Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000381785
Ethics application status
Approved
Date submitted
21/02/2022
Date registered
4/03/2022
Date last updated
21/06/2024
Date data sharing statement initially provided
4/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study
Scientific title
Childhood Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study
Secondary ID [1] 306426 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 325260 0
Condition category
Condition code
Metabolic and Endocrine 322661 322661 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME & WHY:
The Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study is a cluster-controlled implementation study comparing the feasibility, acceptability, and costs of three different screening models to identify the most appropriate strategy for type 1 diabetes screening in the paediatric general population in Australia.

WHAT (MATERIALS & PROCEDURES):
MATERIALS:
Parents/guardians of all participating children will be provided with a hard-copy/electronic Participant Information Statement. Cohort 2 (infants aged 6–12 months) will receive a saliva swab self-sampling kit and instructions, and Cohort 3 (children aged 2, 6 or 10 years) will receive a capillary blood (finger prick) self-sampling kit and instructions. These resources will also be available to participating Primary Care Providers within the catchment areas should the parent/guardian require assistance from them in obtaining a sample from their child. In-school screening by a Registered Nurse will be offered to children in Cohort 3 (Kindergarten or Year 4) attending a participating school.

Parent/guardians will also be provided with any relevant information relating to their child’s screening result e.g. explanation of the result, and/or recommendations for follow-up or specialist referral.

PROCEDURES
Cohort 1: Genetic screening (polygenic risk score) using newborn dried bloodspots (heel prick) with autoantibody follow-up of at-risk children at 12 months of age.
Cohort 2: Genetic screening (polygenic risk score) using saliva at 6-12 months of age with autoantibody follow-up of at-risk children at 12 months of age.
Cohort 3: Autoantibody screening using a capillary dried bloodspot (finger prick) in children aged 2, 6 or 10 years old OR in Kindergarten or Year 4.

WHO DELIVERED/PROVIDED THE INTERVENTION & WHERE:
Cohort 1 (newborns): The ‘intervention’ (i.e. dried bloodspot sampling for genetic analysis) will be performed by a research midwife, postnatal midwife, or hospital blood collector with pre-existing training in newborn heel prick blood spot collection.

Cohort 2 (6-12 month old infants): The ‘intervention’ (i.e. saliva swab sampling for genetic analysis) can be performed in two ways according to participant preference. The saliva testing kits will be posted to registered families who can choose:
1) ‘self-sampling’ at home (i.e. the parent/guardian collects the sample from the infant); or
2) the parent/guardian can take the test kit to their Primary Care Provider who can perform the sample collection.

Alternatively, selected Primary Care Providers will have test kits in their clinic, and they can screen and consent the participant and perform the swab during a routine consultation. Participating Primary Care Providers will have pre-existing training in saliva swab sample collection, and will receive protocol-specific training for sample collection.

Cohort 3 (2, 6 and 10yr old children): The ‘intervention’ (i.e. dried capillary bloodspot sampling for autoantibody testing) can be performed in two ways according to participant preference. The finger prick blood test kits will be posted to registered families who can choose:
1) ‘self-sampling’ at home (i.e. the parent/guardian collects the sample from the infant); or
2) the parent/guardian can take the test kit to their Primary Care Provider who can perform the sample collection.

Alternatively, selected Primary Care Providers will have test kits in their clinic, and they can screen and consent the participant and perform the blood spot collection during a routine consultation. Participating Primary Care Providers will have pre-existing training in finger prick blood spot sample collection, and will receive protocol-specific training for sample collection.

Cohort 3 (children in Kindergarten or Year 4): The ‘intervention’ (i.e. dried capillary bloodspot sampling for autoantibody testing) will be performed in-school by a visiting registered nurse with pre-existing training in finger prick blood spot sample collection.
Intervention code [1] 322879 0
Early detection / Screening
Comparator / control treatment
Autoantibody screening using a capillary dried bloodspot (finger prick) in children aged 2, 6 or 10 years old.
Control group
Active

Outcomes
Primary outcome [1] 330482 0
Uptake rates for screening and follow-up as assessed by the number of samples received.
Timepoint [1] 330482 0
End of trial.
Secondary outcome [1] 406810 0
REACH assessed as:
- Number of participants overall, number of participant registrations/consent/follow-up (REACH (Penetration)), determined from study records.
Timepoint [1] 406810 0
End of trial.
Secondary outcome [2] 406822 0
REACH assessed as:
- Proportion of eligible children residing in catchment area screened for type 1 diabetes (REACH (Penetration)), determined from study records and Medicare data.
Timepoint [2] 406822 0
End of trial.
Secondary outcome [3] 406823 0
REACH assessed as:
- Number of letters sent via Services Australia and GP Clinics (REACH (Penetration)), determined from study records.
Timepoint [3] 406823 0
End of trial.
Secondary outcome [4] 406825 0
REACH assessed as:
- Number of families approached by Midwives and GPs/Practice Nurses/Child Family Health Nurses/Pharmacists (REACH (Penetration)), determined from study records.
Timepoint [4] 406825 0
End of trial.
Secondary outcome [5] 406827 0
REACH assessed as:
- Demographic comparison of children who: registered but did not consent vs. registered, consented, and participated vs. general population of the catchment area (REACH (Representativeness)), determined from study records and Medicare data.
Timepoint [5] 406827 0
End of recruitment phase.
Secondary outcome [6] 406828 0
REACH assessed as: - Number of services involved, and children recruited from each health service (General Practices or Pharmacies) (REACH (Adoption)), determined from study records.
Timepoint [6] 406828 0
End of trial.
Secondary outcome [7] 406830 0
REACH assessed as: - Number of children screened by each health service (GP/Practice Nurses or Pharmacists) (REACH (Adoption)), determined from study records.
Timepoint [7] 406830 0
End of trial.
Secondary outcome [8] 406831 0
FEASIBILITY assessed as:
- Self-reported feasibility by families e.g. barriers and facilitators (how easy it was for them to participate) (FEASIBILITY (feasibility for families)), determined from study-specific questionnaires.
Timepoint [8] 406831 0
- Post-test (baseline screening; all cohorts)
- Post-test (follow-up testing if indicated; Cohorts 1 and 2 only)
Secondary outcome [9] 406832 0
FEASIBILITY assessed as:
- Proportion of families completing the screening and follow-up tests and whether this was at home vs. in a primary care service (FEASIBILITY (feasibility for families)), determined from study records.
Timepoint [9] 406832 0
- Post-test (baseline screening; all cohorts)
- Post-test (follow-up testing if indicated; Cohorts 1 and 2 only)
Secondary outcome [10] 406833 0
FEASIBILITY assessed as:
- Self-reported feasibility for Health Professionals e.g. barriers and facilitators to participating in screening (including cultural and contextual issues, or workforce or workflow issues) (FEASIBILITY (feasibility for Health Professionals)), determined from study-specific questionnaires.
Timepoint [10] 406833 0
Nine months after pilot commencement (in line with the completion of genetic testing for Cohort 1 and 2) and at the conclusion of the pilot (18-20 months).
Secondary outcome [11] 406834 0
FEASIBILITY assessed as:
- Proportion children being recruited and/or completing the screening and follow-up tests with primary care (FEASIBILITY (feasibility for Health Professionals)), determined from study records.
Timepoint [11] 406834 0
Nine months after pilot commencement (in line with the completion of genetic testing for Cohort 1 and 2) and at the conclusion of the pilot (18-20 months).
Secondary outcome [12] 406835 0
FEASIBILITY assessed by:
- The proportion of essential study data that were captured, and records/reasons for any major barriers to data completion (FEASIBILITY (Data Completion and Accuracy)), determined from study records.
Timepoint [12] 406835 0
End of trial.
Secondary outcome [13] 406837 0
FEASIBILITY assessed as:
- The proportion of ‘successfully collected samples’ i.e. samples of sufficient volume and quality to provide definitive genetic or autoantibody results, including confirmation of positive results by repeat assay (FEASIBILITY (Data Completion and Accuracy)), determined from study records.
Timepoint [13] 406837 0
End of trial.
Secondary outcome [14] 406838 0
FEASIBILITY assessed as:
- The comparison of planned vs. actual time taken and budget required for evaluations/analyses (FEASIBILITY (Data Completion and Accuracy)), determined from the study project plans, budget, and records.
Timepoint [14] 406838 0
End of trial.
Secondary outcome [15] 406840 0
ACCEPTABILITY assessed by:
- Self-reported overall degree of severity and changes over time in psychological distress and anxiety levels before and after screening and at follow-up (ACCEPTABILITY (Parental Anxiety)), determined from the State-Trait Anxiety Inventory (STAI).
Timepoint [15] 406840 0
- Pre-test (baseline screening; all cohorts)
- Post-test (baseline screening; all cohorts)

- Pre-test (follow-up testing if indicated; Cohorts 1 and 2 only)
- Post-test (follow-up testing if indicated; Cohorts 1 and 2 only)
Secondary outcome [16] 406842 0
ACCEPTABILITY assessed as:
- Self-reported family satisfaction and experience with the screening process (ACCEPTABILITY (Family Satisfaction)), determined from study-specific questionnaires.
Timepoint [16] 406842 0
- Post-test (baseline screening; all cohorts)
- Post-test (follow-up testing if indicated; Cohorts 1 and 2 only)
Secondary outcome [17] 406843 0
ACCEPTABILITY assessed as:
- Proportion of withdrawal of consent, including reason where provided (ACCEPTABILITY (Family Satisfaction)), determined from study records.
Timepoint [17] 406843 0
- Post-test (baseline screening; all cohorts)
- Post-test (follow-up testing if indicated; Cohorts 1 and 2 only)
Secondary outcome [18] 406844 0
ACCEPTABILITY assessed as:
- Self-reported family attitudes towards screening, motivations for participating in screening (ACCEPTABILITY (Families’ Attitudes and Motivation)), determined from study-specific questionnaires.
Timepoint [18] 406844 0
- Pre-test (baseline screening; all cohorts)
- Pre-test (follow-up testing if indicated; Cohorts 1 and 2 only)
Secondary outcome [19] 406845 0
ACCEPTABILITY assessed as:
- Self-reported family interest, barriers, and facilitators to co-screening for other diseases, e.g. coeliac disease (ACCEPTABILITY (Families’ Attitudes and Motivation)), determined from study-specific questionnaires.
Timepoint [19] 406845 0
- Pre-test (baseline screening; all cohorts)
- Pre-test (follow-up testing if indicated; Cohorts 1 and 2 only)
Secondary outcome [20] 406846 0
ACCEPTABILITY assessed as:
- Self-reported Health Professional satisfaction, experience, and self-efficacy with the screening process (ACCEPTABILITY (Health Professional Satisfaction)), determined from study-specific questionnaires.

Timepoint [20] 406846 0
Nine months after pilot commencement (in line with the completion of genetic testing for Cohort 1 and 2) and at the conclusion of the pilot (18-20 months).
Secondary outcome [21] 406847 0
ACCEPTABILITY assessed as:
- Self-reported Health Professional attitudes towards screening, perceived program complexity, sustainability, adaptability to meet local needs, suitability of screening to workforce/workplace, alignment of screening with role/priorities/values of the profession (ACCEPTABILITY (Health Professional Attitudes)), determined from study-specific questionnaires.
Timepoint [21] 406847 0
Nine months after pilot commencement (in line with the completion of genetic testing for Cohort 1 and 2) and at the conclusion of the pilot (18-20 months).
Secondary outcome [22] 406848 0
ACCEPTABILITY assessed as:
- Interest, barriers, and facilitators to co-screening for other diseases, e.g. coeliac disease (ACCEPTABILITY (Health Professional Attitudes)), determined from study-specific questionnaires.
Timepoint [22] 406848 0
Nine months after pilot commencement (in line with the completion of genetic testing for Cohort 1 and 2) and at the conclusion of the pilot (18-20 months).
Secondary outcome [23] 406851 0
KNOWLEDGE assessed as:
- Family knowledge of type 1 diabetes and its early signs and symptoms before and after screening and follow-up (KNOWLEDGE (Families’ Knowledge)), determined from study-specific questionnaires.
Timepoint [23] 406851 0
- Pre-test (baseline screening; all cohorts)
- Post-test (baseline screening; all cohorts)

- Pre-test (follow-up testing if indicated; Cohorts 1 and 2 only)
- Post-test (follow-up testing if indicated; Cohorts 1 and 2 only)
Secondary outcome [24] 406854 0
KNOWLEDGE assessed as:
- Family change in perception of and beliefs about risk before and after screening and follow-up, accuracy of risk perception. (KNOWLEDGE (Families’ Knowledge)), determined from study-specific questionnaires.
Timepoint [24] 406854 0
- Pre-test (baseline screening; all cohorts)
- Post-test (baseline screening; all cohorts)

- Pre-test (follow-up testing if indicated; Cohorts 1 and 2 only)
- Post-test (follow-up testing if indicated; Cohorts 1 and 2 only)
Secondary outcome [25] 406855 0
KNOWLEDGE assessed as:
- Health Professional knowledge of type 1 diabetes, early signs, and symptoms, and key steps in clinical pathway including triggers for referral (KNOWLEDGE (Health Professionals’ Knowledge)), determined from study-specific questionnaires.
Timepoint [25] 406855 0
Nine months after pilot commencement (in line with the completion of genetic testing for Cohort 1 and 2) and at the conclusion of the pilot (18-20 months).
Secondary outcome [26] 406856 0
KNOWLEDGE assessed as:
- Health Professional accuracy of perception of average risk before and after screening and follow-up (KNOWLEDGE (Health Professionals’ Knowledge)), determined from study-specific questionnaires.
Timepoint [26] 406856 0
Nine months after pilot commencement (in line with the completion of genetic testing for Cohort 1 and 2) and at the conclusion of the pilot (18-20 months).
Secondary outcome [27] 406857 0
FIDELITY assessed as: - Proportion of participants recruited/consented through each available channel i.e. self-directed online or via a health professional (GP/Practice Nurse/Pharmacist) (FIDELITY (Process Evaluation)), determined from study records.
Timepoint [27] 406857 0
End of trial.
Secondary outcome [28] 406859 0
FIDELITY assessed as:
- Compliance with the screening model activities i.e. proportion of eligible participants who complete each step of the screening and follow-up pathway (FIDELITY (Process Evaluation)), determined from study records.
Timepoint [28] 406859 0
End of trial.
Secondary outcome [29] 406860 0
FIDELITY assessed as:
- Comparison of actual vs. predicted timing and budget for screening and follow-up analyses completion (FIDELITY (Process Evaluation)), determined from the study records, project plans, and budget.
Timepoint [29] 406860 0
End of trial.
Secondary outcome [30] 406861 0
FIDELITY assessed as:
- The time intervals between steps in the screening pathway (e.g. time between mailout and enrolment, times between sample collection, analysis, and result reporting) (FIDELITY (Process Evaluation)), determined from study records.
Timepoint [30] 406861 0
End of trial.
Secondary outcome [31] 406862 0
FIDELITY assessed as:
- Records of major barriers to completion of trial components (FIDELITY (Process Evaluation)), determined from study records.
Timepoint [31] 406862 0
End of trial.
Secondary outcome [32] 406869 0
FIDELITY assessed as:
- Total number of calls and emails to the study (FIDELITY (Hotline Use)), determined from study records.
Timepoint [32] 406869 0
End of trial.
Secondary outcome [33] 406870 0
FIDELITY assessed as:
- Number of calls and emails to specific trial staff (i.e. Operations Staff/Genetic Counselor/Credentialled Diabetes Educator) including the average call length, and frequency of key call topics (FIDELITY (Hotline Use)), determined from study records.
Timepoint [33] 406870 0
End of trial.
Secondary outcome [34] 406874 0
COST assessed as:
- Total and breakdown costings for staff, resources, screening consumables, and postage of test kits/sample transport, including the comparison of actual vs. budgeted costs (COST (Costings)), determined from study records, project plans, and budget.
Timepoint [34] 406874 0
End of trial.
Secondary outcome [35] 406875 0
COST assessed as:
- Program cost (i.e. cost per child screened) and the cost to families participating (COST (Costings)), determined from the study records, project plans, and budget.
Timepoint [35] 406875 0
End of trial.
Secondary outcome [36] 406891 0
EXPLORATORY CLINICAL OUTCOMES assessed as:
- Proportion of children who: a) are identified as high genetic risk; b) return a postitive antibody test; and c) are diagnosed with type 1 diabetes (stage 1, 2 and 3) (CLINICAL OUTCOMES (screening and diagnostic results)), determined from study records.
Timepoint [36] 406891 0
- Post-test (baseline screening; all cohorts)
- Post-test (follow-up if indicated; Cohort 1 and 2)
Secondary outcome [37] 406893 0
EXPLORATORY CLINICAL OUTCOMES assessed as:
- Quality of Life scores (CLINICAL OUTCOMES (Clinical Results)), determined from PedsQL (for children) and EQ-5D-5L (for adults).
Timepoint [37] 406893 0
- Pre-test (baseline screening; all cohorts)
- Post-test (baseline screening; all cohorts)

- Pre-test (follow-up if indicated; Cohort 1 and 2)
- Post-test (follow-up if indicated; Cohort 1 and 2)
Secondary outcome [38] 406894 0
EXPLORATORY CLINICAL OUTCOMES assessed as:
- Rate of Diabetic Ketoacidosis (DKA) at time of diagnosis (CLINICAL OUTCOMES (Clinical Results)), determined by data-linkage with the Australian Diabetes Data Network (ADDN), the National Diabetes Services Scheme (NDSS), statewide type 1 diabetes registries (e.g. NSW Australasian Paediatric Endocrine Group Register) and hospital, and emergency departments.
Timepoint [38] 406894 0
At any time throughout the trial where diagnosis and DKA may occur.

Eligibility
Key inclusion criteria
Cohort 1: Newborns delivered in a recruiting hospital.
Cohort 2: Infants aged 6 to 12 months AND residing in or attending a GP Practice/participating pharmacy in a relevant cohort catchment area.
Cohort 3: Children aged 2 years old OR 6 years old OR 10 years old AND residing in or attending a GP Practice/participating pharmacy in a relevant cohort catchment area, OR attending Kindergarten or Year 4 at a participating primary school.
Minimum age
0 Hours
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cohort 1: None
Cohort 2: Pre-existing type 1 diabetes.
Cohort 3: Pre-existing type 1 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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Implementation science (feasibility, acceptability, and cost-effectiveness) of a pilot program comparing 3 non-randomised cohorts.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For each cohort, data will be combined from each site and descriptive statistics determined to assess socio-demographic characteristics, including child age, location, socio-economic status, parental age and education, country of birth, ethnicity, and family history of type 1 diabetes.

Study outcomes will be determined by scoring 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. Study outcomes will then be compared by the three cohorts and differences 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.

Costs of screening will be determined for each cohort and include staffing, resource use, screening consumables, postage/sample transport and costs to families to participate in screening (latter collected as a supplement to the psychological surveys). Costs will be aggregated and mean (standard deviation) costs between cohorts compared using ANOVA and multiple comparison tests.

All analyses will be performed using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA) and p values <0.05 considered statistically significant.

Power calculation: As the outcome measures are feasibility, acceptability, and cost-effectiveness, the sample size is not determined through power calculation but rather the maximum sample size considered feasible and the minimum needed for the Bayesian decision theory evaluation.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/07/2022
Actual
19/07/2022
Date of last participant enrolment
Anticipated
18/10/2023
Actual
31/12/2023
Date of last data collection
Anticipated
10/08/2029
Actual
Sample size
Target
9000
Accrual to date
Final
6701
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 21749 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 21750 0
Royal Hospital for Women - Randwick
Recruitment hospital [3] 21751 0
St George Hospital - Kogarah
Recruitment hospital [4] 21752 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 36803 0
2050 - Camperdown
Recruitment postcode(s) [2] 36804 0
2031 - Randwick
Recruitment postcode(s) [3] 36805 0
2217 - Kogarah
Recruitment postcode(s) [4] 36806 0
5006 - North Adelaide
Recruitment postcode(s) [5] 42761 0
2234 - Bangor

Funding & Sponsors
Funding source category [1] 310775 0
Charities/Societies/Foundations
Name [1] 310775 0
JDRF Australia (formerly Juvenile Diabetes Research Foundation)
Country [1] 310775 0
Australia
Funding source category [2] 310798 0
Charities/Societies/Foundations
Name [2] 310798 0
JDRF International (formerly Juvenile Diabetes Research Foundation)
Country [2] 310798 0
United States of America
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 312041 0
None
Name [1] 312041 0
Address [1] 312041 0
Country [1] 312041 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310350 0
Sydney Children’s Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 310350 0
Ethics committee country [1] 310350 0
Australia
Date submitted for ethics approval [1] 310350 0
25/10/2021
Approval date [1] 310350 0
12/05/2022
Ethics approval number [1] 310350 0
2022/ETH00537

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117338 0
Dr Kirstine Bell
Address 117338 0
Charles Perkins Centre
John Hopkins Drive
Camperdown NSW 2006
Country 117338 0
Australia
Phone 117338 0
+61 286274250
Fax 117338 0
Email 117338 0
[email protected]
Contact person for public queries
Name 117339 0
Shannon Brodie
Address 117339 0
Charles Perkins Centre
John Hopkins Drive
Camperdown NSW 2006
Country 117339 0
Australia
Phone 117339 0
+61 1800 505 909
Fax 117339 0
Email 117339 0
[email protected]
Contact person for scientific queries
Name 117340 0
Shannon Brodie
Address 117340 0
Charles Perkins Centre
John Hopkins Drive
Camperdown NSW 2006
Country 117340 0
Australia
Phone 117340 0
+61 2 8627 1938
Fax 117340 0
Email 117340 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
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
15152Study protocol  [email protected]
15153Informed consent form  [email protected]
15154Ethical approval  [email protected]



Results publications and other study-related documents

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