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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
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Scientific title
Evaluating Early Initiation of Advanced Hybrid Closed Loop Therapy in Children and Adolescents with a New Diagnosis of Type 1 Diabetes
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Secondary ID [1]
312568
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes
334471
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Condition category
Condition code
Metabolic and Endocrine
331089
331089
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0
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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).
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Intervention code [1]
329082
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Not applicable
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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.
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Control group
Historical
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Outcomes
Primary outcome [1]
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Glycated Haemoglobin (HbA1c)
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Assessment method [1]
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DCA Vantage HbA1c analyser (clinically collected), as a %
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Timepoint [1]
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Every 3 months within the first 2 years post-diagnosis of Type 1 diabetes
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Secondary outcome [1]
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Glycaemic outcomes
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Assessment method [1]
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Using continuous glucose monitoring (CGM) metrics (time in range (3.9-10.0 mmol/L), time below range (<3.9 mmol/L), time in tight range (3.9-7.8 mmol/L), time above range (>10.0 mmol/L)), as %s (clinically collected)
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Timepoint [1]
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Every 3 months within the first 2 years post-diagnosis of Type 1 diabetes
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Secondary outcome [2]
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Quality of Life
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Assessment method [2]
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Child Health Utility-9D (CHU-9D) Questionnaire
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Timepoint [2]
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At insulin pump start (or 120 days post-diagnosis of Type 1 diabetes, whichever occurs first), and at 12- and 24-months post-diagnosis
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Secondary outcome [3]
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Insulin delivery requirements
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Assessment method [3]
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Total Daily Dose (TDD) and total basal units, in International Units (U) (clinically collected, provided by their clinical records and/or insulin pump device history).
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Timepoint [3]
437702
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Every 3 months within the first 2 years post-diagnosis of Type 1 diabetes
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Secondary outcome [4]
437703
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Anthropometrics
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Assessment method [4]
437703
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Height, Weight, calculated BMI (clinically collected)
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Timepoint [4]
437703
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Every 3 months within the first 2 years post-diagnosis of Type 1 diabetes
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Secondary outcome [5]
437704
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Anxiety
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Assessment method [5]
437704
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Generalised Anxiety Disorder Questionnaire (GAD-7)
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Timepoint [5]
437704
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At insulin pump start (or 120 days post-diagnosis of Type 1 diabetes, whichever occurs first), and at 12- and 24-months post-diagnosis
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Secondary outcome [6]
437705
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Sleep Quality
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Assessment method [6]
437705
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Pittsburgh Sleep Quality Index (PSQI) Questionnaire
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Timepoint [6]
437705
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At insulin pump start (or 120 days post-diagnosis of Type 1 diabetes, whichever occurs first), and at 12- and 24-months post-diagnosis
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Secondary outcome [7]
437706
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Diabetes Treatment Satisfaction
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Assessment method [7]
437706
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Diabetes Treatment Satisfaction Questionnaire (DTSQ)
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Timepoint [7]
437706
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At insulin pump start (or 120 days post-diagnosis of Type 1 diabetes, whichever occurs first), and at 12- and 24-months post-diagnosis
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Secondary outcome [8]
437707
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Fear of Hypoglycaemia
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Assessment method [8]
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Hypoglycaemia Fear Survey (HFS)
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Timepoint [8]
437707
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At 12- and 24-months post-diagnosis of Type 1 diabetes
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Secondary outcome [9]
437708
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Quality of Life
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Assessment method [9]
437708
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Type 1 Diabetes and Life (T1DAL) Questionnaire (clincally collected)
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Timepoint [9]
437708
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At 12- and 24-months post-diagnosis of Type 1 diabetes
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Secondary outcome [10]
437709
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Quality of Life
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Assessment method [10]
437709
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Problem Areas in Diabetes (PAID) Questionnaire (clinically collected)
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Timepoint [10]
437709
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At 12- and 24-months post-diagnosis of Type 1 diabetes
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Secondary outcome [11]
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Uptake in Hybrid Closed Loop therapy
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Assessment method [11]
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Number of patients that begin HCL therapy within the first two years post-diagnosis of Type 1 diabetes, as a % out of all newly diagnosed patients, provided by the Western Australian Children's Diabetes Database (WACDD).
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Timepoint [11]
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Every 3 months up to 2 years post-diagnosis of Type 1 diabetes
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Secondary outcome [12]
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Significant clinical events (number of severe hypoglycaemic episodes, number of diabetic ketoacidosis (DKA) events)
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Assessment method [12]
437772
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Patient self-reports to the Diabetes clinical team at Perth Children's Hospital (clinically collected)
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Timepoint [12]
437772
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Every 3 months within the first 2 years post-diagnosis of Type 1 diabetes
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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.
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Minimum age
1
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
Psychosocial
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Duration
Longitudinal
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Selection
Defined population
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Timing
Both
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
4/07/2024
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Date of last participant enrolment
Anticipated
31/05/2025
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Actual
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Date of last data collection
Anticipated
31/05/2027
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Actual
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Sample size
Target
120
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Accrual to date
8
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
26819
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Perth Children's Hospital - Nedlands
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Recruitment postcode(s) [1]
42869
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
316995
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Government body
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Name [1]
316995
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The State of Western Australia acting through the Department of Health
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Address [1]
316995
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Country [1]
316995
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Australia
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Funding source category [2]
316996
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Charities/Societies/Foundations
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Name [2]
316996
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Channel 7 Telethon Trust
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Address [2]
316996
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Country [2]
316996
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Australia
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Primary sponsor type
Other
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Name
Telethon Kids Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
319244
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Hospital
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Name [1]
319244
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Perth Children's Hospital
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Address [1]
319244
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Country [1]
319244
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315751
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Child and Adolescent Health Service Human Research Ethics Committee
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Ethics committee address [1]
315751
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https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
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Ethics committee country [1]
315751
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Australia
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Date submitted for ethics approval [1]
315751
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25/03/2024
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Approval date [1]
315751
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16/04/2024
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Ethics approval number [1]
315751
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RGS0000006605
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Kate Lomax
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Address
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Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave, Nedlands, WA 6009
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Country
135694
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Australia
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Phone
135694
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+61 08 6456 8287
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Fax
135694
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Email
135694
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[email protected]
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Contact person for public queries
Name
135695
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Kate Lomax
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Address
135695
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Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave, Nedlands, WA 6009
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Country
135695
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Australia
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Phone
135695
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+61 08 6456 8287
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Fax
135695
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Email
135695
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[email protected]
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Contact person for scientific queries
Name
135696
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Kate Lomax
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Address
135696
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Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave, Nedlands, WA 6009
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Country
135696
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Australia
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Phone
135696
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+61 08 6456 8287
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Fax
135696
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Email
135696
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
Download to PDF