Diabetes Mellitus, Type 1KiTNCT05434754
Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care
A study testing eHealth Tool in people with Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 6 sites in Canada.
Trial summary
The investigators are testing the effectiveness of an eHealth digital tool co-designed with patients and providers to improve diabetes self-efficacy in young adults as they transition to adult type 1 diabetes care. Read more about this study
- Who is it for?
- Ages 17 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- eHealth Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 6 sitesCanada
- Study dates
- 16 Jan 2022to 23 Aug 2025
- 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 17 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with type 1 diabetes, ascertained from patient's medical chart
- Receiving out-patient care for T1D at a pediatric diabetes center participating in this study
- Is within 6 months of either planned transfer or 18th birthday so research coordinator can approach patient and inform them about the study, and then can be re-approached for consenting and enrollment only within 3-4 months of either: planned transfer to adult diabetes care OR 18th birthday
- Proficient in written and spoken English or French
- Possession of their own personal mobile device that can support SMS with sufficient capacity to send and receive SMS/texts
- Valid and working mobile phone number
Show all 10Show fewer
- Valid email address
- Willing to engage with intervention if randomized to intervention arm
- Willing to complete study outcome measures (questionnaires) at all study time-points regardless of which arm they are randomized to: baseline, 6 months, and 12 months
- Willing to provide informed consent
Who cannot join
- Unable to carry out their diabetes care independently due to an intellectual or neurocognitive disability; discerned from medical chart during pre-screening
- Non-resident of Ontario or Quebec
- Planning to move out of either province in the next 6-12 months and after moving, will not be receiving diabetes care in either province and/or will not have a valid and working mobile number
- Currently enrolled in any other clinical research trial with an SMS-based intervention
- Currently enrolled in another diabetes intervention trial that will continue beyond the final pediatric diabetes visit
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Oak Valley Health
Markham, Ontario, L9P1S4
Trillium Health Partners
Mississauga, Ontario, L5B2V2
McGill University Health Center
Montreal, Quebec, H3G1A4
Saint Justine Hospital
Montreal, Quebec, H3T1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H8L1
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
About this study
Official title: Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care: a Randomized Control Trial Testing the Effectiveness of an eHealth Text Message-based Intervention to Improve Diabetes Self-efficacy
The investigators are testing the effectiveness of an eHealth digital tool co-designed with patients and providers to improve diabetes self-efficacy in young adults as they transition to adult type 1 diabetes care.
Read the detailed description
The intervention is an eHealth digital solution co-designed with patients and providers. The intervention is a text message based algorithm that operates similar to a chatbot and will send SMS messages to participants in the experimental arm, consisting of T1D personalized support, education, resources, and a collection of outcome measures. Participants in the control arm will also be onboarded to the KiT algorithm but will only receive text-messages asking them to complete outcome measures at baseline, 6 and 12 months -- all outcome measures will be URL linkouts to REDCap surveys, housed on the SickKids REDCap servers. An embedded process evaluation of high and low engagers will also be conducted to understand how and why the intervention achieved or failed to achieve the desired effects.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- eHealth Tool
- 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.
eHealth ToolOther
text messaging algorithm
| Study group | Role | What they receive |
|---|---|---|
| eHealth Tool | Experimental | The Intervention is a text messaging algorithm that will operate like a chatbot, querying adolescents with T1D about their confidence with different aspects of T1D self-management as they are preparing to transition to adult diabetes care. The intervention has 4 components of messaging: personalized Educational Content, Standard Educational Curriculum, Provide participant compensation for filling out the questionnaires, Question \& Answer feature. Receives: Other: eHealth Tool |
| Control | No intervention | Participants randomized to the control arm will also be offered the same incentives to complete questionnaires (outcome measures) but will not receive any other components of the intervention - no personalized/customized support or diabetes resource messages and no reminders. Control arm participants will continue with their usual T1D transition care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the effect of a text message-based T1D transition intervention compared to control at 12 months in the Self-Efficacy for Diabetes management scale. A higher score indicates better self-efficacy.
The primary objective of this study is to compare the effectiveness of a text message-based T1D transition intervention that will personalize transition education and support, as an adjunct to usual T1D transition care versus usual transition care alone on a patient-reported outcome measure (PROM) called the Self-Efficacy for Diabetes Management (SEDM) scale, measured at 12 months after enrollment in the study. The SEDM has scale from 1-10 where 1 denotes 'not at all sure' and 10 denotes 'completely sure' where higher scores mean better outcomes. Minimal clinically important difference is 10%.
Measured: 12 months
Secondary outcomes (17)
Compare text message-based T1D transition intervention to control at 6 months in the Self-Efficacy for Diabetes management scale. Higher score indicates better self efficacy.
A secondary objective of this study is to compare the effectiveness of a text message-based T1D transition intervention that will personalize transition education and support, as an adjunct to usual T1D transition care versus usual transition care alone on a patient-reported outcome measures (PROM) called the Self-Efficacy for Diabetes Management (SEDM) scale, measured at 6 months.
The SEDM has scale from 1-10 where 1 denotes 'not at all sure' and 10 denotes 'completely sure' where higher scores mean better outcomes.
Minimal clinically important difference is 10%.
Measured: 6 months
To compare diabetes self-efficacy in the intervention vs. control group at baseline. A higher score indicates better self efficacy.
The Self-Efficacy for Diabetes Management (SEDM) scale will be used to measure diabetes self-efficacy at baseline. The SEDM has scale from 1-10 where 1 denotes 'not at all sure' and 10 denotes 'completely sure' where higher scores mean better outcomes.
Minimal clinically important difference is 10%.
Measured: Baseline
Evaluate the impact of this text message-based intervention compared to usual care at 12 months using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) Tool. Higher scores indicating more confidence
- transition readiness measured by the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) tool at 12 months; READDY is a transition readiness assessment for emerging adults with diabetes diagnosed in youth. The READDY tool assesses diabetes-related knowledge or skill items by querying respondents on 42 total items split into 5 domains: knowledge, navigation, health behaviors, and insulin pump skills. Respondents answer on a Likert scale from "yes, I can do this" scored 5 to "Haven't thought about it" scored 1; confidence level is evaluated in each domain with a higher score indicating more confidence
Measured: 12 months
Evaluate the impact of this text message-based intervention compared to usual care at 6 months using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) Tool. Higher scores indicating more confidence
- transition readiness measured by the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) tool at 6 months; READDY is a transition readiness assessment for emerging adults with diabetes diagnosed in youth. The READDY tool assesses diabetes-related knowledge or skill items by querying respondents on 42 total items split into 5 domains: knowledge, navigation, health behaviors, and insulin pump skills. Respondents answer on a Likert scale from "yes, I can do this" scored 5 to "Haven't thought about it" scored 1; confidence level is evaluated in each domain with a higher score indicating more confidence
Measured: 6 months
To compare transition readiness in the intervention and control groups at baseline using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) Tool. Higher scores indicating more confidence
- transition readiness measured by the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) tool at baseline. READDY is a transition readiness assessment for emerging adults with diabetes diagnosed in youth. The READDY tool assesses diabetes-related knowledge or skill items by querying respondents on 42 total items split into 5 domains: knowledge, navigation, health behaviors, and insulin pump skills. Respondents answer on a Likert scale from "yes, I can do this" scored 5 to "Haven't thought about it" scored 1; confidence level is evaluated in each domain with a higher score indicating more confidence
Measured: Baseline
Evaluate the impact of this text message-based intervention compared to usual care at 12 months on self-reported Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma subscale
- perceived stigma of living with T1D using the Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma Subscale; in our study, stigma will be defined as an affirmative response to at least one of three key items on this subscale. The scale ranges from "not at all true" (1) to "completely true" (5). Where a score greater than 2 to at least 1 of 3 key items indicates stigma.
Measured: 12 months
Evaluate the impact of this text message-based intervention compared to usual care at 6 months on self-reported Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma subscale
- perceived stigma of living with T1D using the Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma Subscale; in our study, stigma will be defined as an affirmative response to at least one of three key items on this subscale. The scale ranges from "not at all true" (1) to "completely true" (5). Where a score greater than 2 to at least 1 of 3 key items indicates stigma.
Measured: 6 months
To compared perceived stigma of living with T1D between the intervention and control groups at baseline using the self-reported Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma subscale
- perceived stigma of living with T1D using the Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma Subscale; in our study, stigma will be defined as an affirmative response to at least one of three key items on this subscale. The scale ranges from "not at all true" (1) to "completely true" (5). Where a score greater than 2 to at least 1 of 3 key items indicates stigma.
Measured: baseline
Evaluate the impact of this text message-based intervention compared to usual care at 12 months using self-reported A1c values
- A1c will be self-reported in the following categories of values: < 7%, 7 to < 8%, 8 to < 9%, >9% where higher percentage indicates poorer diabetes management
Measured: 12 months
Evaluate the impact of this text message-based intervention compared to usual care at 6 months using self-reported A1c
A1c will be self-reported in the following categories of values: < 7%, 7 to < 8%, 8 to < 9%, >9% where higher percentage indicates poorer diabetes management
Measured: 6 months
To compare A1c between the intervention and control groups at baseline by measuring self-reported A1c
A1c will be self-reported in the following categories of values: < 7%, 7 to < 8%, 8 to < 9%, >9% where higher percentage indicates poorer diabetes management
Measured: baseline
Evaluate the impact of this text message-based intervention compared to usual care on number of diabetes-related ED visits during the 12 months of intervention
- Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 12 months of intervention. ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario. RAMQ manages, administers and publishes health data in the province of Quebec.
Measured: 12 months
To compare the number of diabetes-related ED visits in the 24 months prior to enrolment in the intervention vs. control group at baseline
- Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 24 months prior to enrolment. ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario. RAMQ manages, administers and publishes health data in the province of Quebec.
Measured: baseline
Evaluate the impact of this text message-based intervention compared to usual care on number of diabetes-related hospitalizations and length of diabetes-related hospitalizations during the 12 months of intervention
- Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 12 months of intervention. ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario. RAMQ manages, administers and publishes health data in the province of Quebec.
Measured: 12 months
Number of diabetes-related hospitalizations and length of diabetes-related hospitalizations 24 months prior to intervention for both intervention and control populations to describe baseline characteristics
- Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 24 months prior to enrolment. ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario. RAMQ manages, administers and publishes health data in the province of Quebec.
Measured: Baseline
Evaluate the impact of this text message-based intervention costs compared to usual care costs
- Costs of implementation will be collected to ascertain the cost of developing and using this intervention in a hospital setting in Ontario and Quebec; variables that will be collected for this analysis will include: salaries for staff working on the design, development and management of the intervention for the entire intervention duration; salary of research coordinators working to onboard participants to the intervention; cost of digital services and office equipment needed to develop and manage the intervention (computers, hosting service, servers); cost of REDcap servers and hospital IT support for REDCap integration with MEMOTEXT platform
- Aggregate and direct medical costs associated with the intervention and its implementation will be measured for the 12 months of the intervention duration using study and administrative data
Measured: 12 months
Exploring how the KiT large language model (LLM) chatbot is used in a real-world setting.
- Analyses for the preliminary safety and performance KiT LLM chatbot testing will include descriptively describing whether the LLM Evaluator acts more conservatively than human raters when scoring answers, and if the answers generated by KiT LLM are acceptable based on the graded criteria.
- After the trial is completed, the investigators will analyze conversation logs between participants and KiT LLM to derive effective engagement with the bot. This will include analyzing the conversation between participants and KiT LLM (eg, duration, breadth, and depth of bot usage).
- The performance of the LLM Evaluator will also be assessed by evaluating conversations flagged and any potentially sensitive conversations missed. This evaluation will provide insights into how KiT LLM was used in a real-world setting and opportunities to improve its performance over time.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start16 Jan 2022
- Primary completion23 Aug 2025
- Study completion23 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Trillium Health Partners, University Health Network, Toronto
- Responsible party
- Principal investigator, Rayzel Shulman, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434754
- Sponsor's protocol ID
- 3986
- Acronym
- KiT
- Status last verified
- Apr 2026
- First submitted
- 29 May 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanmugalingham G, Mok E, Cafazzo JA, Desveaux L, Brazeau AS, Booth GL, Greenberg M, Kichler J, Rac VE, Austin P, Goldbloom E, Henderson M, Landry A, Zenlea I, Taylor M, Nakhla M, Shulman R. Text message-based intervention, Keeping in Touch (KiT), to support youth as they transition to adult type 1 diabetes care: a protocol for a multisite randomised controlled superiority trial. BMJ Open. 2023 May 8;13(5):e071396. doi: 10.1136/bmjopen-2022-071396.
PubMed 37156577
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care: a Randomized Control Trial Testing the Effectiveness of an eHealth Text Message-based Intervention to Improve Diabetes Self-efficacy
- ClinicalTrials.gov ID
- NCT05434754
- Acronym / sponsor ID
- KiT / 3986
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Trillium Health Partners, University Health Network, Toronto
- Study start
- 16 Jan 2022 (actual)
- Primary completion
- 23 Aug 2025 (actual)
- Study completion
- 23 Aug 2025 (actual)
- First posted
- 28 Jun 2022 (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 investigators are testing the effectiveness of an eHealth digital tool co-designed with patients and providers to improve diabetes self-efficacy in young adults as they transition to adult type 1 diabetes care.
Detailed description
The intervention is an eHealth digital solution co-designed with patients and providers. The intervention is a text message based algorithm that operates similar to a chatbot and will send SMS messages to participants in the experimental arm, consisting of T1D personalized support, education, resources, and a collection of outcome measures. Participants in the control arm will also be onboarded to the KiT algorithm but will only receive text-messages asking them to complete outcome measures at baseline, 6 and 12 months -- all outcome measures will be URL linkouts to REDCap surveys, housed on the SickKids REDCap servers. An embedded process evaluation of high and low engagers will also be conducted to understand how and why the intervention achieved or failed to achieve the desired effects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eHealth Tool | Experimental | Other: eHealth ToolThe Intervention is a text messaging algorithm that will operate like a chatbot, querying adolescents with T1D about their confidence with different aspects of T1D self-management as they are preparing to transition to adult diabetes care. The intervention has 4 components of messaging: personalized Educational Content, Standard Educational Curriculum, Provide participant compensation for filling out the questionnaires, Question \& Answer feature. |
| Control | No intervention | –Participants randomized to the control arm will also be offered the same incentives to complete questionnaires (outcome measures) but will not receive any other components of the intervention - no personalized/customized support or diabetes resource messages and no reminders. Control arm participants will continue with their usual T1D transition care. |
Who may qualify
- Ages
- 17 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Diagnosed with type 1 diabetes, ascertained from patient's medical chart
- Receiving out-patient care for T1D at a pediatric diabetes center participating in this study
- Is within 6 months of either planned transfer or 18th birthday so research coordinator can approach patient and inform them about the study, and then can be re-approached for consenting and enrollment only within 3-4 months of either: planned transfer to adult diabetes care OR 18th birthday
- Proficient in written and spoken English or French
- Possession of their own personal mobile device that can support SMS with sufficient capacity to send and receive SMS/texts
Key exclusion criteria (5 listed)
- Unable to carry out their diabetes care independently due to an intellectual or neurocognitive disability; discerned from medical chart during pre-screening
- Non-resident of Ontario or Quebec
- Planning to move out of either province in the next 6-12 months and after moving, will not be receiving diabetes care in either province and/or will not have a valid and working mobile number
- Currently enrolled in any other clinical research trial with an SMS-based intervention
- Currently enrolled in another diabetes intervention trial that will continue beyond the final pediatric diabetes visit
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 |
|---|---|---|
| eHealth Tooltext messaging algorithm | Other | eHealth Tool |
Primary outcome
To test the effect of a text message-based T1D transition intervention compared to control at 12 months in the Self-Efficacy for Diabetes management scale. A higher score indicates better self-efficacy.
Time frame: 12 months
The primary objective of this study is to compare the effectiveness of a text message-based T1D transition intervention that will personalize transition education and support, as an adjunct to usual T1D transition care versus usual transition care alone on a patient-reported outcome measure (PROM) called the Self-Efficacy for Diabetes Management (SEDM) scale, measured at 12 months after enrollment in the study. The SEDM has scale from 1-10 where 1 denotes 'not at all sure' and 10 denotes 'completely sure' where higher scores mean better outcomes. Minimal clinically important difference is 10%.
17 secondary outcomes
Compare text message-based T1D transition intervention to control at 6 months in the Self-Efficacy for Diabetes management scale. Higher score indicates better self efficacy.
Time frame: 6 months
To compare diabetes self-efficacy in the intervention vs. control group at baseline. A higher score indicates better self efficacy.
Time frame: Baseline
Evaluate the impact of this text message-based intervention compared to usual care at 12 months using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) Tool. Higher scores indicating more confidence
Time frame: 12 months
Evaluate the impact of this text message-based intervention compared to usual care at 6 months using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) Tool. Higher scores indicating more confidence
Time frame: 6 months
To compare transition readiness in the intervention and control groups at baseline using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) Tool. Higher scores indicating more confidence
Time frame: Baseline
Evaluate the impact of this text message-based intervention compared to usual care at 12 months on self-reported Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma subscale
Time frame: 12 months
Evaluate the impact of this text message-based intervention compared to usual care at 6 months on self-reported Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma subscale
Time frame: 6 months
To compared perceived stigma of living with T1D between the intervention and control groups at baseline using the self-reported Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma subscale
Time frame: baseline
Evaluate the impact of this text message-based intervention compared to usual care at 12 months using self-reported A1c values
Time frame: 12 months
Evaluate the impact of this text message-based intervention compared to usual care at 6 months using self-reported A1c
Time frame: 6 months
To compare A1c between the intervention and control groups at baseline by measuring self-reported A1c
Time frame: baseline
Evaluate the impact of this text message-based intervention compared to usual care on number of diabetes-related ED visits during the 12 months of intervention
Time frame: 12 months
To compare the number of diabetes-related ED visits in the 24 months prior to enrolment in the intervention vs. control group at baseline
Time frame: baseline
Evaluate the impact of this text message-based intervention compared to usual care on number of diabetes-related hospitalizations and length of diabetes-related hospitalizations during the 12 months of intervention
Time frame: 12 months
Number of diabetes-related hospitalizations and length of diabetes-related hospitalizations 24 months prior to intervention for both intervention and control populations to describe baseline characteristics
Time frame: Baseline
Evaluate the impact of this text message-based intervention costs compared to usual care costs
Time frame: 12 months
Exploring how the KiT large language model (LLM) chatbot is used in a real-world setting.
Time frame: 12 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 29 Apr 2026.
- Derived from this study: PubMed 37156577Sanmugalingham G, Mok E, Cafazzo JA, Desveaux L, Brazeau AS, Booth GL, Greenberg M, Kichler J, Rac VE, Austin P, Goldbloom E, Henderson M, Landry A, Zenlea I, Taylor M, Nakhla M, Shulman R. Text message-based intervention, Keeping in Touch (KiT), to support youth as they transition to adult type 1 diabetes care: a protocol for a multisite randomised controlled superiority trial. BMJ Open. 2023 May 8;13(5):e071396. doi: 10.1136/bmjopen-2022-071396.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth Tool in people with Diabetes Mellitus, Type 1, run by The Hospital for Sick Children at 6 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 10 inclusion and 5 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
To test the effect of a text message-based T1D transition intervention compared to control at 12 months in the Self-Efficacy for Diabetes management scale. A higher score indicates better self-efficacy. (time frame: 12 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 NCT05434754, which also lists 1 linked publication.
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 29 Apr 2026.