Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children (CCM)

University of Calgary

Status: Completed

Conditions: Retinopathy; Type 1 Diabetes; Neuropathy

Treatments: Procedure: Corneal Confocal Microscopy; Procedure: Neuropathy Symptom Score; Procedure: Quantitative sensory testing; Procedure: Nerve Conduction Studies; Procedure: Clinical nerve examination

Study type: Observational

Funder types: Other

Identifiers

NCT02321904

E-21944

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 176 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• CASES: Children with Type 1 Diabetes 8 to 18 years old followed at the Alberta Children's Hospital Diabetes Clinic with a duration of diabetes of at least 5 years.
• CONTROLS: Healthy children aged 8 to 18 years.

Exclusion criteria

• Patients with known history of corneal abnormality, trauma, or surgery
• Any other cause of neuropathy
• Individuals with uncontrolled hypothyroidism
• Individuals with celiac disease
• Other serious chronic illnesses besides diabetes
• Inability to cooperate with testing
• Families unwilling to provide written informed consent

Trial design

176 participants in 2 patient groups

Diabetic cases

Description:

Children with Type 1 Diabetes 8 to 18 years old followed at the Alberta Children's Hospital Diabetes Clinic with duration of diabetes for at least 5 years will undergo Corneal Confocal Microscopy, Nerve Conduction Studies, Quantitative sensory testing, Neuropathy Symptom Scoring and Clinical nerve examinations.

Treatment:

Procedure: Quantitative sensory testing

Procedure: Nerve Conduction Studies

Procedure: Corneal Confocal Microscopy

Procedure: Clinical nerve examination

Procedure: Neuropathy Symptom Score

Normal controls

Description:

Healthy children aged 8 to 18 years will undergo Corneal Confocal Microscopy, Nerve Conduction Studies, Quantitative sensory testing, Neuropathy Symptom Scoring and Clinical nerve examinations.

Treatment:

Procedure: Quantitative sensory testing

Procedure: Nerve Conduction Studies

Procedure: Corneal Confocal Microscopy

Procedure: Clinical nerve examination

Procedure: Neuropathy Symptom Score