TECC-T1D3 Program for Type 1 Diabetes and Diabetes Distress

(TECC-T1D3 Trial)

Overseen By Anika Saiva, MPH

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Centre for Addiction and Mental Health

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of the study is to evaluate the acceptability and feasibility of a co-designed, Technology-Enabled Collaborative Care for Young Adults with Type-1 Diabetes and Diabetes Distress (TECC-T1D3) program. Through this program, the investigators aim to deliver a collaborative care intervention, featuring a health coach and a virtual care team, designed to help participants manage mental health and overall wellbeing.

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 data supports the effectiveness of the TECC-T1D3 Program treatment for Type 1 Diabetes and Diabetes Distress?

The TECC-T1D3 Program may be effective based on similar programs that provide structured education and support for young patients with type 1 diabetes, which have shown positive results in managing the transition from pediatric to adult care. Additionally, diabetes treatment programs that teach flexible insulin therapy have been proven safe and effective in routine care, suggesting that structured educational programs can improve diabetes management. ^{1 2 3 4 5}

Is the TECC-T1D3 Program safe for humans?

The TECC-T1D3 Program, which may involve SGLT inhibitors, has been studied for safety in people with type 1 diabetes. These studies show that while it can help with blood sugar control, it may increase the risk of genital infections and diabetic ketoacidosis (a serious condition where the body produces high levels of blood acids). However, a very low dose of one SGLT inhibitor, empagliflozin, did not increase the risk of diabetic ketoacidosis. ^{6 7 8 9 10}

How does the TECC-T1D3 Program treatment differ from other treatments for type 1 diabetes?

The TECC-T1D3 Program is unique because it focuses on addressing both type 1 diabetes and diabetes distress, potentially offering a more holistic approach compared to traditional treatments that primarily target blood sugar levels. This program may incorporate elements of immunotherapy, similar to treatments like teplizumab, which aim to preserve insulin-producing cells and reduce the need for external insulin. ^{11 12 13 14 15}

Research Team

Peter Selby

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

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 am between 18 and 29 years old.

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

Exclusion Criteria

I cannot participate in studies in English.

Unable to participate via telephone or web-conferencing

Trial Timeline

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)

Treatment Details

Interventions

• TECC-T1D3 Program (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Spain 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. [2021]

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

Type 1 Diabetes Patient Experiences Before and After Transfer from a Paediatric to an Adult Hospital. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Reducing Diabetic Ketoacidosis Readmissions with a Hospital-School-Based Improvement Partnership. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Insulin is necessary but not sufficient: changing the therapeutic paradigm in type 1 diabetes. [2020]

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

Flexible intensive insulin therapy in adults with type 1 diabetes and high risk for severe hypoglycemia and diabetic ketoacidosis. [2015]

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

Sodium glucose cotransporter2 inhibitors for type 1 diabetes mellitus: A meta-analysis of randomized controlled trials. [2023]

7. England 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. [2020]

8. Australia pubmed.ncbi.nlm.nih.gov

Insulin glargine in pediatric patients with type 1 diabetes in Japan. [2021]

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

Efficacy and safety of sotagliflozin adjuvant therapy for type 1 diabetes mellitus: A systematic review and meta-analysis. [2022]

10. United States 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. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Treatment of new onset type 1 diabetes with teplizumab: successes and pitfalls in development. [2021]

12. England pubmed.ncbi.nlm.nih.gov

A perspective on treating type 1 diabetes mellitus before insulin is needed. [2023]

13. Belgium 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]. [2017]

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

Immunotherapeutic treatment of autoimmune diabetes. [2019]

15. England 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). [2022]