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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06888687




Registration number
NCT06888687
Ethics application status
Date submitted
10/03/2025
Date registered
21/03/2025
Date last updated
23/05/2025

Titles & IDs
Public title
Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.
Scientific title
Continuous Glucose Monitoring-Assisted Remote E-health Dietetics to Empower People With Type 2 Diabetes
Secondary ID [1] 0 0
2024-3690HC
Universal Trial Number (UTN)
Trial acronym
CARE-T2D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus (T2DM) 0 0
Continuous Glucose Measurement 0 0
Dietary Modification 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Dietetic support
Treatment: Devices - Continuous glucose monitoring

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.

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.

Treatment: Devices: 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.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
baseline, 6 months
Secondary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
24 h assessment of glycaemia
Timepoint [2] 0 0
baseline, 6 months
Secondary outcome [3] 0 0
Fasting blood glucose
Timepoint [3] 0 0
baseline, 3 months, 6 months
Secondary outcome [4] 0 0
hs-CRP
Timepoint [4] 0 0
baseline, 3 months, 6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/11/2026
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian Catholic University - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian Catholic University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Abbott Diabetes Care
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Adelaide
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The University of Queensland
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Monash University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Melbourne
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Deakin University
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Evelyn B Parr, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 9230 8278
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06888687