The Food and Drug Administration (FDA), on August 22nd, approved the iPro2 Continuous Glucose Monitoring System. The device is owned by Medtronic Inc, and is invasive. The iPro2 recorder is to be used with either Enlite sensor or Sof-sensor, which are glucose sensors and is intended to continuously record interstitial glucose levels in persons with diabetes mellitus.
The iPro2 is a masterfully engineered piece of equipment that serves as a professional-use continuous glucose monitoring (CGM) system for measuring glucose levels in fluid under the skin for up to six days. The values and data the system records are stored by the iPro2 recorder for future reference. Medical professionals, clinicians and personal health experts can then view the data to monitor a patient’s glucose management. A downside of the system is that patients cannot view the data in real time.
The whole iPro2 continuous glucose monitoring suite contains the Enlite Sensor and iPro2 reorder. The sensor contains a wire that is inserted under the skin of the abdomen region and measures the blood glucose levels in the fluid around the cells, known as the interstitial fluids which is the main component of the extracellular fluid, which also includes plasma and transcellular fluid. Hence it is an invasive procedure.
Patients have to wear the device for 6 to 7 days and after the data has been recorded by the iPro2 recorder, it is then returned to the health care provider who downloads the data and builds a diagnosis using the data. The data can be uploaded to a computer and shared with the healthcare professionals, according to the FDA guidelines. The FDA made sure that the device can only be used under prescription basis only, in accordance with 21 CFR 801.109 and under section 515(d)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act. FDA has determined that this restriction on sale and distribution is necessary to provide reasonable assurance of the safety and effectiveness of the device.
What sets apart the iPro2 Glucose Monitoring System from other devices is that it allows for continuous monitoring of the blood glucose levels for up to 6 days in patients with diabetes mellitus, and helps identify patterns in blood glucose level changes. It is meant as a supplementary device and is not meant as a replacement for standard home use blood glucose monitoring device. The data allows identification of fluctuation patterns of glucose levels above or below the acceptable range and helps plan adjustments to treatment.
This data enables a healthcare professional to identify patterns in their patient’s glucose levels. When used along with a blood glucose meter, a CGM system can also help healthcare practitioners advise their patients in making long-term adjustments to their treatment plan.
One thing to be cautious of when using the device is that it should not be used during magnetic resonance imaging (MRI), X rays, computed tomography (CT) scans, intensity modulated radiation therapy (IMRT), or other treatment methods that involve presence of strong magnetic fields or high frequency ionizing radiation.
FDA gave expiration guidelines about the device as such: Expiration dating for this device has been established and approved six months for the Enlite Sensor when stored between 36°F and 86°F.
Medtronic’s Innovation In Diabetes Technology
Medtronic has been at the forefront of leading innovation in diabetes technology. On 13 April, 2016, the company released data in the publication Diabetes, Obesity and Metabolism about their OpT2mise, which provided further evidence to support insulin pumps for diabetes treatments. The OpT2mise study was the largest randomized controlled trial study that compared the practicality, effectiveness and safety of insulin pump therapy as compared to multiple daily injections (MDI) for type 2 patients.
The randomized, controlled OpT2mise study was sponsored by Medtronic and conducted on 331 diabetic patients, whose age ranged from 30 to 75 years. Initial six-month study results which made a comparison of MiniMed insulin pump therapy to MDI were published in The Lancet in July 2014. During the six-month continuation phase of the study, the MDI group was switched to MiniMed pump therapy and follow-up of both groups was continued, making the total study period to 12 months.
The results showed that MiniMed insulin pumps safely provided significantly measurable, sustainable and reproducibly marked improvements in glucose control when compared to multiple daily injections of glucose. At 12 months, the group that crossed over to MiniMed insulin pumps after an initial six months of MDI doubled their A1C reduction (a blood measurement technique that measures average levels of blood glucose over the past 3 months, used to indicate glucose control) from 0.4% to 0.8% while using 19% less insulin.
For diabetes patients, glucose control is the key to preventing both short-term and long-term health altercations. A 1% reduction in A1C is associated with a reduction in the risk of long-term medical complications like stroke, heart disease, eye diseases and kidney disease by 40%.