Overview
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.
Description
In a parallel groups design, a total of 156 individuals will be recruited. After baseline pathology (HbA1c), blinded (Libre Pro iQ) continuous glucose monitoring (CGM) data and questionnaires (via REDCap) have been collected, participants will be randomised into one of two groups (DIET, dietetic support only; CGMD, CGM plus dietetic support). All participants will receive four (4) dietetic consults via telehealth at weeks 2, 6, 10 and 16, the content of which will be related to the randomised condition. Measurements will be repeated at 3 and 6 months from baseline to assess the changes in primary and secondary outcomes.
Eligibility
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)