Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000237583
Ethics application status
Approved
Date submitted
13/12/2023
Date registered
11/03/2024
Date last updated
11/03/2024
Date data sharing statement initially provided
11/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diabetes technology in Ageing: Insulin pumping in patients aged 65+ years
Scientific title
Diabetes Technology in Ageing: Comparison of results from clinical prioritisation statements, as identified by a survey of patients with type 1 diabetes on insulin pumps aged 65+, and diabetes clinical staff.
Secondary ID [1] 311144 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes associated with absolute insulinopenia 332309 0
Ageing with diabetes 332310 0
Condition category
Condition code
Metabolic and Endocrine 329019 329019 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Eligible participants (i.e. using an insulin pump with diabetes and aged 65+ years) will be asked to complete a 10-statement survey using the 1000minds decision-making and adaptive conjoint analysis software tool (see https://www.1000minds.com/). Participants will be asked to prioritize the 10 statements, in terms of what they would like to discuss at a routine diabetes clinic visit. Participants will access the survey via a desktop or laptop computer that will be set up with the 1000minds survey ready to go. They will be offered support to complete the online survey, with help from a member of the research team. The survey should typically take 15 minutes or less to complete.
Additionally, participants will be interviewed by a research team member and asked semi-structured questions. These questions will explore their personal views and experiences of using an insulin pump. Baseline demographics and clinical information will also be collected. This questionnaire should also typically take 15 minutes or less to complete and so the total time for the interview (questionnaire and online survey) will be 30 minutes.
Intervention code [1] 327588 0
Not applicable
Comparator / control treatment
Staff with clinical expertise in the care of patients on insulin pumps will be the comparator group. These staff participants will complete a near-identical 1000minds online survey on what is important for them to prioritize with their patients during a diabetes clinic visit. The 1000minds survey will be sent to the staff members via an email link and can be completed in their own time. These staff participants are not interviewed by a research team member unlike the patient participants. They only complete the anonymized online survey.
Control group
Active

Outcomes
Primary outcome [1] 336815 0
Comparing the prioritization of factors between patient and staff participants on what they think are important conversations to have at the diabetes clinic regarding insulin pumping.
Timepoint [1] 336815 0
This is a one-off survey completed by each patient and staff participant at a time point that is convenient to them.
Primary outcome [2] 336816 0
Identifying important clinical focus points for discussion at diabetes appointments.
Timepoint [2] 336816 0
This is a one-off survey completed by each patient and staff participant at a time point that is convenient to them.
Secondary outcome [1] 429747 0
Patients' views on insulin pumping.
Timepoint [1] 429747 0
This is a one-off interview with each patient.

Eligibility
Key inclusion criteria
For patient participants:
- Aged 65+
- Diabetes associated with absolute insulinopenia (e.g. type 1 diabetes, post-pancreatitis or total pancreatectomy)
- Established on insulin pump for 3 months or more
- Currently domiciled in the Canterbury region (New Zealand)

For staff participants:
- Health professionals working for Te Whatu Ora Waitaha Canterbury
- Clinical experience working with insulin pumps
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For patient participants
- Patients with type 2 diabetes
-Patients who their attending physician has considered to be unsuitable for the study (within the context of the population studied this may relate to cognitive decline e.g. dementia or palliative care with limited life expectancy)

For staff participants: None

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The statements presented to participants for prioritizing will be paired using the 1000minds multi-criteria decision, adaptive conjoint analysis technique. Anonymized individual participant results from patients and staff will be grouped for cluster analysis.
This study is exploratory. It is anticipated that 24 participants will be recruited for each group. No prior information is available that might help with the determination of sample size. For example, 1000minds can detect ‘noise’ (inconsistency) in individual answers and it is unknown how much ‘noise’ that pairwise statements may generate. This information will help inform study design for any future, larger study.
An important aspect of this research is the study co-design process undertaken with relevant clinical stakeholders, including patients. A narrative approach to emerging findings from this co-design process will be therefore another important study outcome.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/12/2023
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
1/05/2024
Actual
Sample size
Target
28
Accrual to date
25
Final
Recruitment outside Australia
Country [1] 26023 0
New Zealand
State/province [1] 26023 0
Canterbury

Funding & Sponsors
Funding source category [1] 315399 0
Charities/Societies/Foundations
Name [1] 315399 0
Maia Foundation - charity of Te Whatu Ora Waitaha
Country [1] 315399 0
New Zealand
Funding source category [2] 315401 0
Charities/Societies/Foundations
Name [2] 315401 0
Diabetes Christchurch
Country [2] 315401 0
New Zealand
Primary sponsor type
Hospital
Name
Te Whatu Ora Waitaha
Address
32 Oxford Terrace, Christchurch Central City, Christchurch, 8011
Country
New Zealand
Secondary sponsor category [1] 317471 0
None
Name [1] 317471 0
Address [1] 317471 0
Country [1] 317471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314317 0
Health and Disability Ethics Committee, Ministry of Health
Ethics committee address [1] 314317 0
Ethics committee country [1] 314317 0
New Zealand
Date submitted for ethics approval [1] 314317 0
30/11/2023
Approval date [1] 314317 0
18/12/2023
Ethics approval number [1] 314317 0

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

Contacts
Principal investigator
Name 131162 0
A/Prof Helen Lunt
Address 131162 0
Te Whatu Ora Waitaha Canterbury: 32 Oxford Terrace, Christchurch Central City, Christchurch, 8011
Country 131162 0
New Zealand
Phone 131162 0
+64 03 3640 860 88866
Fax 131162 0
Email 131162 0
helen.lunt@cdhb.health.nz
Contact person for public queries
Name 131163 0
Niranjula Hewapathirana
Address 131163 0
Te Whatu Ora Waitaha Canterbury: 32 Oxford Terrace, Christchurch Central City, Christchurch, 8011
Country 131163 0
New Zealand
Phone 131163 0
+64 03 3640 860 88685
Fax 131163 0
Email 131163 0
niranjula.hewapathirana@cdhb.health.nz
Contact person for scientific queries
Name 131164 0
Helen Lunt
Address 131164 0
Te Whatu Ora Waitaha Canterbury: 32 Oxford Terrace, Christchurch Central City, Christchurch, 8011
Country 131164 0
New Zealand
Phone 131164 0
+64 03 3640 860 88866
Fax 131164 0
Email 131164 0
helen.lunt@cdhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small exploratory study and the quality of the data that might be generated from the study is therefore uncertain. Also, it is unclear in advance if data is truly anonymous or merely de-identifiable. In addition, the semi-qualitative patient questionnaire may include potentially identifiable data.


What supporting documents are/will be available?




Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4176Plain language summaryNo This real-world study asked two research questions... [More Details]

Documents added automatically
No additional documents have been identified.