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Trial registered on ANZCTR


Registration number
ACTRN12623000395639p
Ethics application status
Submitted, not yet approved
Date submitted
14/02/2023
Date registered
19/04/2023
Date last updated
19/04/2023
Date data sharing statement initially provided
19/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study Evaluating Continuous Glucose Monitoring (CGM)-User Education for Type 1 Diabetes
Scientific title
A Pilot Study Evaluating an Education Module Empowering People Living with Type 1 Diabetes to Understand their Continuous Glucose Monitoring Data: The Making Sense Program
Secondary ID [1] 308973 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 328986 0
Condition category
Condition code
Metabolic and Endocrine 325969 325969 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The education intervention, ‘The Making Sense Program’ was designed based on and in the light of ongoing input by people living with diabetes and an expert reference group consisting of endocrinologists, diabetes educators, industry, dieticians, psychologists, community engagement and education specialists. The education intervention will be conducted over a period of two weeks. Participants will attend in groups of approximately eight. It will be implemented as a combination of teleconferencing, on-line, and face-to face sessions. The time required to implement each stage of the education intervention will be recorded. A facilitator training day will be delivered by a registered nurse-credentialled diabetes educator and Diabetes Victoria, and will occur 1-2 weeks prior to the introductory group session. The facilitator training day will provide orientation to the program and will cover the objectives of the education modules.
There are three stages to the education intervention, detailed below. Once completing stage 1, participants will immediately move to stage 2. Stage 3 will commence two weeks after stage 2. Attendance to stage 1 and 3 will be recorded, and completion of stage 2 will be monitored through registration via the online platform.
Stage 1: All participants have had a 90-minute introductory group session where they will be provided with an overview of the program. The virtual group session will be facilitated by a peer (a person living with type 1 diabetes (T1D) experienced in the use of technology who has undertaken the facilitator training day). The peer facilitator is supported by a registered nurse-credentialled diabetes educator (RN-CDE) who has also participated in the facilitator training day. During this session participants will meet one another and have an opportunity to identify their expectations for the program. They will also be provided with instructions on how to move through the program including the on-line education modules.
Stage 2: The three training modules are hosted on a web-based platform. (EdApp [edapp.com]) which provides flexibility and may be completed at the person’s convenience. The platform can be accessed from a desktop or laptop computer, smartphone, or tablet. People may leave a module and return to it later. The training modules are:
(i) Making the most of glucose monitoring technology (CGM and Flash): An Introduction
(ii) Making the most of glucose monitoring technology (CGM and Flash): Interpreting your Data
(iii) Making the most of glucose monitoring technology (CGM and Flash): An Introduction to Insulin Pumps and Hybrid Closed Loop Systems
Modules 1 and 3 may be optional as determined by the study team. Module 1 provides basic information that the experienced device user may be already familiar with. Module 2 provides core information and is to be completed by all participants. Module 3 can only be attempted after completing Module 2 and will not be applicable to those participants using multiple daily injections (MDI).
Each module comprises a series of lessons and a ‘Briefcase’ feature with supporting material. The ‘Briefcase’ has been specifically designed for this study.
The lessons within each module are to be completed sequentially. Apart from the first lesson, each subsequent lesson can only be attempted after an earlier lesson is completed. Each lesson starts with a title page and then a dot point summary of the information to be covered by the lesson. There are videos embedded within each lesson expanding on specific points. There are also quiz questions during each lesson whose sole purpose is to reinforce important study points and they will not be used to determine a “pass” or “fail”. At the end of each quiz question, the person will be provided with a “correct” or a “not quite” message and reinforcing information will then be provided. Upon completion, a lesson can be repeated, or the person can go on to the next lesson in the module.
The ’Briefcase’ feature contains a list of resources relevant to the module. These may take the form of written pdf documents, links to on-line resources, or further activities
Stage 3: It is anticipated that participants will complete the on-line module(s) within two weeks. After this time, they will attend a 4-hour group session (virtual or face-to-face). The group session will be facilitated by the same peer who led the introductory session, and they will be supported by the same RN-CDE. During the final group session, participants will have an opportunity to consolidate their online learning and to practice their new skills in interpreting data from their glucose sensing device. They will be encouraged to provide examples of their own CGM data though this will not be mandatory.
Intervention code [1] 325416 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333812 0
The proportion of the number of participants (n=62) who complete the study per-protocol. This will be assessed using data from the online education platform, and the study database.
Timepoint [1] 333812 0
Assessed at the conclusion of the study.
Secondary outcome [1] 418404 0
Process Outcomes: To assess the feasibility of those processes that will be key to the successful implementation of a definitive large randomized-control study aimed at evaluating the ‘Making Sense’ education program. This is a composite outcome that involves assessing the specific outcomes listed below. Upon completion of the study, teams at the study sites will be interviewed to elicit their input about matters for improvement regarding study processes which will include:
(i) Clarity and suitability of the eligibility criteria
(ii) Recruitment rates
(iii) Retention rates
(iv) Proportion of participants who successfully complete the education program.
(v) A better understanding of data collection tools and outcomes including unanticipated responses
This will be assessed using data from the study database and adherence to the education module.
Timepoint [1] 418404 0
Assessed at the conclusion of the study.
Secondary outcome [2] 418405 0
Resource Outcomes: To assess resources that will be required for the conduct of the study. This is a composite secondary outcome that will assess the specific outcomes listed below. In addition, at the end of the study staff will be interviewed to elicit their input about matters for improvement regarding study resourcing.
(i) Determining the time taken for each study site visit
(ii) Determining the time taken to implement the education program (Stage 1 and Stage 3 group sessions as well as time spent by participants on the on-line modules [Stage 2]).
(iii) Determining qualification and capacity issues regarding human resources (lived experience and RN-CDE) available to implement the education program
(iv) Determining if the on-line platforms for Stages 1 and 2 of the education program perform as expected
This will be assessed through participant and study coordinator documentation of time taken for study visit and intervention, and through semi-structured interviews one-on-one interview with a member of the research team.
Timepoint [2] 418405 0
Assessed at the conclusion of the study
Secondary outcome [3] 418406 0
Scientific Glycaemic Outcomes: This is a composite secondary outcome. CGM data collected over the final two weeks of the study will be examined according to standardised criteria described by Battelino et al. (14) CGM metrics for 24 h/day, day [06:00–00:00] and night [00:00–06:00],
(i) Proportion of time spent 3.9–10.0 mmol/L
(ii) Proportion of time spent <3.0 mmol/L
(iii) Proportion of time spent <3.9 mmol/L
(iv) Proportion of time spent >10.0 mmol/L
(v) Proportion of time spent >13.9 mmol/L
(vi) Glucose variability: coefficient of variation (CV)
(vii) Mean glucose (mmol/L)
(viii) HbA1c
Timepoint [3] 418406 0
Measured continuously over week 26-28 post-intervention commencement
Secondary outcome [4] 418407 0
Scientific Psychological Outcomes: This is a composite secondary outcome. Validated measures will be completed via a Qualtrics survey administered via an iPad. These will include:
(i) Perceived satisfaction with diabetes management experience (22-item DME-Q), which includes three subscales: perceived effectiveness, convenience, intrusiveness)
(ii) Diabetes-specific positive well-being (a 4-item scale from the W-BQ28)
(iii) User engagement with the education module (including interest, attention, flow)
(iv) Brief study-specific rating scales
(v) Problem Areas In Diabetes (PAID) questionnaire

Open-ended questions to explore the acceptability and feasibility of the education and participants’ recommendations for further refinements.
Timepoint [4] 418407 0
At 2 and 26 weeks post-intervention commencement.
Secondary outcome [5] 418408 0
Safety Outcomes: This is a composite secondary outcomes.
(i) Hospitalisations for diabetic ketoacidosis (n)
(ii) Severe hypoglycaemia (n) defined as requiring third party assistance.
(iii) Symptomatic hypoglycaemia (n)

This will be assessed from patient medical records, participant diaries and review of CGM data.
Timepoint [5] 418408 0
At 26 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
T1D (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus); Age >18Y; HbA1c <9.5%; Fluent in English; using carbohydrate counting; >3 months On MDI or insulin pump therapy (IPT) and safely operating a real time-continuous glucose monitor (RT-CGM) or intermittent scanning glucose monitor (ISGM) device; Willing and able to download and review device data; Living in an area with internet and cellular phone coverage; English speaking. Recruitment will be stratified approximately 1:1 MDI and IPT and at least 40% of all participants will be on either RT-CGM or ISGM. At least 10 days of CGM data between screening and the baseline visit.
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or planning pregnancy; Using open-source artificial pancreas system (so-called ‘do-it-yourself’ (DIY) technology); Use of any non-insulin glucose-lowering agent within the past 3 months; Oral or injected steroid use within the past 3 months; active significant nondiabetic illness impacting glucose management (e.g. coeliac disease, thyroid disease, myocardial ischaemia) or any severe or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the ability to meet protocol requirements.

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
Who is / are masked / blinded?



Intervention assignment
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
5/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313187 0
Other Collaborative groups
Name [1] 313187 0
Australian Centre for Accelerating Diabetes Innovations
Country [1] 313187 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
St Vincent's Hospital 41 Victoria Pde
Fitzroy 3065
Victoria
Country
Australia
Secondary sponsor category [1] 314898 0
None
Name [1] 314898 0
Address [1] 314898 0
Country [1] 314898 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312421 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 312421 0
Research Governance Unit

St Vincent's Hospital

PO Box 2900

Fitzroy VIC 3065
Ethics committee country [1] 312421 0
Australia
Date submitted for ethics approval [1] 312421 0
14/02/2023
Approval date [1] 312421 0
Ethics approval number [1] 312421 0

Summary
Brief summary
The main purpose of this research is to evaluate the feasibility of a two-week education module designed to inform individuals living with type 1 diabetes how to assess device generated data. This education module has been created by endocrinologists, diabetes educators, industry, dieticians, psychologists, community engagement and education specialists. The researchers will also evaluate participant’s satisfaction with the module and satisfaction in the management of their diabetes, as well as looking at their blood glucose control after the education module.
Involvement will last around 26-28 weeks and will involve 7 visits, and at least 4 of these visits will occur at the clinical trial site. Participants will be asked to wear a continuous glucose monitor, and a keep a study diary at specified times over the course of the trial.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124602 0
Prof David O'Neal
Address 124602 0
Department of Medicine and Department of Endocrinology St. Vincent’s Hospital
34 Victoria Parade, Fitzroy 3065
Victoria
Country 124602 0
Australia
Phone 124602 0
+61 03 9231 2574
Fax 124602 0
Email 124602 0
[email protected]
Contact person for public queries
Name 124603 0
Georgina Manos
Address 124603 0
Department of Medicine and Department of Endocrinology St. Vincent’s Hospital
35 Victoria Parade
Fitzroy 3065
Victoria
Country 124603 0
Australia
Phone 124603 0
+61 402644725
Fax 124603 0
Email 124603 0
[email protected]
Contact person for scientific queries
Name 124604 0
David O'Neal
Address 124604 0
Department of Medicine and Department of Endocrinology St. Vincent’s Hospital
34 Victoria Parade, Fitzroy 3065
Victoria
Country 124604 0
Australia
Phone 124604 0
+61 03 9231 2211
Fax 124604 0
Email 124604 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18339Study protocol    385386-(Uploaded-27-03-2023-17-12-52)-Study-related document.docx



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.