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Abstract
Objective Diabetic sensorimotor peripheral neuropathy (DSP) is the most prevalent complication in diabetes mellitus. Identifying DSP risk is essential for intervening early in the natural history of the disease. Small nerve fibers are affected earliest in the disease progression and evidence of this damage can be identified using in vivo corneal confocal microscopy (IVCCM).
Research design and methods We applied IVCCM to a cohort of 40 patients with type 1 diabetes to identify their DSP risk profile. We measured standard IVCCM parameters including corneal nerve fiber length (CNFL), and performed nerve conduction studies and quantitative sensory testing.
Results 40 patients (53% female), with a mean age of 48±14, BMI 28.1±5.8, and diabetes duration of 27±18 years were enrolled between March 2014 and June 2015. Mean IVCCM CNFL was 12.0±5.2 mm/mm2 (normal ≥15 mm/mm2). Ten patients (26%) without DSP were identified as being at risk of future DSP with mean CNFL 11.0±2.1 mm/mm2. Six patients (15%) were at low risk of future DSP with mean CNFL 19.0±4.6 mm/mm2, while 23 (59%) had established DSP with mean CNFL 10.5±4.5 mm/mm2.
Conclusions IVCCM can be used successfully to identify the risk profile for DSP in patients with type 1 diabetes. This methodology may prove useful to classify patients for DSP intervention clinical trials.
- Neuropathy
- Neuropathy Clinical Trials
- CCM
- Risk Assessment
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Footnotes
Contributors EJHL, BAP, RPB, TMSW, and VB designed the study. EJHL and LEL performed the statistical analysis. All authors contributed to the discussion, reviewed, and edited the manuscript. EJHL and VB are the guarantors of this work and, as such, had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Funding This work was supported by the Canadian Diabetes Association (#OG-2-13-4093-VB), a Banting and Best Diabetes Centre Studentship (EJHL), an Ontario Graduate Scholarship (EJHL), a James F. Crothers Family Fellowship in Peripheral Nerve Damage (EJHL), and a Peterborough K. M. Hunter Graduate Studentship (EJHL).
Competing interests TMSW is a part owner, president, and medical director of Glycemic Index Laboratories, Toronto, Canada and has authored several popular diet books on the glycemic index for which he has received royalties from Phillipa Sandall Publishing Services and CABI Publishers. He has received consultant fees, honoraria, travel funding, or served on the scientific advisory board for McCain Foods, Temasek Polytechnic, Singapore, Glycemic Index Symbol program, CreaNutrition AG, and the National Sports and Conditioning Association. His wife is an employee and part owner of Glycemic Index Laboratories.
Patient consent Obtained.
Ethics approval University Health Network Research Ethics Board.
Provenance and peer review Not commissioned; internally peer reviewed.
Data sharing statement All data from this study was published.