Type 1 DiabetesPhase 4TransClinNCT01351857
Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes
A Phase 4 study testing Transition Coordinator in people with Type 1 Diabetes, run by University of Western Ontario, Canada at 4 sites in Canada.
Trial summary
Structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance as well as glycemic control after transition from pediatric to adult diabetes care. Read more about this study
- Who is it for?
- Ages 17 to 20 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Transition Coordinator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 4 sitesCanada
- Study dates
- Apr 2012to 30 Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 17 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Established T1D diagnosis for a minimum of one year (chosen to allow time for adjustment to a new diagnosis and more stable disease control).
- Between the ages of 17 and 20 years. It is left to the clinical judgment of the pediatric endocrinologist to determine individually the appropriate age of the transition for each subject
- At least 1 visit during the previous year with the pediatric endocrinologist at a Diabetes Clinic (aim is to minimize the non-adherence with the intervention).
- Ability to participate in all aspects of this clinical trial.
- Written informed consent/assent must be obtained and documented.
- Resident of Ontario.
Who cannot join
- Pregnant or lactating females or intent to become pregnant during the next 3 years.
- Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
- Prior enrollment in the current study.
- Current participation in another clinical trial or participation in another clinical trial in the 6 months prior to enrollment.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
St. Joseph's Health Care
London, Ontario, N6A 4V2
London Health Sciences Centre - Children's Hospital
London, Ontario, N6A 5W9
Trillium Pediatric Diabetes Clinic
Mississauga, Ontario, L5B 1B8
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
About this study
Official title: Multicentre Randomized Controlled Trial of Structured Transition on Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes
Structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance as well as glycemic control after transition from pediatric to adult diabetes care.
Read the detailed description
The purpose of this study is to determine if a structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance and management as well as glycemic control after transition from pediatric to adult diabetes care.
- Conditions
- Type 1 Diabetes
- Being tested
- Transition Coordinator
- Keywords
- Type 1 Diabetes, 17 to 20 years of age
- 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.
Transition CoordinatorOther
The Transition Coordinator is central to the intervention and will provide ongoing contact with the medical system as well as education and clinical support where appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Transition Coordinator | Other | A Transition Coordinator, a Certified Diabetes Educator, will provide transition support and the link between pediatric and adult diabetes care. The Transition Coordinator is central to the intervention and will provide ongoing contact with the medical system as well as education and clinical support where appropriate. Receives: Other: Transition Coordinator |
| Current Standard of Care | No intervention | Subjects in the control group will transition to adult care equal to the intervention group and will differ only by exclusion of Transition Coordinator. Control group will receive the current standard of diabetes care otherwise unchanged. Three months following randomization, subjects in the control group will be referred to the adult endocrinologist in the same way as subjects in the intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care.
Measured: 30 months
Secondary outcomes (1)
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test)
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test) \& mean levels Frequency of retinal exam microalbumin to creatinine ratio fasting lipid profile and foot exam testing Rate of hospitalization/ER visits for acute complications of diabetes
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startApr 2012
- Primary completion28 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Cheril Clarson, MD, Principal investigator, London Health Sciences Centre - Children's HospitalTamara Spaic, Principal investigator, St. Joseph's Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351857
- Sponsor's protocol ID
- CCTN1102
- Acronym
- TransClin
- Status last verified
- Nov 2018
- First submitted
- 10 May 2011
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Osgood DW, Foster EM, Courtney ME. Vulnerable populations and the transition to adulthood. Future Child. 2010 Spring;20(1):209-29. doi: 10.1353/foc.0.0047.
PubMed 20364628Spaic T, Robinson T, Goldbloom E, Gallego P, Hramiak I, Lawson ML, Malcolm J, Mahon J, Morrison D, Parikh A, Simone A, Stein R, Uvarov A, Clarson C; JDRF Canadian Clinical Trial CCTN1102 Study Group. Closing the Gap: Results of the Multicenter Canadian Randomized Controlled Trial of Structured Transition in Young Adults With Type 1 Diabetes. Diabetes Care. 2019 Jun;42(6):1018-1026. doi: 10.2337/dc18-2187. Epub 2019 Apr 22.
PubMed 31010873Spaic T, Mahon JL, Hramiak I, Byers N, Evans K, Robinson T, Lawson ML, Malcolm J, Goldbloom EB, Clarson CL; JDRF Canadian Clinical Trial CCTN1102 Study Group. Multicentre randomized controlled trial of structured transition on diabetes care management compared to standard diabetes care in adolescents and young adults with type 1 diabetes (Transition Trial). BMC Pediatr. 2013 Oct 9;13:163. doi: 10.1186/1471-2431-13-163.
PubMed 24106787
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Controlled Trial of Structured Transition on Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01351857
- Acronym / sponsor ID
- TransClin / CCTN1102
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, 17 to 20 years of age
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Apr 2012
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 11 May 2011 (estimated)
- 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.
Structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance as well as glycemic control after transition from pediatric to adult diabetes care.
Detailed description
The purpose of this study is to determine if a structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance and management as well as glycemic control after transition from pediatric to adult diabetes care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transition Coordinator | Other | Other: Transition CoordinatorA Transition Coordinator, a Certified Diabetes Educator, will provide transition support and the link between pediatric and adult diabetes care. The Transition Coordinator is central to the intervention and will provide ongoing contact with the medical system as well as education and clinical support where appropriate. |
| Current Standard of Care | No intervention | –Subjects in the control group will transition to adult care equal to the intervention group and will differ only by exclusion of Transition Coordinator. Control group will receive the current standard of diabetes care otherwise unchanged. Three months following randomization, subjects in the control group will be referred to the adult endocrinologist in the same way as subjects in the intervention group |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Established T1D diagnosis for a minimum of one year (chosen to allow time for adjustment to a new diagnosis and more stable disease control).
- Between the ages of 17 and 20 years. It is left to the clinical judgment of the pediatric endocrinologist to determine individually the appropriate age of the transition for each subject
- At least 1 visit during the previous year with the pediatric endocrinologist at a Diabetes Clinic (aim is to minimize the non-adherence with the intervention).
- Ability to participate in all aspects of this clinical trial.
- Written informed consent/assent must be obtained and documented.
Key exclusion criteria (4 listed)
- Pregnant or lactating females or intent to become pregnant during the next 3 years.
- Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
- Prior enrollment in the current study.
- Current participation in another clinical trial or participation in another clinical trial in the 6 months prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transition CoordinatorThe Transition Coordinator is central to the intervention and will provide ongoing contact with the medical system as well as education and clinical support where appropriate. | Other | Transition Coordinator |
Primary outcome
The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care.
Time frame: 30 months
1 secondary outcome
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test)
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Background: PubMed 20364628Osgood DW, Foster EM, Courtney ME. Vulnerable populations and the transition to adulthood. Future Child. 2010 Spring;20(1):209-29. doi: 10.1353/foc.0.0047.
- Derived from this study: PubMed 31010873Spaic T, Robinson T, Goldbloom E, Gallego P, Hramiak I, Lawson ML, Malcolm J, Mahon J, Morrison D, Parikh A, Simone A, Stein R, Uvarov A, Clarson C; JDRF Canadian Clinical Trial CCTN1102 Study Group. Closing the Gap: Results of the Multicenter Canadian Randomized Controlled Trial of Structured Transition in Young Adults With Type 1 Diabetes. Diabetes Care. 2019 Jun;42(6):1018-1026. doi: 10.2337/dc18-2187. Epub 2019 Apr 22.
- Derived from this study: PubMed 24106787Spaic T, Mahon JL, Hramiak I, Byers N, Evans K, Robinson T, Lawson ML, Malcolm J, Goldbloom EB, Clarson CL; JDRF Canadian Clinical Trial CCTN1102 Study Group. Multicentre randomized controlled trial of structured transition on diabetes care management compared to standard diabetes care in adolescents and young adults with type 1 diabetes (Transition Trial). BMC Pediatr. 2013 Oct 9;13:163. doi: 10.1186/1471-2431-13-163.
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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. This study is not recruiting at the moment.
Cheril Clarson, MD principal investigator
London Health Sciences Centre - Children's Hospital
Tamara Spaic principal investigator
St. Joseph's Healthcare Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transition Coordinator in people with Type 1 Diabetes, run by University of Western Ontario, Canada at 4 sites in Canada.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care. (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351857, which also lists 3 linked publications.
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 9 Nov 2018.