None listed
Conditions
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 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
Study design
Eligibility
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