Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes. (CARE-T2D)

Continuous Glucose Monitoring-Assisted Remote E-health Dietetics to Empower People With Type 2 Diabetes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dietary Modification; Type 2 Diabetes Mellitus (T2DM); Continuous Glucose Measurement
• Intervention / Treatment: Behavioral: Dietetic support; Device: Continuous glucose monitoring

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3065
      • Australian Catholic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dietetic support only; This group is designed to act as a comparator using 'standard care' in dietetics practice. Dietary advice provided to this participant group will be performed 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.	Behavioral: Dietetic support; 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.
Experimental: CGM plus dietetic support; The CGM plus dietetic support group will be provided 'standard care' dietetic support alongside the use, and interpretation of, the CGM data collected to assist in the understanding of dietary modifications on glucose management. As per the DIET group, dietary advice provided to this participant group will be performed 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. The CGM data collected via LibreLink will be used by both the participant and the dietitian to inform dietary modifications.	Behavioral: Dietetic support; 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.; Device: Continuous glucose monitoring; Abbott FreeStyle Libre 2+ CGM sensors will be used to provide feedback on interstitial glucose concentrations over 15 day periods per sensor. Nine sensors will be provided for the 6-month period, for 3 months of continuous use and 3 months of intermittent (2 weeks on - 2 weeks off) use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Glycated haemoglobin concentration	baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Glycated haemoglobin concentration	3 months
24 h assessment of glycaemia	24 h glucose measures assessed by blinded CGM (including, but not limited to, time in range, CV)	baseline, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood glucose	fasting blood glucose concentrations	baseline, 3 months, 6 months
hs-CRP	fasting high sensitive C-Peptide concentrations	baseline, 3 months, 6 months
CGM application and use	number of days of CGM use and interaction with viewing CGM data (via LibreLink); CGMD group ony	From 0 to 26 weeks, per 2 week period of sensor use
Dietary intake	energy and macronutrient composition calculated from food records	baseline, 3 months, 6 months
Adherence	measures of adherence assessed by self-report (questionnaire)	baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 18 weeks, 20 weeks, 26 weeks
Fasting cholesterol	Fasting cholesterol concentrations (total, HDL and LDL)	baseline, 3 months, 6 months
Fasting lipid concentration	fasting triglyceride concentrations	baseline, 3 months, 6 months
Medication effect score (MES)	Medication effect score for antihyperglycemic medications	baseline, 6 months
Participant experience	Qualitative semi-structured interviews	6 months
Physical activity	Self-reported questionnaire (International Physical Activity Questionnaire (IPAQ) - Long Form)	baseline, 3 months, 6 months
Sleep quality and quantity	Self-reported questionnaire (Pittsburgh Sleep Quality Index (PSQI))	baseline, 3 months, 6 months
Eating behaviours	Self-reported questionnaire (Eating Disorders Examination Questionnaire (EDEQ))	baseline, 3 months, 6 months
Health literacy	self-reported questionnaire (Health Literacy Questionnaire (HLQ))	baseline, 3 months, 6 months
Dietary quality	Assessed using the Healthy Eating Index For Australian adults (HEIFA)	baseline, 3 months, 6 months
Diabetes self-management	Self-reported questionnaire (Diabetes Self-Management Questionnaire (DSMQ-R))	baseline, 3 months, 6 months
Diabetes distress	Self-reported questionnaire (Type 2 Diabetes Distress Assessment Scale (T2DDAS))	baseline, 3 months, 6 months
Overall well-being	Self-reported questionnaire (WHO-5)	baseline, 3 months, 6 months
Diabetes-specific well-being	Self-reported questionnaire (DAWN Impact of Diabetes Profile (DIDP-7))	baseline, 3 months, 6 months
Treatment satisfaction	self-reported questionnaire (Diabetes Treatment Satisfaction Questionnaire (DTSQs (status) and DTSQc (change)))	baseline, 3 months, 6 months
Per protocol analysis	Primary analysis of the primary outcome (0-6 months HbA1c) is going to be intention to treat. Therefore, secondary analysis of all other variables will be a per-protocol (PP) analysis. Inclusion in PP analysis will be defined by: 1. Attendance at ≥3 dietetic consults, within ±10 days of the designated 2-, 6-, 10- and 16-week time points.	6 months

Collaborators and Investigators

• Sponsor: Australian Catholic University
• Collaborators: Monash University; University of Adelaide; University of Melbourne; Abbott Diabetes Care; The University of Queensland; Deakin University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): November 28, 2026
• Study Completion (Estimated): November 28, 2026

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Health Behaviours; Continual Glucose Monitoring; Non-insulin dependant Diabetes; Dietitian Support
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: 2024-3690HC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study will be available from the corresponding author for a period of 36 months from publication, upon reasonable request for academic use. The data will not be made publicly available, as it contains information that could compromise research participant consent.
• IPD Sharing Access Criteria: Reasonable requests of data for academic use will be considered. Requests can be made to the corresponding author of the publication. Data will not be made publicly available as it contains information that could compromise research participant consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No