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Trial registered on ANZCTR


Registration number
ACTRN12623000955617
Ethics application status
Approved
Date submitted
14/07/2023
Date registered
4/09/2023
Date last updated
5/10/2024
Date data sharing statement initially provided
4/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An innovative care model using continuous glucose monitoring metric data to provide real-time personalised care for children with diabetes.
Scientific title
An innovative care model using continuous glucose monitoring metric data to provide real-time personalised care for children with diabetes: effect on glycaemic metrics, treatment satisfaction and economic outcomes.
Secondary ID [1] 309372 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 329590 0
Condition category
Condition code
Metabolic and Endocrine 326517 326517 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited from two age-matched clinical cohorts that attend Diabetes Outpatient Clinics at Perth Children's Hospital on different days.
All participants who attend their outpatient clinic on one day will be allocated to the participant group, those who attend on the alternate day will be allocated to control.
The allocation of clinic groups to intervention or control will be done randomly.
Participants will use their existing continuous glucose monitor (CGM) and their report will be reviewed every fortnight by the principal investigator (doctor) to identify "flags" of adverse blood glucose control.
CGM data is accessed by clinicians logging onto device specific platforms where data is stored on a "cloud", access to this data is granted by families, who link their devices to the clinic account.
Flags will be percentage time in range (3.9-10.0mmol/L) <50%, reduction in time in range >10%, percentage time below range (<3.9mmol/L) >4% and CGM percentage use <75%. Participants with one or more flags of adverse blood glucose control will be contacted via text message to offer a phone call from the study diabetes nurse educator or an email with educational resources provided.
Text messages will be sent from a study specific mobile phone through WhatsApp messaging application. This application allows confirmation when messages are received and read and is secure with end to end encryption.
For participants who request contact the diabetes nurse educator will review the CGM upload for the fortnight to identify glucose patterns.
If the participant requests a phone call the educator will call the participant to provide diabetes management advice based on their upload review (time up to 20minutes).
If the participant requests an email, a link to relevant education material from the Children's Diabetes Centre website will be provided (1-2 page document taking approximately 5 minutes to review).
Participants who are identified to have positive glucose control including percentage time in range >70%, increase in time in range >10% will receive positive feedback via a text message.
The intervention will repeat every two weeks over a six month period. Participants have the opportunity to opt out of contact from the team, this will be recorded. The intervention will occur in addition to the participants usual diabetes care.
Intervention code [1] 325806 0
Treatment: Other
Intervention code [2] 326588 0
Treatment: Devices
Comparator / control treatment
Usual care.
The control group will attend multidisciplinary outpatient appointments (doctor, diabetes educator, dietician, social worker) every 3 months and will have access to 24/7 phone support of medical and nurse educator teams for diabetes management adjustment and emergency support. In this instance, The parent or caregiver can choose to contact the diabetes team if they identify they need support.
The difference in care between intervention and control group is that the intervention group will be contacted if they meet pre-defined flags on CGM review whereas the control group will not have their CGM reviewed or be called between clinics unless they contact the diabetes team for review or support.
Control group
Active

Outcomes
Primary outcome [1] 334360 0
Continuous glucose monitoring percentage time in range 3.9-10.0mmol/L
Timepoint [1] 334360 0
Baseline, 3 months and 6 months post intervention commencement
Secondary outcome [1] 420377 0
HbA1c via point of care fingerprick blood test
Timepoint [1] 420377 0
Baseline, 3 months and 6 months post intervention commencement
Secondary outcome [2] 420378 0
CGM Percentage time below range <3.9mmol/L
Timepoint [2] 420378 0
Baseline, 3 months and 6 months post intervention commencement
Secondary outcome [3] 420379 0
Diabetes Treatment Satisfaction Questionnaire
Timepoint [3] 420379 0
Baseline and 6 Months post-intervention commencement
Secondary outcome [4] 420380 0
Type 1 Diabetes and Life Questionnaire (Diabetes related Quality of Life)
Timepoint [4] 420380 0
Baseline and 6 Months post-intervention commencement
Secondary outcome [5] 420384 0
Participant and family experiences will be explored as a composite secondary outcome with semi-structured interviews for a subset of participants
Timepoint [5] 420384 0
6 months post intervention commencement
Secondary outcome [6] 422874 0
Health economics - questionnaire recording hours of school or work time lost and instances of health provider use in the previous 6 months
Timepoint [6] 422874 0
Baseline and 6 months post intervention commencement
Secondary outcome [7] 424752 0
CGM use expressed as a percentage of time worn over a 14 day period.
CGM data is accessed by clinicians logging onto device specific platforms where data is stored on a "cloud", access to this data is granted by families, who link their devices to the clinic account.
Percentage time worn over a 14 days period is a standard metric recorded as part of a CGM report
Timepoint [7] 424752 0
Baseline, 3 months and 6 months post intervention commencement
Secondary outcome [8] 424753 0
CGM time below range <3.0mmol/L
CGM data is accessed by clinicians logging onto device specific platforms where data is stored on a "cloud", access to this data is granted by families, who link their devices to the clinic account.
Percentage time <3.0mmol/L over a 14 days period is a standard metric recorded as part of a CGM report
Timepoint [8] 424753 0
Baseline, 3 months and 6 months post intervention commencement
Secondary outcome [9] 424754 0
Clinician time - time spent on CGM review
Will be recorded on a fortnightly basis in a study-specific password protected electronic spreadsheet
Timepoint [9] 424754 0
Collected on a fortnightly basis from commencement of intervention to completion of 6 months post intervention commencement.
Secondary outcome [10] 424755 0
Clinician time - time spent on patient contact
Will be recorded on a fortnightly basis in a study-specific password protected electronic spreadsheet
Timepoint [10] 424755 0
Collected on a fortnightly basis from commencement of intervention to completion of 6 months post intervention commencement.
Secondary outcome [11] 424756 0
Number of participants contacted each fortnight
Will be recorded on a fortnightly basis in a study-specific password protected electronic spreadsheet
Timepoint [11] 424756 0
Collected on a fortnightly basis from commencement of intervention to completion of 6 months post intervention commencement.
Secondary outcome [12] 424757 0
Health related QALYs through validated tool: Child Health Utility-9D (CHU-9D) CHU9D - Measuring health and calculating QALYs for children and adolescents
Timepoint [12] 424757 0
Baseline and 6 months post intervention commencement

Eligibility
Key inclusion criteria
Children aged 5-14 years and their parents or primary caregivers
CGM use greater than or equal to 75% of the time in the 2-week period leading up to study start
Insulin administration via multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)
Minimum age
5 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children not using CGM

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 not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Entire clinic patient groups will be allocated either intervention clinic or control clinic based on a coin flip
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
No randomisation of individual participants. Participiants will be allocated to control or intervention group based on which clinic they attend at Perth Children's Hospital
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A difference-in-difference analysis will be conducted using a mixed model framework to analyse the primary outcome. The model will include main effects for time (baseline, end of study), group (intervention, control) and an interaction term for time x group, and a random intercept for individual. The treatment effect will be estimated based on the interaction term. The difference-in-difference approach is preferred over ANCOVA in non-equivalent group designs as it is less prone to bias where there are imbalances at baseline due to the non-random allocation of participants. Tests will be two-sided and a p value < 0.05 will be considered statistically significant. Secondary outcomes will be analysed using a similar approach outlined above, or non-parametric comparisons of change scores where assumptions for parametric modelling are not met.

Semi-structured interviews will be transcribed and imported into qualitative data management software NVivo (QRS International Pty Ltd, 2014) for management, retrieval, and interrogation. Qualitative data collected during this study will be analysed using Reflexive Thematic Analysis. All qualitative data will be analysed inductively to develop themes and the processes will be audited. Analysis will be conducted according to Braun and Clarke’s six phases of reflexive thematic analyses: Familiarisation with the data; Coding; Generating initial themes; Reviewing themes; Defining and naming themes; and Writing up.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/10/2023
Actual
10/11/2023
Date of last participant enrolment
Anticipated
15/01/2024
Actual
26/05/2024
Date of last data collection
Anticipated
26/11/2024
Actual
Sample size
Target
180
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 24456 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 40038 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 313568 0
Government body
Name [1] 313568 0
WA Government Research Excellence Award (REA) awarded to Professor Elizabeth Davis
Country [1] 313568 0
Australia
Primary sponsor type
Hospital
Name
Child and Adolescent Health Service
Address
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS WA 6009
Country
Australia
Secondary sponsor category [1] 315352 0
None
Name [1] 315352 0
Address [1] 315352 0
Country [1] 315352 0
Other collaborator category [1] 282610 0
Hospital
Name [1] 282610 0
Telethon Kids Institute
Address [1] 282610 0
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS WA 6009
Country [1] 282610 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312749 0
Child and Adolescent Health Service HREC (EC00268)
Ethics committee address [1] 312749 0
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS WA 6009
Ethics committee country [1] 312749 0
Australia
Date submitted for ethics approval [1] 312749 0
17/10/2022
Approval date [1] 312749 0
23/03/2023
Ethics approval number [1] 312749 0
RGS0000005749

Summary
Brief summary
Currently we are not meeting glycaemic targets using standard care models. This provides the opportunity to review models of care to maximise outcomes. The use of continuous glucose monitor (CGM) data to detect changes in glycaemic control provides an opportunity to adapt our model of care to deliver more personalised and targeted care for young people with diabetes. This trial will test a new model of care, aiming to use CGM data to detect early adverse changes in glycaemic control and provide targeted and tailored intervention to those individuals needing more intensive support.

Aim:
This study aims to investigate if using fortnightly review CGM for early identification of adverse markers in glycaemic control, with implementation of targeted intervention improves glycaemic outcomes and patient reported outcomes in children living with diabetes compared to those receiving care using the current standard model of care.

Objectives:
1) To investigate if targeted intervention based on adverse glycaemic control on CGM metrics improves glycaemic control compared to standard models of care
2) To investigate if patient and family reported satisfaction and outcomes are improved with targeted intervention based on CGM metrics
3) To conduct cost-benefit analysis of targeted intervention compared to standard models of care
4) To conduct post study consultation with consumers and health care professionals for feedback on the study and relevant comments on next stages of digital dashboard development

Hypothesis:
1. Using fortnightly review of digital CGM upload for early identification of adverse changes in glycaemic control with targeted personalised clinical intervention can improve overall glycaemic control and patient and family satisfaction compared to 3-monthly review at multidisciplinary appointments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125766 0
Dr Frances Gehrmann
Address 125766 0
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS
WA 6009
Country 125766 0
Australia
Phone 125766 0
+61864568532
Fax 125766 0
Email 125766 0
[email protected]
Contact person for public queries
Name 125767 0
Frances Gehrmann
Address 125767 0
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS
WA 6009
Country 125767 0
Australia
Phone 125767 0
+61864562222
Fax 125767 0
Email 125767 0
[email protected]
Contact person for scientific queries
Name 125768 0
Frances Gehrmann
Address 125768 0
Perth Children's Hospital
15 Hospital Avenue
NEDLANDS
WA 6009
Country 125768 0
Australia
Phone 125768 0
+61864568532
Fax 125768 0
Email 125768 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?

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.