Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-01-24 @ 11:23 PM
Study NCT ID:
NCT02321904
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2013-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCM
Brief Summary:
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.
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: