Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001099415
Ethics application status
Approved
Date submitted
28/08/2025
Date registered
8/10/2025
Date last updated
8/10/2025
Date data sharing statement initially provided
8/10/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Capacity Building Education Towards Type 2 Diabetes Care Using Smart Technologies: Pilot Randomised Control Trial (RCT)
Scientific title
Pilot Randomised Controlled Trial to Assess the Effectiveness of E-Learning Modules on Type 2 Diabetes Care Using Smart Technologies Among Healthcare Professionals
Secondary ID [1] 315256 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 338710 0
Condition category
Condition code
Metabolic and Endocrine 335000 335000 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The e-Learning modules were developed by a multidisciplinary team, including diabetes endocrinologists, diabetes educators, pharmacologists, podiatrists, and nurses. The modules provide comprehensive education on the management of Type 2 Diabetes (T2D) using digital technology, with a focus on interpreting the Ambulatory Glucose Profile (AGP).
Participants will complete three sequential modules over three weeks:
- Module 1: Introduction and understanding of the AGP
- Module 2: Interpretation of Time in Range
- Module 3: Practical application of the AGP in clinical practice
Module Presentation and Interactivity:
- Each module includes short instructional videos, interactive activities, and knowledge-check quizzes at the end of sections to reinforce learning.
- Modules are hosted on the Canvas Catalog platform, with participants progressing sequentially (Module 1, Module 2, and Module 3).
Completion of each module unlocks the next.
- Participants may review previously completed modules at any time.
- Comprehensive resources pages accompany each module, containing hyperlinks to academic papers, guidelines (e.g., ADA, International Consensus on Time in Range, ADS), and educational videos to reinforce learning.
Engagement and Support:
- Weekly announcements and personalized notifications on Canvas remind participants to access modules, complete assessments, and stay engaged.
- Participant activity and completion are monitored through Canvas analytics, including module completion rates, attendance, and overall engagement.
This structure ensures that participants not only acquire knowledge and decision-making skills but also remain actively engaged through a combination of videos, interactive exercises, quizzes, and supplementary resources.
Intervention code [1] 331864 0
Treatment: Other
Comparator / control treatment
- The control group will be provided with a pre-recorded PowerPoint (PPT) presentation that covers general revisions of T2D management in a clinical setting, based on the latest evidence. This differs from the intervention modules, which focus on the interpretation and application of digital technology and the Ambulatory Glucose Profile (AGP).
- An email will be used to share the PPT with the control group participants
- Participants will be asked to complete the pre-recorded PowerPoint (PPT) presentation.
- The PowerPoint presentation will include interactive features, specifically short quizzes at the end of each module, designed to reinforce learning and confirm understanding.
- Participants will not have access to the e-learning intervention through the Canvas Catalog.
- Participants will be given a three-week window to complete the modules. The estimated duration of the pre-recorded educational content is a total of 3 hours over three weeks.
- Adherence will be monitored by completion of the end-of-module quizzes and a post-module survey, which will confirm engagement with the content.
Participants will be asked to attend a two-hour online (ZOOM) simulation clinical exam scheduled between week 3 and week 6 post-module completion.

•Participants will be given a three-week window to complete the modules. The estimated duration of the pre-recorded educational content is a total of 3 hours over three weeks.
•participants will be asked to attend a two-hour online (ZOOM) simulation clinical exam scheduled between week 3 and week 6 post-module completion.
Control group
Active

Outcomes
Primary outcome [1] 342633 0
Impact of an educational e-Learning module for Type 2 Diabetes (T2D) smart technology on diabetes care.
Timepoint [1] 342633 0
Measured at baseline, immediately post-intervention (week 3), and during the follow-up clinical simulation exam (week 6).
Secondary outcome [1] 451612 0
Change in knowledge regarding the use of smart technology for the management of type 2 diabetes,
Timepoint [1] 451612 0
Baseline and 3 weeks after completion of the allocated education module.
Secondary outcome [2] 451619 0
Change in confidence regarding the use of smart technology for the management of Type 2 Diabetes
Timepoint [2] 451619 0
Baseline and 3 weeks after completion of allocated education module
Secondary outcome [3] 452463 0
Change in engagement level with the e-Learning module.
Timepoint [3] 452463 0
Baseline and 3 weeks after completion of the allocated education module.

Eligibility
Key inclusion criteria
• Participant must be registered GP, AHP (such as diabetes educators), and RNs.
• Treating and/or managing patients with T2DM.
• Participants must be registered with the Australian Health Professionals Regulatory Agency in order to be considered for eligibility.
• Access to a desktop, laptop computer or tablet with an internet connection.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
•Having completed digital technology training in T2D in the last 2 years.
• Unwilling to use a PC / tablet in order to complete the online training.
• Unwilling to complete the survey or 2hr virtual examination.
• Currently engaged in another research project (to prevent concurrent participation in multiple studies, minimising the potential for interference that may compromise the integrity of the results).
• Participants who include in feasibility and acceptability study will be exclude from Pilot RCT phase.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be rigorously maintained through a single-blinding technique. Participants will remain unaware of whether they are assigned to receive the prerecorded module presentation or the e-Learning module on platform. To achieve this, we will utilise a central allocation w computer software programme with controlled randomisation, overseen by an independent statistician. Only the CI will possess knowledge of the participants' group assignments. The e-Learning module interventions will be delivered through the CANVAS platform, and pre-coded PowerPoint presentations will be sent via email. These measures minimise bias resulting from any participant's knowledge of the assigned interventions and ensure the blinding of outcome assessment while controlling exposure time. Participants will initiate the e-Learning module interventions simultaneously over a 3-week period, followed by a follow-up virtual simulation clinical exam during weeks 4 to 6 after module completion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To ensure an unbiased sequence generation, we will employ the computer-based random number generator. This tool will utilise a block randomisation technique (blocks sequence generation, blocks of 8) using a 1:1 ratio, generating two sets of 36 unique, sorted numbers within the range of 1 to 2. In this context, '1' will correspond to allocation in the control group, while '2' signifies allocation in the intervention group. This method guarantees equal opportunities for all participants in group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/06/2025
Date of last participant enrolment
Anticipated
20/11/2025
Actual
Date of last data collection
Anticipated
16/12/2025
Actual
Sample size
Target
32
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319821 0
University
Name [1] 319821 0
Hail University - PhD scholarship'
Country [1] 319821 0
Saudi Arabia
Primary sponsor type
University
Name
the University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 322343 0
None
Name [1] 322343 0
NA
Address [1] 322343 0
Country [1] 322343 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318382 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 318382 0
Ethics committee country [1] 318382 0
Australia
Date submitted for ethics approval [1] 318382 0
10/04/2023
Approval date [1] 318382 0
30/11/2023
Ethics approval number [1] 318382 0
H-2023-0308

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

Contacts
Principal investigator
Name 144006 0
Ms Maha Mouidh A Alanazi
Address 144006 0
University of Newcastle, 10 Chittaway Rd, Ourimbah NSW 2258
Country 144006 0
Australia
Phone 144006 0
+61 243484507
Fax 144006 0
Email 144006 0
[email protected]
Contact person for public queries
Name 144007 0
Maha Mouidh A Alanazi
Address 144007 0
University of Newcastle, 10 Chittaway Rd, Ourimbah NSW 2258
Country 144007 0
Australia
Phone 144007 0
+61 243484507
Fax 144007 0
Email 144007 0
[email protected]
Contact person for scientific queries
Name 144008 0
Maha Mouidh A Alanazi
Address 144008 0
University of Newcastle, 10 Chittaway Rd, Ourimbah NSW 2258
Country 144008 0
Australia
Phone 144008 0
+61 243484507
Fax 144008 0
Email 144008 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Studies exploring new research questions
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Maha Mouidh A Alanazi
[email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: The datasets used and/or analyzed during the current study are available from the researcher
on reasonable request.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected] protocol Pilot Randomised Controlled Trial Protocol.docx


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ProtocolNo [email protected] Pilot Randomised Controlled Trial Protocol.docx

Documents added automatically
No additional documents have been identified.