Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000510943
Ethics application status
Approved
Date submitted
20/03/2020
Date registered
24/04/2020
Date last updated
2/11/2021
Date data sharing statement initially provided
24/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Type1Screen: Diabetes autoantibody screening to identify individuals at risk for type 1 diabetes
Scientific title
Type1 Screen: Diabetes autoantibody screening to identify individuals at risk for type 1 diabetes
Secondary ID [1] 300424 0
None
Universal Trial Number (UTN)
U1111-1248-4603
Trial acronym
Type1Screen
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 316189 0
Condition category
Condition code
Metabolic and Endocrine 314481 314481 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
15
Target follow-up type
Years
Description of intervention(s) / exposure
The Type1Screen study provides antibody screening for individuals aged 2-30 years old; in particular screening is for IA2, GAD, ZnT8 and insulin antibodies.

For participants under the age of 18, repeat antibody screening will be offered every 5 years until adulthood (age 18 years).

Antibody screening is not part of routine clinical care and is being offered to family members who wish to know their risk of developing type 1 diabetes and, if the test is positive, wish to consider joining intervention trials that aim to delay or prevent progression to insulin dependence.

Participation involves reading and signing a consent form (20 minutes), completing an online survey (10 minutes) and presenting to a community blood collection centre for a blood test (30 minutes).

Alternatively, where additional validated assays for antibodies become available, instead of a community blood collection, participation may involve a home test kit with instructions to collect saliva and blood prick samples (30mins).
Intervention code [1] 316815 0
Early Detection / Screening
Comparator / control treatment
No
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322811 0
The number of participants who test positive by blood test to one or more islet autoantibodies against insulin, GAD, IA2 and ZnT8.



Timepoint [1] 322811 0
Blood test that confirms the presence of one or more islet antibodies (usually the confirmatory test following the initial sample).
Secondary outcome [1] 379869 0
The development of diabetes defined as:
i) Unequivocal symptoms of diabetes (severe/persistent polyuria, polydipsia and/or
significant unexplained weight loss) AND at least one of the following:
• Random glucose greater than or equal to 11.1 mmol/L OR
• 2-hour glucose greater than or equal to 11.1 mmol/L 2 hours after an oral glucose load
(glucose dose 1.75g/kg up to a maximum of 75g) OR
• Fasting Glucose at least 7 mmol/L OR
• HbA1c at least 6.5%

ii) If not unequivocally symptomatic, two separate objective measures are required for
diagnosis. These tests must occur within 1 year of each other and must be
consecutive, defined as without an intervening non-diabetic oral glucose tolerance
test. The preferred criterion for diagnosis of this so-called ‘silent diabetes’ is the
finding of 2 consecutive diabetic oral glucose tolerance tests on separate days.
However, the following three combinations of results obtained on separate days can
also constitute a diagnosis of diabetes:
• Diabetic oral glucose tolerance test (glucose dose 1.75g/kg up to a maximum of
75g) with fasting glucose at least 7 mmol/L OR
• Diabetic oral glucose tolerance test (glucose dose 1.75g/kg up to a maximum of
75g) with HbA1c at least 6.5% OR
• Fasting Glucose at least 7 mmol/L and HbA1c at least 6.5%.

In all cases, the date of the confirmatory test will be recorded as the date of
diagnosis.
Timepoint [1] 379869 0
Any time point during the study when the criteria for Secondary outcome 1 are met.

Eligibility
Key inclusion criteria
1. People aged 2 to 30 AND
2. Live in Australia or New Zealand AND
3. Have a relative diagnosed with type 1 diabetes OR have previously had a positive antibody screen
4. Participant or guardian willing and competent to provide informed consent.
Minimum age
2 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Someone with a diagnosis of diabetes (other than gestational diabetes which resolved after the baby was born)
2. Someone who is unable to give a blood test
3. A participant, or their legal guardian, who is unable to give consent to participate

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study does not test a specific hypothesis thus sample size justification and power calculation are not required. The data obtained will be analysed to generate descriptive dataset that, for example, describe rates of antibody positivity and of diabetes and their relationships to age, body mass index and duration of follow up in the study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10000
Accrual to date
811
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 15831 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 15904 0
Perth Children's Hospital - Nedlands
Recruitment hospital [3] 15905 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [4] 15906 0
Monash Children’s Hospital - Clayton
Recruitment hospital [5] 15907 0
The Canberra Hospital - Garran
Recruitment hospital [6] 15908 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [7] 15909 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [8] 15910 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [9] 15911 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [10] 15912 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 29361 0
6009 - Nedlands
Recruitment postcode(s) [2] 29362 0
5006 - North Adelaide
Recruitment postcode(s) [3] 29363 0
3168 - Clayton
Recruitment postcode(s) [4] 29364 0
2605 - Garran
Recruitment postcode(s) [5] 29365 0
2145 - Westmead
Recruitment postcode(s) [6] 29366 0
2560 - Campbelltown
Recruitment postcode(s) [7] 29367 0
2065 - St Leonards
Recruitment postcode(s) [8] 29368 0
2291 - Merewether
Recruitment postcode(s) [9] 29369 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 22343 0
New Zealand
State/province [1] 22343 0
Auckland & Otago

Funding & Sponsors
Funding source category [1] 304990 0
Charities/Societies/Foundations
Name [1] 304990 0
Juvenile Diabetes Research Foundation Australia
Country [1] 304990 0
Australia
Primary sponsor type
Government body
Name
Melbourne Health
Address
300 Grattan Street, Parkville, VIC, 3050
Country
Australia
Secondary sponsor category [1] 305350 0
None
Name [1] 305350 0
Address [1] 305350 0
Country [1] 305350 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305254 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 305254 0
Melbourne Health Human Research Ethics Committee
Level 2
South West
300 Grattan Street
Parkville Victoria
Ethics committee country [1] 305254 0
Australia
Date submitted for ethics approval [1] 305254 0
Approval date [1] 305254 0
21/06/2019
Ethics approval number [1] 305254 0
HREC/54606/MH-2019

Summary
Brief summary
Title:
Type1Screen: Diabetes autoantibody screening to identify individuals at risk for type 1 diabetes

Objectives:
1) To identify individuals who have diabetes autoantibodies
2) To support antibody-positive individuals through a national network of diabetes centres and to perform metabolic testing to determine their risk of developing type 1 diabetes
Trial website
www.type1screen.org
Trial related presentations / publications
Public notes
Additional sites:

New Zealand sites
1. Liggins Institute
2. Dunedin Children’s Hospital

Contacts
Principal investigator
Name 99782 0
A/Prof John Wentworth
Address 99782 0
The Royal Melbourne Hospital
300 Grattan Street
Parkville, VIC, 3050
Country 99782 0
Australia
Phone 99782 0
+61 422922891
Fax 99782 0
Email 99782 0
[email protected]
Contact person for public queries
Name 99783 0
Ms Felicity Healy
Address 99783 0
The Royal Melbourne Hospital
300 Grattan Street
Parkville, VIC, 3050
Country 99783 0
Australia
Phone 99783 0
+61 3 9342 7063
Fax 99783 0
Email 99783 0
[email protected]
Contact person for scientific queries
Name 99784 0
A/Prof John Wentworth
Address 99784 0
The Royal Melbourne Hospital
300 Grattan Street
Parkville, VIC, 3050
Country 99784 0
Australia
Phone 99784 0
+61 422922891
Fax 99784 0
Email 99784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data except identifiers, which include name, date of birth and contact information.
When will data be available (start and end dates)?
1/1/2020 until 1/1/2035
Available to whom?
Researchers who obtain ethical approval to use the data and whose request to use the data are deemed reasonable by the PI and other members of the study team.
Available for what types of analyses?
Studies relating to type 1 diabetes.
How or where can data be obtained?
Contact study PI at [email protected]


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
SourceTitleYear of PublicationDOI
Dimensions AIDecreased occurrence of ketoacidosis and preservation of beta cell function in relatives screened and monitored for type 1 diabetes in Australia and New Zealand2022https://doi.org/10.1111/pedi.13422
N.B. These documents automatically identified may not have been verified by the study sponsor.