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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01279928




Registration number
NCT01279928
Ethics application status
Date submitted
19/01/2011
Date registered
20/01/2011
Date last updated
25/01/2011

Titles & IDs
Public title
Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
Scientific title
Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
Secondary ID [1] 0 0
HNEHREC 09/04/15/5.10
Universal Trial Number (UTN)
Trial acronym
DIVIDEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Video Nailfold Capillaroscopy
Treatment: Devices - Ambulatory 24 hr Blood Pressure Monitoring
Treatment: Surgery - Fundoscopy of eyes
Treatment: Surgery - Laser Doppler Flowmetry

Type 1 Diabetes Paediatric - Paediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital.


Treatment: Surgery: Video Nailfold Capillaroscopy
Single session of video Nailfold Capillaroscopy wit KKK technology

Treatment: Devices: Ambulatory 24 hr Blood Pressure Monitoring
24 hr upper arm cuff measurement of Blood Pressure

Treatment: Surgery: Fundoscopy of eyes
examination of microvascular health of eye with the use of opthalmoscope

Treatment: Surgery: Laser Doppler Flowmetry
Examination of vascular flow
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* 8-18 years old
* Have a diagnosis of type 1 diabetes mellitus
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* < 8 years or > 18 years old
* Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 0 0
2305 - New Lambton

Funding & Sponsors
Primary sponsor type
Government body
Name
John Hunter Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rani Bhatia, MD
Address 0 0
John Hunter Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01279928