Type1diabetesNCT03781973
Bridging the Gap to Adult Diabetes Care
A study testing Data platform +Quality Performance feedback reports in people with Type1diabetes, run by The Hospital for Sick Children at 5 sites in Canada.
Trial summary
Adolescents with type 1 diabetes face particular challenges related to having a chronic illness that requires daily intensive self-management and medical follow-up during a period when their social, developmental, educational, and family situations are in flux. Read more about this study
- Who is it for?
- Ages 16 to 19 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Data platform +Quality Performance feedback reports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Jun 2019to 31 Dec 2022
- Phase
- Interventional
- 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 16 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All youth with a clinical diagnosis of type 1 diabetes followed at participating centres at the time of their final pediatric clinic visit between Jan 1, 2018 and Dec 31, 2020.
- Participants will be transitioning to Adult Care (ages ~16-19 yrs).
- Capacity to read and understand English (we estimate that >95% of participants will fulfill this requirement).
- Capacity to consent for themselves.
Who cannot join
- Individuals with non-type 1 diabetes.
- Individuals with type 1 diabetes who move out of Ontario within 12 months after their final pediatric visit.
- Individuals with type 1 diabetes who do not have the capacity to consent for themselves.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
McMaster Children's Hospital
Hamilton, Ontario
Children's Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9
Markham Stouffville Hospital, Clinic 4
Markham, Ontario, L3P 7P7
Trillium Health Partners
Mississauga, Ontario
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
About this study
Official title: Bridging the Gap to Optimize Care and Outcomes for Youth With Diabetes Between Pediatric and Adult Diabetes Care
Adolescents with type 1 diabetes face particular challenges related to having a chronic illness that requires daily intensive self-management and medical follow-up during a period when their social, developmental, educational, and family situations are in flux. When transitioning from pediatric to adult care, over a third of youth have a care gap of >6 months. During this vulnerable period youth are at risk for acute life-threatening complications such as diabetic ketoacidosis, and for poor glycemic control, which confers an increased risk of chronic diabetes complications. Gaps in care may be a result of deficiencies in transition processes causing some young people to be poorly prepared for adult care and dissatisfied with the transition process. Ineffective transition can lead to decreased frequency of diabetes visits and an increased risk of adverse events in young adulthood. Further, risk factors such as psychiatric comorbidity and behavioural problems in adolescents with type 1 diabetes are associated with poor outcomes in early adulthood. Quality improvement initiatives can be designed to optimize care processes such as referral systems to adult diabetes providers.
Our overall objective is to optimize care and outcomes for youth with diabetes as they transition to adult care.
Specific Aim 1: To improve glycemic control in youth around the time of transition from pediatric to adult diabetes care Specific Aim 2: To evaluate the fidelity and quality of a quality improvement intervention designed to improve transition care processes and to identify contextual factors associated with variation in outcomes.
- Conditions
- Type1diabetes
- Being tested
- Data platform +Quality Performance feedback reports
- Keywords
- Transition to adult care, Glycemic control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data platform +Quality Performance feedback reportsBehavioural
Teams from each of the participating sites will attend the webinars. Each site will share an example of a QI initiative that they are executing and describe the success and challenges.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | Those whose last pediatric visit was in the year before the intervention (2018). Medical record data abstracted from patient charts at the time of the final pediatric visit. |
| Early Intervention | Other | Those whose last pediatric visit was in the year immediately after the start of the intervention (2019).
The intervention will begin on Jan 1, 2019 and includes the following :
1. Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. .
2. Quality performance feedback reports: We will generate centre-level performance reports. Centres will be able to compare their performance to that of all other centres and to achievable benchmarks.
3. Patient transition experience surveys at the final pediatric visit and 12 months later.
4. Diabetes teams may direct patients and families to online transition resources. Receives: Behavioral: Data platform +Quality Performance feedback reports |
| Post-Intervention | Other | Those whose last pediatric visit was in the second year after the intervention (2020).
The intervention includes the following :
1. Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. .
2. Quality performance feedback reports: We will generate centre-level performance reports. Centres will be able to compare their performance to that of all other centres and to achievable benchmarks.
3. Patient transition experience surveys at the final pediatric visit and 12 months later.
4. Diabetes teams may direct patients and families to online transition resources. Receives: Behavioral: Data platform +Quality Performance feedback reports |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Hemoglobin A1c
Measured: HbA1c value up to 12 months after the final pediatric visit.
Secondary outcomes (2)
Number of Diabetes-related admissions, ED visits, death
The occurrence of at least one diabetes-related admissions or emergency department visit or death
Measured: number of occurrences up to12 months after the final pediatric visit.
Time from the final pediatric visit to the first adult diabetes visit
identified using physician service claims and defined as the first diabetes office visit by an adult endocrinologist, internist, or family physician
Measured: Time in months up to 12 months after the final pediatric visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Jun 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- An intervention with integrated components
- Masking
- None (open label)
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Rayzel Shulman, The Hospital for Sick Children
- Investigators
- Rayzel Shulman, Md, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781973
- Sponsor's protocol ID
- CTO project ID: 1581
- Status last verified
- Apr 2025
- First submitted
- 13 Dec 2018
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmad SZ, Ivers N, Zenlea I, Parsons JA, Shah BR, Mukerji G, Punthakee Z, Shulman R. An assessment of adaptation and fidelity in the implementation of an audit and feedback-based intervention to improve transition to adult type 1 diabetes care in Ontario, Canada. Implement Sci Commun. 2024 Mar 18;5(1):25. doi: 10.1186/s43058-024-00563-2.
PubMed 38500183Shulman R, Zenlea I, Shah BR, Clarson C, Harrington J, Landry A, Punthakee Z, Palmert MR, Mukerji G, Austin PC, Parsons J, Ivers N. Testing an audit and feedback-based intervention to improve glycemic control after transfer to adult diabetes care: protocol for a quasi-experimental pre-post design with a control group. BMC Health Serv Res. 2019 Nov 25;19(1):885. doi: 10.1186/s12913-019-4690-0.
PubMed 31766999
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Gap to Optimize Care and Outcomes for Youth With Diabetes Between Pediatric and Adult Diabetes Care
- ClinicalTrials.gov ID
- NCT03781973
- Acronym / sponsor ID
- CTO project ID: 1581
- Conditions
- Type1diabetes
- Keywords
- Transition to adult care, Glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Dec 2018 (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.
Adolescents with type 1 diabetes face particular challenges related to having a chronic illness that requires daily intensive self-management and medical follow-up during a period when their social, developmental, educational, and family situations are in flux. When transitioning from pediatric to adult care, over a third of youth have a care gap of >6 months. During this vulnerable period youth are at risk for acute life-threatening complications such as diabetic ketoacidosis, and for poor glycemic control, which confers an increased risk of chronic diabetes complications. Gaps in care may be a result of deficiencies in transition processes causing some young people to be poorly prepared for adult care and dissatisfied with the transition process. Ineffective transition can lead to decreased frequency of diabetes visits and an increased risk of adverse events in young adulthood. Further, risk factors such as psychiatric comorbidity and behavioural problems in adolescents with type 1 diabetes are associated with poor outcomes in early adulthood. Quality improvement initiatives can be designed to optimize care processes such as referral systems to adult diabetes providers.
Our overall objective is to optimize care and outcomes for youth with diabetes as they transition to adult care.
Specific Aim 1: To improve glycemic control in youth around the time of transition from pediatric to adult diabetes care Specific Aim 2: To evaluate the fidelity and quality of a quality improvement intervention designed to improve transition care processes and to identify contextual factors associated with variation in outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- An intervention with integrated components
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –Those whose last pediatric visit was in the year before the intervention (2018). Medical record data abstracted from patient charts at the time of the final pediatric visit. |
| Early Intervention | Other | Behavioral: Data platform +Quality Performance feedback reportsThose whose last pediatric visit was in the year immediately after the start of the intervention (2019). The intervention will begin on Jan 1, 2019 and includes the following : 1. Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. . 2. Quality performance feedback reports: We will generate centre-level performance reports. Centres will be able to compare their performance to that of all other centres and to achievable benchmarks. 3. Patient transition experience surveys at the final pediatric visit and 12 months later. 4. Diabetes teams may direct patients and families to online transition resources. |
| Post-Intervention | Other | Behavioral: Data platform +Quality Performance feedback reportsThose whose last pediatric visit was in the second year after the intervention (2020). The intervention includes the following : 1. Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. . 2. Quality performance feedback reports: We will generate centre-level performance reports. Centres will be able to compare their performance to that of all other centres and to achievable benchmarks. 3. Patient transition experience surveys at the final pediatric visit and 12 months later. 4. Diabetes teams may direct patients and families to online transition resources. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All youth with a clinical diagnosis of type 1 diabetes followed at participating centres at the time of their final pediatric clinic visit between Jan 1, 2018 and Dec 31, 2020.
- Participants will be transitioning to Adult Care (ages ~16-19 yrs).
- Capacity to read and understand English (we estimate that >95% of participants will fulfill this requirement).
- Capacity to consent for themselves.
Key exclusion criteria (3 listed)
- Individuals with non-type 1 diabetes.
- Individuals with type 1 diabetes who move out of Ontario within 12 months after their final pediatric visit.
- Individuals with type 1 diabetes who do not have the capacity to consent for themselves.
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 |
|---|---|---|
| Data platform +Quality Performance feedback reportsTeams from each of the participating sites will attend the webinars. Each site will share an example of a QI initiative that they are executing and describe the success and challenges. | Behavioural | Early Intervention, Post-Intervention |
Primary outcome
HbA1c
Time frame: HbA1c value up to 12 months after the final pediatric visit.
Hemoglobin A1c
2 secondary outcomes
Number of Diabetes-related admissions, ED visits, death
Time frame: number of occurrences up to12 months after the final pediatric visit.
Time from the final pediatric visit to the first adult diabetes visit
Time frame: Time in months up to 12 months after the final pediatric visit
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 24 Apr 2025.
- Derived from this study: PubMed 38500183Ahmad SZ, Ivers N, Zenlea I, Parsons JA, Shah BR, Mukerji G, Punthakee Z, Shulman R. An assessment of adaptation and fidelity in the implementation of an audit and feedback-based intervention to improve transition to adult type 1 diabetes care in Ontario, Canada. Implement Sci Commun. 2024 Mar 18;5(1):25. doi: 10.1186/s43058-024-00563-2.
- Derived from this study: PubMed 31766999Shulman R, Zenlea I, Shah BR, Clarson C, Harrington J, Landry A, Punthakee Z, Palmert MR, Mukerji G, Austin PC, Parsons J, Ivers N. Testing an audit and feedback-based intervention to improve glycemic control after transfer to adult diabetes care: protocol for a quasi-experimental pre-post design with a control group. BMC Health Serv Res. 2019 Nov 25;19(1):885. doi: 10.1186/s12913-019-4690-0.
- Individual participant dataSharing planned: No
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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.
Rayzel Shulman, Md, PhD principal investigator
The Hospital for Sick Children
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data platform +Quality Performance feedback reports in people with Type1diabetes, run by The Hospital for Sick Children at 5 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 4 inclusion and 3 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
HbA1c (time frame: HbA1c value up to 12 months after the final pediatric visit.). 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 NCT03781973, which also lists 2 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 24 Apr 2025.