← Back to Search

Immunosuppressant

Modified Edmonton Protocol for Diabetes

Phase 1

Waitlist Available

Research Sponsored by National Center for Research Resources (NCRR)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 1 diabetes for more than 5 years AND Hypoglycemia unawareness, not felt adequately by patient (glucose less than 54mg/dL) in the last 1.6 years, not otherwise explained, requiring outside help

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will use two classes of oral antidiabetic drugs to improve insulin action and reduce the amount of insulin needed to have normal blood sugars in conjunction with the Edmonton Protocol in order to allow for successful islet transplantation from islets isolated from a single pancreas.

Who is the study for?

This trial is for Type 1 diabetes patients who've had the condition for over 5 years and struggle with severe low blood sugar without feeling it, needing help from others. They should have unstable glucose levels despite intensive insulin therapy. It's not suitable for those with certain health issues that aren't specified here.Check my eligibility

What is being tested?

The study tests if modifying the 'Edmonton Protocol' can allow successful islet cell transplantation from one pancreas instead of multiple, potentially reducing insulin injections. It also explores using this protocol in kidney transplant recipients to improve their outcomes.See study design

What are the potential side effects?

Long-term use of immunosuppressive drugs required by the Edmonton Protocol may increase infection and cancer risks, but these drugs are chosen to be less harmful to kidneys and less likely to cause diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had Type 1 diabetes for over 5 years and have experienced severe low blood sugar without feeling it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Research Resources (NCRR)Lead Sponsor

537 Previous Clinical Trials

317,016 Total Patients Enrolled

3 Trials studying Diabetes

47 Patients Enrolled for Diabetes

Juvenile Diabetes Research FoundationOTHER

232 Previous Clinical Trials

141,749 Total Patients Enrolled

4 Trials studying Diabetes

611 Patients Enrolled for Diabetes

Media Library

Edmonton Protocol (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT00021580 — Phase 1

Diabetes Clinical Trial 2023: Edmonton Protocol Highlights & Side Effects. Trial Name: NCT00021580 — Phase 1

Edmonton Protocol (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00021580 — Phase 1

Frequently Asked Questions

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

What potential harms could someone risk if they undergo this treatment?

"The safety of this intervention is estimated to be a 1 due to its Phase 1 status, which implies that there are only small amounts of data about both efficacy and protection."

Answered by AI