Actively Recruiting Trials
Teaching Adolescents with type 1 diabetes Self-compassion (TADS) to reduce diabetes distress: A randomized controlled trial
Site(s): The Children’s Hospital of Eastern Ontario
PI(s): Dr. Marie-Eve Robinson
Project Summary: The aim of the study is to assess the effectiveness of a mindful self-compassion program on improving the diabetes distress experienced by youth aged 12-17 years with T1D. The mindful self-compassion program will consist of weekly virtual 1.5-hour sessions/workshops for 8 weeks, led by a trained facilitator. It will cover a variety of self-compassion practices, such as dealing with difficult emotions and developing a kind inner voice.
*Please note that recruitment is currently only via the endocrinology clinic at CHEO.
Using a virtual care platform to deliver peer-led mental health support to rural and remote communities in BC: A randomized wait-list controlled trial of the REACHOUT intervention
Site(s): Various sites in BC
PI(s): Dr. Tricia Tang
Project Summary: Dr. Tang and her team at the University of British Columbia will use a virtual care platform to deliver peer-led mental health support to rural and remote communities in BC, through an intervention called REACHOUT. REACHOUT is a Mobile App developed in collaboration with adults with T1D, clinical psychologists, biomedical engineers, behavioural scientists, and rural health experts with the aim to reduce diabetes distress. REACHOUT uses digital health technology to “drive” mental health support to people living with T1D in the greatest need.
*Please note that participant recruitment will begin in BC in January 2023
Technology-enabled comprehensive care for young adults with type 1 diabetes (T1D) experiencing diabetes distress
Site(s): The Center for Addiction and Mental Health
PI(s): Dr. Peter Selby
Project Summary: Dr. Selby and his team at the Center for Addiction and Mental Health in Toronto are bringing experts in mental health and T1D care together with those who have lived experience of T1D to co-develop a solution for diabetes distress that is accessible and acceptable to adults with T1D, their caregivers, and health care practitioners. This project adapts proven approaches to managing diabetes distress to a virtual format (using video chat, telephone calls, and text messaging) supported and directed by mental health and T1D experts.
*Please note that recruitment is taking place for People With Lived Experience (PWLE) – reach out to research@jdrf.ca for additional information.
Clinical phase II/III trial of Ustekinumab to treat type 1 diabetes
Sponsor: Dr. Jan Dutz
PI(s): Dr. Bruce Perkins and Dr. Tom Elliot
Site(s): Vancouver, BC and Toronto, ON
Project Summary: A JDRF-funded clinical trial is examining whether ustekinumab (pronounced oos·teh·KIN·yoo·mab), a drug currently used for the treatment of psoriasis (which affects the skin), Crohn’s disease (an inflammatory bowel disease), and other autoimmune conditions, can also treat T1D. Manufactured by Janssen and sold under the name Stelara®, it is a monoclonal antibody that inhibits two molecules that regulate the immune system. The researchers are investigating if the simultaneous inhibition of two immune cell pathways—those involving T cells that make interleukin-17 or interferon-gamma, which are believed to harm beta cells—can halt the progression of, or reverse disease in people aged 18-35 who have been diagnosed with T1D within 100 days.
Clinical trial registry: https://clinicaltrials.gov/ct2/show/NCT03941132
Adolescent Type 1 Diabetes Treatment with SGLT2i for hyperglycEMia & hyPerfilTration Trial (ATTEMPT)
PI(s): Dr. Farid Mahmud
Site(s): Toronto, ON and London, ON
Project Summary: ATTEMPT is a 22-week clinical trial that aims to determine the safety and effectiveness an SGLT2 inhibitor called dapagliflozin on managing blood glucose and on preventing kidney complications in adolescents aged 12 to 18 with T1D.
Clinical trial registry: https://clinicaltrials.gov/ct2/show/NCT04333823
A Novel, Dual-Hormone, Fully Automated Artificial Pancreas for Type 1 Diabetes
PI(s): Dr. Ahmad Haidar
Site(s): Montreal, QC
Project Summary: Dr. Haidar and his team are looking at ways to improve the quality of life of people living with type 1 diabetes (T1D) using a novel insulin-plus-pramlintide artificial pancreas that may alleviate the need for carbohydrate counting.
Blog: https://breakthrought1d.ca/can-we-eliminate-carb-counting-for-people-with-type-1-diabetes/
Clinical trial registry: https://clinicaltrials.gov/ct2/show/NCT05199714
Email: biomed.engineering@mcgill.ca
Polyclonal Regulatory T cell (PolyTreg) Immunotherapy in Islet Transplantation
PI(s): Dr. A.M. James Shapiro
Site(s): University of Alberta, Edmonton
Project Summary:
Islet cell transplant has been successful in treating people with Type 1 Diabetes, providing insulin independence in many cases. The drawback, however, is that transplant recipients require life-long anti-rejection drugs, which are associated with increased risk of certain cancers and infections. Anti-rejection drugs are also toxic to the freshly transplanted islets, leading to loss of function – most recipients require 2 or more islet transplants to achieve insulin independence.
The purpose of this trial is to infuse specialized immune-regulatory cells called polyclonal regulatory T cells (PolyTregs) into patients receiving islet transplant to determine their safety and efficacy in improving islet transplant outcomes with the hope of requiring immune suppression lower drug doses.
PolyTregs are a subtype of white blood cells that are part of one’s own immune system. Studies in both humans and animal models have suggested that high numbers of PolyTregs could improve long-term organ transplantation outcomes and control Type 1 Diabetes. PolyTregs therapy is a new immunotherapy developed by our colleagues at University of California San Francisco (UCSF). PolyTregs are isolated from a participant’s blood and cultured before being infused back into the patient.
All participants will receive islet transplants following the current Edmonton islet transplant procedure and maintained on lower doses of anti-rejection drugs. The treatment group will receive PolyTregs six weeks after transplant. Participants will be followed for 1 year after PolyTreg infusion to assess safety and efficacy of the PolyTreg therapy.
Eligible participants for this study must be an adult (18-68 years old) with T1D for >5 years and is a candidate for an islet transplant, i.e., with hypoglycemia unawareness.
A Pilot Trial Evaluating a Device-Less Technique in Islet Transplantation
Site(s): University of Alberta, Edmonton
PI(s): Dr. A.M. James Shapiro
Project Summary:
Transplanting islet cells within the liver has been effective in of restoring blood glucose control to patients with T1D; however, the procedure often results in graft loss and carries procedural risks. Moreover, islet transplant within the liver does not permit imaging or retrieval of the islets, which is important for safety monitoring in stem cell-derived cell therapy. Implant of cells beneath the skin (subcutaneous site) is an attractive alternate to islet and stem cell infusion into the liver site due to its accessibility and potential for monitoring transplant function; however, the subcutaneous site has poor blood vessel system that delivers oxygen and nutrition, thereby has failed to reverse diabetes in human and animal studies.
We have developed a novel subcutaneous ‘Device-Less’ (DL) transplant modality. Briefly, a catheter is implanted under the skin to induce growth of new blood vessels. The catheter will then be removed, leaving a subcutaneous space enriched with new blood vessels. We have found that implanting islets with the DL technique can reverse diabetes in rodents.
In this trial, we aim to test the safety of the DL technique in people with T1D receiving islet transplant and to examine the graft under the microscope. We will implant a small portion of the islet cells in parallel with the islets transplanted into the liver. Portions of the implanted islets will be removed and examined periodically within 9 months period. This will provide us a ‘window’ to the parallel islets in the liver. In addition, the results of this trial will help us in identifying an alternative transplant site and in testing stem cell-derived islets using the DL technique.
Eligible participants for this study must be an adult (18-68 years old) with T1D for >5 years and is a candidate for an islet transplant, i.e., with hypoglycemia unawareness.