Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000154404
Ethics application status
Approved
Date submitted
23/01/2025
Date registered
10/02/2025
Date last updated
10/02/2025
Date data sharing statement initially provided
10/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Rethinking Models of Outpatient Type 2 Diabetes care using eHealth (REMODeL) – in General Practice
Scientific title
REMODeL DT2DGP- Bringing General Practice Type 2 Diabetes into the Future with Digital Health
Secondary ID [1] 313658 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 336229 0
Condition category
Condition code
Metabolic and Endocrine 332768 332768 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Utilising a smartphone application (available of app stores for free), participants will have the capability to record their blood glucose readings at least once a day and monitor their daily blood glucose levels and receive automated feedback to improve their self-management for a 3-month period. This data will be readily accessible to both a practice nurse and a GP (via an online dashboard) within the local area, facilitating prompt intervention and personalized care. We will be noting the number of entries in the dashboard per participant but that is not an outcome of this study. By leveraging technology, the study seeks to bridge the gap in diabetes care for regional populations, offering efficient and accessible monitoring and support. The feedback a participant may be about frequency of blood sugar testing, about diet, exercise, etc. An example would be "Getting 30 minutes of exercise a day can be split into 2x 15-minute sessions- this could be as simple as walking to work, to the shop, or around the block.".
Intervention code [1] 330259 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340293 0
Change in Glycated haemoglobin (HbA1c)
Timepoint [1] 340293 0
At 3 months from baseline
Secondary outcome [1] 443708 0
To measure participants' confidence and self-management skills in managing their diabetes
Timepoint [1] 443708 0
At baseline and 3 months from baseline
Secondary outcome [2] 443638 0
To evaluate the presence of diabetes related distress among the participants
Timepoint [2] 443638 0
At baseline and 3 months from baseline
Secondary outcome [3] 443709 0
To measure perceived subjective assessment of usability of diabetes tools and system usability
Timepoint [3] 443709 0
At 3 months from baseline
Secondary outcome [4] 443710 0
To measure and assess technology acceptability of telehealth services
Timepoint [4] 443710 0
At 3 months from baseline

Eligibility
Key inclusion criteria
• T2D,
• A glycated haemoglobin (HbA1c) result that is greater than or equal to 8% within the 6 weeks prior to trial consent,
• Type 2 diabetes duration for at least 6 months prior to trial consent,
• aged greater than equal to 18 years,
• currently on insulin for at least 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• do not have a compatible smartphone with wifi / internet access,
• unable to communicate (read and write) in English,
• use a continuous glucose monitor,
• are pregnant or planning to be pregnant, due to the difference in diabetes management,
• unstable medical conditions that may impact on diabetes management as determined by the clinician or General Practitioner (for e.g., if they have been on corticosteroids),
• has diabetes related medication (including steroids) changes within the last 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
10/03/2025
Actual
Date of last data collection
Anticipated
10/03/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318124 0
Government body
Name [1] 318124 0
Queensland Regional Clinical Trials Coordinating Centre
Country [1] 318124 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 320507 0
None
Name [1] 320507 0
Address [1] 320507 0
Country [1] 320507 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316771 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 316771 0
Ethics committee country [1] 316771 0
Australia
Date submitted for ethics approval [1] 316771 0
17/04/2024
Approval date [1] 316771 0
09/07/2024
Ethics approval number [1] 316771 0

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

Contacts
Principal investigator
Name 138962 0
Dr Anish Menon
Address 138962 0
Princess Alexandra Hospital 199 Ipswich Road Woolloongabba, QLD 4102
Country 138962 0
Australia
Phone 138962 0
+61401409585
Fax 138962 0
Email 138962 0
[email protected]
Contact person for public queries
Name 138963 0
Anish Menon
Address 138963 0
Princess Alexandra Hospital 199 Ipswich Road Woolloongabba, QLD 4102
Country 138963 0
Australia
Phone 138963 0
+61 7 3176 2111
Fax 138963 0
Email 138963 0
[email protected]
Contact person for scientific queries
Name 138964 0
Anish Menon
Address 138964 0
Princess Alexandra Hospital 199 Ipswich Road Woolloongabba, QLD 4102
Country 138964 0
Australia
Phone 138964 0
+61 7 3176 2111
Fax 138964 0
Email 138964 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This is a pilot study of only 10 participants



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.