by Dr. Michael Berry, M.D., FAA Federal Air Surgeon

As my office works to implement significant changes to our insulin-treated diabetes mellitus (ITDM) protocol, let me take this opportunity to provide an overview.

Not long after the Wright Brothers first flew, the need for airman physical standards became apparent. Early U.S. Army pilot candidates included those medically disqualified for infantry or cavalry. This was unsuccessful as shown by the British during the first year of WWI: two-percent of aviation losses were due to enemy action, eight-percent to mechanical issues, and ninety-percent medical issues. Sixty-percent of the losses had physical deficits. Once medical standards were in place, the accidents secondary to medical causes dropped to twenty-percent after one year and twelve-percent the following year.

Early civilian aeromedical standards closely mirrored those of the U.S. Army. Just as today, the medical standards for commercial pilots were more rigorous than for a private pilot, which balances public safety and an individual’s freedom to fly. Through today’s Special Issuance Medical Certificate process, provisions for appropriate evaluation and risk mitigation allow us to routinely evaluate and issue for conditions that were once cause for automatic disqualification. This change is a testament to ongoing improvements in treatment and diagnostic tools.

Thanks to specific improvements in the management of ITDM and through consultation with prominent clinical specialists in diabetes, we have determined that some applicants with ITDM can now be favorably considered for either a Class I or II medical certificate under 14 CFR part 67. As you may be aware, in 1996 one of my predecessors determined that technology had matured sufficiently to allow special issuance of medical certificates for ITDM at the Class III level. The new protocol is an option for Class III medical certificates (although they can also use the prior protocol). It has no effect on pilots using BasicMed or sport pilot privileges.

You may also know that Canada and the United Kingdom (UK) both allowed use of insulin by commercial pilots some years ago. The U.S. couldn’t follow suit right away because both countries, to mitigate risk, imposed limitations not feasible here in the United States. For instance, they limit use of the medical certificate to two-pilot operations, require specific training for the non-diabetic pilot, and require informing other crewmember(s) of the ITDM condition. Recent improvements in CGM (continuous glucose monitoring) technology are sufficient that the FAA can now favorably consider special issuance for Class I and II medical certificates for some individuals without the need for these restrictions. My expectation is that our special issuance will provide a template for other International Civil Aviation Organization (ICAO) member states including Canada and the UK.

We announced the new ITDM protocols via the Federal Register on November 7, 2019. We designed the protocols to ensure that the pilot remains in good control and avoids incapacitation, subtle or overt. Both low and high blood sugar (hypo- and hyperglycemia, respectively) are associated with cognitive impairment that can cause poor decision making, slowed reaction time, and an inattention to detail, among other problems. The use of CGM allows the pilot to closely monitor blood sugar irrespective of workload and ambient conditions (turbulence, emergencies, etc.) and take corrective action in all phases of flight. In addition, a predictive function allows the pilot to take action to prevent blood sugar excursions outside the desired range rather than merely reacting to them, as is the case with finger-stick blood sugar testing. We have already begun to review cases under this protocol and will grant a special issuance when it is safe to do so. This is a win for the professional pilot community and it also maintains safety in the National Airspace System.

• Federal Register notice on new ITDM protocol: go.usa.gov/xdr3D

Dr. Michael Berry received an M.D. from the University of Texas Southwestern Medical School, and a master’s in preventive medicine from Ohio State University. He is certified by the American Board of Preventive Medicine in aerospace medicine. He served as an FAA senior aviation medical examiner and vice-president of Preventive and Aerospace Medicine Consultants for 25 years before joining the FAA. He also served as both a U.S. Air Force and NASA flight surgeon.