Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.
Continuous Glucose Monitoring-Assisted Remote E-health Dietetics to Empower People With Type 2 Diabetes
Australian Catholic University
156 participants
May 12, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria11
- 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)
Interventions
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.
Abbott FreeStyle Libre 2+ CGM sensors will be used to provide feedback on interstitial glucose concentrations over 15 day periods per sensor.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06888687