None listed
Conditions
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.
Interventions
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 (CG
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.
Sponsors
Health NZ
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed