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Trial registered on ANZCTR


Registration number
ACTRN12624000470594
Ethics application status
Approved
Date submitted
6/03/2024
Date registered
16/04/2024
Date last updated
16/04/2024
Date data sharing statement initially provided
16/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Type 1 Diabetes National Screening Pilot: Monitoring Children with Early Stage Type 1 Diabetes
Scientific title
Type 1 Diabetes National Screening Pilot: Evaluating the Feasibility and Acceptability of Monitoring Children with Early Stage Type 1 Diabetes
Secondary ID [1] 311586 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Sub-study of ACTRN12622000381785, This study is a follow-on from the Australian Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Pilot (2022/ETH00537)

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes
 332970 0
Condition category
Condition code
Metabolic and Endocrine 329682 329682 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328041 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337466 0
Uptake rate of the monitoring program
Timepoint [1] 337466 0
Baseline i.e. prior to the commencement of dysglycaemia monitoring and end of study (3 years from commencement of monitoring).
Primary outcome [2] 337467 0
Feasibility of monitoring in children with early stage type 1 diabetes - composite primary outcome using the assessment methods below.
Timepoint [2] 337467 0
Baseline i.e. prior to the commencement of dysglycaemia monitoring, each study visit, end of study ( 3 years from commencement of monitoring).
Primary outcome [3] 337468 0
Acceptability of monitoring children with early stage diabetes - composite outcome using the assessment methods below.
Timepoint [3] 337468 0
Baseline i.e. prior to the commencement of dysglycaemia monitoring, each study visit.
Secondary outcome [1] 431987 0
To determine what metabolic changes are seen in children with
presymptomatic type 1 diabetes?
Timepoint [1] 431987 0
Baseline, 3, 6 or 12monthly based on age and antibody status for 3 years from the commencement of monitoring.
Secondary outcome [2] 431988 0
• To assess how many children progress from single to multiple islet antibodies.
Timepoint [2] 431988 0
6 monthly or 12 monthly based on participant age over 3 years from the commencement of monitoring.
Secondary outcome [3] 431989 0
To assess how many children progress to Stage 3 type 1 diabetes
Timepoint [3] 431989 0
Baseline, 3, 6 or 12 monthly based on age and antibody status over 3 years from the commencement of monitoring.
Secondary outcome [4] 433107 0
Changes in glucose profile and variability from continuous glucose monitoring in children who are multiple antibody positive.
Timepoint [4] 433107 0
Baseline, 3 or 6 monthly based on age for a period of 3 years from the commencement of monitoring.
Secondary outcome [5] 433795 0
To determine what glycaemic changes are seen in children with presymptomatic type 1 diabetes.
Timepoint [5] 433795 0
Baseline, 3, 6 or 12 monthly based on age and antibody status for 3 years from the commencement of monitoring.

Eligibility
Key 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
Minimum age
1 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of stage 3 type 1 diabetes at the time of recruitment
Type 2 diabetes

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data will be combined from each site and descriptive statistics determined to assess sociodemographic characteristics, including child age, location, socio-economic status, parental age and education, country of birth, ethnicity and family history of type 1 and type 2 diabetes.

Study outcomes, including feasibility and acceptability outcomes, will be determined by scoring survey responses and aggregating items using appropriate scales. Frequency and
proportion of responses for each study outcome of interest will be determined overall and
assessed by site and socio-demographic characteristics. Pearson’s chi-squared, t-tests or Wilcoxen tests will be used to compare differences between socio-demographic characteristics and study outcomes for categorical and parametric and non-parametric continuous/ordinal variables, respectively. Differences in study outcomes will be assessed
using multiple comparison tests and logistic or multinomial regression analysis for dichotomous or multiple outcome categories, respectively. Multivariate analysis will be conducted to take into account potential confounding by socio-demographic factors.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2028
Actual
Date of last data collection
Anticipated
30/06/2031
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 315893 0
Other Collaborative groups
Name [1] 315893 0
Australasian Paediatric Endocrine Group Research Grant
Country [1] 315893 0
Australia
Funding source category [2] 315949 0
Charities/Societies/Foundations
Name [2] 315949 0
Juvenile Diabetes Research Foundation
Country [2] 315949 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318036 0
None
Name [1] 318036 0
Address [1] 318036 0
Country [1] 318036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314734 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 314734 0
http://www.schn.health.nsw.gov.au/health-professionals/our-research/ethics-research-governance
Ethics committee country [1] 314734 0
Australia
Date submitted for ethics approval [1] 314734 0
28/07/2023
Approval date [1] 314734 0
28/09/2023
Ethics approval number [1] 314734 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132566 0
Dr Kirstine Bell
Address 132566 0
Charles Perkins Centre, The University of Sydney, NSW 2006
Country 132566 0
Australia
Phone 132566 0
+61 400 167 043
Fax 132566 0
Email 132566 0
kirstine.bell@sydney.edu.au
Contact person for public queries
Name 132567 0
Shannon Brodie
Address 132567 0
Charles Perkins Centre, John Hopkins Drive, Camperdown NSW 2006
Country 132567 0
Australia
Phone 132567 0
+61 1800 505 909
Fax 132567 0
Email 132567 0
shannon.brodie@sydney.edu.au
Contact person for scientific queries
Name 132568 0
Kruthika Narayan
Address 132568 0
The Children's Hospital at Westmead, Hawkesbury Road, Westmead NSW 2145
Country 132568 0
Australia
Phone 132568 0
+612 7825 3171
Fax 132568 0
Email 132568 0
kruthika.narayan@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be made available as consent has not been obtained for this.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21808Study protocol  kruthika.narayan@sydney.edu.au
21809Informed consent form  kruthika.narayan@sydney.edu.au
21810Ethical approval  kruthika.narayan@sydney.edu.au



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.