ORCID Profile
0000-0003-1686-7998
Current Organisation
University of Michigan
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Publisher: American Diabetes Association
Date: 06-2019
DOI: 10.2337/DB19-323-OR
Abstract: Corneal Nerve Fibre Length (CNFL) reasonably identifies the presence of neuropathy in patients with T1D and T2D. In this longitudinal diagnostic study, we aimed to determine its ability to predict future neuropathy. Among 998 participants with diabetes, we examined the 387 who did not have neuropathy at baseline and who had follow-up in a 5-centre multinational consortium study. Participants underwent corneal nerve quantification and clinical and electrophysiological examination for neuropathy at baseline and in scheduled follow-up. Predictive validity and diagnostic thresholds were determined using time-dependent receiver operating characteristic (ROC) curves that accounted for censoring, and used baseline and time-updated CNFL. Estimates were derived in the T1D subcohort and validated in the T2D subcohort. The 387 participants had mean follow-up of 4.8 years (interquartile range 3-7y). 288 had T1D (baseline mean age 35±17 years and A1c 8.2±1.5%) and 99 had T2D (baseline age 59±8 years and A1c 7.3±1.1%). New onset neuropathy occurred in 85 participants (22% incidence rate 5.05 events per 100 person years). The crude area under the ROC curve (AUC) for CNFL was 0.64 (95% CI 0.56-0.73, p=0.001) in the T1D derivation set, which was confirmed in the T2D validation set (AUC 0.69, 95% CI 0.57-0.81, p=0.002). In the combined cohort, time-dependent ROC curves were generated for 2, 4, 6, and 8 years AUC ranged from 0.67 to 0.71 for baseline CNFL, and 0.66 to 0.68 for time-updated CNFL. The optimal diagnostic threshold for baseline CNFL was 14.1mm/mm2 (sensitivity 67%, specificity 63%, 1ikelihood ratio (LR) positive 1.8, LR negative 0.5, Cox proportional hazard rate ratio 2.79, p& .001). CNFL showed modest but statistically significant predictive validity. Though its utility may be limited as a diagnostic tool in estimating risk for in idual patients, it could play a role in identifying higher-risk groups of in iduals for inclusion in clinical research and trials. B.A. Perkins: Advisory Panel Self Abbott, Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH, Insulet Corporation. Research Support Self Boehringer Ingelheim International GmbH. Other Relationship Self Abbott, Boehringer Ingelheim International GmbH, Lilly Diabetes, Medtronic, Novo Nordisk Inc., Sanofi. L. Lovblom: None. V. Bril: Advisory Panel Self Akcea Therapeutics, Alexion Pharmaceuticals, Inc., Alnylam, CSL Behring. Consultant Self Pfizer Inc. Research Support Self Baxter, Biogen, Grifols, UCB, Inc. M. Ferdousi: None. A. Orszag: None. K. Edwards: None. N. Pritchard: None. A.W. Russell: None. C. Dehghani: None. D. Pacaud: Other Relationship Self Novo Nordisk A/S, Sandoz, TOLMAR. K. Romanchuk: None. J. Mah: None. M. Jeziorska: None. A. Marshall: None. R.M. Shtein: None. R. Pop-Busui: Consultant Self Novo Nordisk A/S. Research Support Self AstraZeneca. Other Relationship Self American Diabetes Association. S.I. Lentz: None. A.J. Boulton: None. M. Tavakoli: None. N. Efron: None. R.A. Malik: None. National Institutes of Health
Publisher: American Diabetes Association
Date: 07-2021
DOI: 10.2337/DC21-0476
Abstract: Corneal nerve fiber length (CNFL) has been shown in research studies to identify diabetic peripheral neuropathy (DPN). In this longitudinal diagnostic study, we assessed the ability of CNFL to predict the development of DPN. From a multinational cohort of 998 participants with type 1 and type 2 diabetes, we studied the subset of 261 participants who were free of DPN at baseline and completed at least 4 years of follow-up for incident DPN. The predictive validity of CNFL for the development of DPN was determined using time-dependent receiver operating characteristic (ROC) curves. A total of 203 participants had type 1 and 58 had type 2 diabetes. Mean follow-up time was 5.8 years (interquartile range 4.2–7.0). New-onset DPN occurred in 60 participants (23% 4.29 events per 100 person-years). Participants who developed DPN were older and had a higher prevalence of type 2 diabetes, higher BMI, and longer duration of diabetes. The baseline electrophysiology and corneal confocal microscopy parameters were in the normal range but were all significantly lower in participants who developed DPN. The time-dependent area under the ROC curve for CNFL ranged between 0.61 and 0.69 for years 1–5 and was 0.80 at year 6. The optimal diagnostic threshold for a baseline CNFL of 14.1 mm/mm2 was associated with 67% sensitivity, 71% specificity, and a hazard ratio of 2.95 (95% CI 1.70–5.11 P & 0.001) for new-onset DPN. CNFL showed good predictive validity for identifying patients at higher risk of developing DPN ∼6 years in the future.
No related grants have been discovered for Stephen Ignatius Lentz.