Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000296033
Ethics application status
Approved
Date submitted
8/04/2010
Date registered
13/04/2010
Date last updated
15/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of insulin pump therapy on an individual's physical & psychological well-being and cognition.
Scientific title
A study examining the physical, psychological and cognitive effects following commencement of continuous subcutaneous insulin infusion therapy (CSII) in Type I Diabetes.
Secondary ID [1] 1603 0
None
Universal Trial Number (UTN)
U1111-1114-4972
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 256999 0
Condition category
Condition code
Metabolic and Endocrine 257160 257160 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study examining the effect of Continuous Subcutaneous Insulin Infusion (CSII) in terms of physical, psychological and cognitive functioning of people with Type 1 diabetes.
This study will administer questionnaires on quality of life and emotional well-being before and after the insulin pump is implanted. The overall study duration is one year with follow-ups at 3 and 6 months after pump insertion.
Intervention code [1] 256175 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258045 0
Primary Endpoint: Glycated haemoglobin (HbA1c). We expect improvements in HbA1c from pre-CSII commencement to three and six-month post commencement.
Timepoint [1] 258045 0
Baseline, three months and six months follow-up
Secondary outcome [1] 263624 0
Improvement in physical and emotional quality of life using validated questionnaires
Timepoint [1] 263624 0
Baseline, three months and six months follow-up
Secondary outcome [2] 263858 0
Improvement in cognition with more stable blood sugar levels. It will be measured using a validated questionnaire.
Timepoint [2] 263858 0
Baseline, three months and six months follow-up

Eligibility
Key inclusion criteria
Patients with Type 1 Diabetes commencing CSII therapy
Age 18 years to 69 years
The capacity to give and accept informed consent to participate in the research
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18 years or >=70 years
Chronic renal disease, stage III or IV
Psychosis or psychiatric disorder
Active cancer within last 5 years
Inability to provide informed consent (i.e. has an intellectual disability, dementia)
Unable to communicate in English

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256679 0
Commercial sector/Industry
Name [1] 256679 0
Medtronic
Country [1] 256679 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medtronic
Address
Medtronic Australasia Pty Ltd
Medtronic
97 Waterloo Road
North Ryde NSW 2113
PO Box 945
North Ryde NSW 1670
Country
Australia
Secondary sponsor category [1] 255967 0
None
Name [1] 255967 0
Address [1] 255967 0
Country [1] 255967 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258703 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 258703 0
Alfred Hospital,
2nd floor, East Block,
Commercial Road,
Prahran, Melbourne, Victoria
Ethics committee country [1] 258703 0
Australia
Date submitted for ethics approval [1] 258703 0
Approval date [1] 258703 0
01/06/2009
Ethics approval number [1] 258703 0
PROJECT 06/09

Summary
Brief summary
The project aims to examine changes in glycosylated haemoglobin (which signifies stability of diabetes), physical, psychological and cognitive functioning following commencement of CSII therapy specifically measuring these parameters at three and six-month follow-up.
The effect of CSII will be measured via routine blood tests, questionnaires examining physical health-related Quality of life (HRQoL), diabetes specific questions, psychological well-being and cognitive functioning. Patients will attend a review clinic at the Alfred specifically for CSII patients.
Patients’ knowledge about their diabetes will be assessed pre and post CSII commencement (at several time points) using specific questionnaires and we will also measure glycaemic control via the recognized blood test of diabetes stability (HbA1c). The questionnaires used will include assessment of patients’ sense of empowerment, a self-care inventory on diabetes, a diabetes-specific treatment satisfaction questionnaire, and an emotional distress questionnaire that is diabetes specific. The aim is to assess whether CSII improves these aspects of an individual’s life with CSII.

Within the project, we aim to set up a group pump review clinic for all patients commencing pump therapy at this hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30962 0
Address 30962 0
Country 30962 0
Phone 30962 0
Fax 30962 0
Email 30962 0
Contact person for public queries
Name 14209 0
Ms Sue Wyatt
Address 14209 0
Dept of Endocrinology & Diabetes,
Alfred Hospital,
Prahran, Melbourne, Victoria 3004.
Country 14209 0
Australia
Phone 14209 0
+61 3 9076 3457
Fax 14209 0
+61 3 8532 1100
Email 14209 0
[email protected]
Contact person for scientific queries
Name 5137 0
Geraldine Lee
Address 5137 0
Baker IDI,
75 Commercial Road, Prahran,
Melbourne, Victoria 3004
Country 5137 0
Australia
Phone 5137 0
+61 3 8532 1637
Fax 5137 0
+61 3 8532 1100
Email 5137 0
[email protected]

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.