Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000049572
Ethics application status
Approved
Date submitted
30/11/2023
Date registered
22/01/2024
Date last updated
28/01/2024
Date data sharing statement initially provided
22/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Rethinking Model of Type 2 Diabetes Care Utilising digital technology
Scientific title
Rethinking Model of Outpatient Type 2 Diabetes care using eHealth (REMODeL) - IPC (Integrated Personalised Care) mHealth system and effect on glycated haemoglobin
Secondary ID [1] 309785 0
Grantor Reference ID: TTRARC010-3B
Universal Trial Number (UTN)
Trial acronym
REMODeL-IPC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 330412 0
Condition category
Condition code
Metabolic and Endocrine 327250 327250 0 0
Diabetes
Public Health 329172 329172 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participant will be given access to the new model of care.

REMODeL is an innovative model of care that provides self-management support outside of the traditional in-person clinic visits for people with T2DM through advances in digital technology (MDMS). This will be administered by the tertiary clinic at the Princess Alexandra Hospital and the participants will be contacted based on dashboard review by the diabetes nurse educators. Ad hoc clinic appointments will be scheduled based on need.

After 12 months of being enrolled in the model of care, patients will be discharged from the REMODeL system. At this point, patients will return to receiving the standard care from the outpatient clinic.

The technology will include the following components:

(1) a Bluetooth-enabled glucose meter which transmits blood glucose level data wirelessly to a smartphone app, a web-based clinician dashboard that the HCP can review daily;
(2) automated alerts for health care professional via the dashboard to identify patients with hyperglycaemia, hypoglycaemia or those not achieving components of their annual cycle of care; this dashboard will be reviewed by diabetes educators from Monday to Friday excluding public holidays. The diabetes educator will respond to dashboard alerts as determined by a pre-existing algorithm, for eg., if there are dangerously out of range measures and will communicate with the participant either via message or a phone call after consulting with the doctor if required.
(3) motivational and educational SMS text messages providing contextual feedback to the people with diabetes (PWD), triggered based on their glycaemic profile 2 times per week. An additional lifestyle message will be sent once per week. Additional dangerous out of range blood glucose measures will be trigger an SMS the following day. The participants can respond to text messages and will be actioned during business hours.
(4) PWD access to educational materials available on the internet like Diabetes Australia will be used.
Intervention code [1] 326359 0
Treatment: Other
Comparator / control treatment
A retrospective cohort from a similar sized tertiary hospital will serve as a comparison at a later stage. The retrospective cohort will be receiving standard diabetes care. This data will be obtained retrospectively to match the period of recruitment for the intervention from Queensland Health records.
Control group
Historical

Outcomes
Primary outcome [1] 335403 0
Change in Glycated haemoglobin (HbA1c) (blood test)
Timepoint [1] 335403 0
6 months from baseline
Secondary outcome [1] 424401 0
Diabetes-related distress will be assessed using Diabetes Distress Scale (DDS) questionnaire
Timepoint [1] 424401 0
At baseline, 6 months from baseline and 12 months from baseline .
Secondary outcome [2] 424403 0
Self-management will be assessed using Skills, Confidence, and Preparedness Index (SCPI) questionnaire
Timepoint [2] 424403 0
At baseline, 6 months from baseline and 12 months from baseline.
Secondary outcome [3] 424404 0
Digital literacy will be assessed using eHealth Literacy Questionnaire (eHLQ)
Timepoint [3] 424404 0
At baseline, 6 months and 12 months from baseline.
Secondary outcome [4] 424405 0
Acceptability of MDMS will be assessed using Service User Technology Acceptability Questionnaire (SUTAQ)
Timepoint [4] 424405 0
At 6 months and 12 months from baseline.
Secondary outcome [5] 429491 0
Change in HbA1c (blood test)
Timepoint [5] 429491 0
12 months from baseline.
Secondary outcome [6] 429492 0
Body weight using available weighing scales at GP practice or the Hospital clinic
Timepoint [6] 429492 0
At baseline and 12 months from baseline.
Secondary outcome [7] 429493 0
Lipid Profile (blood test)
Timepoint [7] 429493 0
At baseline and 12 months from baseline.
Secondary outcome [8] 429494 0
Blood Pressure using available sphygmomanometer
Timepoint [8] 429494 0
At baseline and 12 months from baseline.
Secondary outcome [9] 429495 0
Diabetes related medication use from health record
Timepoint [9] 429495 0
At baseline, 6 months and 12 months from baseline.
Secondary outcome [10] 429496 0
Self-reported Hypoglycaemic events through study specific online survey
Timepoint [10] 429496 0
At 3, 6 and 12 months from baseline.
Secondary outcome [11] 430977 0
Attendance rates at diabetes specialist clinic outpatients. The method of assessment is being worked on.
Timepoint [11] 430977 0
12 months.
Secondary outcome [12] 430978 0
Attendance rate at emergency department. The method of assessment is being worked on.
Timepoint [12] 430978 0
12 months,
Secondary outcome [13] 430979 0
Hospital admissions. The method of assessment is being worked on.
Timepoint [13] 430979 0
12 months
Secondary outcome [14] 430980 0
Healthcare delivery cost. The method of assessment is being worked on.
Timepoint [14] 430980 0
12 months
Secondary outcome [15] 430981 0
Cost-effectiveness of this model of care. The method of assessment is being worked on.
Timepoint [15] 430981 0
12 months

Eligibility
Key inclusion criteria
• Type 2 diabetes duration for at least 2 years prior to consent,
• A glycated haemoglobin (HbA1c) result greater than equal to 8% within the 6 weeks prior to consenting to participate in the study,
• Referred to Diabetes Clinic for management of type 2 diabetes (includes inpatient referral),
• Consent to access their Queensland Health data related to diabetes care.
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,
• Pregnant or planning to be pregnant, due to the difference in diabetes management in
this group
• Unable to communicate in English
• Bariatric surgery within the last 12 months, due to impact on clinical markers which
may skew trial results,
• Severe mental illness,
• Cognitive impairment,
• Unstable medical condition as determined by the treating clinician,
• Use a continuous glucose monitor,
• Enrol in other clinical trials.
• Previous enrolment into REMODel randomised control trial or implementation project

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
Other
Other design features
Retrospective comparison will be done
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/01/2024
Actual
22/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25206 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 40876 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 313969 0
Other Collaborative groups
Name [1] 313969 0
Australian Centre for Accelerating Diabetes Innovations (ACADI).
Country [1] 313969 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
ST LUCIA QLD 4072, Australia.
Country
Australia
Secondary sponsor category [1] 315842 0
None
Name [1] 315842 0
Address [1] 315842 0
Country [1] 315842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313104 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 313104 0
Ethics committee country [1] 313104 0
Australia
Date submitted for ethics approval [1] 313104 0
13/10/2022
Approval date [1] 313104 0
03/05/2023
Ethics approval number [1] 313104 0
HREC/2022/QMS/89937

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

Contacts
Principal investigator
Name 127022 0
Dr Anish Menon
Address 127022 0
Centre for Health Services Research, The University of Queensland. Building 33, PA Hospital Campus, 199 Ipswich Road, Brisbane, QLD - 4102
Country 127022 0
Australia
Phone 127022 0
+61 7 31765363
Fax 127022 0
Email 127022 0
anish.menon@uq.net.au
Contact person for public queries
Name 127023 0
Anish Menon
Address 127023 0
Centre for Health Services Research, The University of Queensland. Building 33, PA Hospital Campus, 199 Ipswich Road, Brisbane, QLD - 4102
Country 127023 0
Australia
Phone 127023 0
+61 731765363
Fax 127023 0
Email 127023 0
anish.menon@uq.net.au
Contact person for scientific queries
Name 127024 0
Anish Menon
Address 127024 0
Centre for Health Services Research, The University of Queensland.Building 33, PA Hospital Campus, 199 Ipswich Road, Brisbane, QLD - 4102
Country 127024 0
Australia
Phone 127024 0
+61 731765363
Fax 127024 0
Email 127024 0
anish.menon@uq.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.