Schulze Diabetes Institute

Am I eligible?


Inclusion Criteria

To participate, you must meet the following criteria:

  • Have had type 1 diabetes for more than 5 years

  • Be between the ages of 18 to 68

  • Be checking blood sugar at least 3 times per day

  • Be administering at least 3 insulin injections per day, or using an insulin pump

  • Have a complication from diabetes, (such as not having warning symptoms when blood sugar is low)

  • Have seen a diabetes care team at last 3 times in the last year

Exclusion Criteria

Any of the following situations will exclude you from being able to participate in an islet transplant trial through the Schulze Diabetes Institute at this time:

  • Females who are currently pregnant, intend to become pregnant, or are presently breast-feeding

  • Males who intend to father children

  • Have an active or past infection with hepatitis C, hepatitis B, HIV, or TB (or under treatment for suspected TB)

  • Have any history of cancer except for adequately treated skin cancer

  • Have had a heart attack within the past 6 months or extensive coronary artery disease

  • Are under treatment for a medical condition requiring chronic use of steroids such as prednisone

Questions to consider before enrolling

  1. There are many follow-up appointments, usually involving 13-16 visits after the transplant. Ask yourself, am I willing to travel to the University of Minnesota for these visits? Can I afford this much travel?
  2. If you choose to participate in an islet transplant clinical trial you will be asked to take immunosuppressive drugs. Ask yourself, am I willing to take immunosuppressive drugs on a continuous basis as long as the transplant is functioning either fully or partially?
  3. Immunosuppressive drugs are paid for during clinical trial participation only. Coverage after the trial period may be available through your health insurance. If your transplant is successful at the end of the study and you have functioning islets, you will have to continue on immunosuppressive drugs indefinitely to keep the islets functioning. Ask yourself, how will the cost of immunosuppressive drugs be covered when the clinical trial ends?
  4. Detailed record keeping is very important during study participation. Ask yourself, will I be able to check my blood glucose 5-7 times/day and maintain adequate records regarding insulin use and side affects of drugs?
  5. The Islet Transplant Research team provides care for blood glucose management and immunosuppression dosing. All other medical care, including potential side effects of drugs, will be provided by your primary care physician, endocrinologist, and other specialists. Ask yourself, do I have a good relationship with my care providers?
  6. Participating in research is voluntary. You have the right to decide whether you wish to become a research subject. Ask yourself, is being a research participant right for me? A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know they wish to leave the study, and the reasons for leaving the study.
  7. There is no guarantee that islet transplantation will be successful. It is possible that a transplant will not make you completely free from insulin use. If the transplant is partially successful, you may benefit from more stable blood sugar control, needing less insulin, with fewer insulin reactions. Because improved control of blood sugar can slow the complications of diabetes, islet transplant recipients may benefit whether their transplant is successful or partially successful. Preliminary studies suggest that islet transplants improve quality of life.
  8. If you do become insulin independent, there is no guarantee that you will maintain this state for any specific length of time. It is unknown why this happens and it could occur at any time.
  9. Should you consider a pancreas transplant? A pancreas transplant means the whole pancreas is transplanted, with islet cells intact. This procedure is considered part of standard medical care and has been done throughout the world for many years. The success rate for recipients being insulin-free one year after transplant is 80 to 85%; after three years it is 75 to 80%. A pancreas transplant is major surgery requiring general anesthesia and a longer recovery time. Complications from the surgery occur in about 10 to 15% of the recipients, requiring a longer hospital stay or readmission to the hospital.

Click here to enroll in a clinical trail.

Contact us to learn more about participating in a clinical trial:

Jayne Pederson
Schulze Diabetes Institute
Email: peder059@umn.edu
Phone: 612-624-8402

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  • Last modified on February 25, 2014