Type 2 Diabetes Mellitus (T2DM)Continuous Glucose MeasurementDietary Modification
Investigational drug(s) / intervention(s)
Dietetic supportContinuous glucose monitoring
Dietetic support: Dietary advice will be provided by Accredited Practicing Dietitians (APDs) in line with evidence-based guidelines, specifically the T2DM best-practice guidelines plus Australian Dietary Guidelines (i.e. Australian Guide to Healthy Eating) to improve diet quality, and strategies to promote adherence.
Continuous glucose monitoring: Abbott FreeStyle Libre 2+ CGM sensors will be used to provide feedback on interstitial glucose concentrations over 15 day periods per sensor. Nine sensors will be provided for the 6-month period, for 3 months of continuous use and 3 months of intermittent (2 weeks on - 2 weeks off) use.
Study summary
A parallel, single-blinded, randomised clinical trial conducted remotely across Australia from the Mary MacKillop Institute for Health Research (MMIHR, Australian Catholic University) for individuals with type 2 diabetes, by researchers from Australian Catholic University, University of Adelaide, University of Queensland, University of Wollongong, Monash University, Monash Partners, Deakin University, La Trobe University and Melbourne University.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Aged 18+ years
* Reside anywhere in Australia and have a postal address
* Confirmed T2D diagnosis by a GP/endocrinologist
* Current HbA1c of ≥7.0%
* Have a smartphone and able to independently use it
Exclusion Criteria:
* Under the age of 18 years
* Use of insulin therapy (within the last three months) or medications which interfere with blood glucose levels (i.e. steroids)
* Use of CGM within the last six months
* Eating Disorder Examination Questionnaire (EDE-Q) global score \>2.8 OR global score \> or equal to 1.52, with sum of Q14-18 \> or equal to 4
* Currently having ongoing consultations with an APD or have had a consult with an APD (within last three months)
* Not weight stable (\>5 kg change over last three months)
* Severe hypoglycaemic event (i.e. requiring assistance) within last six months
* Change of antihyperglcyaemic medications within last three months
* Women who are pregnant or breastfeeding (within 24 weeks)
* History of psychotic disorder, or current diagnosis of other major psychiatric illness (e.g. mood disorder, eating disorder, substance use disorder)
* History of blood disorders (including but, not limited to, anemia and thalassemia) that impact the primary outcome (HbA1c)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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