Clinical trial NCT06888687: Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.
Official title: Continuous Glucose Monitoring-Assisted Remote E-health Dietetics to Empower People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Continuous Glucose Measurement
Dietary Modification
Keywords: Continual Glucose Monitoring
Type 2 Diabetes
Non-insulin dependant Diabetes
Dietitian Support
Health Behaviours
Lead sponsor: Australian Catholic University
Sponsor class: OTHER
Collaborators: name: Abbott Diabetes Care
name: University of Adelaide
name: The University of Queensland
name: Monash University
name: University of Melbourne
name: Deakin University
First posted: 2025-03-21
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: HbA1c
timeFrame: baseline, 6 months
Secondary outcomes:
measure: HbA1c
timeFrame: 3 months
measure: 24 h assessment of glycaemia
timeFrame: baseline, 6 months
measure: Fasting blood glucose
timeFrame: baseline, 3 months, 6 months
measure: hs-CRP
timeFrame: baseline, 3 months, 6 months
Other outcomes:
measure: CGM application and use
timeFrame: From 0 to 26 weeks, per 2 week period of sensor use
measure: Per protocol analysis
timeFrame: 6 months
measure: Dietary intake
timeFrame: baseline, 3 months, 6 months
measure: Adherence
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 18 weeks, 20 weeks, 26 weeks
measure: Fasting cholesterol
timeFrame: baseline, 3 months, 6 months
measure: Fasting lipid concentration
timeFrame: baseline, 3 months, 6 months
measure: Medication effect score (MES)
timeFrame: baseline, 6 months
measure: Participant experience
timeFrame: 6 months
measure: Physical activity
timeFrame: baseline, 3 months, 6 months
measure: Sleep quality and quantity
timeFrame: baseline, 3 months, 6 months
measure: Eating behaviours
timeFrame: baseline, 3 months, 6 months
measure: Health literacy
timeFrame: baseline, 3 months, 6 months
measure: Dietary quality
timeFrame: baseline, 3 months, 6 months
measure: Diabetes self-management
timeFrame: baseline, 3 months, 6 months
measure: Diabetes distress
timeFrame: baseline, 3 months, 6 months
measure: Overall well-being
timeFrame: baseline, 3 months, 6 months
measure: Diabetes-specific well-being
timeFrame: baseline, 3 months, 6 months
measure: Treatment satisfaction
timeFrame: baseline, 3 months, 6 months
Locations:
city: Melbourne
country: Australia
facility: Australian Catholic University
state: Victoria
Study officials:
References: