None listed
Conditions
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.
Interventions
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
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).
Sponsors
The Kids Research Institute Australia
Eligibility
Sex/Gender
All
Age
1 Years to 17 Years
Healthy volunteers
No
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.
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
Outcome results
None listed