Type 1 DiabetesNCT06300047
Diabetes Transition Coordinator Study
A study testing Non-Medical Transition Coordinator in people with Type 1 Diabetes, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis. The 3 main aims are: 1. Read more about this study
- Who is it for?
- Ages 17 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Non-Medical Transition Coordinator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2025to 31 Dec 2028
- Phase
- Interventional
- 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 17 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- a diagnosis of T1D according to Diabetes Canada's guidelines for at least 12 months
- aged 17 to 18 years
- have had an appointment with their pediatric endocrinologist in the last 12 months
- in the last year of pediatric care and transferring to adult care in Alberta within the next year
- English proficiency (for surveys)
- Personal Health Number (PHN) for data linkage.
Who cannot join
- -
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: Aiming for Something Sweeter: Supporting Youth With Type 1 Diabetes During Transition From Pediatric to Adult Diabetes Care
The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis.
The 3 main aims are:
Read more
- To assess the effects of our transition intervention on clinical and patient-reported outcomes.
- To implement the transition intervention and evaluate the implementation outcomes.
- To evaluate the economic impacts of the transition intervention. Participants will have access to a transition coordinator before, during, and after their planned transition from pediatric to adult care as standard of care.
Researchers will compare a pre-intervention cohort to evaluate the impact of the transition coordinator intervention.
Read the detailed description
Both usual care and intervention groups will receive routine diabetes care as per Canadian national guidelines. Usual care (routine care) includes regular appointments with their pediatric diabetes care team (i.e., pediatric endocrinologist, diabetes nurse or dietician) and post-transfer with their adult diabetes team (i.e., physician and as needed visits with a diabetes educator and/or a dietician). The transition process usually starts at age 14 with discussions during clinic with youth and families around increased autonomy, self-care, organization of adult healthcare services and specific transition topics such as driving, drugs, alcohol, relationships, finances and living away from home.
The usual care group is defined as the group who receives usual care and serves as the control group. This group is defined prior to the implementation of the intervention. We include a two month wash out period between our two groups to avoid care providers 'holding on' to patients they feel may benefit from the intervention.
The intervention group (in addition to usual care) is provided additional support by way of a non-medical transition coordinator during the transition and transfer from pediatric to adult diabetes care. The non-medical transition coordinator encourages problem solving, self-management skills, and supports navigating the 'adult world'. In the year prior to transfer, the transition coordinator will meet each participant in person or virtually once during their routine pediatric diabetes appointment to explain their role prior to transfer. The transition coordinator role includes the following tasks: (1) use of text messaging, email, or phone communication (as per participant's preference) to maintain contact with the participant every 2 months for 12 months past the transfer date; (2) use of text messaging, email, or telephone as needed when participants reach out to them to answer any questions whereby the transition coordinator would provide direction; (3) assisting participants with finding family physicians (if needed); (4) assisting with completion of financial assistance, disability, insurance forms; (4) addressing any stated psychosocial needs by relaying information on community supports for participants and families; and, (5) maintaining a private Facebook® page and a transition website in which participants were encouraged to use. Website contents include information on transition, adult diabetes care (i.e., location, contact numbers, what to expect in adult care), diabetes resources as well as mental health resources. The website will be updated to have information relevant to each implementation site. We may add other types of social media to share information about transition (i.e., TikTok, Instagram), and this will be considered during our pre-implementation phase. The transition coordinator will not provide any medical advice or counselling.
- Conditions
- Type 1 Diabetes
- Being tested
- Non-Medical Transition Coordinator
- 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.
Non-Medical Transition CoordinatorOther
Participants in this intervention arm will have access to the non-medical transition coordinator to support their transition from pediatric to adult care.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | No intervention | No intervention group used as a control leading into the intervention for comparative analysis. Patients in this arm receive care as usual with no changes and are not aware of the intervention group. |
| Intervention Group | Experimental | Patients in this arm receive access to and support from a Transition coordinator who will meet with them prior to transition from pediatric to adult care and follow up with them every 2 months throughout the first year of their transition period utilizing phone, text, email, social media. Receives: Other: Non-Medical Transition Coordinator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lost to Followup
% of participants who are lost to follow up as defined by not attending at least one routine clinic visit in adult diabetes care with a health care professional to be ascertained from physician billing claims or NACRS claims data
Measured: within 1 year of transfer date from pediatric care
Secondary outcomes (9)
Patient Reported Outcome Survey 1
Problem Areas in Diabetes - Teen version Survey
Measured: within 2 months of transfer from pediatric care, repeated at 12 months after transfer
Patient Reported Outcome Survey 2
Diabetes Self-Efficacy Survey
Measured: within 2 months of transfer from pediatric care, repeated at 12 months after transfer
Patient Reported Outcome Survey 3
Diabetes Quality of Life for Youth Survey (short version)
Measured: within 2 months of transfer from pediatric care, repeated at 12 months after transfer
Clinical Outcome 1
mean total number of clinic visits with any health care professional collected from NACRS claims data and physician claims data
Measured: one year prior to transfer from pediatric care up to 18 months post transfer
Clinical Outcome 2
total number of diabetes related emergency department visits and hospitalizations for diabetic ketoacidosis
Measured: one year prior to transfer from pediatric care up to 18 months post transfer
Clinical outcome 3
mean HbA1c
Measured: one year prior to transfer from pediatric care up to 18 months post transfer
Clinical outcome 4
total number of HbA1c tests completed
Measured: one year prior to transfer from pediatric care up to 18 months post transfer
Clinical Outcome 5
mean urinary albumin:creatinine ratio
Measured: one year prior to transfer from pediatric care up to 18 months post transfer
Clinical Outcome 6
total number of urinary albumin:creatinine ratio tests completed
Measured: one year prior to transfer from pediatric care up to 18 months post transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Oct 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The usual care group is defined as the group who receives usual care and serves as the control group. This group is defined prior to the implementation of the intervention. We include a two month wash out period between our two groups to avoid care providers 'holding on' to patients they feel may benefit from the intervention
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Sonia Butalia, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300047
- Sponsor's protocol ID
- REB23-0679
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2023
- Last updated
- 1 May 2026
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aiming for Something Sweeter: Supporting Youth With Type 1 Diabetes During Transition From Pediatric to Adult Diabetes Care
- ClinicalTrials.gov ID
- NCT06300047
- Acronym / sponsor ID
- REB23-0679
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Mar 2024 (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.
The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis.
The 3 main aims are:
- To assess the effects of our transition intervention on clinical and patient-reported outcomes.
- To implement the transition intervention and evaluate the implementation outcomes.
- To evaluate the economic impacts of the transition intervention. Participants will have access to a transition coordinator before, during, and after their planned transition from pediatric to adult care as standard of care.
Researchers will compare a pre-intervention cohort to evaluate the impact of the transition coordinator intervention.
Detailed description
Both usual care and intervention groups will receive routine diabetes care as per Canadian national guidelines. Usual care (routine care) includes regular appointments with their pediatric diabetes care team (i.e., pediatric endocrinologist, diabetes nurse or dietician) and post-transfer with their adult diabetes team (i.e., physician and as needed visits with a diabetes educator and/or a dietician). The transition process usually starts at age 14 with discussions during clinic with youth and families around increased autonomy, self-care, organization of adult healthcare services and specific transition topics such as driving, drugs, alcohol, relationships, finances and living away from home.
The usual care group is defined as the group who receives usual care and serves as the control group. This group is defined prior to the implementation of the intervention. We include a two month wash out period between our two groups to avoid care providers 'holding on' to patients they feel may benefit from the intervention.
The intervention group (in addition to usual care) is provided additional support by way of a non-medical transition coordinator during the transition and transfer from pediatric to adult diabetes care. The non-medical transition coordinator encourages problem solving, self-management skills, and supports navigating the 'adult world'. In the year prior to transfer, the transition coordinator will meet each participant in person or virtually once during their routine pediatric diabetes appointment to explain their role prior to transfer. The transition coordinator role includes the following tasks: (1) use of text messaging, email, or phone communication (as per participant's preference) to maintain contact with the participant every 2 months for 12 months past the transfer date; (2) use of text messaging, email, or telephone as needed when participants reach out to them to answer any questions whereby the transition coordinator would provide direction; (3) assisting participants with finding family physicians (if needed); (4) assisting with completion of financial assistance, disability, insurance forms; (4) addressing any stated psychosocial needs by relaying information on community supports for participants and families; and, (5) maintaining a private Facebook® page and a transition website in which participants were encouraged to use. Website contents include information on transition, adult diabetes care (i.e., location, contact numbers, what to expect in adult care), diabetes resources as well as mental health resources. The website will be updated to have information relevant to each implementation site. We may add other types of social media to share information about transition (i.e., TikTok, Instagram), and this will be considered during our pre-implementation phase. The transition coordinator will not provide any medical advice or counselling.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The usual care group is defined as the group who receives usual care and serves as the control group. This group is defined prior to the implementation of the intervention. We include a two month wash out period between our two groups to avoid care providers 'holding on' to patients they feel may benefit from the intervention
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | No intervention | –No intervention group used as a control leading into the intervention for comparative analysis. Patients in this arm receive care as usual with no changes and are not aware of the intervention group. |
| Intervention Group | Experimental | Other: Non-Medical Transition CoordinatorPatients in this arm receive access to and support from a Transition coordinator who will meet with them prior to transition from pediatric to adult care and follow up with them every 2 months throughout the first year of their transition period utilizing phone, text, email, social media. |
Who may qualify
- Ages
- 17 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- a diagnosis of T1D according to Diabetes Canada's guidelines for at least 12 months
- aged 17 to 18 years
- have had an appointment with their pediatric endocrinologist in the last 12 months
- in the last year of pediatric care and transferring to adult care in Alberta within the next year
- English proficiency (for surveys)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Non-Medical Transition CoordinatorParticipants in this intervention arm will have access to the non-medical transition coordinator to support their transition from pediatric to adult care. | Other | Intervention Group |
Primary outcome
Lost to Followup
Time frame: within 1 year of transfer date from pediatric care
% of participants who are lost to follow up as defined by not attending at least one routine clinic visit in adult diabetes care with a health care professional to be ascertained from physician billing claims or NACRS claims data
9 secondary outcomes
Patient Reported Outcome Survey 1
Time frame: within 2 months of transfer from pediatric care, repeated at 12 months after transfer
Patient Reported Outcome Survey 2
Time frame: within 2 months of transfer from pediatric care, repeated at 12 months after transfer
Patient Reported Outcome Survey 3
Time frame: within 2 months of transfer from pediatric care, repeated at 12 months after transfer
Clinical Outcome 1
Time frame: one year prior to transfer from pediatric care up to 18 months post transfer
Clinical Outcome 2
Time frame: one year prior to transfer from pediatric care up to 18 months post transfer
Clinical outcome 3
Time frame: one year prior to transfer from pediatric care up to 18 months post transfer
Clinical outcome 4
Time frame: one year prior to transfer from pediatric care up to 18 months post transfer
Clinical Outcome 5
Time frame: one year prior to transfer from pediatric care up to 18 months post transfer
Clinical Outcome 6
Time frame: one year prior to transfer from pediatric care up to 18 months post transfer
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 1 May 2026.
- 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.
Sonia Butalia, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Medical Transition Coordinator in people with Type 1 Diabetes, run by University of Calgary at 1 site 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 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 1 May 2026. 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 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?
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?
Lost to Followup (time frame: within 1 year of transfer date from pediatric care). 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 1 May 2026.