The Association’s 2001 comments on the proposed diabetes exemption program (attached as Exhibit A and incorporated in these comments) emphasized the safety of state waiver programs for insulin-treated commercial drivers.40 At the time we included information about the Oregon waiver program:
Oregon reported that their commercial drivers with insulin-treated diabetes are safer than commercial drivers as a whole. The preventable accident rate per million miles traveled was 0.59 for commercial drivers with insulin-treated diabetes as opposed to 0.75 for all commercial drivers.41
The Association is not aware of any problems with the states’ diabetes waiver programs since our 2001 comments.
(9) Should new and emerging therapies for treatment of diabetes mellitus be considered in reviewing and revising the current standard? If so, how? If a revised FMCSA standard for drivers with ITDM is established, how would new and emerging therapies, particularly injectable medications (e.g., incretin mimetics) and continuous subcutaneous insulin infusion therapy, affect the implementation of a new standard?
Physician guidelines to implement the new diabetes standard should specify a short adjustment period (e.g., two weeks) during which individuals must refrain from driving after “new and emerging therapies” are initiated if there is a reasonable basis to conclude that the particular therapy could negatively impact susceptibility to hypoglycemia. A list of such therapies should be made and updated periodically, on advice of the FMCSA Diabetes Panel. The list should only include therapies that affect insulin delivery, not those involved with monitoring glucose. Continuous subcutaneous insulin infusion therapy – a.k.a. “insulin pumps” – is not a new and emerging therapy (and has been a part of modern diabetes management since long before the establishment of the Diabetes Exemption Program in 2003) and should not be treated any differently than insulin taken in any other manner (e.g., syringe, pen), as the determination of what method of insulin administration is best for an individual should be left to the individual and his or her treating physician.
What quantitative data are there on safety performance of drivers with ITDM?
Do these studies link efficacy of medication and therapy with risk and incidence of crashes in commercial and non-commercial motor vehicles? If so, how?
It is essential to keep in mind that FMCSA has already extensively studied the safety of commercial driving by individuals with insulin-treated diabetes, and found that “there was no significant difference in the accident rates for ITDM drivers and the comparisons” and that “a more direct comparison . . . shows that the ITDM group has an accident rate lower than
40 See Comments of the American Diabetes Association, Docket No. FMCSA-2001-9800 (Oct. 1, 2001) (stating that “some states have noted that drivers with insulin-treated diabetes are sometimes safer than other commercial operators.”).