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Type 1 Diabetes National Screening Pilot: Monitoring Children with Early Stage Type 1 Diabetes

Type 1 Diabetes National Screening Pilot: Evaluating the Feasibility and Acceptability of Monitoring Children with Early Stage Type 1 Diabetes

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000470594
Enrollment
36
Registered
2024-04-16
Start date
2024-05-01
Completion date
2028-06-30
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Type 1 diabetes is a lifelong autoimmune condition characterised by high blood glucose levels. Children with early stage type 1 diabetes (defined as two or more (multiple) islet antibodies, Stage 1-2 type 1 diabetes) or at-risk of the condition (defined as a single antibody, pre-type 1 diabetes) require ongoing clinical monitoring for disease progression and to avoid life-threatening complications arising from late recognition of symptom onset and insulin requirement (i.e. Stage 3 type 1 diabetes). This study is a follow-on from The Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study. It aims to include up to 36 children with type 1 diabetes antibodies, detected via screening, to evaluate the feasibility and acceptability of the international clinical guidelines for ongoing monitoring of children with early stage- or pre- type 1 diabetes.

Interventions

Type 1 diabetes is a lifelong autoimmune condition. There are two very early stages of type 1 diabetes (stage 1 and stage 2) that arise when the autoimmune disease is triggered but symptoms are not yet present. These two pre symptomatic stages can be detected through screening for type 1 diabetes-specific autoantibodies. International clinical guidelines recommend monitoring children with early stage type 1 diabetes to detect progression to stage 3 and allow for timely commencement of insulin th

Type 1 diabetes is a lifelong autoimmune condition. There are two very early stages of type 1 diabetes (stage 1 and stage 2) that arise when the autoimmune disease is triggered but symptoms are not yet present. These two pre symptomatic stages can be detected through screening for type 1 diabetes-specific autoantibodies. International clinical guidelines recommend monitoring children with early stage type 1 diabetes to detect progression to stage 3 and allow for timely commencement of insulin therapy before children develop life-threatening diabetic ketoacidosis. The feasibility and acceptability of these new clinical guidelines have not yet been assessed in the Australian paediatric type 1 diabetes population. This study aims to assess the implementation of these new guidelines as part of care for children in the Pilot. This study will follow each participant for 3 years from the start of recruitment. Children with single or multiple diabetes specific auto-antibodies, detected through the National Screening Pilot, will be monitored for dysglycaemia via random blood glucose and HbA1c levels by their local paediatric diabetes team. Children with multiple antibodies will also be offered 2-week periods of continuous glucose monitoring (CGM) at intervals over the 3 years. Single Antibody Children aged 36 months or younger - 6 monthly HbA1c, glucose and antibody measurements (30min to 1h) Single Antibody Positive Children aged over 36 months - 12 monthly HbA1c, glucose and antibody measurements (30min to 1h) Multiple Antibody Positive Children aged 36 months or younger - 3 monthly HbA1c, glucose and CGM - study visit 30min to 1h Multiple Antibody Positive Children aged over 36 months - 6 monthly HbA1c, glucose and CGM - study visit 30min to 1h Adherence to study visits and monitoring as well as attrition rates will be recorded to assess feasibilty and acceptability of the monitoring guidelines. In order to assess feasibility and acceptability, parents will also be offered curated surveys at each monitoring study visit to understand the acceptability of monitoring. Attrition rates will also be assessed as a measure of feasibility and acceptability. Surveys will be sent electronically before and after the monitoring visit and are estimated to take approximately 15min to complete. The number of completed surveys will be used to assess acceptability of these surveys.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
1 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Children recruited from the Childhood Type 1 Diabetes National Screening Pilot Feasibility and Acceptability Study’, ACTRN12622000381785 with - Pre-type 1 diabetes (defined as a single type 1 diabetes antibody) OR - Early stage type 1 diabetes (defined as multiple type 1 diabetes antibodies, not requiring insulin). - Parents of children with early stage or pre-type 1 diabetes in order to complete surveys

Exclusion criteria

Presence of stage 3 type 1 diabetes at the time of recruitment Type 2 diabetes

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026