Support-t Online Training in Youth Living With Type 1 Diabetes Transitioning to Adult Care

NCT05910840 | Recruiting

• 1 other identifier: MP-37-2024-9734
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

The investigators will conduct a randomized controlled trial (RCT) to examine how an online training and peer support platform could help the preparation to transition to adult care. Among 14-16 year old youth with Type 1 Diabetes (T1D), the investigators aim to assess the effect of an online training and peer support platform (Support-t) integrated in usual care, compared with usual care on Hemoglobin A1c (HbA1c), adverse outcomes and psychosocial measures during the preparation for transition to adult care. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority RCT of adolescents with T1D (14-16 years of age) followed at one of 4 university teaching hospital-based pediatric diabetes clinics in the province of Quebec.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders (Including Diabetes Mellitus); Metabolic Disease; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Keywords

Transition Care; Pediatric; Adolescent; Education; Hemaglobin A1c; Self-management; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Hemaglobin A1c (HbA1c) at 18 months

  HbA1c measured with a venous or capillary blood sample as part of the standard of diabetes care will be derived from the medical record chart or measured using an A1c Test Kit, which is a non-fasting, finger prick, whole blood test

  18 months

Secondary Outcomes (18)

• Change from Baseline Hemaglobin A1c (HbA1c) at 6 and 12 months

  6, 12 months

• Continuous Glucose Monitoring (CGM) - % Time in range

  0, 6, 12, 18 months

• Continuous Glucose Monitoring (CGM) - % Time above range

  0, 6, 12, 18 months

• Continuous Glucose Monitoring (CGM) - % Time below range

  0, 6, 12, 18 months

• Continuous Glucose Monitoring (CGM) - Standard deviation

  0, 6, 12, 18 months

Other Outcomes (14)

• Engagement with Support-t platform (T1D patient) - time in minutes on platform

  6, 12, 18 months

• Engagement with Support-t platform (T1D patient) - discussion forum participation

  6, 12, 18 months

• Engagement with Support-t platform (T1D patient) - content accessed

  6, 12, 18 months

Study Arms (2)

Support-t plus usual diabetes care

EXPERIMENTAL

Access to the Support-t online training and peer support platform in addition to usual diabetes care for 18 months. Support-t contains 3 components: 1) Educational material, 2) News blog and 3) Patients' discussion forum. Health care providers from the pediatric diabetes clinics will receive Support-t training and will be encouraged to recommend the Support-t platform during routine care with their patients from the active arm.

Other: Support-t

Usual diabetes care only

NO INTERVENTION

Usual diabetes care for 18 months, which consists of visits with their health care provider and ad-hoc diabetes education with nurses and dietitians. Health care providers from the pediatric diabetes clinics will be instructed not to discuss or refer to the Support-t platform with patients from the control arm. Control arm participants will have the option to use the Support-t platform after the 18-month study.

Interventions

Support-t OTHER

Support-t plus usual diabetes care for 18 months

Support-t plus usual diabetes care

Eligibility Criteria

• Age: 14 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents with a clinical diagnosis of T1D
• years of age
• Receiving diabetes care at one of 4 university teaching hospital-based pediatric diabetes clinics in Quebec: Montreal Children's Hospital-McGill University Health Centre, Centre hospitalier universitaire de Sherbrooke, Le Copain-Hôpital de Gatineau, Centre Hospitalier Universitaire de Québec
• Having access to internet
• Having an active email address
• Fluent in English or French

You may not qualify if:

• Severe neurocognitive disabilities
• Patients with conditions associated with shortened erythrocyte survival, such as hemolytic anemia or other conditions associated with inaccurate HbA1c

Sponsors & Collaborators

• Anne-Sophie Brazeau: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• CSSS de Gatineau: collaborator
• Centre de recherche du CHU de Sherbrooke: collaborator
• CHU de Quebec-Universite Laval: collaborator

Study Sites (4)

Clinique de pédiatrie Le Copain-Hôpital de Gatineau

Gatineau, Canada

NOT YET RECRUITING

Montreal Children's Hospital - McGill University Health Centre

Montreal, Canada

RECRUITING

Centre Hospitalier Universitaire de Québec

Québec, Canada

NOT YET RECRUITING

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Canada

NOT YET RECRUITING

Related Publications (14)

• 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.

  PMID: 37156577 BACKGROUND

• Xie LF, Housni A, Nakhla M, Cianci R, Leroux C, Da Costa D, Brazeau AS. Adaptation of an Adult Web Application for Type 1 Diabetes Self-management to Youth Using the Behavior Change Wheel to Tailor the Needs of Health Care Transition: Qualitative Interview Study. JMIR Diabetes. 2023 Apr 26;8:e42564. doi: 10.2196/42564.

  PMID: 37121571 BACKGROUND

• Ladd JM, Reeves-Latour J, Dasgupta K, Bell LE, Anjachak N, Nakhla M. Toward a better understanding of transition from paediatric to adult care in type 1 diabetes: A qualitative study of adolescents. Diabet Med. 2022 May;39(5):e14781. doi: 10.1111/dme.14781. Epub 2022 Jan 7.

  PMID: 34967058 BACKGROUND

• Mok E, Henderson M, Dasgupta K, Rahme E, Hajizadeh M, Bell L, Prevost M, Frei J, Nakhla M. Group education for adolescents with type 1 diabetes during transition from paediatric to adult care: study protocol for a multisite, randomised controlled, superiority trial (GET-IT-T1D). BMJ Open. 2019 Nov 11;9(11):e033806. doi: 10.1136/bmjopen-2019-033806.

  PMID: 31719096 BACKGROUND

• Alwadiy F, Mok E, Dasgupta K, Rahme E, Frei J, Nakhla M. Association of Self-Efficacy, Transition Readiness and Diabetes Distress With Glycemic Control in Adolescents With Type 1 Diabetes Preparing to Transition to Adult Care. Can J Diabetes. 2021 Jul;45(5):490-495. doi: 10.1016/j.jcjd.2021.05.006. Epub 2021 May 19.

  PMID: 34176613 BACKGROUND

• Michaud S, Dasgupta K, Bell L, Yale JF, Anjachak N, Wafa S, Nakhla M. Adult care providers' perspectives on the transition to adult care for emerging adults with Type 1 diabetes: a cross-sectional survey. Diabet Med. 2018 Jul;35(7):846-854. doi: 10.1111/dme.13627. Epub 2018 May 2.

  PMID: 29577410 BACKGROUND

• Lafontaine S, Mok E, Frei J, Henderson M, Rahme E, Dasgupta K, Nakhla M. Associations of Diabetes-related and Health-related Quality of Life With Glycemic Levels in Adolescents With Type 1 Diabetes Preparing to Transition to Adult Care. Can J Diabetes. 2023 Aug;47(6):525-531. doi: 10.1016/j.jcjd.2023.05.002. Epub 2023 May 12.

  PMID: 37182591 BACKGROUND

• Soufi A, Mok E, Henderson M, Dasgupta K, Rahme E, Nakhla M. Association of stigma, diabetes distress and self-efficacy with quality of life in adolescents with type 1 diabetes preparing to transition to adult care. Diabet Med. 2024 Jan;41(1):e15159. doi: 10.1111/dme.15159. Epub 2023 Jun 21.

  PMID: 37269172 BACKGROUND

• Wafa S, Nakhla M. Improving the Transition from Pediatric to Adult Diabetes Healthcare: A Literature Review. Can J Diabetes. 2015 Dec;39(6):520-8. doi: 10.1016/j.jcjd.2015.08.003. Epub 2015 Oct 20.

  PMID: 26498219 BACKGROUND

• Nakhla M, Daneman D, To T, Paradis G, Guttmann A. Transition to adult care for youths with diabetes mellitus: findings from a Universal Health Care System. Pediatrics. 2009 Dec;124(6):e1134-41. doi: 10.1542/peds.2009-0041. Epub 2009 Nov 23.

  PMID: 19933731 BACKGROUND

• Nakhla M, Daneman D, Frank M, Guttmann A. Translating transition: a critical review of the diabetes literature. J Pediatr Endocrinol Metab. 2008 Jun;21(6):507-16.

  PMID: 18717235 BACKGROUND

• Nakhla M, Bell LE, Wafa S, Dasgupta K. Improving the transition from pediatric to adult diabetes care: the pediatric care provider's perspective in Quebec, Canada. BMJ Open Diabetes Res Care. 2017 Jun 30;5(1):e000390. doi: 10.1136/bmjdrc-2017-000390. eCollection 2017.

  PMID: 28761657 BACKGROUND

• Robinson ME, Simard M, Larocque I, Shah J, Rahme E, Nakhla M. Psychiatric disorders in emerging adults with diabetes transitioning to adult care: A retrospective cohort study. Diabet Med. 2021 Jun;38(6):e14541. doi: 10.1111/dme.14541. Epub 2021 Feb 19.

  PMID: 33576092 BACKGROUND

• Roy-Fleming A, Nakhla M, Mok E, Vanasse A, Cianci L, Kichler J, Simoneau-Roy J, Couture Y, Gagne J, Dupont M, Brazeau AS. Support-t, an online training and peer support platform to accompany youth living with type 1 diabetes transitioning to adult healthcare: protocol of an effectiveness-implementation trial. BMJ Open. 2025 Oct 6;15(10):e105514. doi: 10.1136/bmjopen-2025-105514.

  PMID: 41057177 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Anne-Sophie Brazeau, PhD

  School of Human Nutrition - McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Sophie Brazeau, PhD

CONTACT

(514) 398-7848; anne-sophie.brazeau@mcgill.ca

Amelie Roy-Fleming, MSc

CONTACT

amelie.roy-fleming@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Active arm: Participants randomized to the active arm will have access to the Support-t online training and peer support platform in addition to their usual diabetes care, over the 18 month intervention period. Support-t contains 3 components: 1) Educational material, 2) News blog and 3) Patients' discussion forum. Control arm: Participants randomized to usual care only will attend their usual diabetes clinic visits, over the 18-month intervention period, which consists of visits with their health care provider and ad-hoc diabetes education with nurses and dietitians.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 20, 2023
• Study Start: October 7, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

CA (4)