NCT06888687

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
May 2025Nov 2026

First Submitted

Initial submission to the registry

March 10, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2026

Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

March 10, 2025

Last Update Submit

May 20, 2025

Conditions

Type 2 Diabetes Mellitus (T2DM)Continuous Glucose MeasurementDietary Modification

Keywords

Continual Glucose MonitoringType 2 DiabetesNon-insulin dependant DiabetesDietitian SupportHealth Behaviours

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Glycated haemoglobin concentration

    baseline, 6 months

Secondary Outcomes (4)

  • HbA1c

    3 months

  • 24 h assessment of glycaemia

    baseline, 6 months

  • Fasting blood glucose

    baseline, 3 months, 6 months

  • hs-CRP

    baseline, 3 months, 6 months

Other Outcomes (18)

  • CGM application and use

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

  • Per protocol analysis

    6 months

  • Dietary intake

    baseline, 3 months, 6 months

  • +15 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Dietetic supportDevice: Continuous glucose monitoring

Interventions

Dietetic supportBEHAVIORAL

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.

CGM plus dietetic supportDietetic support only
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.

CGM plus dietetic support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Australian Catholic University

Melbourne, Victoria, 3065, Australia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Central Study Contacts

Evelyn B Parr, PhD

CONTACT

+61 3 9230 8278evelyn.parr@acu.edu.au

Katherine Roberts-Thomson, PhD

CONTACT

katherine.roberts-thomson@acu.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 21, 2025

Study Start

May 12, 2025

Primary Completion (Estimated)

November 28, 2026

Study Completion (Estimated)

November 28, 2026

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
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.

Locations

AU(1)