Status:
RECRUITING
Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.
Lead Sponsor:
Australian Catholic University
Collaborating Sponsors:
Abbott Diabetes Care
University of Adelaide
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Continuous Glucose Measurement
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed 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 RED...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2026
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06888687
Start Date
May 12 2025
End Date
November 28 2026
Last Update
May 23 2025
Active Locations (1)
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1
Australian Catholic University
Melbourne, Victoria, Australia, 3065