Key result
Rapid HbA1c reduction is not linked to worse neurophysiological function compared to smaller drops.
Why the study?
A treatment-induced drop in HbA1c has been suggested to be a risk factor for treatment induced diabetic neuropathy (TIND).
Does antidiabetic treatment causing a drop in HbA1c > 2% affect neurophysiologic functional tests in patients with severe diabetes mellitus?
Cohort (n=21)
No
Does antidiabetic treatment causing a drop in HbA1c > 2% affect neurophysiologic functional tests in patients with severe diabetes mellitus?
A prospective pilot study evaluating treatment-induced diabetic neuropathy was limited by poor adherence and small sample size, yielding no statistically significant neurophysiological changes.
Rapid HbA1c reduction was not associated with neurophysiologic worsening; leaves open treatment-induced neuropathy risk pending larger trials.
BACKGROUND: A treatment-induced drop in HbA1c has been suggested to be a risk factor for TIND. METHODS: From 60 included patients with severe diabetes mellitus (HbA1c over 8.5) only 21 patients adhered to the study protocol over 1 year with a battery of autonomic nervous system tests scheduled before and after starting antidiabetic treatment. RESULTS: In patients with a drop of HbA1c greater than 2 per cent points only some neurophysiologic tests and lab values tended to deteriorate with a trend to improve at later time points along the study. None of these changes were statistically significant, most likely because the study failed to reach the planned number of patients. CONCLUSION: Poor adherence to diabetes treatment and to following the study protocol were the assumed obstacles in our patient cohort selected for very high HbA1c levels. In future studies a multi-center trial and case numbers of up to 500 patients may be needed to account for drop outs in the range observed here. Moreover, the number of tests in each patient at each visit may have to be reduced and special educational group sessions are warranted to cope with the limited adherence. Trial registration Ethic Committee University of Leipzig 439/15-ek. Registered 22 April 2016.
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Hoffmann et al. (2022) conducted a cohort in Severe diabetes mellitus (n=21). Rapid reduction in HbA1c (≥2 percentage points) vs. Reduction in HbA1c <2 percentage points was evaluated on Deterioration in neurophysiological functional tests between baseline and 3 months. A rapid treatment-induced reduction in HbA1c of 2 percentage points or more did not result in statistically significant deterioration of neurophysiological functional tests compared to a smaller HbA1c reduction.
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