Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001345875
Ethics application status
Approved
Date submitted
7/08/2021
Date registered
7/10/2021
Date last updated
7/10/2021
Date data sharing statement initially provided
7/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
REthinking the Model of Outpatient Diabetes Care utilising eHeaLth in Regional, Rural and Remote Populations
Scientific title
Clinical outcomes of an eHealth-facilitated model of type 2 diabetes care in regional, rural and remote populations: The REMODeL-R3 trial
Secondary ID [1] 303754 0
None
Universal Trial Number (UTN)
Trial acronym
REMODEL-R3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 321234 0
Condition category
Condition code
Metabolic and Endocrine 319024 319024 0 0
Diabetes
Public Health 320899 320899 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In order to avoid bias, all participants will receive a Bluetooth-enabled glucose meter and a box of 100 test strips, and they will be encouraged to test their blood glucose levels daily, however, there are no specified testing requirements for this trial.

The participants in the intervention group will be connected to a Mobile Diabetes Management System (MDMS), which consists of a smartphone application where participants can track their glucose readings and access their insulin prescriptions, and a browser-based clinician portal for patient monitoring and communication. Participants using the MDMS will also receive text messages with self-management advice, which will be based on their most recent readings and their frequency of testing. There will also be general lifestyle advice.

Examples of text messages:
•“Blood glucose checks were less than once daily. More regular checks can help your diabetes management. Any problem? Talk to your diabetes team”
•“Foods that affect blood sugar are carbohydrates - breads, cereals, starchy vegetables (potato & corn), snack foods (biscuits & cake) and some fruits.”

Every Monday, participants will receive insulin dose adjustment (IDA) advice based on the previous week’s glucose readings. The advice will be generated by Insulin Insights, an FDA-cleared insulin titration algorithm from Mellitus Health. For safety, an endocrinologist will review the IDA advice before the patient is notified of the new advice via text message.

The insulin dose adjustment service will be available for the first 8 weeks of the 6-month trial. After that, participants will have access to the app and receive text message advice until the end of the study at the 6-month mark.

Adherence and fidelity to the system can be estimated by observing the participants’ testing frequency in the clinician portal, as well as the number of insulin dose adjustment advice generated and accepted by the participants.
Intervention code [1] 320070 0
Treatment: Other
Intervention code [2] 321503 0
Treatment: Devices
Comparator / control treatment
The control group will receive standard care from the Princess Alexandra Hospital's Telehealth Diabetes Clinic. Standard care is an initial review by the endocrinologist at the telehealth clinic and having periodic follow-up reviews as determined by the endocrinologist. The person with diabetes might be referred to the nurse-led insulin dose adjustment service at the endocrinologist's discretion.
Control group
Active

Outcomes
Primary outcome [1] 326927 0
change in HbA1c - (blood sample)
Timepoint [1] 326927 0
3 months post-intervention commencement
Secondary outcome [1] 393150 0
change in HbA1c - (blood sample)
Timepoint [1] 393150 0
6 months post-intervention commencement
Secondary outcome [2] 393151 0
change in Quality of life using the EQ-5D
Timepoint [2] 393151 0
6 months post-intervention commencement
Secondary outcome [3] 393152 0
Percentage of participants achieving individual target HbA1c (blood sample)
Timepoint [3] 393152 0
6 months post-intervention commencement
Secondary outcome [4] 393153 0
body weight as assessed by remote clinic data at GP or community health centres
Timepoint [4] 393153 0
6 months post-intervention commencement
Secondary outcome [5] 393154 0
change in Health literacy using eHealth literacy questionnaire (eHLQ)
Timepoint [5] 393154 0
6 months post-intervention commencement
Secondary outcome [6] 393155 0
change in diabetes related self-management using the SCPI (Diabetes Skills, Confidence & Preparedness Index)
Timepoint [6] 393155 0
6 months post-intervention commencement
Secondary outcome [7] 393156 0
Acceptability of the MDMS using the modified SUTAQ questionnaire ( Service User Technology Acceptability Questionnaire)
Timepoint [7] 393156 0
6 months post-intervention commencement
Secondary outcome [8] 395870 0
Self-reported hypoglycaemic events at 3 and 6 months, collected through an electronic survey emailed to participants via REDCap
Timepoint [8] 395870 0
3 and 6 months post-intervention commencement

Eligibility
Key inclusion criteria
People living with type 2 diabetes, attending the PA diabetes telehealth service:
• with a glycated haemoglobin (HbA1c) >8%,
• with an age >=18 years,
• with pre-existing type 2 diabetes for at least 6 months, and
• on insulin.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria will be participants
• those referred to conventional IDA
• those using the insulin pump, flash glucose monitoring or continuous glucose monitoring devices,
• with a recent bariatric surgery of less than 12 months,
• unable to communicate in English,
• who are pregnant or those planning pregnancy in the next 12 months,
• on insulin Ryzodeg
• those who do not have a reliable internet connection (either through Wi-fi at home or 3G/4G).

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)
Allocation will be concealed. The randomisation table will be through the REDCap software (randomisation table to be uploaded by the study statistician who will not be recruiting the participants)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
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
The primary analysis will be an intention-to-treat and differences in repeated measurements will be compared using a linear mixed model, adjusting for baseline glycated haemoglobin (HbA1c). We will also look at self-reported hypoglycaemic events to asses the safety of this intervention

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18985 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 33492 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 308162 0
Government body
Name [1] 308162 0
QLD Health
Country [1] 308162 0
Australia
Funding source category [2] 309366 0
Government body
Name [2] 309366 0
Metro South Health
Country [2] 309366 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 308996 0
None
Name [1] 308996 0
Address [1] 308996 0
Country [1] 308996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308148 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 308148 0
Ethics committee country [1] 308148 0
Australia
Date submitted for ethics approval [1] 308148 0
14/01/2021
Approval date [1] 308148 0
10/02/2021
Ethics approval number [1] 308148 0
HREC/2020/QMS/66107

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

Contacts
Principal investigator
Name 109698 0
Dr Anish Menon
Address 109698 0
Princess Alexandra Hospital
199 Ipswich Road
Woollongabba,
Brisbane Qld 4102 Australia
Country 109698 0
Australia
Phone 109698 0
+617 3176 2690
Fax 109698 0
Email 109698 0
[email protected]
Contact person for public queries
Name 109699 0
Anish Menon
Address 109699 0
Princess Alexandra Hospital
199 Ipswich Road
Woollongabba,
Brisbane Qld 4102 Australia
Country 109699 0
Australia
Phone 109699 0
+61 7 3176 2690
Fax 109699 0
Email 109699 0
[email protected]
Contact person for scientific queries
Name 109700 0
Anish Menon
Address 109700 0
Princess Alexandra Hospital
199 Ipswich Road
Woollongabba,
Brisbane Qld 4102 Australia
Country 109700 0
Australia
Phone 109700 0
+617 3176 2690
Fax 109700 0
Email 109700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified primary outcome data only
When will data be available (start and end dates)?
Immediately following publication for 5 years after.
Available to whom?
Researchers only
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
By contacting the principal investigator via email: [email protected]


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.