Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06113588




Registration number
NCT06113588
Ethics application status
Date submitted
21/06/2023
Date registered
2/11/2023
Date last updated
2/11/2023

Titles & IDs
Public title
Transition of Care in Type 1 Diabetes Mellitus
Scientific title
Improving Transition of Care in Type 1 Diabetes Mellitus: A Collaborative Approach
Secondary ID [1] 0 0
2022/ETH02412
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Retrospective cohort - Patients with type 1 diabetes mellitus known to Royal North Shore Hospital, who underwent transition from paediatric to adult health care from 1st January 2020-8th June 2023

Prospective cohort - Patients with type 1 diabetes mellitus known to Royal North Shore Hospital, undergoing transition from paediatric to adult health care, from 9th June 2023 onwards
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient self-efficacy (patient, family and staff member) relating to diabetes
Timepoint [1] 0 0
From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews
Primary outcome [2] 0 0
Diabetes knowledge questionnaire (patient and family member)
Timepoint [2] 0 0
From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews
Primary outcome [3] 0 0
Diabetes-related distress (patient and family member)
Timepoint [3] 0 0
From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews
Secondary outcome [1] 0 0
Patient medical outcomes
Timepoint [1] 0 0
From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews
Secondary outcome [2] 0 0
Patient medical outcomes
Timepoint [2] 0 0
From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews
Secondary outcome [3] 0 0
Patient medical outcomes
Timepoint [3] 0 0
From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews

Eligibility
Key inclusion criteria
Adolescents who have an existing diagnosis of type 1 diabetes mellitus and who underwent
(in 2020 to 8th June, 2023) or who are undergoing (from 9th June, 2023 and subsequent
cohorts) transition from paediatric care to adult health care at Royal North Shore Hospital
and Mona Vale Community Health Centre. Adolescents with type 1 diabetes will be 16 years or
older

A family member or caregiver of the participant of the adolescent patient with type 1
diabetes mellitus

A staff member who is a member of the patient's treating diabetes team within the
paediatric diabetes service (first study visit and second study visit) and young adult
diabetes service (third study visit)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
There are no specific exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/06/2028
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2065 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Northern Sydney and Central Coast Area Health Service
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This research project seeks to address the question of how to improve the transition of
patients with type 1 diabetes mellitus from the paediatric to the adult health service at
RNSH and Mona Vale Community Health Centre (seeking the perspectives of patients, families,
and staff)?
Trial website
https://clinicaltrials.gov/ct2/show/NCT06113588
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shihab Hameed, MBBS
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06113588