NCT06113588

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 Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
26mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jun 2023Jun 2028

Study Start

First participant enrolled

June 9, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2024

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2028

Expected
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

June 21, 2023

Last Update Submit

October 30, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Patient self-efficacy (patient, family and staff member) relating to diabetes

    From prospective questionnaires, with higher scores indicative of higher self-efficacy

    From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews

  • Diabetes knowledge questionnaire (patient and family member)

    From prospective questionnaires, with a single correct answer per question

    From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews

  • Diabetes-related distress (patient and family member)

    From prospective questionnaires, with higher scores indicative of higher distress levels

    From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews

Secondary Outcomes (3)

  • Patient medical outcomes

    From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews

  • Patient medical outcomes

    From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews

  • Patient medical outcomes

    From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews

Study Arms (2)

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

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with type 1 diabetes mellitus meeting inclusion criteria, above

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Shihab Hameed, MBBS

    Royal North Shore Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2023

First Posted

November 2, 2023

Study Start

June 9, 2023

Primary Completion

June 9, 2024

Study Completion (Estimated)

June 9, 2028

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations