None listed
Conditions
Brief summary
This is a multi-site, 6-month randomized controlled study, followed by a 6-month continuation phase where those initially randomized to routine care (control arm) cross over into the CGM intervention (CGM treatment arm). All participants will be involved in the main study for 12 months.
Interventions
Intervention arm - Continuous Glucose Monitor (CGM: Dexcom ONE) wear plus usual clinical care for 26 weeks (primary outcome) followed by a further 26 weeks of continuous CGM wear (continuation phase). Monitors will be administered by a diabetes clinical nurse specialist (CNS) or endocrinologist on the care team. Adherence to CGM wear will be monitored by the CNS - and will also be explored in later qualitative interviews with participants.
Control arm - usual clinical care (no CGM) for 26 weeks
Intervention arm - Continuous Glucose Monitor (CGM: Dexcom ONE) wear plus usual clinical care for 26 weeks (primary outcome) followed by a further 26 weeks of continuous CGM wear (continuation phase). Monitors will be administered by a diabetes clinical nurse specialist (CNS) or endocrinologist on the care team. Adherence to CGM wear will be monitored by the CNS - and will also be explored in later qualitative interviews with participants. Control arm - usual clinical care (no CGM) for 26 weeks (primary outcome) then crossed over into intervention arm (continuous CGM wear during continuation phase). Both arms will have in person hospital (diabetes clinic) visits at baseline and weeks 12, 26, 38 and 52, with remote (phone call) reviews and collection of any adverse events at weeks 2,8, 18, 28 and 44). The baseline visit is anticipated to take up to three hours, and will include patient demographics, HbA1c, height, weight, blood pressure, medical review, urine pregnancy test, cardiometabolic panel, urinary ACR and psychosocial questi0nnaires (EQ-5D and DSMQ). Other clinic visits are expected to take up to 90 minutes and will include a repeat of all relevant clinical measures. Remote check in visits will take approximately 10 minutes. In both study arms, participants have access to a full clinical team including a diabetes specialist / endocrinologist, clinical nurse specialist and psychologist. Glucose lowering medication will be used as clinical indicated. Primary outcome is change in HbA1c at 26w vs baseline in intervention versus control arms.
Sponsors
University of Waikato
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes as per the American Diabetes Association (ADA) classification within 12 weeks of initial diagnosis 2. HbA1c at baseline of > 58 mmol/mol 3. Aged 12-25 years (parental consent required for those under 16 years).
Exclusion criteria
1. History of T1DM 2. History of other types of diabetes such as MODY, secondary pancreatic diabetes, diabetes due to endocrinopathies 3. Use of systemic corticosteroids > 14 days, or repeated pharmacologic systemic courses of corticosteroids 4. Recurrent or chronic systemic infections that in the view of the investigator would significantly impact on glycaemia. 5. Major cardiovascular event (including or not limited to MI, CVA, CABG, PTCA) or major surgery in last 3 months 6. Active malignancy requiring ongoing treatment 7. Previous or planned bariatric surgery. 8. Gestational Diabetes 9. Current or planned pregnancy
Outcome results
None listed