more effective and better preferred in comparison to the manual method of monitoring.
Figure 2. Adults on the MiniMed 670G (pink) vs. Open Loop (gray) (photo credit: diatribe.org).
The device does have a few shortcomings, such as:
- Recalibration through the traditional finger-stick reading needs to be done every 12 hours
- The glucose sensor requires charging every 7 days
- The insulin pump must be refilled every 3 days.
Despite a few disadvantages, most of the patients involved in the trials agree that it is a much easier method of monitoring blood glucose, one that doesn’t require as much time everyday as the manual method would. The FDA approval is expected to come out later this year.
Featured image credit: Medtronic MiniMed – How does the MiniMed 640G insulin pump work? © Medtronic Plc.