Type 1 DiabetesCCMNCT02321904
Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
An observational study of Type 1 Diabetes and Neuropathy, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Neuropathy, Retinopathy
- What is being tested?
- Corneal Confocal Microscopy, Nerve Conduction Studies and Quantitative sensory testing
- Type of treatment
- Surgery or procedure
- How many people
- 176 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Cases: Children seen at the Alberta Children's Hospital Diabetes Clinic in Calgary Controls: 8-18 year old healthy children
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
In phase 1: To compare corneal nerve density (CND), length (CNL), and branching (CBD) by CCM between
- children with type 1 diabetes for 5 years or more to children without diabetes;
- children with type 1 diabetes with and without evidence of diabetic neuropathy;
- to examine the relationship between CND, CNL \& CBD and known risk factors of diabetic neuropathy
In phase 2:
- to examine for changes in corneal nerve morphology two years after the initial CCM exam.
- to describe the evolution of diabetic neuropathy based on clinical symptoms, neurological deficits, and other tests of nerve dysfunction.
- to assess if changes in corneal nerve morphology correlate with changes in nerve conduction velocity and autonomic testing.
- To examine the risk factors associated with progression of diabetic neuropathy in our pediatric population.
- Conditions
- Type 1 Diabetes, Neuropathy, Retinopathy
- Being tested
- Corneal Confocal Microscopy, Nerve Conduction Studies, Quantitative sensory testing, Neuropathy Symptom Score, Clinical nerve examination
- Keywords
- Confocal microscopy, Cornea, Neuropathy, Detection, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Retinal Diseases, Corneal Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Confocal MicroscopyProcedure or surgery
Close-up pictures of the front part of the eye (the cornea)
Nerve Conduction StudiesProcedure or surgery
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.
Quantitative sensory testingProcedure or surgery
Standardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe.
Neuropathy Symptom ScoreProcedure or surgery
A list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview.
Clinical nerve examinationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic cases | 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. Receives: Procedure: Corneal Confocal Microscopy; Procedure: Nerve Conduction Studies; Procedure: Quantitative sensory testing; Procedure: Neuropathy Symptom Score; Procedure: Clinical nerve examination | |
| Normal controls | 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. Receives: Procedure: Corneal Confocal Microscopy; Procedure: Nerve Conduction Studies; Procedure: Quantitative sensory testing; Procedure: Neuropathy Symptom Score; Procedure: Clinical nerve examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
Corneal nerve density (CND) by CCM
To compare corneal nerve density (CND) between
- children with T1D for 5 years or more to children without diabetes;
- children with T1D with and without evidence of DN;
- to examine the relationship between CND, CNL \& CBD and known risk factors of DN
Measured: 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.
- to describe the evolution of DN in based on clinical symptoms, neurological deficits, and other tests of nerve dysfunction.
- 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.
Measured: 2 years
Corneal nerve length (CNL) by CCM.
To compare corneal nerve length (CNL), by CCM between
- children with T1D for 5 years or more to children without diabetes;
- children with T1D with and without evidence of DN;
- to examine the relationship between CND, CNL \& CBD and known risk factors of DN
Measured: Single time point
Corneal nerve branching density (CBD) by CCM
To compare corneal nerve branching density (CBD) by CCM between
- children with T1D for 5 years or more to children without diabetes;
- children with T1D with and without evidence of DN;
- to examine the relationship between CND, CNL \& CBD and known risk factors of DN
Measured: Single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startJun 2008
- Primary completionAug 2014
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Dr. Danièle Pacaud, University of Calgary
- Investigators
- Danièle Pacaud, Md, FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321904
- Sponsor's protocol ID
- E-21944
- Acronym
- CCM
- Status last verified
- Oct 2019
- First submitted
- 17 Jun 2013
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
- ClinicalTrials.gov ID
- NCT02321904
- Acronym / sponsor ID
- CCM / E-21944
- Conditions
- Type 1 Diabetes, Neuropathy, Retinopathy
- Keywords
- Confocal microscopy, Cornea, Neuropathy, Detection, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Jun 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- children with type 1 diabetes for 5 years or more to children without diabetes;
- children with type 1 diabetes with and without evidence of diabetic neuropathy;
- to examine the relationship between CND, CNL \& CBD and known risk factors of diabetic neuropathy
In phase 2:
- to examine for changes in corneal nerve morphology two years after the initial CCM exam.
- to describe the evolution of diabetic neuropathy based on clinical symptoms, neurological deficits, and other tests of nerve dysfunction.
- to assess if changes in corneal nerve morphology correlate with changes in nerve conduction velocity and autonomic testing.
- To examine the risk factors associated with progression of diabetic neuropathy in our pediatric population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic cases | – | Procedure: Corneal Confocal Microscopy, Procedure: Nerve Conduction Studies, Procedure: Quantitative sensory testing, Procedure: Neuropathy Symptom Score, Procedure: Clinical nerve examinationChildren 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. |
| Normal controls | – | Procedure: Corneal Confocal Microscopy, Procedure: Nerve Conduction Studies, Procedure: Quantitative sensory testing, Procedure: Neuropathy Symptom Score, Procedure: Clinical nerve examinationHealthy children aged 8 to 18 years will undergo Corneal Confocal Microscopy, Nerve Conduction Studies, Quantitative sensory testing, Neuropathy Symptom Scoring and Clinical nerve examinations. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Cases: Children seen at the Alberta Children's Hospital Diabetes Clinic in Calgary Controls: 8-18 year old healthy children
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal Confocal MicroscopyClose-up pictures of the front part of the eye (the cornea) | Procedure or surgery | Diabetic cases, Normal controls |
| Nerve Conduction StudiesThe 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. | Procedure or surgery | Diabetic cases, Normal controls |
| Quantitative sensory testingStandardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe. | Procedure or surgery | Diabetic cases, Normal controls |
| Neuropathy Symptom ScoreA list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview. | Procedure or surgery | Diabetic cases, Normal controls |
| Clinical nerve examinationSummated 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. | Procedure or surgery | Diabetic cases, Normal controls |
Primary outcome
The utility of corneal confocal microscopy to assess diabetic neuropathy in children.
Time frame: 2 years
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.
4 secondary outcomes
Corneal nerve density (CND) by CCM
Time frame: Single time point
Changes in corneal nerve morphology two years after the initial CCM exam.
Time frame: 2 years
Corneal nerve length (CNL) by CCM.
Time frame: Single time point
Corneal nerve branching density (CBD) by CCM
Time frame: Single time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danièle Pacaud, Md, FRCPC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Neuropathy, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The utility of corneal confocal microscopy to assess diabetic neuropathy in children. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.