Not a smart solution

Not a smart solution

According to a story posted on the in-Pharma web site Johnson and Johnson (NYSE: JNJ) is finally getting ready to launch their “dumb” patch pump otherwise known as the OneTouch Via. Approved back in 2012, the Via then called the Calibra Finesse is one of several “dumb” patch pumps. The premise behind all of these systems is they will .. wait for it .. improve therapy compliance. That insulin using patients will not skip insulin injections because they will be wearing their insulin delivery system.

Perhaps learning from the mistakes of others in this category JNJ is at least not peddling the myth that patients fail to take their insulin because insulin injections are “painful”. No when it comes to the Via it’s all about therapy compliance, something which we suspect was designed to please payors as much as patients. Yes for years we’ve been hearing from physicians that if patients would just take their medications as prescribed we would see improved outcomes which .. wait for it … lowers costs.

Frankly Diabetic Investor has never bought into this fascination with “dumb” patch pumps. Although insulin injections are not pleasant they are not as painful as many of these companies have claimed. Thanks in large part to improved needle technology insulin injections are in reality less painful then using a lancet for a glucose test.

Nor have we bought into this theory that using a “dumb” pump will improve compliance. Keep in mind that the Via requires a patient to interact with the device to deliver insulin, it does not like other “dumb” pumps automatically deliver a preprogramed amount of insulin. The Via is set to deliver two units of insulin per click.

Now in this age when it seems every diabetes device is connected to the cloud the Via is a true “dumb” pump as it does not yet come with a way cool app that tells the patient how many clicks they need to perform. Nope a Via using patient must determine on their own whether they need one or multiple clicks. Sticking with this for a moment, and yes the pun is very intentional, what happens when the patient needs an odd amount of insulin, let’s say 5 or 7 units. Do they under or over click? Do they risk running high or do they risk a hypoglycemic event?

Would it not be more effective from an outcomes standpoint to actually deliver the exact amount of insulin a patient needs? Let’s assume for a moment, that yes because of the Via therapy compliance improves. Yet given the limitations of the device, only delivering insulin in 2 unit clicks, it is possible we would say even likely that outcomes would not necessarily improve. In fact, we would go on step further and state that the risk of hypoglycemia increases. Insulin is safe and effective when properly administered, however it is also a lethal drug when improperly administered.

To be honest we just don’t see where any of these “dumb” pumps, patch pens or whatever they are called fit in. What problem are they solving? According to JNJ’s own research just over half the patients using the device reported improved therapy compliance.

Back at the ADA in NOLA JNJ released a study which stated “The MAE study followed 44 patients with a median age of 57 years, who used the OneTouch Via™ patch for 60 days, instead of their bolus injection device (75 percent pen users and 25 percent syringe and vial users).  Patients responded to insulin usage questionnaires at baseline, then after 1, 4 and 8 weeks.  By weeks 4 to 8, more than half (58 percent and 52 percent, respectively) of study participants acknowledged dosing more often than they would with a pen or syringe – with satisfaction rates increasing the longer they used OneTouch Via™. “

Now we hate to point out the obvious here but dosing more as we have just noted is not always a good thing. We should also note that this study was NOT designed to measure the impact on patient outcomes, so we have no clue as to whether these patients were clicking correctly. At the same time the company released the MAE study data they also stated; “An additional Clinical Outcomes Study, being conducted across 60 trial sites in the U.S. and Europe, will measure the change in A1C levels, glycemic variability and patient reported quality of life seen in patients using OneTouch Via™ compared to insulin pens over the course of 24 and 44 weeks.”

Even if the results of this study show an improvement in outcomes we’re still not sure we see a place for these “dumb” devices in the marketplace. We just don’t see what problem they solve. Had the study shown upwards of 80% of patients dosing more often and looked at periods longer than 60 days, maybe JNJ would have something to talk about. But as it stands today one could actually make a strong argument that old-fashioned syringes and insulin pens actually are better options than a device that only delivers insulin in 2 unit clicks.

The simple fact is there is nothing wrong with syringes or pens. To Diabetic Investor all of these “dumb” pumps, patch pens or whatever they are called are examples of engineers over thinking things. They prove once again how companies in the diabetes device world just love to tinker and just can’t resist way cool whiz bang gadgets.

The reality is the most effective method at improving therapy compliance is not a device but better patient education. Helping patients understand why they should not skip insulin doses. The fact is, yes back to those pesky facts, it does not matter which device a patient uses to dose their insulin if they don’t use the device as intended. That outcomes will only improve when a patient not just takes their insulin but takes the proper amount of insulin. To believe that a “dumb” device alone will help is just plain dumb.