ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12626001002370

Ethics application status

Approved

Date submitted

17/07/2026

Date registered

14/08/2026

Date last updated

14/08/2026

Date data sharing statement initially provided

14/08/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Can the use continuous glucose monitors in a Diabetes Multidisciplinary Team High Risk Foot Clinic improve patient related outcomes - A feasibility study.

Scientific title

A randomised feasibility trial assessing the impact of continuous glucose monitor sensors in a Diabetes Multidisciplinary Team High Risk Foot Clinic in people with active diabetes related foot complications.

Additional trial identifiers [1]

Nil known

Universal Trial Number (UTN)

U1111-1343-4350

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Diabetes

Diabetic Foot Ulcer

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Skin

Other skin conditions

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

The intervention is the use of Continuous Glucose Monitoring System (CGMS) during an occasion of service in a Diabetes Multidisciplinary Team (MDT) High Risk Foot Clinic (HRFC). The intervention is delivered by the diabetes educator within the MDT clinic and supported by the wider MDT. The clinic is conducted face to face and last for approx. 1 hour and usually consists of fortnightly consults over approximately 3 months (depending on the course of wound healing). Participants are provided with appointment times and reminders are provided through the health service booking system. For those in the intervention group, the CGMS will be applied at the initial appointment with the Diabetes MDT HRFC and will last for up to 15 days. A second sensor will be applied a fortnight later in a subsequent Diabetes MDT HRFC appointment. The CGMS is in addition to the usual care that is provided with this clinic.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Lifestyle

Description of the comparator or control

Control treatment consists of usual care that is provided in the Diabetes MDT High Risk Foot Clinic. This consists of podiatry, diabetes educator, dietitian and other medical professions including endocrinology, infectious disease and orthopeadics as required. The control group will not be provided with a CGMS. The clinic is conducted face to face and usually consists of fortnightly consults over approximately 3 months (depending on the course of wound healing). Participants are provided with appointment times and reminders are provided through the health service booking system.

Control group

Active

Outcomes

Primary outcome [1]

glycated haemoglobin (HbA1c)

Timepoint [1]

At admission to the Diabetes MDT High Risk Foot Clinic and three months later.

Secondary outcome [1]

Time in Target (3.9-10.0 mmol/L)

Timepoint [1]

At 2 and 4 weeks post commencement of CCGMS in intervention group

Secondary outcome [2]

Glucose variability. Percent coefficient of variation (%CV); A target of less than 36% is set as being define as having adequate glucose variability.

Timepoint [2]

At 2 and 4 weeks post commencement of CCGMS in intervention group

Secondary outcome [3]

Glucose Management Indicator (GMI). An estimated HbA1c level based on CGMS data over a set period

Timepoint [3]

At 2 and 4 weeks post commencement of CCGMS in intervention group

Secondary outcome [4]

CGMS Compliance - % of data availability over the sensor life

Timepoint [4]

At 2 and 4 weeks post commencement of CCGMS in intervention group.

Secondary outcome [5]

Food and nutrient composition of participants usual dietary intake.

Timepoint [5]

Baseline, On discharge from service - exact timepoint dependent on depending on the course of wound healing. Approximate length of admission in the Diabetes MDT HRFC is 3-months.

Secondary outcome [6]

Emotional distress related to diabetes management.

Timepoint [6]

Baseline, On discharge from service - exact timepoint dependent on depending on the course of wound healing. Approximate length of admission in the Diabetes MDT HRFC is 3-months

Secondary outcome [7]

Wound Assessments - Time to heal

Timepoint [7]

Time To Heal - Baseline to full healing.

Secondary outcome [8]

Adverse effects

Timepoint [8]

Assessed throughout admission to HRFC. Approximate length of admission in the Diabetes MDT HRFC is 3-months

Secondary outcome [9]

Loss to follow-up

Timepoint [9]

Throughout the course of the 12 month study.

Secondary outcome [10]

Risk of lower limb amputation

Timepoint [10]

Baseline and at each wound assessment by Podiatrist until wound healing or

Secondary outcome [11]

Time Above Target (Cat 1: 10.1 - 13.9 mmol/L & Cat 2: >13.9mmol/L)

Timepoint [11]

At 2 and 4 weeks post commencement of CCGMS in intervention group

Secondary outcome [12]

Time Below Target (Cat: 1: 3.0-3.8mmol/L & Cat2: <3.0mmol/L).

Timepoint [12]

At 2 and 4 weeks post commencement of CCGMS in intervention group.

Secondary outcome [13]

Health service utilisation related to participants diabetic foot ulcer - Emergency Department (ED) presentations.

Timepoint [13]

Throughout the course of the study. Approximately 15 months - 12 months of recruitment plus approximately 3 months until final participants are discharged for the Diabetes MDT HRFC.

Secondary outcome [14]

Health service utilisation - admission to hospital related to participants diabetic foot ulcer.

Timepoint [14]

Throughout the course of the study. Approximately 15 months - 12 months of recruitment plus approximately 3 months until final participants are discharged for the Diabetes MDT HRFC.

Secondary outcome [15]

Rates of screening.

Timepoint [15]

Throughout the course of the study recruitment - 12 months.

Secondary outcome [16]

Percentage randomised.

Timepoint [16]

Throughout the course of the study recruitment - 12 months.

Secondary outcome [17]

Rates of recruitment

Timepoint [17]

Throughout the course of the study recruitment - 12 months.

Secondary outcome [18]

Adherence to study protocol.

Timepoint [18]

Throughout the course of the study. Approximately 15 months - 12 months of recruitment plus approximately 3 months until final participants are discharged for the Diabetes MDT HRFC.

Secondary outcome [19]

Percentage of missing data.

Timepoint [19]

Throughout the course of the study. Approximately 15 months - 12 months of recruitment plus approximately 3 months until final participants are discharged for the Diabetes MDT HRFC.

Eligibility

Key inclusion criteria

All adult (18 years old or greater) patients of the HRFS diagnosed with type 1 or type 2 diabetes and with an active foot wound, including re-ulceration.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

People who are treated for palliative wound management.
People already using CGMS to monitor their glucose levels.

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)

Central randomisation

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer-generated random sequence.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Data obtained throughout the study will be entered into R statistical software for analysis. Study participant demographic and clinical characteristics will be analysed descriptively by calculating the mean and standard deviation (SD) for continuous variables, percentage and number (N) by response level for categorical variables, number and interquartile range for count data.

Study group comparisons for continuous variables, including the primary outcome, HbA1c, other measures of glycaemic control (GMI, glycaemic variability and time in range), rate of foot healing, and relevant questionnaire data (FFQ and PAID), will be undertaking using univariate independent samples t-tests. Binary categorical data, including adverse events and health service utilisation (ED presentation, admission to hospital), will be analysed using the z-test for proportions.

For feasibility outcomes, rates of screening and recruitment, percentage randomised, adherence to study protocol, loss to follow-up and percentage of missing data will be calculated.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/09/2026

Actual

Date of last participant enrolment

Anticipated

12/08/2027

Actual

Date of last data collection

Anticipated

12/11/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

The Tweed Hospital - Tweed Heads

Recruitment postcode(s) [1]

2487 - Cudgen

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Northern NSW LHD

Address [1]

Country [1]

Australia

Funding source category [2]

University

Name [2]

Bond University

Address [2]

Country [2]

Australia

Primary sponsor type

Government body

Name

Northern NSW LHD

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

North Coast NSW Human Research Ethics Committee

Ethics committee address [1]

http://nnswlhd.health.nsw.gov.au/about/northern-nsw-local-health-district/human-research-ethics-and-governance/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/09/2025

Approval date [1]

28/04/2026

Ethics approval number [1]

Summary

Brief summary

This project is designed to assess the feasibility and acceptability of using Continuous Glucose Monitor Sensors (CGMS) in people with diabetes attending the Tweed Valley Hospital High Risk Foot Clinic Diabetes Multidisciplinary Team (TVH HRFC Diabetes MDT). The clinic comprises of the lead podiatrist, a diabetes educator and diabetes dietitian as well as consulting medical specialists including vascular, infectious disease, orthopeadic and endocrinology. The MDT clinic manages people with diabetes and active diabetes related foot ulcers, understanding the importance of achieving adequate glucose control to assist in the management of these wounds. The study protocol proposes a randomised feasibility trial where the intervention in the study is the use of CGMS within a cohort in the TVH HRFC Diabetes MDT and comparing this to another group that does not receive the CGMS. Both groups will otherwise receive the usual care that is provided within this clinic.  We hypothesize that the use of the CGMS will assist to improve glucose control, improve diet quality, reduce diabetes distress and ultimately improve wound healing. Further, we believe that participants using the sensor will find the process acceptable and beneficial to their care.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Damien McDermid

Address

Tweed Valley Hospital 771 Cudgen Road, Cudgen, NSW 2487

Country

Australia

Phone

+61 419 400 937

Fax

[email protected]

Contact person for public queries

Name

Damien McDermid

Address

Tweed Valley Hospital 771 Cudgen Road, Cudgen, NSW 2487

Country

Australia

Phone

+61 419 400 937

Fax

[email protected]

Contact person for scientific queries

Name

Damien McDermid

Address

Tweed Valley Hospital 771 Cudgen Road, Cudgen, NSW 2487

Country

Australia

Phone

+61 419 400 937

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically