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Trial registered on ANZCTR


Registration number
ACTRN12609000657224
Ethics application status
Not yet submitted
Date submitted
23/07/2009
Date registered
4/08/2009
Date last updated
4/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Skin changes related to insulin therapy in type 1 diabetes
Scientific title
Skin changes related to insulin therapy in type 1 diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 237338 0
Condition category
Condition code
Metabolic and Endocrine 239661 239661 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective observational study of skin changes related to insulin therapy.
Patients will be seen at their routine 3 monthly clinic appointment. All patients will be invited to participate and have thier clinical risk factors assessed and invited to have a skin biopsy and intradermal tesing performed. Those with skin changes will have their clinical risk factors assessed, be asked to complete a short questionnaire about the impact that these skin changes have on their diabetes self manageemnt, and invited to have their skin changes photographed, a skin biopsy taken, intradermal skin testing, and patch testing.
This is not an interventional trial.
Intervention code [1] 237001 0
Not applicable
Comparator / control treatment
Patients with and without skin changes will be compared
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238437 0
skin biopsy- Histological changes will be examined and summarised.
Timepoint [1] 238437 0
12 months after enrollment in the study.
Secondary outcome [1] 244938 0
clinical risk factors- from clinical data (history, examination, blood tests) collected at routine clinical appointments prospectively
Timepoint [1] 244938 0
12 months
Secondary outcome [2] 244998 0
intradermal testing- skin reaction to insulin and the diluent insulin is mixed with
Timepoint [2] 244998 0
12 months
Secondary outcome [3] 245000 0
patch testing- skin reaction to the teflon cannula of the insulin pump
Timepoint [3] 245000 0
12 months
Secondary outcome [4] 245001 0
psychological impact of skin changes by questionnaire
Timepoint [4] 245001 0
12 months

Eligibility
Key inclusion criteria
known type 1 or 2 diabetes
understand the research protocol
consent
Minimum age
5 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
moderate-severe eczema or other skin condition,

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237386 0
Hospital
Name [1] 237386 0
Royal North Shore Hospital (RNSH)
Country [1] 237386 0
Australia
Funding source category [2] 237407 0
Hospital
Name [2] 237407 0
Department of Endocrinology Diabetes Trust Fund
Country [2] 237407 0
Australia
Primary sponsor type
Hospital
Name
RNSH
Address
Pacific Highways
St Leonards
Sydney NSW 2065
Country
Australia
Secondary sponsor category [1] 236886 0
None
Name [1] 236886 0
Address [1] 236886 0
Country [1] 236886 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239518 0
Ethics committee address [1] 239518 0
Ethics committee country [1] 239518 0
Date submitted for ethics approval [1] 239518 0
17/06/2009
Approval date [1] 239518 0
Ethics approval number [1] 239518 0

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

Contacts
Principal investigator
Name 29954 0
Address 29954 0
Country 29954 0
Phone 29954 0
Fax 29954 0
Email 29954 0
Contact person for public queries
Name 13201 0
Dr Monique Stone
Address 13201 0
Level 5 Douglas Buidling
RNSH
St Loenards NSW 2065
Country 13201 0
Australia
Phone 13201 0
+61 2 9926 6904
Fax 13201 0
Email 13201 0
stonem@med.usyd.edu.au
Contact person for scientific queries
Name 4129 0
Dr Monique Stone
Address 4129 0
Level 5 Douglas Building
RNSH
St Leonards NSW 2065
Country 4129 0
Australia
Phone 4129 0
+61 2 9926 6904
Fax 4129 0
Email 4129 0
stonem@med.usyd.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.