Patients with type 1 diabetes experiencing recurrent severe hypoglycemia have stopped reporting these episodes to their diabetes care team as a result of new EU driving regulations, a study from Denmark published online October 6, 2014 in Diabetes Care has discovered.
The new rules mean diabetes patients can lose their driving license if they report two or more severe hypoglycemic events within a year; the (perhaps-unintended) consequences of this change are dangerous because of the potential for an increase in traffic accidents, say the study authors.
Prior to the new regulations, which came into effect in 2012, patient reporting of hypoglycemic events was ad hoc, and this depended on the clinician, the patient, and their mutual relationship, explained lead author Dr Ulrik Pedersen-Bjergaard (Nordsjællands Hospital Hillerød, Denmark). "The clinician could prohibit driving temporarily based on a general medical judgment. Authorities were informed only if the patient did not comply with the clinician's instructions," he said.
But now patients are expected to report to their clinician, who is responsible for taking appropriate action and who will inform authorities in case of noncompliance with the restrictions. This could jeopardize doctor-patient relations, Dr Pedersen-Bjergaard added.
"When the clinician is put in the position to be the person determining whether the patient can maintain their driving license, it is a serious threat against the clinician-patient relationship that may result in poorer treatment results and increased risk of road accidents," he commented. "The problem is that severe hypoglycemia is not a disease per se but rather a side effect of the life-necessary treatment for these patients with type 1 diabetes."
Medscape Medical News asked Dr Brian Frier (University of Edinburgh, Scotland) to comment on the new findings. In 2010, Dr Frier was the chair of the UK National Driving Panel on Diabetes, and he was closely involved with discussions about how the changes in EU regulations for licenses should be applied in the United Kingdom.
Dr Frier said that although the new regulations are "evidence based," he acknowledged that this study reveals a serious limitation regarding the honesty of patients' declaring recurrent hypoglycemia.
"This potential issue has not been assessed in the UK as yet, but there is every likelihood that a similar problem exists here," he acknowledged. However, in the United Kingdom, the patient reports hypoglycemia episodes to a driving authority, so at least the doctor/patient relationship is not affected.
Drop in Recurrent Reporting, Not Single Episode
The new regulations are an elaboration of the EU Third Directive on Driving (2006) and apply across all member states. They require that if, within a 1-year timeframe, a patient reports two or more severe hypoglycemic events — defined as an episode requiring assistance for recovery — the driving license should be withdrawn.
To examine the consequences of this change, Dr Pedersen-Bjergaard and colleagues conducted a retrospective cohort study, including data on a total of 309 patients with type 1 diabetes attending the outpatient clinic at Nordsjællands University Hospital Hillerød, between the years 2010 and 2012.
Records of reporting of hypoglycemic events during routine consultation in 2012 (after the introduction of new EU regulations) were compared with reporting rates from 2010 and 2011.
The comparison showed that following the EU regulation change, which occurred at the beginning of 2012, there was a 55% reduction in reporting of severe hypoglycemic events (P = 0.034).
And the mean yearly rate of severe hypoglycemic events documented in the medical records was 0.42 (range, 0–6.5) events per patient-year in 2010 to 2011, vs 0.19 (range, 0–5) events per patient-year in 2012.
Of note, the proportion of subjects reporting recurrent episodes of hypoglycemia dramatically fell from 5.6% to 1.5% (P = 0.014), a 73% relative reduction.
License loss is linked to the reporting of two or more episodes of hypoglycemia.
By comparison, single-episode reporting was not significantly reduced (P = 0.88).
Risk of Accidents Related to Previous Severe Hypoglycemia
Dr Frier explained that the change in EU regulations was supported by published studies.
"These show that the risk of driving accidents by insulin-treated diabetic drivers is related to a history of preceding severe hypoglycemia, particularly in the past 2 years, so this change was evidence based and not an arbitrary decision."
However, he admitted that there are legitimate concerns that this regulation could encourage concealment of episodes of severe hypoglycemia by drivers treated with insulin, once they realize the consequence of reporting a recurrent event.
He acknowledged that this new Danish study strongly suggests that drivers with type 1 diabetes have changed their reporting behavior since the new EU regulations were implemented in Denmark and are concealing many episodes to avoid jeopardizing their driving licenses.
Prior to the change in EU regulations, he and his colleagues conducted a small study of drivers with type 1 diabetes with a high risk for severe hypoglycemia in the United Kingdom. They found that about one in 10 were being economical with the truth, when their reports were compared with those of their medical attendances.
Now in the United Kingdom, the new EU rules require that if a driver experiences a recurrent episode of hypoglycemia, this has to be reported to the Driver and Vehicle Licensing Agency (DVLA) by the driver, and their driving license will then be revoked until the annual rate of hypoglycemic events returns to one. At this point, the patient can reapply for a license.
Dr. Frier pointed out that a patient who has a serious traffic accident and has not reported events would be breaking the law and negating their motor-vehicle insurance if the hypoglycemic event comes to light.
Dr Pedersen-Bjergaard has declared that he has served on advisory boards for AstraZeneca/Bristol-Myers Squibb and Novo Nordisk and received lecture fees from AstraZeneca/Bristol-Myers Squibb, Sanofi, and Novo Nordisk. Dr Frier has declared that he is a speaker and/or advisory-board member for Novo Nordisk, Lilly, MSD, Janssen, Sanofi, and Boehringer Ingelheim.
Diabetes Care. Published online October 6, 2014. Abstract
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Cite this: New EU Driving Rules for Type 1 Diabetes Could Spell Danger - Medscape - Oct 16, 2014.
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