Support-t Online Training for Type 1 Diabetes Transition Care

(Support-t Trial)

Recruiting at 3 trial locations

Overseen By Amelie Roy-Fleming, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Anne-Sophie Brazeau

Disqualifiers: Severe neurocognitive disabilities, hemolytic anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on online training and support, so it's likely you can continue your usual diabetes care.

What data supports the effectiveness of the treatment Support-t Online Training for Type 1 Diabetes Transition Care?

The research on a similar eHealth tool for self-management in type 1 diabetes showed that it was well accepted by users and had a positive impact on learning self-management skills, which could help prevent complications related to diabetes. ^{1 2 3 4 5}

How is the Support-t Online Training treatment for Type 1 Diabetes unique?

Support-t Online Training is unique because it focuses on helping young adults transition from pediatric to adult diabetes care, aiming to improve clinic attendance, diabetes control, and reduce hospital admissions. Unlike traditional treatments that focus solely on medical management, this program provides structured support during a critical life stage, addressing both medical and psychosocial needs. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Anne-Sophie Brazeau, PhD

Principal Investigator

School of Human Nutrition - McGill University

Eligibility Criteria

This trial is for 14-16 year olds with Type 1 Diabetes who are patients at one of four specific pediatric diabetes clinics in Quebec. They must have internet access, an active email, and speak English or French. It's not specified who can't join.

Inclusion Criteria

I am a teenager diagnosed with Type 1 Diabetes.

Having access to internet

I am between 14 and 16 years old.

Exclusion Criteria

Severe neurocognitive disabilities

I have a condition like hemolytic anemia that affects my red blood cell lifespan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive access to the Support-t online training and peer support platform in addition to usual diabetes care

18 months

Regular visits as per usual diabetes care

Follow-up

Participants are monitored for changes in HbA1c and other secondary outcomes

18 months

Assessments at baseline, 6, 12, and 18 months

Post-study Access

Control group participants have the option to use the Support-t platform after the 18-month study

Treatment Details

Interventions

• Support-t

Trial Overview The study tests 'Support-t', an online training and peer support platform designed to help youths with Type 1 Diabetes as they prepare to move from child to adult care services. The effect on blood sugar control, health outcomes, and mental well-being will be compared with usual care.

Participant Groups

Group I: Support-t plus usual diabetes care Experimental Treatment 1 Intervention

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.

Group II: Usual diabetes care only Active Control 1 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.

Support-t is already approved in Canada for the following indications:

Approved in Canada as Support-t for:

• Type 1 Diabetes Transition Support

Who Is Running the Clinical Trial?

Anne-Sophie Brazeau

Lead Sponsor

Trials

1

Recruited

200+

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

CHU de Quebec-Universite Laval

Collaborator

Trials

177

Recruited

110,000+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Trials

64

Recruited

33,600+

CSSS de Gatineau

Collaborator

Trials

2

Recruited

250+

Findings from Research

A pilot study involving 35 participants with type 1 diabetes demonstrated that a user-centered eHealth tool for functional insulin therapy (FIT) was well accepted and positively impacted learning outcomes.

The study found strong correlations between users' success in learning tasks and their perceived utility, educational adequacy, and ease of use of the tool, suggesting it effectively supports self-management skills in diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centered approach in the development of an eHealth tool for self-management skills in functional insulin therapy to prevent complications of diabetes. Fezzi, C., Refahi, H., Albuisson, E., et al.[2022]

A study involving 35 patients with type 1 diabetes showed that insulin pump user retraining significantly improved their knowledge and application skills related to insulin management, leading to better glycemic control as indicated by a reduction in HbA1c levels.

Despite the improvements in knowledge and metabolic parameters, the retraining did not result in significant changes in quality of life or treatment satisfaction, suggesting that while retraining is beneficial for managing diabetes, it may not address all aspects of patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Retraining on Treatment Success, Quality of Life, and Metabolic Parameters in Patients with Type 1 Diabetes Using an Insulin Pump. Ozgen Saydam, B., Yilmazmis, F., Aydin, N., et al.[2022]

Patients with type 1 diabetes who attended structured education programs reported varying preferences for social support, which influenced their self-management practices and ability to sustain new skills over time.

The study found that patients often sought more social support after learning self-management skills, but the effectiveness of this support could be hindered by outdated knowledge from family members, highlighting the need for better education for patients' social networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 diabetes patients' experiences of, and need for, social support after attending a structured education programme: a qualitative longitudinal investigation. Rankin, D., Barnard, K., Elliott, J., et al.[2022]

A study involving 14 patients with type 1 diabetes and 11 healthcare providers highlighted that effective education and support for exercise are influenced by both patient engagement and the consistency of information from care providers.

To improve exercise support for patients with type 1 diabetes, any educational program should be tailored to individual patient needs, delivered early after diagnosis, and include peer stories to enhance relatability, while also ensuring healthcare staff receive proper training to provide consistent advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Healthcare Professionals Perspectives on the Delivery of Exercise Education for Patients With Type 1 Diabetes. Litchfield, I., Andrews, RC., Narendran, P., et al.[2021]

A virtual platform called EncoDiab was developed based on feedback from 33 type 1 diabetes patients, providing tools and resources to aid in self-management of their condition.

The platform includes practical tools like an insulin-dose calculator and a library of information, demonstrating its feasibility for improving patient engagement and management of type 1 diabetes in a public health setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, construction, and implementation of an online platform for patients with type 1 diabetes: EncoDiab. Alvarado-Martel, D., Cañas, F., Velasco, R., et al.[2020]

A transition support program for young adults with Type 1 diabetes significantly improved diabetes control, with HbA1c levels decreasing from 9.3% to 8.8% after a median of five clinic visits, indicating better management of blood sugar levels.

The program also led to a one-third reduction in hospital admissions for diabetic ketoacidosis (DKA) and decreased the length of hospital stays, demonstrating its effectiveness in preventing serious complications and suggesting that the cost savings from reduced admissions offset the program's expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A transition care programme which improves diabetes control and reduces hospital admission rates in young adults with Type 1 diabetes aged 15-25 years. Holmes-Walker, DJ., Llewellyn, AC., Farrell, K.[2022]

A structured transition program for young adults with type 1 diabetes significantly improved clinic attendance and satisfaction with care during the 18-month intervention, with participants attending an average of 4.1 visits compared to 3.6 in standard care.

While the program reduced diabetes-related distress and showed a trend toward better glycemic control (HbA1c levels), these benefits did not persist 12 months after the intervention ended, indicating the need for ongoing support beyond the initial program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closing the Gap: Results of the Multicenter Canadian Randomized Controlled Trial of Structured Transition in Young Adults With Type 1 Diabetes. Spaic, T., Robinson, T., Goldbloom, E., et al.[2022]

The PATHWAY program is the first structured transition initiative for young individuals with Type 1 diabetes in Delhi, India, designed to improve their transition from pediatric to adult care through a series of educational and behavioral sessions over 15 months.

The program includes a unique 'overlap period' where patients alternate visits between pediatric and adult providers, aiming to enhance self-management and clinic attendance, which is crucial for better health outcomes in emerging adults with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and design of the first structured clinic-based program in lower resource settings to transition emerging adults with type 1 diabetes from pediatric to adult care. Cristello Sarteau, A., Peerzada, A., Goyal, A., et al.[2023]

A survey of 53 adult diabetes care providers revealed that less than half were familiar with the American Diabetes Association's guidelines on transition care for young adults with Type 1 diabetes, indicating a knowledge gap in best practices.

Despite a strong interest in improving transition care, significant barriers exist, such as inadequate preparation from pediatric teams and limited access to psychosocial services, which hinder effective implementation of transition strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult care providers' perspectives on the transition to adult care for emerging adults with Type 1 diabetes: a cross-sectional survey. Michaud, S., Dasgupta, K., Bell, L., et al.[2019]

Transitioning from pediatric to adult care for patients with type 1 diabetes is often difficult, with unstable metabolic control and the need to address psychiatric and social factors during this period.

Establishing an interdisciplinary transfer clinic and ensuring close collaboration between pediatricians and adult endocrinologists can significantly improve the success of this transition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Building bridges during transition of patients with type 1 diabetes. Adult medical and pediatric point of views]. Busse-Voigt, FP., Kiess, W., Stumvoll, M., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

User-centered approach in the development of an eHealth tool for self-management skills in functional insulin therapy to prevent complications of diabetes. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Retraining on Treatment Success, Quality of Life, and Metabolic Parameters in Patients with Type 1 Diabetes Using an Insulin Pump. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Type 1 diabetes patients' experiences of, and need for, social support after attending a structured education programme: a qualitative longitudinal investigation. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Patient and Healthcare Professionals Perspectives on the Delivery of Exercise Education for Patients With Type 1 Diabetes. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Design, construction, and implementation of an online platform for patients with type 1 diabetes: EncoDiab. [2020]

6. England pubmed.ncbi.nlm.nih.gov

A transition care programme which improves diabetes control and reduces hospital admission rates in young adults with Type 1 diabetes aged 15-25 years. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Closing the Gap: Results of the Multicenter Canadian Randomized Controlled Trial of Structured Transition in Young Adults With Type 1 Diabetes. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Development and design of the first structured clinic-based program in lower resource settings to transition emerging adults with type 1 diabetes from pediatric to adult care. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Adult care providers' perspectives on the transition to adult care for emerging adults with Type 1 diabetes: a cross-sectional survey. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Building bridges during transition of patients with type 1 diabetes. Adult medical and pediatric point of views]. [2021]