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

INTERVENTION: 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 w CONDITION: Metabolic and Endocrine ‐ Diabetes type 2 diabetes; ; type 2 diabetes PRIMARY OUTCOME: Change in HbA1c at 6 months[blood test (HbA1c) 6 months from the time each participant commences the study] SECONDARY OUTCOME: Change in cardiovascular measurements (3, 6, 12 months) from the time that a participant commences enrolment into the study ; [Lipids (blood test) 3, 6 and 12 months from the time each participant commences the study] Change in HbA1c[HbA1c blood test 3 and 12 months from the time of participant commencing the study] diabetes self management / psychosocial scores[diabetes self management questionnaire 6 and 12 months from the time each participant commences the study (compared to baseline)] 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