Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06888687

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Continuous Glucose Measurement Diabetes Mellitus Diabetes Mellitus, Type 2 Dietary Modification Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Australian Catholic University

Melbourne, Victoria, 3065, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dietetic support

Behavioral

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 monitoring

Device

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.

Primary outcomes

  1. HbA1c

    Time frame: baseline, 6 months

    Glycated haemoglobin concentration

Secondary outcomes

  1. HbA1c

    Time frame: 3 months

    Glycated haemoglobin concentration

  2. 24 h assessment of glycaemia

    Time frame: baseline, 6 months

    24 h glucose measures assessed by blinded CGM (including, but not limited to, time in range, CV)

Other outcomes

  1. CGM application and use

    Time frame: From 0 to 26 weeks, per 2 week period of sensor use

    number of days of CGM use and interaction with viewing CGM data (via LibreLink); CGMD group ony

  2. Per protocol analysis

    Time frame: 6 months

    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:

    • Attendance at ≥3 dietetic consults, within ±10 days of the designated 2-, 6-, 10- and 16-week time points.

  3. Dietary intake

    Time frame: baseline, 3 months, 6 months

    energy and macronutrient composition calculated from food records

  4. Fasting blood glucose

    Time frame: baseline, 3 months, 6 months

    fasting blood glucose concentrations

  5. Adherence

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 18 weeks, 20 weeks, 26 weeks

    measures of adherence assessed by self-report (questionnaire)

  6. hs-CRP

    Time frame: baseline, 3 months, 6 months

    fasting high sensitive C-Peptide concentrations

  7. Fasting cholesterol

    Time frame: baseline, 3 months, 6 months

    Fasting cholesterol concentrations (total, HDL and LDL)

  8. Fasting lipid concentration

    Time frame: baseline, 3 months, 6 months

    fasting triglyceride concentrations

  9. Medication effect score (MES)

    Time frame: baseline, 6 months

    Medication effect score for antihyperglycemic medications

  10. Participant experience

    Time frame: 6 months

    Qualitative semi-structured interviews

  11. Physical activity

    Time frame: baseline, 3 months, 6 months

    Self-reported questionnaire (International Physical Activity Questionnaire (IPAQ) - Long Form)

  12. Sleep quality and quantity

    Time frame: baseline, 3 months, 6 months

    Self-reported questionnaire (Pittsburgh Sleep Quality Index (PSQI))

  13. Eating behaviours

    Time frame: baseline, 3 months, 6 months

    Self-reported questionnaire (Eating Disorders Examination Questionnaire (EDEQ))

  14. Health literacy

    Time frame: baseline, 3 months, 6 months

    self-reported questionnaire (Health Literacy Questionnaire (HLQ))

  15. Dietary quality

    Time frame: baseline, 3 months, 6 months

    Assessed using the Healthy Eating Index For Australian adults (HEIFA)

  16. Diabetes self-management

    Time frame: baseline, 3 months, 6 months

    Self-reported questionnaire (Diabetes Self-Management Questionnaire (DSMQ-R))

  17. Diabetes distress

    Time frame: baseline, 3 months, 6 months

    Self-reported questionnaire (Type 2 Diabetes Distress Assessment Scale (T2DDAS))

  18. Overall well-being

    Time frame: baseline, 3 months, 6 months

    Self-reported questionnaire (WHO-5)

  19. Diabetes-specific well-being

    Time frame: baseline, 3 months, 6 months

    Self-reported questionnaire (DAWN Impact of Diabetes Profile (DIDP-7))

  20. Treatment satisfaction

    Time frame: baseline, 3 months, 6 months

    self-reported questionnaire (Diabetes Treatment Satisfaction Questionnaire (DTSQs (status) and DTSQc (change)))

Sponsors and collaborators

Lead sponsor

Australian Catholic University

Other

Collaborators

  • Abbott Diabetes Care
  • Deakin University
  • Monash University
  • The University of Queensland
  • University of Adelaide
  • University of Melbourne

Registry information

Official study title

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

Acronym: CARE-T2D

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.