Type 1 Diabetes MellitusDIVIDENDNCT01279928
Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
An observational study of Type 1 Diabetes Mellitus, run by John Hunter Hospital at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Video Nailfold Capillaroscopy, Ambulatory 24 hr Blood Pressure Monitoring and Fundoscopy of eyes
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2010to Oct 2010
- 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
- No healthy volunteers
- Child, Adult
Study population: Participants were recruited from the John Hunter Children's Hospital paediatric diabetes clinic. They were between the ages of 8-18 years old.
Who may be able to join
- 8-18 years old
- Have a diagnosis of type 1 diabetes mellitus
Who cannot join
- < 8 years or > 18 years old
- Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)
Trial locations and contacts
1 site in 1 country.
Australia1 site
John Hunter Children's Hospital
New Lambton, New South Wales, 2305
About this study
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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Video Nailfold Capillaroscopy, Ambulatory 24 hr Blood Pressure Monitoring, Fundoscopy of eyes, Laser Doppler Flowmetry
- Keywords
- paediatric and adolescent population, nailfold capillaroscopy, laser Doppler flowmetry, retinal vessel calibre, retinal vessel fractal analysis, 24 hour Ambulatory Blood Pressure Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Nailfold CapillaroscopyProcedure or surgery
Single session of video Nailfold Capillaroscopy wit KKK technology
Ambulatory 24 hr Blood Pressure MonitoringDevice
24 hr upper arm cuff measurement of Blood Pressure
Fundoscopy of eyesProcedure or surgery
examination of microvascular health of eye with the use of opthalmoscope
Laser Doppler FlowmetryProcedure or surgery
Examination of vascular flow
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes Paediatric | Paediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital. Receives: Procedure: Video Nailfold Capillaroscopy; Device: Ambulatory 24 hr Blood Pressure Monitoring; Procedure: Fundoscopy of eyes; Procedure: Laser Doppler Flowmetry |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Hunter Hospital
- Sponsor type
- Other government
- Investigators
- Rani Bhatia, MD, Principal investigator, John Hunter Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279928
- Sponsor's protocol ID
- HNEHREC 09/04/15/5.10
- Acronym
- DIVIDEND
- Status last verified
- Jan 2011
- First submitted
- 19 Jan 2011
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24093770
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
- ClinicalTrials.gov ID
- NCT01279928
- Acronym / sponsor ID
- DIVIDEND / HNEHREC 09/04/15/5.10
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- paediatric and adolescent population, nailfold capillaroscopy, laser Doppler flowmetry, retinal vessel calibre, retinal vessel fractal analysis, 24 hour Ambulatory Blood Pressure Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- John Hunter HospitalOther government
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 20 Jan 2011 (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.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes Paediatric | – | Procedure: Video Nailfold Capillaroscopy, Device: Ambulatory 24 hr Blood Pressure Monitoring, Procedure: Fundoscopy of eyes, Procedure: Laser Doppler FlowmetryPaediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants were recruited from the John Hunter Children's Hospital paediatric diabetes clinic. They were between the ages of 8-18 years old.
Key inclusion criteria (2 listed)
- 8-18 years old
- Have a diagnosis of type 1 diabetes mellitus
Key exclusion criteria (2 listed)
- < 8 years or > 18 years old
- Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)
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 |
|---|---|---|
| Video Nailfold CapillaroscopySingle session of video Nailfold Capillaroscopy wit KKK technology | Procedure or surgery | Type 1 Diabetes Paediatric |
| Ambulatory 24 hr Blood Pressure Monitoring24 hr upper arm cuff measurement of Blood Pressure | Device | Type 1 Diabetes Paediatric |
| Fundoscopy of eyesexamination of microvascular health of eye with the use of opthalmoscope | Procedure or surgery | Type 1 Diabetes Paediatric |
| Laser Doppler FlowmetryExamination of vascular flow | Procedure or surgery | Type 1 Diabetes Paediatric |
Primary outcome
Not reported in the source record.
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 25 Jan 2011.
- Derived from this study: PubMed 24093770Hosking 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.
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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.
Rani Bhatia, MD principal investigator
John Hunter Children's Hospital
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 Mellitus, run by John Hunter Hospital at 1 site in Australia.
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 2 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 25 Jan 2011. 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 Australia. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01279928, which also lists 1 linked publication.
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 25 Jan 2011.