Evaluation of Corneal Confocal Microscopy for the Identification and Prediction of Neuropathy in Type 1 Diabetes

Completed

Conditions studied: Diabetic Polyneuropathy, Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Complications

In brief

Through the multinational pooled dataset approach, this trial will aim to derive and validate specific in vivo Corneal Confocal Microscopy (CCM) parameter thresholds for the identification of diabetic polyneuropathy, and - more importantly - the identification of individuals at future risk. Results of the study will permit application in clinical practice and intervention trials for diabetic polyneuropathy (DPN) risk stratification. The primary goal of the study is to re-examine individuals with type 1 and type 2 diabetes with and without neuropathy, who had CCM performed in the past as a part of their neurological examination, to assess concurrent and predictive validity of different CCM parameters in individuals . These subjects will be invited to the study to be re-examined by CCM along with other neurological tests (physical exam, nerve conduction studies, quantitative sensory testing, blood test and in some centres also skin biopsy) during the single study visit. Additionally CCM data will be analyzed both manually and by recently developed automated analytical software to evaluate accuracy of the automated method. Evaluation of automated image analysis will influence likelihood of successful knowledge translation of this surrogate biomarker for DPN into clinical practice - in which the procedure could be harmonized with annual retinal examinations - and into intervention trials. Secondary aim of the study is to determine the factors associated with CCM parameters and their longitudinal change and collect bio-samples for future research in this field.

Key facts

Study ID

NCT02423434

Run by

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

People needed

624

Starts

2014-09-01

Expected to finish

2018-08-01

Last updated by the study team

2019-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals of any gender or race aged 18 or above
• Type 1 diabetes mellitus or type 2 diabetes mellitus as defined by the American Diabetes Association guidelines (2014) of any duration
• Availability of the initial CCM examination performed two to eight years ago
• Ability to understand and cooperate with study procedures

You may not qualify if…

• Confirmed to have neuropathy owing to non-diabetic causes (such as familial, alcoholic, nutritional, uremic)
• Current eye infection, corneal damage, or severe movement disorders which could preclude a safe CCM exam
• Allergy to proparacaine (the ocular topical anaesthetic used for the CCM exam)

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States
• Queensland University of Technology — Brisbane, Australia
• University of Calgary — Calgary, Alberta, Canada
• Mount Sinai Hospital and University Health Network — Toronto, Ontario, Canada
• University of Manchester — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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