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Trial registered on ANZCTR


Registration number
ACTRN12624001050549
Ethics application status
Approved
Date submitted
16/08/2024
Date registered
29/08/2024
Date last updated
5/10/2024
Date data sharing statement initially provided
29/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating Early Initiation of Hybrid Closed Loop Therapy in Newly Diagnosed Type 1 Diabetes
Scientific title
Evaluating Early Initiation of Advanced Hybrid Closed Loop Therapy in Children and Adolescents with a New Diagnosis of Type 1 Diabetes
Secondary ID [1] 312568 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 334471 0
Condition category
Condition code
Metabolic and Endocrine 331089 331089 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational evaluation will assess whether a new model of care, where all patients diagnosed with Type 1 diabetes (T1D) are given access to Hybrid Closed Loop (HCL) therapy within the first 12 weeks post-diagnosis, is associated with improved glycaemic outcomes. All patients diagnosed between the 31st of May 2024 and the 31st of May 2025 will be included in the new model of care, regardless of their participation in this evaluation. The glycaemic data, including HbA1c, time in range from their continuous glucose monitor (CGM) and time spent in closed loop therapy, of all newly diagnosed patients will be retrieved from the Western Australian Children's Diabetes Database (WACDD), a clinical database used at Perth Children's Hospital. If willing, participants will also be asked to complete online questionnaires sent by members of the research team at baseline, 12 months and 24 months post-diagnosis of Type 1 diabetes (T1D), which will investigate diabetes-related burden, treatment satisfaction and psychosocial wellbeing within the first 2 years post-diagnosis of T1D.

The following questionnaires will be used in this evaluation:
- Health Resource Use Questionnaire [estimated 5-10 minutes]
- Generalised Anxiety Disorder 7 (GAD-7) - Parent and Child over 7 years [estimated 2 minutes each]
- Pittsburgh Sleep Quality Index (PSQI) - Parent and Child over 12 years [estimated 5-10 minutes each]
- Child Health Utility 9D (CHU-9D) - Child over 7 years (Parent proxy for children <7y.o.) [estimated 3 minutes]
- Diabetes Treatment Acceptance and Satisfaction Questionnaire - Parent and Children over 12 years [estimated 5-10 minutes each]
- Hypoglycaemia Fear Survey (only at 12- and 24-month timepoints) [estimated 10 minutes]
- Diabetes Treatment Acceptance and Satisfaction Questionnaire Change - Parent and Children over 12 years (only 12 months post-insulin pump start, if the child began pump therapy) [estimated 5-10 minutes each]

Estimated total time spent on the surveys: 30-60 minutes per time point (90-180 minutes over the two-year period).
Intervention code [1] 329082 0
Not applicable
Comparator / control treatment
Glycaemic outcomes in the prospective cohort will be compared with the historical cohort, which is defined as all newly diagnosed patients from the 1st of April 2022 to the 31st of March 2023. These dates are prior to the change in model of care, but recent enough where glycaemic outcomes would not be affected by technological advances with regards to new or improved HCL systems.
Glycaemic and clinical data from both cohorts will be collected up to the first two years post-diagnosis of T1D.
Control group
Historical

Outcomes
Primary outcome [1] 338860 0
Glycated Haemoglobin (HbA1c)
Timepoint [1] 338860 0
Every 3 months within the first 2 years post-diagnosis of Type 1 diabetes
Secondary outcome [1] 437700 0
Glycaemic outcomes
Timepoint [1] 437700 0
Every 3 months within the first 2 years post-diagnosis of Type 1 diabetes
Secondary outcome [2] 437701 0
Quality of Life
Timepoint [2] 437701 0
At insulin pump start (or 120 days post-diagnosis of Type 1 diabetes, whichever occurs first), and at 12- and 24-months post-diagnosis
Secondary outcome [3] 437702 0
Insulin delivery requirements
Timepoint [3] 437702 0
Every 3 months within the first 2 years post-diagnosis of Type 1 diabetes
Secondary outcome [4] 437703 0
Anthropometrics
Timepoint [4] 437703 0
Every 3 months within the first 2 years post-diagnosis of Type 1 diabetes
Secondary outcome [5] 437704 0
Anxiety
Timepoint [5] 437704 0
At insulin pump start (or 120 days post-diagnosis of Type 1 diabetes, whichever occurs first), and at 12- and 24-months post-diagnosis
Secondary outcome [6] 437705 0
Sleep Quality
Timepoint [6] 437705 0
At insulin pump start (or 120 days post-diagnosis of Type 1 diabetes, whichever occurs first), and at 12- and 24-months post-diagnosis
Secondary outcome [7] 437706 0
Diabetes Treatment Satisfaction
Timepoint [7] 437706 0
At insulin pump start (or 120 days post-diagnosis of Type 1 diabetes, whichever occurs first), and at 12- and 24-months post-diagnosis
Secondary outcome [8] 437707 0
Fear of Hypoglycaemia
Timepoint [8] 437707 0
At 12- and 24-months post-diagnosis of Type 1 diabetes
Secondary outcome [9] 437708 0
Quality of Life
Timepoint [9] 437708 0
At 12- and 24-months post-diagnosis of Type 1 diabetes
Secondary outcome [10] 437709 0
Quality of Life
Timepoint [10] 437709 0
At 12- and 24-months post-diagnosis of Type 1 diabetes
Secondary outcome [11] 437771 0
Uptake in Hybrid Closed Loop therapy
Timepoint [11] 437771 0
Every 3 months up to 2 years post-diagnosis of Type 1 diabetes
Secondary outcome [12] 437772 0
Significant clinical events (number of severe hypoglycaemic episodes, number of diabetic ketoacidosis (DKA) events)
Timepoint [12] 437772 0
Every 3 months within the first 2 years post-diagnosis of Type 1 diabetes

Eligibility
Key inclusion criteria
1. New Diagnosis of T1D between 31st May 2024 and 31st May 2025.
2. Age 1-17.99 years.
3. Willing to complete study questionnaires.
Minimum age
1 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age <1 year old (no TGA-approved HCL system for this age group).
2. Unwillingness to complete study questionnaires.
3. Does not have at least one caregiver that can read and write English for instruments that are not available in translated versions

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Descriptive statistics (mean/SD, median/IQR, or frequency/% as appropriate) will be presented for key demographic and clinical measures. The 24-month HbA1c in the contemporary cohort will be compared to the historical control through multivariable regression model adjusting for potential imbalances in clinical/sociodemographic characteristics. The adjusted mean difference along with 95% confidence intervals will be calculated. A sensitivity analysis using an inverse probability of treatment weighted regression based on propensity score will also be conducted.
Interim analyses employing similar models examining HbA1c difference between the cohorts at 6 and 12 months will be conducted. Further exploratory analyses presenting mean HbA1c over various clinical factors (e.g. urban/remote postcode/SEIFA, insurance status, age at diagnosis, timing of HCL commencement, etc) will also be conducted. Subanalysis reviewing mean HbA1c on those commencing on AHCL within 12 weeks from diagnosis will similarly be examined.
Device uptake and attrition will be presented as frequencies and proportions along with 95% confidence intervals. Bivariate predictors of device use at uptake will be presented through simple contingency tables of device use by clinical and sociodemographic factors (Age group (=12 years, >12 years), gender, socioeconomic indices for areas quintile (lowest quintile, other 4 quintiles), DKA at diagnosis.
Simple descriptive statistics (mean/SD, median/IQR, or frequency/%) will be presented for CGM metrics and psychosocial measures at each of the follow-up points for the contemporary cohort. Where appropriate, mixed models or non-parametric Friedman tests will be conducted to assess within person change over time.
Final analysis will occur after the final study participant has completed the 24-month data collection, however interim analyses will occur approximately 6 monthly from initial pump start in the contemporary cohort.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/07/2024
Date of last participant enrolment
Anticipated
31/05/2025
Actual
Date of last data collection
Anticipated
31/05/2027
Actual
Sample size
Target
120
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26819 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 42869 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 316995 0
Government body
Name [1] 316995 0
The State of Western Australia acting through the Department of Health
Country [1] 316995 0
Australia
Funding source category [2] 316996 0
Charities/Societies/Foundations
Name [2] 316996 0
Channel 7 Telethon Trust
Country [2] 316996 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Country
Australia
Secondary sponsor category [1] 319244 0
Hospital
Name [1] 319244 0
Perth Children's Hospital
Address [1] 319244 0
Country [1] 319244 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315751 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 315751 0
https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
Ethics committee country [1] 315751 0
Australia
Date submitted for ethics approval [1] 315751 0
25/03/2024
Approval date [1] 315751 0
16/04/2024
Ethics approval number [1] 315751 0
RGS0000006605

Summary
Brief summary
Automated insulin delivery via an advanced hybrid closed loop (AHCL) system is accepted as the most effective management strategy, proven in clinical trials and real-world studies, wherein a continuous glucose monitor (CGM) provides glucose information to an insulin pump which can then adjust insulin delivery via an algorithm (housed in an application or in the pump). Due to the established glycaemic benefits, access to AHCL therapy is recommended for all children with T1D according to the latest international guidelines.
However, despite national subsidy for CGM, AHCL access in Australia is limited as insulin pumps are primarily self-funded or accessed via health insurance funds or philanthropic programs. This has led to significant inequity in accessing AHCL.
The Department of Endocrinology and Diabetes at Perth Children’s Hospital is implementing a new clinical model of care that will provide early access to AHCL to all children with a new diagnosis of T1D. This study aims to evaluate the impact of the new model of care through a combination of routinely collected clinical information and prospectively collected survey data. The overall objective is to comprehensively evaluate a model of care providing early access to AHCL following diagnosis of T1D.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135694 0
Dr Kate Lomax
Address 135694 0
Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave, Nedlands, WA 6009
Country 135694 0
Australia
Phone 135694 0
+61 08 6456 8287
Fax 135694 0
Email 135694 0
[email protected]
Contact person for public queries
Name 135695 0
Kate Lomax
Address 135695 0
Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave, Nedlands, WA 6009
Country 135695 0
Australia
Phone 135695 0
+61 08 6456 8287
Fax 135695 0
Email 135695 0
[email protected]
Contact person for scientific queries
Name 135696 0
Kate Lomax
Address 135696 0
Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave, Nedlands, WA 6009
Country 135696 0
Australia
Phone 135696 0
+61 08 6456 8287
Fax 135696 0
Email 135696 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.