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Trial registered on ANZCTR


Registration number
ACTRN12624000438550p
Ethics application status
Submitted, not yet approved
Date submitted
12/03/2024
Date registered
10/04/2024
Date last updated
10/04/2024
Date data sharing statement initially provided
10/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous glucose monitors plus kaiawhina (healthcare assistant)-based care to support patients with Type 2 Diabetes in New Zealand
Scientific title
The effectiveness of continuous Glucose Monitors plus kaiawhina-based care on glycemic control and cardiovascular outcomes in patients with Type 2 Diabetes in New Zealand
Secondary ID [1] 311720 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 333197 0
Condition category
Condition code
Metabolic and Endocrine 329887 329887 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm 1 - Continuous Glucose Monitor (CGM) plus kaiawhina based care:
- participants will be provided with a Freestyle Libre device at weeks 1-4 and again at weeks 13-14.
- Kaiawhina will engage with participants (and their family/ whanau) primarily through home-based visits. These visits will include education around diet, exercise and medication, and patients are encouraged to review their CGM data alongside a food diary to understand the impact of food and exercise choices on glycaemic control. We anticipate visits to be approximately 45-60 minutes every 2-3 days during weeks 1-4 and 13-14, but time and frequency will differ depending on the needs and availability of participants.
- Kaiawhina-based care is delivered during the same weeks as CGM wear (weeks 1-4 and 13-14).
- Kaiawhina are trained in the use of CGMs and diabetes education.
- Additional support is provided by a registered nurse on the team who can co-ordinate and facilitate clinical review, medication review and prescribing activities. The nurse may engage with patients either in their home or in the clinic. The nurse will provide at least one visit within the first 2 weeks to review the need for medications. Additional visits will be undertaken if deemed necessary by the kaiawhina.
- Clinical data are to be recorded throughout the study including HbA1c and lipid results (baseline, 3, 6 and 12 month), review of diabetes self-management (diabetes self management questionnaire (DSMQ) )- baseline, 6 and 12 months) and the number of healthcare engagements / visits.

Intervention arm 2- kaiawhina based care
- this is replication of Intervention arm but WITHOUT the use of CGM devices. All other variables remain the same,

both arms will run for a period of 26 weeks and the primary outcome will be HbA1c at 26 weeks
Intervention code [1] 328184 0
Lifestyle
Comparator / control treatment
Control group is "usual care' where patients continue to access primary healthcare through regular channels and have no engagement with the research / study team.
Usual care is defined as the 'no intervention' in that patients may approach primary care at any time as if they were not enrolled in the study. Primary care and medical services are provided as they would be provided to any patient at any time, and GPs will not be informed that patients are enrolled into this study group.
Control group
Active

Outcomes
Primary outcome [1] 337654 0
Change in HbA1c at 6 months
Timepoint [1] 337654 0
6 months from the time each participant commences the study
Secondary outcome [1] 432703 0
Change in cardiovascular measurements (3, 6, 12 months) from the time that a participant commences enrolment into the study
Timepoint [1] 432703 0
3, 6 and 12 months from the time each participant commences the study
Secondary outcome [2] 432704 0
diabetes self management / psychosocial scores
Timepoint [2] 432704 0
6 and 12 months from the time each participant commences the study (compared to baseline)
Secondary outcome [3] 433544 0
Change in HbA1c
Timepoint [3] 433544 0
3 and 12 months from the time of participant commencing the study

Eligibility
Key inclusion criteria
Inclusion: confirmed diagnosis of T2D for at least 1 year, HbA1c greater than or equal to 80mmol/mol (minimum two readings in 12 months prior to study), and prioritisation for Maori or Pacific ethnicity
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion: pregnancy, previous bariatric surgery, glucocorticoid use, severe diabetic eye disease, and/or history of any previous cardiovascular events or diagnosis with renal failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation - Minimisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/05/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 26197 0
New Zealand
State/province [1] 26197 0
Waikato

Funding & Sponsors
Funding source category [1] 316050 0
Government body
Name [1] 316050 0
Health Research Coouncil of New Zealand
Country [1] 316050 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
Country
New Zealand
Secondary sponsor category [1] 318210 0
None
Name [1] 318210 0
Address [1] 318210 0
Country [1] 318210 0
Other collaborator category [1] 282978 0
Other
Name [1] 282978 0
Hauraki Primary Healthcare Organisation
Address [1] 282978 0
Country [1] 282978 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314870 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 314870 0
https://ethics.health.govt.nz/about/northern-a-health-and-disability-ethics-committee/
Ethics committee country [1] 314870 0
New Zealand
Date submitted for ethics approval [1] 314870 0
22/03/2024
Approval date [1] 314870 0
Ethics approval number [1] 314870 0

Summary
Brief summary
This is a three arm study working in partnership with Hauraki PHO to explore the use of continuous glucose monitors and kaiawhina (cultural healthcare assistants) to support patients living with type 2 diabetes. Our study will use a novel model of healthcare delivery based on mobile care, education and wrap-around support. Our hypothesis is that the use of both technology and kaiawhina will lead to greater improvements in glycaemia (blood glucose levels) and cardiovascular biomarkers compared to the use of 'usual' healthcare.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132998 0
A/Prof Associate Professor Lynne Chepulis
Address 132998 0
School of Health, University of Waikato, Hillcrest Road, Hamilton, 3216
Country 132998 0
New Zealand
Phone 132998 0
+64 226753353
Fax 132998 0
Email 132998 0
Lynne.chepulis@waikato.acz.nz
Contact person for public queries
Name 132999 0
Associate Professor Lynne Chepulis
Address 132999 0
School of Health, University of Waikato, Hillcrest Road, Hamilton, 3216
Country 132999 0
New Zealand
Phone 132999 0
+64 226753353
Fax 132999 0
Email 132999 0
Lynne.chepulis@waikato.acz.nz
Contact person for scientific queries
Name 133000 0
Associate Professor Lynne Chepulis
Address 133000 0
School of Health, University of Waikato, Hillcrest Road, Hamilton, 3216
Country 133000 0
New Zealand
Phone 133000 0
+64 226753353
Fax 133000 0
Email 133000 0
Lynne.chepulis@waikato.acz.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.