Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
DIVIDEND
1 other identifier
observational
26
1 country
1
Brief Summary
This project aimed to explore novel methods of detecting small blood vessel disease in a paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory Blood Pressure Monitoring were used. Each of these techniques investigated different areas of small blood vessels around the body. It was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel investigations would be associated with small blood vessel disease and that widespread changes to these blood vessels would be detected through associations between the different novel investigations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 19, 2011
CompletedFirst Posted
Study publicly available on registry
January 20, 2011
CompletedJanuary 25, 2011
January 1, 2011
6 months
January 19, 2011
January 24, 2011
Conditions
Keywords
Study Arms (1)
Type 1 Diabetes Paediatric
Paediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital.
Interventions
Single session of video Nailfold Capillaroscopy wit KKK technology
24 hr upper arm cuff measurement of Blood Pressure
examination of microvascular health of eye with the use of opthalmoscope
Eligibility Criteria
Participants were recruited from the John Hunter Children's Hospital paediatric diabetes clinic. They were between the ages of 8-18 years old.
You may qualify if:
- years old
- Have a diagnosis of type 1 diabetes mellitus
You may not qualify if:
- \< 8 years or \> 18 years old
- Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John Hunter Children's Hospital
New Lambton, New South Wales, 2305, Australia
Related Publications (1)
Hosking SP, Bhatia R, Crock PA, Wright I, Squance ML, Reeves G. Non-invasive detection of microvascular changes in a paediatric and adolescent population with type 1 diabetes: a pilot cross-sectional study. BMC Endocr Disord. 2013 Oct 5;13:41. doi: 10.1186/1472-6823-13-41.
PMID: 24093770DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rani Bhatia, MD
John Hunter Children's Hospital
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
January 19, 2011
First Posted
January 20, 2011
Study Start
March 1, 2010
Primary Completion
September 1, 2010
Study Completion
October 1, 2010
Last Updated
January 25, 2011
Record last verified: 2011-01