The overall aim of this study is to confirm the utility of corneal confocal microscopy (CCM) as a new technique to rapidly and non-invasively assess diabetic neuropathy (DN) in children. This study will be divided into two phases: Phase 1 will be a cross-sectional study of children with type 1 diabetes and normal controls, while phase 2 will be a longitudinal assessment of a subgroup of children with type 1 diabetes recruited during Phase 1.
In phase 1: To compare corneal nerve density (CND), length (CNL), and branching (CBD) by CCM between 1. children with type 1 diabetes for 5 years or more to children without diabetes; 2. children with type 1 diabetes with and without evidence of diabetic neuropathy; 3. to examine the relationship between CND, CNL \& CBD and known risk factors of diabetic neuropathy In phase 2: 1. to examine for changes in corneal nerve morphology two years after the initial CCM exam. 2. to describe the evolution of diabetic neuropathy based on clinical symptoms, neurological deficits, and other tests of nerve dysfunction. 3. to assess if changes in corneal nerve morphology correlate with changes in nerve conduction velocity and autonomic testing. 4. To examine the risk factors associated with progression of diabetic neuropathy in our pediatric population.
Study Type
OBSERVATIONAL
Enrollment
176
Close-up pictures of the front part of the eye (the cornea)
The following assessments will be made: a) amplitude of nerve action potential (μV) and conduction velocity (m/s) of the sural sensory nerve by antidromic stimulation; b) motor nerve conduction velocity (m/s), maximum M-wave amplitude (mV) and motor nerve distal latency (ms) of the peroneal motor nerve; and c) tibial nerve conduction study will also be obtained if tolerated.
Standardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe.
Alberta Children's Hospital
Calgary, Alberta, Canada
The utility of corneal confocal microscopy to assess diabetic neuropathy in children.
To confirm the utility of corneal confocal microscopy (CCM) as a new technique to rapidly assess diabetic neuropathy (DN) in children. This non-invasive eye imaging method may be a superior alternative to traditional nerve conduction studies. This study will be divided into two phases: Phase 1 will be a cross-sectional study of children with Type 1 Diabetes (T1D) and normal controls, while phase 2 will be a longitudinal assessment of a subgroup of T1D children recruited during Phase 1.
Time frame: 2 years
Corneal nerve density (CND) by CCM
To compare corneal nerve density (CND) between 1. children with T1D for 5 years or more to children without diabetes; 2. children with T1D with and without evidence of DN; 3. to examine the relationship between CND, CNL \& CBD and known risk factors of DN
Time frame: Single time point
Changes in corneal nerve morphology two years after the initial CCM exam.
In phase 2 : 1) to examine for changes in corneal nerve morphology two years after the initial CCM exam. 2\) to describe the evolution of DN in based on clinical symptoms, neurological deficits, and other tests of nerve dysfunction. 3\) to assess if changes in corneal nerve morphology correlate with changes in nerve conduction velocity and autonomic testing. 4) To examine the risk factors associated with progression of DN in our pediatric population.
Time frame: 2 years
Corneal nerve length (CNL) by CCM.
To compare corneal nerve length (CNL), by CCM between 1. children with T1D for 5 years or more to children without diabetes; 2. children with T1D with and without evidence of DN; 3. to examine the relationship between CND, CNL \& CBD and known risk factors of DN
Time frame: Single time point
Corneal nerve branching density (CBD) by CCM
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A list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview.
Summated score of the lower extremities. Neurological examination assessing muscle strength, knee and ankle reflexes, sensation in the great toes will be evaluated for light touch-pressure, temperature, pin-prick, vibratory sense and joint position sense.
To compare corneal nerve branching density (CBD) by CCM between 1. children with T1D for 5 years or more to children without diabetes; 2. children with T1D with and without evidence of DN; 3. to examine the relationship between CND, CNL \& CBD and known risk factors of DN
Time frame: Single time point