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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12625001114437p
Ethics application status
Submitted, not yet approved
Date submitted
26/09/2025
Date registered
13/10/2025
Date last updated
13/10/2025
Date data sharing statement initially provided
13/10/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Optimising Type 2 Diabetes Outcomes Utilising Continuous Glucose Monitoring and A Culturally Appropriate Primary Care Pharmacist Prescriber Model of Care
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Scientific title
Optimising Type 2 Diabetes Outcomes in Pacific Adults Utilising Continuous Glucose Monitoring and A Culturally Appropriate Primary Care Pharmacist Prescriber Model of Care
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Secondary ID [1]
315274
0
None
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Universal Trial Number (UTN)
UTN: U1111-1327-8490
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
339022
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Condition category
Condition code
Metabolic and Endocrine
335311
335311
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a 13-week single arm study conducted in the Southern Region of New Zealand. All participants will be involved in the study for 15 weeks (2 weeks of baseline monitoring and 13-week intervention). The main study will be followed by a 39-week extension phase(to a total of 12-months).
The study will enrol 20 participants, aged 16 years and over. Following consent, baseline data will be collected from eligible subjects. Subjects will receive the Care Sens Air continuous glucose monitoring (CGM) system. Following a run-in period of 2 weeks to collect baseline blinded glycaemic values, participants will begin the 13-week intervention phase. The intervention will utilise the CGM data to optimise the NZSSD type 2 diabetes management algorithm, led by the study pharmacist. Participants will continue to wear the Care Sens Air CGM throughout the 13-weeks (replacing the sensor every 14
days).
Participants will visit the study pharmacist at baseline (after blinded CGM), and receive a follow up sessions at week 2, and 8 to help titrate medications in line with guidelines. CGM data will be automatically uploaded to the Sens365 online diabetes management portal via the CareSens Air mobile application. After completion of the main study (13-weeks), participants will be invited into the extension study (up to 12-months) to collect longitudinal data in this population group.
All participants will receive appropriate lifestyle management advice during the intervention as per the local primary care, model of care. Within 7 days of the baseline visit with the pharmacist, participants will also have an initial lifestyle management consultation. This session will be conducted by either a health coach and/or a Pacific provider nurse, and cultural support workers as appropriate and is estimated to take ~30-45 minutes. Topics discussed and goals set during these sessions will be guided by the participants specific requirements/needs as identified by the practitioners. Examples of which may include, but are not limited to: physical activity, sleep, sedentary time, social support, cultural support. They will also see a dietitian. This appointment will also be 30-45 min in duration. As above, topics and goals set during these sessions will be guided by the participants specific requirements/needs as identified by the practitioners. Examples of which may include, but are not limited to: general healthy eating, fibre intake, carbohydrate quality.
Allied health reviews will be offered in a Pacific provider setting at the convenience of the patient, allowing for extended consultations, convenient appointment times and inclusion of family members involved in care. Transport, social services and support in understanding and navigating the health system will also be offered as required. Within a Pacific provider setting, Pacific led diabetes awareness programmes will also be on offer building diabetes awareness and health literacy. Participants will receive remote follow up regarding lifestyle management goals at weeks 2 and 8, with additional appointments scheduled at the discretion of the care team. All participants will be supported by cultural support workers for the duration of the study.
Expected duration of subject participation is a minimum of 14 weeks:
Day -14 Visit: Commence run-in period and baseline data collection (including blinded CGM). During this time participants will continue with current medications and diabetes management.
Day 1 Visit: Appointment with study pharmacist for intervention start and lifestyle management initial consultation with a health coach/pacific provider nurse + cultural support worker + dietitian (may be conducted between days 1-7 depending on practitioner availability).
Week 2 (Day 14) Phone Call: Follow up with study pharmacist + assisted remote upload of data + lifestyle management (health coach)
Week 8 (Day 56) Phone Call: Follow up with study pharmacist+ assisted remote upload of data + lifestyle management (health coach)
Week 13 (Day 91) Visit: Primary end point, repeat baseline measures and qualitative interviews
After completion of the main study, participants will be invited into the 13-week extension phase study.:
Week 17 remote follow up by health coach and/or cultural support worker
Week 21 remote follow up by health coach and/or cultural support worker
Week 26 (Day 182) Visit: Repeat baseline measures + lifestyle management (health coach)
Week 36 (Day 252) Visit: Repeat baseline measures + lifestyle management (health coach)
Week 52 (Day 365) Visit: Extension study completion, repeat baseline measures.
Note: Attendance at sessions will be recorded in the study CRFs. Remote reviews will be conducted via phone and/or video calling. Lifestyle management will be guided by previous sessions whereby exisiting goals may continue to be supported and new goals may be developed if indicated.
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Intervention code [1]
332080
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Treatment: Devices
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Intervention code [2]
332081
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Lifestyle
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Glycaemic control as measured by percentage of time in range 3.9 – 10mmol/L.
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Assessment method [1]
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By way of continuous glucose monitoring (CGM) data analysis.
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Timepoint [1]
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Baseline and end of 13-week intervention.
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Secondary outcome [1]
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Glycaemic control as measured by percentage of time in range 3.9 – 10mmol/L.
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Assessment method [1]
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By way of continuous glucose monitoring (CGM) data analysis.
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Timepoint [1]
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26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [2]
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Glycaemic control as measured by percentage of time below 3.9 mmol/L.
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Assessment method [2]
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By way of CGM data analysis.
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Timepoint [2]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [3]
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Glycaemic control as measured by percentage of time below 3.0 mmol/L.
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Assessment method [3]
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By way of CGM data analysis.
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Timepoint [3]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [4]
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Glycaemic control as measured by percentage of time above 10.0 mmol/L.
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Assessment method [4]
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By way of CGM data analysis.
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Timepoint [4]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [5]
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Glycaemic control as measured by percentage of time above 13.9 mmol/L.
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Assessment method [5]
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By way of CGM data analysis.
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Timepoint [5]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [6]
452581
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Glycaemic control as measured by percentage of time in tight range 3.9 to 7.8 mmol/L.
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Assessment method [6]
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By way of CGM data analysis.
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Timepoint [6]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [7]
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Glycaemic control as measured by glycated hemoglobin (HbA1c) from blood samples.
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Assessment method [7]
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Measured via point-of-care analyzer or diagnostics laboratory whole blood analysis.
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Timepoint [7]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [8]
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Glycaemic Variability as measured by Glycaemic management index (GMI)
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Assessment method [8]
452584
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By way of CGM data analysis.
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Timepoint [8]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [9]
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Glycaemic Variability as measured by coefficient of variation.
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Assessment method [9]
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By way of CGM data analysis.
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Timepoint [9]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [10]
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Glycaemic variability as measured my Mean Amplitude of Glycaemic Excursion (MAGE)
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Assessment method [10]
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By way of CGM data analysis.
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Timepoint [10]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [11]
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Glucose levels during the day (0600-2359 hours).
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Assessment method [11]
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By way of CGM data analysis.
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Timepoint [11]
452589
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [12]
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Glucose levels during the night (0000 to 0559 hours).
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Assessment method [12]
452590
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By way of CGM data analysis.
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Timepoint [12]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [13]
452592
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Glucose levels during each 24-hour period (0000 to 2359 hours)
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Assessment method [13]
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By way of CGM data analysis.
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Timepoint [13]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [14]
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Cardiovascular Profile as measured by Fasting Lipid Profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides and Total:HDL-cholesterol).
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Assessment method [14]
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Measured via diagnostic laboratory whole blood analysis.
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Timepoint [14]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [15]
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Renal function (Urine micro-albuminuria and Estimated glomerular filtration rate)
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Assessment method [15]
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Measured via diagnostic laboratory whole blood and urine analysis.
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Timepoint [15]
452595
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [16]
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Full blood count
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Assessment method [16]
452596
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Measured via diagnostic laboratory whole blood analysis.
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Timepoint [16]
452596
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [17]
452598
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Liver Function Tests
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Assessment method [17]
452598
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Measured via diagnostic laboratory whole blood analysis.
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Timepoint [17]
452598
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [18]
452599
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Cardiovascular Profiles as measured by Anthropometric Data
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Assessment method [18]
452599
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Measured using weight (digital scales. kg), height (stadiometer, cm) and waist circumference (tape measure, cm)
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Timepoint [18]
452599
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [19]
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Cardiovascular Profile as measured by Blood Pressure
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Assessment method [19]
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Measured as seated blood pressure (mmHg) using an automated sphygmomanometer.
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Timepoint [19]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [20]
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The change in diabetes treatment satisfaction.
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Assessment method [20]
452601
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Measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ).
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Timepoint [20]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [21]
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The change in eating behaviours
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Assessment method [21]
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As measured by a 4-day food diary
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Timepoint [21]
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Baseline, and 13, 26, 38 and 52-weeks post-intervention commencement (extension).
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Secondary outcome [22]
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Acceptability of Intervention
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Assessment method [22]
452603
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Semi-structured, face to face interviews will be conducted by a member of the research team with participants. Interviews may be up to 60 minutes in duration. Interview will be audio recorded and transcribed verbatim. Transcripts will be analysed using thematic analysis.
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Timepoint [22]
452603
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13-weeks post-intervention commencement
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Secondary outcome [23]
452974
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Lived Experiences
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Assessment method [23]
452974
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Semi-structured, face to face interviews will be conducted by a member of the research team with participants. Interviews may be up to 60 minutes in duration. Interview will be audio recorded and transcribed verbatim. Transcripts will be analysed using thematic analysis.
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Timepoint [23]
452974
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13-weeks post-intervention commencement
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Eligibility
Key inclusion criteria
Type 2 diabetes as per ADA classification.
HbA1c greater than or equal to 7.5% (58mmol/mol)
Aged 16 years and over.
Be willing and able to conform to the study protocol
On at least 1 therapeutic agent for diabetes (e.g., metformin, insulin, GLP-1 receptor agonists, sulfonylureas)
Identify with Pacific ethnicity living in southern region
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
History of T1DM
History of other types of diabetes such as MODY, secondary pancreatic diabetes, diabetes due to endocrinopathies
Use of systemic corticosteroids > 14 days, or repeated pharmacologic systemic courses of corticosteroids
Recurrent or chronic systemic infections that in the view of the investigator would significantly impact on glycaemia.
Major cardiovascular event (including or not limited to Myocardial infarction, Cerebrovascular accident, Coronary Artery Bypass Graft, Percutaneous Transluminal Coronary Angioplast) or major surgery in last 3 months
Active malignancy requiring ongoing treatment
Previous or planned bariatric surgery.
Pregnancy
Any other reason that investigator feels may not be in best interest of patient to participate.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/12/2025
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Actual
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Date of last participant enrolment
Anticipated
31/12/2026
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Actual
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Date of last data collection
Anticipated
31/12/2027
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
27385
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New Zealand
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State/province [1]
27385
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Funding & Sponsors
Funding source category [1]
319844
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Commercial sector/Industry
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Name [1]
319844
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i-Sens Inc
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Address [1]
319844
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Country [1]
319844
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Korea, Republic Of
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Funding source category [2]
320057
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University
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Name [2]
320057
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University of Otago
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Address [2]
320057
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Country [2]
320057
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New Zealand
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Primary sponsor type
Government body
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Name
Health NZ
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Address
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Country
New Zealand
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Secondary sponsor category [1]
322604
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None
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Name [1]
322604
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Address [1]
322604
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Country [1]
322604
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
318400
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Northern B Health and Disability Ethics Committee
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Ethics committee address [1]
318400
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https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
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Ethics committee country [1]
318400
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New Zealand
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Date submitted for ethics approval [1]
318400
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25/09/2025
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Approval date [1]
318400
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Ethics approval number [1]
318400
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Summary
Brief summary
Continuous glucose monitoring (CGM) has been successfully used in type 1 diabetes for improving health outcomes and reducing the risk of hypoglycaemia (low blood sugars) for over a decade. New modern CGM systems are more accurate and no longer require finger prick glucose calibration. Therefore, modern real-time CGM has an even greater potential to be used by people with diabetes to improve glucose levels. There is a need for cost effective and culturally appropriate models of diabetes health care (such as primary care based) to support people to manage their diabetes. This new model of care should include a range of primary health care professionals such as pharmacist prescribers, dietitians, cultural support workers and health coaches. The purpose of our study is to find out whether using CGM and being supported by a new model of care for up to 12-months, can keep glucose levels in a healthy range and improve other outcomes, such as quality of life.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Ben Wheeler
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Address
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Department of Paediatrics and Child Health, 3rd Floor Children's Pavilion, Dunedin Public Hospital, 201 Great King Street, Dunedin, 9016, New Zealand
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Country
144062
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New Zealand
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Phone
144062
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+64 274701980
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Fax
144062
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Email
144062
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[email protected]
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Contact person for public queries
Name
144063
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Ben Wheeler
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Address
144063
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Department of Paediatrics and Child Health, 3rd Floor Children's Pavilion, Dunedin Public Hospital, 201 Great King Street, Dunedin, 9016, New Zealand
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Country
144063
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New Zealand
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Phone
144063
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+64 274701980
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Fax
144063
0
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Email
144063
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[email protected]
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Contact person for scientific queries
Name
144064
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Ben Wheeler
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Address
144064
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Department of Paediatrics and Child Health, 3rd Floor Children's Pavilion, Dunedin Public Hospital, 201 Great King Street, Dunedin, 9016, New Zealand
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Country
144064
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New Zealand
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Phone
144064
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+64 274701980
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Fax
144064
0
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Email
144064
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
Download to PDF