What it is, what it isn’t and likely won’t be

It’s now official as Tandem has the coolest toy in the toy chest with the company announcing the Control IQ is now commercially available. The Control IQ has replaced the 670G from Medtronic as the best hybrid closed loop insulin delivery system. How long this lasts is anyone’s guess as Insulet announced at JPM the Horizon should be here in the second half of this year, making it the third entry into the hybrid closed loop category.

Based on what we know and what is available in the public domain we’d say it will be a tough job for Medtronic to regain the lead no matter what data they have to show at ATTD or ADA. Until the company can fix the issues with their CGM sensor whatever system it’s attached to will be inferior to any system which communicates with the Dexcom sensor. The CGM is the straw that stirs the closed loop drink and yes, it is that simple. As my old college professors used to say garbage in yields garbage out and right now the Medtronic sensor is producing lots of garbage.

One thing is certain from this day forward the lives of insulin using patients are going to get much better. As good as the Dexcom sensor is it won’t be long before there are multiple sensors which produce accurate readings. Correspondingly insulin dosing algorithms will only get better too. Whether the insulin is delivered continuously using a pump or one injection at a time using a connected insulin pen, much of the heavy lifting, a great deal of the guesswork will be gone. Outcomes will improve and patients using insulin will be at a much lower risk of severe hypoglycemic events.

Now as much as we like the Control IQ and what we have seen so far with the Horizon it’s important to examine the limitations of these systems along with the 670G. First and foremost it’s a mistake to call any of these systems closed loop or even hybrid closed loop as closed loop implies all the decision making has been taken out of the hands of the patient. That is not the case and should NOT be the case either.

Yet one problem with the 670G and the Control IQ are system presets which exist to protect the patient yet can interfere with patient outcomes. We won’t get overly technical here but both the 670G and Control IQ come with certain presets the patient cannot change. These presets are designed to protect the patient and the company as insulin as we all know may be a life sustaining drug but it is also a lethal drug when improperly dosed. Some patients using these systems have complained that their A1C actually went UP not down after they began using them. That due to these presets they could not be more aggressive managing their diabetes.

Some Tandem patients have noted this was not an issue with the Basal IQ that came with low glucose suspend. Knowing they were protected from severe hypoglycemic events, that the system would shut down insulin delivery if it detached the patient was headed for a major low, patients could be more aggressive. Since the system allowed for greater patient control and came with fewer hard-wired presets patients who sought tight control had a safety net with the low glucose suspend. Since the Control IQ comes with higher hard-wired presets i.e. target glucose it is possible a patient would see higher A1C using the Control IQ then they did while using the Basal IQ.

Another problem and not sure this is even fixable is patient expectations. Thanks to our friends at JDRF and the diabetes blogging community patients hear the term closed loop and they think the system does all the work. Slap it on, turn it on and off you go. This perception isn’t even close to reality.

We’ll probably catch a lot of flak for this but were getting used to that but in our opinion the patient should be an ACTIVE not passive participant with their insulin delivery system. Think of it this way today when you get on a plane 95% of your flight will be performed on autopilot. Now think of how safe you would feel if before you stepped on the plane the flight attendant told you there were no humans in the cockpit and the entire flight from takeoff to landing would be handled by a computer. Just how safe would you feel? Would you get on that flight?

The late Al Mann used to say the more decisions a patient has to make the more likely it is they are going to screw up. Therefore how do we balance this conundrum between allowing these systems to do their thing while at the same protecting the patient from making mistakes. To us the solution is to eliminate as many steps as we can yet allow the patient to be an active participant in their diabetes management.

We do not think the goal should be an insulin delivery system that takes the patient out of the loop. The goal should not be where the system makes ALL the decisions. Let the system fly 95% of the flight but when it comes to takeoffs and landings let the patient be an active participant. This is one more reason we could argue that a Tyler has one more advantage over an insulin pump other than comparable outcomes at a lower price point. Because a Tyler patient is an ACTIVE participant, they can prevent dosing too much insulin, they would not be subjected to insulin delivery malfunctions and we don’t care how good pumps have become THEY ARE DEVICES AND DEVICES CAN AND DO FAIL OR MALFUNCTION.

Although we think it’s a long shot it would be better if the JDRF got off their throne and put patient safety before whiz bang way cool. No amount of data, no amount of regulation, no amount of FDA oversight will change one unchangeable very pesky fact an insulin pump is a MEDICAL DEVICE AND MEDICAL DEVICES CAN AND DO FAIL OR MALFUNCTION. This may not be a problem for some devices, but an insulin pump delivers a drug which is LETAHL when delivered improperly. Have we become so obsessed with the toys in the toy chest, the way cool whiz bang that we have forgotten about the patient who is supposed to be playing with these way cool whiz bang toys?

Just in case anyone thinks we are being overly conservative, something we are rarely accused of, go check the MAUDE database. In 2019 there were 42 deaths associated with the 670G. Now let’s be very clear here WE ARE NOT ACCUSING MEDTRONIC of anything and we suspect a year from now Tandem might have similar numbers with the Control IQ. Yes, the Control IQ works with a better CGM than the 670G but its still a medical device and MEDICAL DEVICES CAN AND DO FAIL OR MALFUNCTION.

It’s about time we consider or more accurately reconsider what the goal should be. Patient safety, a patient’s life should come before anything else and that should NEVER change. We should pull back from this useless obsession with ever more whiz bang way cool technology. Technology which by the way hasn’t done a damn thing to change the most important statistic of all that with all this way cool whiz bang technology we have not seen a corresponding improvement in patient outcomes. That after all the money spent all the money made all the noise all the hype nearly two thirds of all patients are not achieving good control.

We are all for making the patients life easier. We are 100% behind making all this technology affordable and accessible. And yes we don’t want any patient to choose between eating or getting their insulin. However it’s not just foolish but dangerous to believe that technology alone will solve the problem. Technology is not infallible.

Most importantly of all technology should serve the needs of the patient, it should help the patient not overrule or control the patient. There is some very dangerous thinking going on out there.