Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM); Continuous Glucose Measurement; Dietary Modification

• Registration Number: NCT06888687
• Lead Sponsor: Australian Catholic University

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 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.

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 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.

Study Timeline

• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-14
• Study First Posted: 2025-03-21
• Status Verified: 2025-05
• Study Start: 2025-05-12
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-11-28
• Study Completion: 2026-11-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	baseline, 6 months	Glycated haemoglobin concentration

Secondary Outcome Measures

Name	Time	Method
HbA1c	3 months	Glycated haemoglobin concentration
24 h assessment of glycaemia	baseline, 6 months	24 h glucose measures assessed by blinded CGM (including, but not limited to, time in range, CV)
Fasting blood glucose	baseline, 3 months, 6 months	fasting blood glucose concentrations
hs-CRP	baseline, 3 months, 6 months	fasting high sensitive C-Peptide concentrations

Trial Locations

Locations (1)

Australian Catholic University; 🇦🇺 Melbourne, Victoria, Australia