Type 2 Diabetes Mellitus (T2DM)CARE-T2DNCT06888687
Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.
A study testing Dietetic support and Continuous glucose monitoring in people with Type 2 Diabetes Mellitus (T2DM) and Continuous Glucose Measurement, run by Australian Catholic University at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Continuous Glucose Measurement, Dietary Modification
- What is being tested?
- Dietetic support and Continuous glucose monitoring
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteAustralia
- Study dates
- 12 May 2025to 28 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Dietetic support, Continuous glucose monitoring
- Keywords
- Continual Glucose Monitoring, Type 2 Diabetes, Non-insulin dependant Diabetes, Dietitian Support, Health Behaviours
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietetic supportBehavioural
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.
Continuous glucose monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietetic support only | Active comparator | 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. Receives: Behavioral: Dietetic support |
| CGM plus dietetic support | Experimental | 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. Receives: Behavioral: Dietetic support; Device: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Glycated haemoglobin concentration
Measured: baseline, 6 months
Secondary outcomes (2)
HbA1c
Glycated haemoglobin concentration
Measured: 3 months
24 h assessment of glycaemia
24 h glucose measures assessed by blinded CGM (including, but not limited to, time in range, CV)
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start12 May 2025
- Primary completion28 Nov 2026 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diabetes Care, University of Adelaide, The University of Queensland, Monash University, University of Melbourne, Deakin University
- Responsible party
- Principal investigator, Evelyn Parr, Australian Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888687
- Sponsor's protocol ID
- 2024-3690HC
- Acronym
- CARE-T2D
- Status last verified
- May 2026
- First submitted
- 10 Mar 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring-Assisted Remote E-health Dietetics to Empower People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06888687
- Acronym / sponsor ID
- CARE-T2D / 2024-3690HC
- Keywords
- Continual Glucose Monitoring, Type 2 Diabetes, Non-insulin dependant Diabetes, Dietitian Support, Health Behaviours
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Australian Catholic UniversityUniversity, hospital or other
- Collaborators
- Abbott Diabetes Care, University of Adelaide, The University of Queensland, Monash University, University of Melbourne, Deakin University
- Study start
- 12 May 2025 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietetic support only | Active comparator | Behavioral: Dietetic supportThis 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. |
| CGM plus dietetic support | Experimental | Behavioral: Dietetic support, Device: Continuous glucose monitoringThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietetic supportDietary 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. | Behavioural | CGM plus dietetic support, Dietetic support only |
| Continuous glucose monitoringAbbott 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. | Device | CGM plus dietetic support |
Primary outcome
HbA1c
Time frame: baseline, 6 months
Glycated haemoglobin concentration
2 secondary outcomes
HbA1c
Time frame: 3 months
24 h assessment of glycaemia
Time frame: baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietetic support and Continuous glucose monitoring in people with Type 2 Diabetes Mellitus (T2DM) and Continuous Glucose Measurement, run by Australian Catholic University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.