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Diabetes management, if limited to FDA recommendations are largely ineffective.

For example the FDA recommends that we not pre-bolus with Fiasp, and that Lantus be taken once a day. But we know that the real world application frequently differs from the pharmacology and FDA approved uses.

Diabetes is not a disease that is managed with “by the book” prescribed therapy and FDA approved use of technology and insulin. It is managed day by day in an entirely individual way. This means that what helps one patient may harm another, and so FDA recommendations are of very little use.

Our Take on the FDA’s “DIY Hand-Slap”:

Someone with type-1 diabetes received too much insulin and had a severe low blood sugar. This actually isn’t an n=1 experience, it happens to insulin users all the time regardless of device in use (pump, pen, and syringe). People are sent home on day 1 of diagnosis with a medication that could be a killer with limited education other than “take as prescribed, eat food and do this if you have these symptoms”.  What made this particular event noteworthy is that it happened to someone who was using a do-it-yourself hybrid closed loop system (DIY HCL for those into acronyms) that was NOT approved by the US FDA.

Reportedly, the episode was caused by a faulty glucose sensor (which happens to be FDA-approved) which produced “repeated incorrect high glucose values” and led to over-delivery of insulin by an insulin pump (which also happens to be FDA-approved).  What drove the insulin delivery was a software program, also called an “algorithm,” which uses glucose data from the sensor to drive adjustments to the pump’s basal insulin delivery.  The algorithm, which is not FDA approved, appears to have performed properly based on the data it was receiving.

So here’s what the FDA had to say:

Patient use of unauthorized diabetes-management devices, alone or along with other devices, could result in inaccurate glucose level readings or unsafe insulin dosing.  These inaccuracies may lead to injuries requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis — the buildup of acids in blood — and death.

The FDA’s response to this incident is entirely expected.  Their job is to follow the letter of the law and state the obvious.  Someone who chose to use a non-FDA-approved system experienced a problem.  Doesn’t matter if the problem was a low blood sugar, a rash, or eyes that turned purple.  A problem occurred, so they have to state that use of a non-approved device can be harmful.  The real problem is that their response can also create a false portrayal of what DIY HCL systems have to offer.  They gave no indication that improper use of approved devices can also be harmful.  In this case, the non-approved devices are actually safer than the approved ones.

Consider a few facts:

  • In a study published in the journal Diabetes in 2018, users of a DIY HCL system were found to spend approximately 82% of time within the target glucose range of 70-180 mg/dl (3.9-10 mmol/l), and had an average glucose of around 130 (7.2).  Compare these values to the observed 70% in-range and 150 (8.3) average for those using HCL systems currently approved by the FDA.  In addition, the study found that people who began using the DIY HCL system saw their time spent in a hypoglycemic range decrease from 6.4% to 4.2%.

Nice results, but let’s translate them into more meaningful terms:  

Currently, there are more than 2000 people using HCL systems, but let’s go with 2000 for our purposes.  Those 2000 people are spending about half hour less time per day in a low range.  That comes to about 180 hours per year per person,  or 360,000 hours per year for those 2000 DIY HCL users.  If the average low blood sugar episode lasts about an hour (the true average is probably less than that), we’re talking about 360,000 fewer lows per year.  Now, let’s say that, conservatively, 1 out of every 100 lows escalates into a severe hypoglycemic event, that means that use of DIY HCL eliminates 3,600 severe lows per year.

Now, let’s think about the damage caused by elevated blood sugar.  Reducing overall averages from 150 (8.3) to 130 (7.2) equates to an A1c reduction of around 0.7%.  Data analysis from the DCCT study showed an approximate 30% reduction in long-term complications from every 1% reduction in A1c, so we’re looking at about a 20% reduction in complications for DIY HCL users.  In a year’s time, if only one out of 10 people with T1D develops a complication of any kind, this means that for the 2000 DIY HCL users, 40 fewer people will develop complications each year.

And this doesn’t even touch on the improved physical/mental/emotional performance that we see with more glucose stability and time in-range.  Going from 70% in-range to 82% is like adding nearly full day each week of feeling great and performing at one’s best!

  • Another good example is for those women using improved technology in pregnancy. Consider the lower targets in pregnancy. There is increased risk with current approved systems for women to experience hypo-unawareness due to the aim for lower targets compared to non-pregnancy. Some of these events can be severe, which is a risk for both mother and developing baby. When we consider the algorithm the looping systems use to contain glucose in a tight range, we can see a lower risk for hypo-unawareness as well as ability to maintain tight control with less risk of actual severe lows.

The FDA has an important role in assuring that we are not directly harmed by medications with dangerous components, effects etc. BUT the misuse of those medications cannot become a contraindication for their use! There are no reports of DIY technology itself causing harm to users. Loop hasn’t gone rogue and dosed someone outside of their set parameters. What has happened is that users have misused their technology. This would be tantamount to the FDA recommending that people not take blood pressure medication because someone misused their blood pressure cuff when taking their blood pressure and so took their blood pressure medication when their blood pressure was low and needed medical intervention. (And this is far more common an occurrence).

The extreme focus on FDA approval as a blockade against litigation has led to patients being uneducated or incorrectly educated. THIS is the threat in the use of DIY systems, and diabetes management as a whole. When we work with patients we often hear that their doctor never taught them things about diabetes that have revolutionized their diabetes management and its impact on their lives. The people with diabetes we work with often say they haven’t learned how to use features in their current devices or how to evaluate their own data to assist with adjustments. This is dangerous and is happening with devices that are approved. It happens often because diabetes education is restricted to “FDA approved” education regarding insulin and technologies. This leaves patients dangerously unprepared for life in the real world!

For example no one is ever taught anything about how to reuse infusion sets or reservoirs/cartridges, because the practice is not FDA approved in pump use. But it does not take long in using a pump for us to come across a situation where we are stranded without sufficient supplies. Something gets dislodged, we don’t get a delivery in time etc. So the user faces potential DKA, intense stress and a feeling of helplessness all because they were not given education on a situation because it’s not FDA approved. A big part of diabetes management is empowerment and confidence. This comes from education and knowing how to handle LIFE, not a clinical setting. The released incidents of patients who have had negative experiences with DIY systems are results of patients not having the education needed to safely and effectively operate the components of that system, because their clinicians refuse to educate them on non-FDA approved systems for fear of not having that to fall back on in litigation. We have even had clients who have reported their prescriber and educators having “fired them” from the practice because they used a DIY system or used a diabetes medication or technology in a non-FDA approved way. This is an example of the prescriber abandoning their clinical duty to their patients to protect their own interests, which borders on unethical. The FDA releasing this statement further prompts clinicians to continue to under educate their patients. This leads to blind self-guided therapy, frustration, victimization and diabetes burnout, a far more life threatening state than has been faced by any DIY technology use thus far. What we do know COULD harm us, but what we don’t know WILL harm us.

The FDA can proclaim whatever it wants.  The hypo episode that triggered the FDA response appears to be due to user error (common sense dictates that we need to check our blood sugar with a fingertsick any time the sensor seems ridiculously off, especially for long stretches of time).

What does it all mean?

Each person needs to weigh the benefits and risks and educate themselves on whatever they choose to use to manage their Diabetes (whether FDA approved or not). Most of the clinicians at IDS have chosen to take their chance with a “non-approved” system that offers known, solid benefits over an “approved” system every time.

If you’d like assistance for navigating use or have questions, give us a call. We can help at IDS!

Written by, Gary Scheiner, Alicia Downs, Annette Valle, and Jennifer Smith