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Procedure

Device-Less Islet Transplantation for Type 1 Diabetes

Phase 1
Recruiting
Led By James Shapiro, MD, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metabolic instability, characterized by erratic blood glucose levels that interfere with daily activities and/or 1 or more hospital visits for diabetic ketoacidosis over the last 12 months.
Reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at plasma glucose levels < 3.0 mmol/L, indicated by, 1 or more episodes of severe hypoglycemia requiring third-party assistance within 12 months, a Clarke score ≥4, HYPO score ≥1,000, lability index (LI) ≥400 or combined HYPO/LI >400/>300.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Study Summary

This trial is testing a new way to transplant insulin-producing cells into the body that may be more effective than current methods.

Who is the study for?
This trial is for adults with Type 1 Diabetes who have unstable blood sugar levels, frequent hospital visits due to diabetic ketoacidosis, or reduced awareness of hypoglycemia. They must understand the study and consent to participate. Excluded are those under 18 or over 68, with certain medical conditions like severe heart disease, kidney issues, psychiatric disorders, high insulin requirements, pregnancy intentions without contraception use, substance abuse history including smoking within the last six months.Check my eligibility
What is being tested?
The trial tests a 'device-less' technique for transplanting insulin-producing cells under the skin in patients with Type 1 Diabetes. This method uses a temporary nylon catheter to create a favorable environment for cell survival by promoting new blood vessel growth without triggering adverse body reactions.See study design
What are the potential side effects?
Potential side effects may include local inflammation at the implant site due to foreign body response before it's controlled by the device-less technique and risks associated with any surgical procedure such as infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your blood sugar levels are not well controlled and have caused problems with your daily activities, or you have been to the hospital for diabetic ketoacidosis in the past year.
Select...
You have trouble recognizing when your blood sugar levels are low and have experienced severe low blood sugar episodes that needed help from someone else within the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Adverse Events/Serious Adverse Events
Rate of inflammation in the DL implant site
Secondary outcome measures
Cellular composition demonstrated by immunohistochemistry
Percentage of live cells measured by immunohistochemistry
Presence of immune response demonstrated by immunohistochemistry
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Implantation of the Device-Less sentinel units. Ultrasound Monitoring. Islet Transplantation. Explantation of Device-Less Sentinels. Standard of Care. Concomitant Care. Post Transplant Testing and Visits. Participant Retention (nine month follow up assessment).

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
883 Previous Clinical Trials
393,204 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
231 Previous Clinical Trials
111,732 Total Patients Enrolled
James Shapiro, MD, PhDPrincipal InvestigatorUniversity of Alberta
8 Previous Clinical Trials
282 Total Patients Enrolled

Media Library

Type 1 Diabetes Research Study Groups: Treatment Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially take part in this research endeavor?

"For consideration in this clinical trial, applicants must have a diagnosis of diabetes and an autoimmune disorder. They must also be between 18 to 68 years old. In total, 5 suitable candidates will be selected for the study."

Answered by AI

Are there still opportunities to join this experiment?

"As indicated by the information on clinicaltrials.gov, this study is actively searching for participants. It was initially published on March 22nd 2022 and received its most recent edit on May 10th 2022."

Answered by AI

What is the anticipated enrollment rate for this clinical trial?

"Affirmative. Clinicaltrials.gov reports that this clinical trial is open for recruitment, having first been published on March 22nd 2022 and last edited on May 10th 2022. The study requires 5 patients to be recruited from 1 medical centre."

Answered by AI

Does this research trial accept elderly adults as participants?

"Adhering to the enrolment restrictions, this medical study requires applicants to be between 18 and 68 years old."

Answered by AI

How hazardous is the insertion of a Nylon catheter (Device-less sentinel unit) for individuals?

"The safety of implantation of a nylon catheter (device-less sentinel unit) was assessed to be a 1, given that this is an early phase trial and limited evidence exists for efficacy and safety."

Answered by AI

Who else is applying?

What site did they apply to?
University of Alberta Clinical Islet Transplant Program
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have tried 8years medicine but that didn't work I wnts to try your therapy.
PatientReceived no prior treatments
~2 spots leftby Mar 2025