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Continuous glucose monitors plus kaiawhina (healthcare assistant)-based care to support patients with Type 2 Diabetes in New Zealand

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000438550
Enrollment
89
Registered
2024-04-10
Start date
2024-06-03
Completion date
2026-10-30
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 glyc

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

Sponsors

University of Waikato
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026