TransitionNCT06113588
Transition of Care in Type 1 Diabetes Mellitus
An observational study of Transition and Type 1 Diabetes Mellitus, run by Northern Sydney and Central Coast Area Health Service at 1 site in Australia.
Trial 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)? Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Transition, Type 1 Diabetes Mellitus
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Jun 2023to 9 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with type 1 diabetes mellitus meeting inclusion criteria, above
Who may be able to join
- 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)
Who cannot join
- There are no specific exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Transition of Care in Type 1 Diabetes Mellitus: A Collaborative Approach
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)?
Read the detailed description
There are significant limitations in the literature relating to transition from paediatric to adult healthcare.
In healthcare, transition describes the purposeful process of planning and moving from paediatric to adult services and usually occurs in adolescence (in itself a time of rapid physical, cognitive and psychosocial growth between childhood and adulthood). The available evidence within the literature to guide this process of transition is often limited and additional evidence to guide clinical practice is required. Although reports within the literature vary, it is known that up to 50% of young adults with an endocrine disorder are lost to follow-up after transition to adult health services. Even if the young person attends the adult service, they may have poor health outcomes related to inability to self-manage their condition, particularly if it is a chronic disease requiring significant daily intervention by the patient, such as in type 1 diabetes mellitus.
Type 1 diabetes mellitus is a life-long condition characterised by autoimmune-mediated destruction of pancreatic β-cells, almost always resulting in absolute insulin deficiency. As a result, patients are required to perform lifelong intensive glucose monitoring and insulin administration. These intensive insulin regimens require an enormous amount of attention and effort on the part of the young person with diabetes and their family, but dramatically reduce their rates of micro- and macro-vascular complications, such as blindness, kidney failure, heart attack and stroke. Evidence for this 'legacy effect' - the long-term clinical benefits of early intensive insulin treatment - are provided through studies including the EDIC (Epidemiology of Diabetes Interventions and Complications) study which undertook long-term follow up of the Diabetes Control and Complications Trial (DCCT). The DCCT, conducted from 1983-1989, randomised 1441 participants with new or recently-diagnosed type 1 diabetes to receive either intensive insulin therapy or standard therapy. The DCCT/EDIC study ultimately recommended maintaining patients' glucose levels as close to the normal range as safely possible, with intensive insulin therapy and monitoring.
Glycaemic control and transition in adolescents with type 1 diabetes mellitus has its own specific challenges. Across all age groups, adolescents are currently the farthest from achieving good glycaemic control (a HbA1c goal of <58 mmol/mol or 7.0%). The factors contributing to this may include hormonal changes during puberty, psycho-social challenges and decreased adherence to insulin therapy regimens.
Appropriate transition of patients with type 1 diabetes from paediatric to adult health care thus needs to take a holistic approach to the individual patient which addresses these factors and which is centred on individual patients' developmental stages and circumstances.
The local transition process at Royal North Shore Hospital has future potential At Royal North Shore Hospital, there is a structured transition process underpinned by the transition policy. However, initial analysis indicates that patients are missing appointments and education, and being lost to follow-up. There is accordingly a pressing need for analysis of the transition process and its outcomes.
Within the current literature, evaluation measures to assess patients' diabetes self-management and transition readiness (including glucose monitoring, insulin and food regulation, exercise, and emergency preparedness) frequently rely on patient self-report and emphasise knowledge and practical skills in diabetes care.
This research will provide additional insights from the patient's family and from treating staff as well as explore self-efficacy (the individual's belief in their capacity to execute behaviours) which are often poorly studied in transition research. It is anticipated that this will provide a comprehensive picture of areas in which patients' efficacy, transition readiness, knowledge and diabetes-related distress can have tailored support provided in an individualised way.
This research project will utilise the following questionnaires, with access for all participants via a QR code using Northern Sydney Local Health District (NSLHD) REDCap (a secure, web-based application for building and managing online surveys and databases).
- A modified READDY tool assessing transition readiness and self-efficacy - with versions that can be answered separately by the patient, the patient's family member, and the patient's healthcare professional.
- Diabetes knowledge questionnaire - with versions that can be answered separately by the patient and patient's family member
- Diabetes distress questionnaire - with versions that can be answered separately by the patient and the patient's family member
- Evaluation of the transition process - with versions that can be answered separately by patient, patient's family member and staff member
- Conditions
- Transition, Type 1 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient self-efficacy (patient, family and staff member) relating to diabetes
From prospective questionnaires, with higher scores indicative of higher self-efficacy
Measured: 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
Measured: 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
Measured: From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews
Secondary outcomes (3)
Patient medical outcomes
HbA1c (%) over time
Measured: From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews
Patient medical outcomes
Frequency (number) of emergency department presentations
Measured: From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews
Patient medical outcomes
Percentage of patients developing diabetes complications
Measured: From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start9 Jun 2023
- Primary completion9 Jun 2024 (estimated)
- Study completion9 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Sydney and Central Coast Area Health Service
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shihab Hameed, Northern Sydney and Central Coast Area Health Service
- Investigators
- Shihab Hameed, MBBS, Principal investigator, Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113588
- Sponsor's protocol ID
- 2022/ETH02412
- Status last verified
- Oct 2023
- First submitted
- 21 Jun 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Transition of Care in Type 1 Diabetes Mellitus: A Collaborative Approach
- ClinicalTrials.gov ID
- NCT06113588
- Acronym / sponsor ID
- 2022/ETH02412
- Conditions
- Transition, Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Northern Sydney and Central Coast Area Health ServiceUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 9 Jun 2024 (estimated)
- Study completion
- 9 Jun 2028 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
Detailed description
There are significant limitations in the literature relating to transition from paediatric to adult healthcare.
In healthcare, transition describes the purposeful process of planning and moving from paediatric to adult services and usually occurs in adolescence (in itself a time of rapid physical, cognitive and psychosocial growth between childhood and adulthood). The available evidence within the literature to guide this process of transition is often limited and additional evidence to guide clinical practice is required. Although reports within the literature vary, it is known that up to 50% of young adults with an endocrine disorder are lost to follow-up after transition to adult health services. Even if the young person attends the adult service, they may have poor health outcomes related to inability to self-manage their condition, particularly if it is a chronic disease requiring significant daily intervention by the patient, such as in type 1 diabetes mellitus.
Type 1 diabetes mellitus is a life-long condition characterised by autoimmune-mediated destruction of pancreatic β-cells, almost always resulting in absolute insulin deficiency. As a result, patients are required to perform lifelong intensive glucose monitoring and insulin administration. These intensive insulin regimens require an enormous amount of attention and effort on the part of the young person with diabetes and their family, but dramatically reduce their rates of micro- and macro-vascular complications, such as blindness, kidney failure, heart attack and stroke. Evidence for this 'legacy effect' - the long-term clinical benefits of early intensive insulin treatment - are provided through studies including the EDIC (Epidemiology of Diabetes Interventions and Complications) study which undertook long-term follow up of the Diabetes Control and Complications Trial (DCCT). The DCCT, conducted from 1983-1989, randomised 1441 participants with new or recently-diagnosed type 1 diabetes to receive either intensive insulin therapy or standard therapy. The DCCT/EDIC study ultimately recommended maintaining patients' glucose levels as close to the normal range as safely possible, with intensive insulin therapy and monitoring.
Glycaemic control and transition in adolescents with type 1 diabetes mellitus has its own specific challenges. Across all age groups, adolescents are currently the farthest from achieving good glycaemic control (a HbA1c goal of <58 mmol/mol or 7.0%). The factors contributing to this may include hormonal changes during puberty, psycho-social challenges and decreased adherence to insulin therapy regimens.
Appropriate transition of patients with type 1 diabetes from paediatric to adult health care thus needs to take a holistic approach to the individual patient which addresses these factors and which is centred on individual patients' developmental stages and circumstances.
The local transition process at Royal North Shore Hospital has future potential At Royal North Shore Hospital, there is a structured transition process underpinned by the transition policy. However, initial analysis indicates that patients are missing appointments and education, and being lost to follow-up. There is accordingly a pressing need for analysis of the transition process and its outcomes.
Within the current literature, evaluation measures to assess patients' diabetes self-management and transition readiness (including glucose monitoring, insulin and food regulation, exercise, and emergency preparedness) frequently rely on patient self-report and emphasise knowledge and practical skills in diabetes care.
This research will provide additional insights from the patient's family and from treating staff as well as explore self-efficacy (the individual's belief in their capacity to execute behaviours) which are often poorly studied in transition research. It is anticipated that this will provide a comprehensive picture of areas in which patients' efficacy, transition readiness, knowledge and diabetes-related distress can have tailored support provided in an individualised way.
This research project will utilise the following questionnaires, with access for all participants via a QR code using Northern Sydney Local Health District (NSLHD) REDCap (a secure, web-based application for building and managing online surveys and databases).
- A modified READDY tool assessing transition readiness and self-efficacy - with versions that can be answered separately by the patient, the patient's family member, and the patient's healthcare professional.
- Diabetes knowledge questionnaire - with versions that can be answered separately by the patient and patient's family member
- Diabetes distress questionnaire - with versions that can be answered separately by the patient and the patient's family member
- Evaluation of the transition process - with versions that can be answered separately by patient, patient's family member and staff member
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with type 1 diabetes mellitus meeting inclusion criteria, above
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient self-efficacy (patient, family and staff member) relating to diabetes
Time frame: From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews
From prospective questionnaires, with higher scores indicative of higher self-efficacy
Diabetes knowledge questionnaire (patient and family member)
Time frame: From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews
From prospective questionnaires, with a single correct answer per question
Diabetes-related distress (patient and family member)
Time frame: From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews
From prospective questionnaires, with higher scores indicative of higher distress levels
3 secondary outcomes
Patient medical outcomes
Time frame: From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews
Patient medical outcomes
Time frame: From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews
Patient medical outcomes
Time frame: From 9th June, 2023, ongoing for initial period of up to 5 years with interim sequential reviews
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Transition
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Not yet recruiting
Multi-level Intervention to Successfully Transition to Adult Care for Survivors of Childhood and Adolescent Cancers: The BRIDGES-YAS! Study
Health Care Transition, Survivorship Care
RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shihab Hameed, MBBS principal investigator
Royal North Shore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transition and Type 1 Diabetes Mellitus, run by Northern Sydney and Central Coast Area Health Service at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient self-efficacy (patient, family and staff member) relating to diabetes (time frame: From 9th June, 2023, ongoing for initial period of 5 years with interim sequential reviews). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.