TECC-T1D3 Program for Type 1 Diabetes and Diabetes Distress

(TECC-T1D3 Trial)

Overseen By Anika Saiva, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Non-English speakers, No phone/web access

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

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to help young adults with Type 1 Diabetes manage their mental health and overall well-being. The TECC-T1D3 Program offers weekly coaching sessions with a health coach and support from a virtual care team, all delivered remotely through various digital platforms. Another group will receive educational emails with resources for mental health and well-being. This trial suits young adults living in Ontario who have had Type 1 Diabetes for at least a year and live independently. As an unphased trial, participants contribute to innovative research that may enhance mental health support for others with Type 1 Diabetes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on mental health and wellbeing support for young adults with Type 1 Diabetes.

What prior data suggests that the TECC-T1D3 Program is safe for young adults with Type-1 Diabetes?

Research shows that the TECC-T1D3 program serves as a virtual care plan for young adults with Type 1 Diabetes and related stress. This program provides weekly coaching sessions and support from a virtual care team.

Currently, reports indicate no side effects or safety issues with this program. The trial is in the "Not Applicable" phase, focusing on the program's effectiveness and ease of use rather than solely on safety. This typically suggests that the program is considered low-risk.

In simpler terms, the TECC-T1D3 program uses technology and coaching to help manage diabetes and stress, with no evidence of safety concerns for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TECC-T1D3 Program for type 1 diabetes and diabetes distress because it offers a unique, personalized coaching experience that integrates mental health support and peer collaboration. Unlike traditional diabetes care, which often centers around medication and routine check-ups, this program provides a 12-week omnichannel coaching intervention using WebEx, phone calls, or text messaging, making it more accessible and tailored to individual needs. Additionally, participants benefit from the guidance of a virtual care team composed of mental health and T1D experts, enhancing both their physical and emotional well-being in a holistic manner.

What evidence suggests that the TECC-T1D3 Program is effective for managing Type 1 Diabetes and Diabetes Distress?

Research has shown that the TECC-T1D3 Program, which participants in this trial may receive, is designed to help young adults with Type 1 Diabetes by reducing diabetes-related stress and improving overall well-being. Participants in a similar program, called STePS, experienced significant stress reduction and increased resilience. The TECC-T1D3 Program offers personalized care by combining health coaching with support from a virtual care team. It is flexible and uses various communication methods, such as phone calls and text messages, to meet participants' needs. Early studies suggest this approach is effective and suitable for those managing Type 1 Diabetes and its emotional challenges. ^{1 2 3 6 7}

Who Is on the Research Team?

Peter Selby

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-29 in Ontario with Type 1 Diabetes diagnosed at least a year ago, who live independently and can participate in English via phone or web. It's not suitable for those needing institutional care or unable to engage in English.

Inclusion Criteria

Resident of Ontario

I have been living with Type 1 Diabetes for at least a year.

Individual is community-living (people who live independently in the community and are not residing in a setting that provides institutional care or support)

Exclusion Criteria

I cannot participate in studies in English.

Unable to participate via telephone or web-conferencing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly allocated to either a coaching intervention or an education intervention for 12 weeks. The coaching intervention includes 8-10 sessions with a health coach, while the education intervention involves receiving 10 automated emails.

12 weeks

8-10 sessions (virtual) for coaching intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-intervention interviews to discuss their experience and potential areas for improvement.

2 weeks

1 interview (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• TECC-T1D3 Program

Trial Overview

The study tests the TECC-T1D3 program, which uses technology and a virtual care team including a health coach to help manage mental health and wellbeing of young adults with Type 1 Diabetes experiencing diabetes-related stress.

How Is the Trial Designed?

Group I: Coaching Intervention (TECC-T1D3 Program) Experimental Treatment 1 Intervention

Participants will complete a 12-weeks, virtual, TECC-T1D3 program, delivered through an omnichannel, patient-centered approach, which may include WebEx, phone calls, or text messaging. The participants will complete weekly coaching sessions with the health coach and is indirectly supported by a virtual care team comprised of mental health and T1D experts as well as peer support.

Group II: Education Intervention Active Control 1 Intervention

Participants will receive a low-intensity, education-focused intervention consisting of 10 automated emails over 12 weeks, providing generalized educational messages with links to resources for mental health support and well-being for individuals living with T1D.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Brain Canada

Collaborator

Trials

22

Recruited

6,100+

Published Research Related to This Trial

A quality improvement initiative using insulin degludec and school-based nurses significantly reduced DKA readmissions in pediatric type 1 diabetes patients from an average of 5.25 to 3.64 per month, representing a 31% decrease over 11 months.

The intervention specifically targeted missed basal insulin dosing, which was responsible for 76.4% of DKA readmissions, demonstrating that this approach is both safe and effective in managing DKA in children with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Diabetic Ketoacidosis Readmissions with a Hospital-School-Based Improvement Partnership. King, ZM., Kurzum, JE., Cooper, MR., et al.[2023]

The Teplizumab Prevention Study has shown that immunotherapy can delay the onset of overt type 1 diabetes (T1D), highlighting the potential for early intervention before hyperglycemia occurs.

Current treatments for T1D often fail to help patients meet glycemic targets, which increases their risk of complications; thus, there is a pressing need for new therapeutic strategies, particularly those being explored by initiatives like Diabetes TrialNet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin is necessary but not sufficient: changing the therapeutic paradigm in type 1 diabetes. Lord, S., Greenbaum, CJ.[2020]

The healthcare and therapeutic education program (TEP) for young patients with type 1 diabetes led to a significant reduction in severe hypoglycaemias, decreasing from 0.23 to 0.05 events per patient per year, although there was no change in overall HbA1c levels after one year.

Patients using Continuous Subcutaneous Insulin Infusion (CSII) showed better adherence to the program and performed more blood glucose checks, but both CSII and Multiple Daily Injections (MDI) groups had similar metabolic control outcomes, highlighting the importance of treatment adherence for better diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a specific and structured program in the transition of young patients with type 1 diabetes from the paediatric center to an adult hospital. The experience of a decade. Vidal Flor, M., Jansà I Morató, M., Roca Espino, D., et al.[2021]

Teplizumab, an anti-CD3 monoclonal antibody, has shown promise in preserving C-peptide levels in patients with type 1 diabetes, indicating it can help maintain insulin production and reduce the need for external insulin.

While teplizumab does not cure type 1 diabetes, it represents a significant advancement in slowing disease progression and delaying complete insulin deficiency, based on data from Phase II-III clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of new onset type 1 diabetes with teplizumab: successes and pitfalls in development. Vudattu, NK., Herold, KC.[2021]

A trial involving young relatives at high risk for type 1 diabetes found that low-dose ultralente insulin did not prevent the disease or preserve insulin secretion, highlighting the challenges in early intervention.

In contrast, a pilot study showed that a humanized monoclonal antibody against CD3 improved insulin production and metabolic control in 9 out of 12 patients during the first year of type 1 diabetes, suggesting a promising new approach for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study of the month. Attempt at preservation of B cells during the initial phase of type 1 diabetes: negative results with ultralente insulin, but promising results with an anti-CD3 monoclonal antibody]. Philips, JC., Scheen, AJ.[2017]

The study involved 11 adolescents with type 1 diabetes, who shared their experiences before and after transferring from pediatric to adult care, highlighting the complexities of managing their condition during this transition.

Participants emphasized the importance of quality care and therapeutic education in both pediatric and adult settings, suggesting that understanding their perspectives can help improve the transfer process and overall management of type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 Diabetes Patient Experiences Before and After Transfer from a Paediatric to an Adult Hospital. Vidal Flor, M., Jansà I Morató, M., Yoldi Vergara, C., et al.[2022]

SGLT inhibitors, when added to insulin therapy for type 1 diabetes, significantly reduced HbA1c levels by -0.39% and improved glucose control without increasing the risk of hypoglycemia, based on a meta-analysis of 10 trials involving 5961 patients.

While SGLT inhibitors were associated with some adverse effects, such as an increased risk of genital infections and diabetic ketoacidosis, the very low dose of empagliflozin (2.5 mg) did not raise the risk of ketoacidosis, indicating a potential safe option for managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sodium-glucose cotransporter (SGLT) inhibitors in addition to insulin therapy on glucose control and safety outcomes in adults with type 1 diabetes: A meta-analysis of randomized controlled trials. Lu, J., Tang, L., Meng, H., et al.[2020]

Sotagliflozin (SOTA) significantly improves blood sugar control in type 1 diabetes mellitus (T1DM) patients, as evidenced by lower hemoglobin A1c levels, reduced insulin use, and better glucose management, based on a meta-analysis of 7 randomized controlled trials.

While SOTA is effective, it is associated with increased risks of genital mycotic infections and diabetic ketoacidosis, highlighting the need for careful monitoring of these side effects in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of sotagliflozin adjuvant therapy for type 1 diabetes mellitus: A systematic review and meta-analysis. Chen, MB., Xu, RJ., Zheng, QH., et al.[2022]

A study involving 9,583 patients with type 1 diabetes showed that participation in diabetes treatment and teaching programs (DTTPs) significantly reduced the incidence of severe hypoglycemia from 6.1 to 1.4 events per patient per year, indicating improved safety for high-risk individuals.

Patients at high risk for severe ketoacidosis also benefited, with a reduction in severe ketoacidosis events from 3.3 to 0.6 per patient per year and a decrease in hospitalization days from 19.4 to 10.2, demonstrating the efficacy of DTTPs in managing diabetes complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexible intensive insulin therapy in adults with type 1 diabetes and high risk for severe hypoglycemia and diabetic ketoacidosis. Sämann, A., Mühlhauser, I., Bender, R., et al.[2015]

Various immunotherapies for type 1 diabetes, including insulin and peptide therapies, have shown some success in delaying disease onset and reducing insulin needs, but they generally do not lead to complete remission in established cases.

Challenges in achieving immune tolerance and the significant loss of insulin-producing β-cells at diagnosis limit the effectiveness of these treatments, highlighting the need for strategies that can safely restore β-cell function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapeutic treatment of autoimmune diabetes. Kim, JH., Jin, SM., Kim, HS., et al.[2019]

SGLT2 inhibitors significantly lower key diabetes markers in type 1 diabetes patients, including glycated hemoglobin (HbA1c) and fasting plasma glucose, while also reducing body weight and total insulin dosage, based on a meta-analysis of 16 randomized controlled trials involving 7192 patients.

Importantly, the use of SGLT2 inhibitors does not increase the risk of hypoglycemia, urinary tract infections, or diarrhea, suggesting they can be safely integrated into treatment regimens for type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium glucose cotransporter2 inhibitors for type 1 diabetes mellitus: A meta-analysis of randomized controlled trials. Nan, J., Wang, D., Zhong, R., et al.[2023]

Insulin glargine treatment in 113 Japanese pediatric patients with type 1 diabetes over 24 weeks led to significant improvements in glycemic control, with HbA1c levels decreasing from 9.10% to 8.09% (P < 0.001).

The treatment was generally safe, with only three reported hypoglycemia events, two of which were severe, but all patients recovered, indicating that insulin glargine can be used effectively with manageable safety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin glargine in pediatric patients with type 1 diabetes in Japan. Urakami, T., Naito, Y., Seino, Y.[2021]

The use of the Webdia app for managing type 1 diabetes in children aged 10-18 led to a significant reduction in HbA1c levels by 0.33%, compared to a control group where HbA1c levels increased by 0.21%.

Importantly, this intervention did not increase the prevalence of hypoglycemia, indicating that the app can improve metabolic control safely for patients with higher initial HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Intervention by a Patient-Designed Do-It-Yourself Mobile Device App Reduces HbA1c in Children and Adolescents with Type 1 Diabetes: A Randomized Double-Crossover Study. Klee, P., Bussien, C., Castellsague, M., et al.[2022]

Stage 3a of Type 1 diabetes mellitus (T1DM) is a newly proposed category for individuals who are diagnosed with diabetes but do not yet require insulin, representing a critical window for intervention.

Managing patients in this stage can potentially delay the need for insulin therapy, reduce the risk of hypoglycemia, and lessen the burden of daily glycemic monitoring, highlighting the importance of recognizing and addressing this phase in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A perspective on treating type 1 diabetes mellitus before insulin is needed. Tatovic, D., Narendran, P., Dayan, CM.[2023]

This study will evaluate the effects of the GLP-1 analogue liraglutide on pancreatic β-cell function in young individuals (ages 10-30) with early stages of type 1 diabetes, including those with multiple islet autoantibodies, over a 6-month period with follow-ups ranging from 6 to 18 months.

Liraglutide aims to support β-cell health and potentially reduce islet autoimmunity, contrasting with most prevention trials that focus solely on the immune system, thus providing a novel approach to managing early type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). Kero, J., Koskenniemi, JJ., Karsikas, S., et al.[2022]

Citations

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Evaluating the feasibility of a co-designed technology-enabled ...

The TECC-T1D3 study will determine whether a TECC model is feasible and acceptable for young adults with T1D and DD. Keywords: Type 1 diabetes, ...

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Problem Areas in Diabetes Scale (PAID-5) Score: This will measure the level of emotional distress and burden associated with living with Type 1 Diabetes.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40755960/

Evaluating the feasibility of a co-designed technology ...

The TECC-T1D3 study will determine whether a TECC model is feasible and acceptable for young adults with T1D and DD.

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journals.sagepub.com

journals.sagepub.com/doi/abs/10.1177/20552076251365134?mi=ehikzz

Evaluating the feasibility of a co-designed technology ...

Conclusion. The TECC-T1D3 study will determine whether a TECC model is feasible and acceptable for young adults with T1D and DD.

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breakthrought1d.org

breakthrought1d.org/grants/united-states/illinois/a-hybrid-effectiveness-implementation-trial-of-an-intervention-to-reduce-diabetes-specific-emotional-distress/

A hybrid effectiveness implementation trial of an ...

STePS reduces diabetes-specific emotional distress and builds diabetes resilience, showing clinically meaningful (and statistically significant) results in a ...

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diabetesaction.ca

diabetesaction.ca/supporting-the-whole-health-of-young-adults-with-type-1-diabetes-a-new-approach-to-diabetes-distress/

Supporting the Whole Health of Young Adults with Type 1 ...

Yet nearly 40% of people with T1D experience diabetes distress, which can impact self-management, mental health, and long-term outcomes. TECC- ...

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Evaluating the feasibility of a co-designed technology ...

Results This paper presents the trial protocol of the TECC-T1D3 study. Recruitment began in December 2024, and the trial was registered on ...