Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
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
Query!
Scientific title
REMODeL DT2DGP- Bringing General Practice Type 2 Diabetes into the Future with Digital Health
Query!
Secondary ID [1]
313658
0
Nil Known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
336229
0
Query!
Condition category
Condition code
Metabolic and Endocrine
332768
332768
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
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.".
Query!
Intervention code [1]
330259
0
Treatment: Other
Query!
Comparator / control treatment
No control group
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
340293
0
Change in Glycated haemoglobin (HbA1c)
Query!
Assessment method [1]
340293
0
Blood test
Query!
Timepoint [1]
340293
0
At 3 months from baseline
Query!
Secondary outcome [1]
443708
0
To measure participants' confidence and self-management skills in managing their diabetes
Query!
Assessment method [1]
443708
0
Survey tools- Skills, Confidence, and Preparedness Index (SCPI) questionnaire
Query!
Timepoint [1]
443708
0
At baseline and 3 months from baseline
Query!
Secondary outcome [2]
443638
0
To evaluate the presence of diabetes related distress among the participants
Query!
Assessment method [2]
443638
0
Survey tools- Diabetes Distress Scale (DDS) questionnaire
Query!
Timepoint [2]
443638
0
At baseline and 3 months from baseline
Query!
Secondary outcome [3]
443709
0
To measure perceived subjective assessment of usability of diabetes tools and system usability
Query!
Assessment method [3]
443709
0
survey tool- System Usability Scale questionnaire
Query!
Timepoint [3]
443709
0
At 3 months from baseline
Query!
Secondary outcome [4]
443710
0
To measure and assess technology acceptability of telehealth services
Query!
Assessment method [4]
443710
0
survey tool- The Service User Technology Acceptability (SUTAQ) questionnaire
Query!
Timepoint [4]
443710
0
At 3 months from baseline
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
3/03/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
10/03/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
10/03/2026
Query!
Actual
Query!
Sample size
Target
10
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Funding & Sponsors
Funding source category [1]
318124
0
Government body
Query!
Name [1]
318124
0
Queensland Regional Clinical Trials Coordinating Centre
Query!
Address [1]
318124
0
Query!
Country [1]
318124
0
Australia
Query!
Primary sponsor type
University
Query!
Name
The University of Queensland
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
320507
0
None
Query!
Name [1]
320507
0
Query!
Address [1]
320507
0
Query!
Country [1]
320507
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
316771
0
Metro South Human Research Ethics Committee
Query!
Ethics committee address [1]
316771
0
https://metrosouth.health.qld.gov.au/research/about-us/hrec
Query!
Ethics committee country [1]
316771
0
Australia
Query!
Date submitted for ethics approval [1]
316771
0
17/04/2024
Query!
Approval date [1]
316771
0
09/07/2024
Query!
Ethics approval number [1]
316771
0
Query!
Summary
Brief summary
This prospective pilot study will assess various implementation factors associated with integration of a digitally enabled model of care for individuals with type 2 diabetes (T2D) from regional areas into primary care using a digital health intervention. The comprehensive assessment of implementation factors will inform strategies to optimize the implementation process and maximize the effectiveness of future Digital Health interventions.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
This study is part of the REMODeL studies which aims to use digital technology to achieve the Quintuple Aims of Healthcare.
Query!
Contacts
Principal investigator
Name
138962
0
Dr Anish Menon
Query!
Address
138962
0
Princess Alexandra Hospital 199 Ipswich Road Woolloongabba, QLD 4102
Query!
Country
138962
0
Australia
Query!
Phone
138962
0
+61401409585
Query!
Fax
138962
0
Query!
Email
138962
0
[email protected]
Query!
Contact person for public queries
Name
138963
0
Anish Menon
Query!
Address
138963
0
Princess Alexandra Hospital 199 Ipswich Road Woolloongabba, QLD 4102
Query!
Country
138963
0
Australia
Query!
Phone
138963
0
+61 7 3176 2111
Query!
Fax
138963
0
Query!
Email
138963
0
[email protected]
Query!
Contact person for scientific queries
Name
138964
0
Anish Menon
Query!
Address
138964
0
Princess Alexandra Hospital 199 Ipswich Road Woolloongabba, QLD 4102
Query!
Country
138964
0
Australia
Query!
Phone
138964
0
+61 7 3176 2111
Query!
Fax
138964
0
Query!
Email
138964
0
[email protected]
Query!
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.
Download to PDF