Another reason why a closed system has such a long way to go

Another reason why a closed system has such a long way to go

Back on March 25th LifeScan, the glucose monitoring unit of Johnson and Johnson (NYSE:JNJ) announced a voluntary recall for their OneTouch® Verio®IQ glucose monitor. According to the company; “LifeScan is recalling and replacing all OneTouch® Verio®IQ Meters because at extremely high blood glucose levels of 1024 mg/dL and above, the meter will not provide a warning that the blood glucose is extremely high and will shut off, thereby potentially leading to incorrect treatment and delaying proper treatment.

The likelihood of experiencing an extremely high blood glucose level of 1024 mg/dL or higher is remote; however, when such a blood glucose level occurs, it is a serious health risk requiring immediate medical attention. Because these products do not provide an appropriate warning at glucose levels of 1024 mg/dL or higher, diagnosis and treatment of extreme hyperglycemia may be delayed or incorrect treatment may be given resulting in potentially serious health risk or fatality.”

Today Diabetic Investor has learned that Medtronic (NYSE:MDT) has also sent out a notification informing patients and physicians of two problems with their Paradigm system. The first issue relates to the pump’s drive support cap which holds the pump motor in place and allows the motor’s piston to press against the insulin reservoir to deliver insulin. According to the notification, “Some customers have experienced a loose drive support cap, and in rare cases the cap may stick out from the bottom of the reservoir compartment.”

The second  issue relates to possible water damage and according to the notification; “exposure to water can damage the pump’s internal electronics.” This second issue really should not be an issue at all IF the patient has been properly trained on how to use and not use their Paradigm pump. The fact that Medtronic felt it necessary to inform patients and their physicians not to expose the pump to water confirms something that Diabetic Investor has been stating for some time, in that, due to increasing pressure from the company, sales reps who used to spend considerable time training patients are spending more and more time trying to hit their sales quotas and less time training patients on how to properly use their pump.

The problem with the VerioIQ and the Paradigm insulin pump should also serve as reminder to all those folks who believe that an artificial pancreas is right around the corner. As we have noted previously while these folks just love to talk about all the possible benefits of such as system, they rarely if ever talk about the tremendous hurdles that must be overcome to turn this dream into a real product. It continually astonishes Diabetic Investor that the proponents of the artificial pancreas conveniently forget that the system is basically a machine and machines can, and do, malfunction. They also seem to forget that even if the machine works properly the machine is being used by a human and humans also make mistakes, may not be properly trained on how to use the machine or use the machine in ways not intended.

Far too often those who are designing all this fancy new technology forget that there is an actual person who one day will depend on this whiz bang technology. They seem to believe that patients will actually read the manual, receive the proper training and understand perfectly how to use these fancy new tools. Tools which are becoming ever more sophisticated and less and less patient friendly. When looked at realistically at a time when patients need and are frankly demanding systems which are easier to use, device companies are coming up with ever more sophisticated systems which are more difficult to use.

Although not directly related to either issue a recent study published in The Cochrane Library noted that; “Despite the wide variety of computer and smartphone technology dedicated to improving the lifestyle of those suffering from diabetes, research show that these programs do little to help people live healthier lives.” According to Kingshuk Pal, the lead researcher of the research department of primary care and population health at UCL in London; “Our review shows that although popular, computer-based diabetes self-management interventions currently have limited evidence supporting their use.”

Pal goes onto to state; “Effective self-management is a complex task that may require changes to many aspects of people’s lives. Any intervention to help that process needs to support sustained behaviour change in different areas like eating habits, physical activity or taking medication regularly and provide emotional support. We did not see any convincing evidence for long-term change like this in the interventions we looked at.”

It is this last statement from Pal that should be read over and over by anyone in the diabetes device arena as it says, albeit in a different way, something Diabetic Investor has been repeating for years that the vast majority of patients with diabetes want to live their lives WITH their diabetes and not FOR their diabetes. While there is a minority of patients who read manuals, pay close attention when they are being trained on a new device and actively seek even more information on how to properly manage their diabetes, this is not the case for the vast majority of patients. Patients who in addition to managing their diabetes must also go to work each day, take care of their families and do all the other things everyone else does.

It would be wise for those who are designing all this fancy technology to remember that managing diabetes is 24x7x265 job with no days off. That unlike those who do not have diabetes, people with diabetes have a host issues they must worry about each and every day. That the goal of diabetes technology, whether it’s an insulin delivery system or a simple glucose monitor, should be to make this task easier and not more complex.

In the eyes of Diabetic Investor the diabetes device world is following the words of Merle Martin who wrote; “There is nothing so simple that it cannot be made difficult.” When they should be following the words of the great Albert Einstein who noted; “Everything should be as simple as possible, but not simpler.”