Frequently Asked Questions About Eligibility

I think I meet the criteria and I'm interested in participating in an islet transplant trial. What do I do next?
Why do I have to have diabetes for at least five years?
Why is there an age limit?
Why is there a weight limit?
Why do I have to see my diabetes care team three times per year?
Why do I have to be using at least three insulin injections per day and checking my blood sugar at least three times per day?
Why is there a limit on the amount of insulin that is used?
How can I make an appointment?

I think I meet the criteria and I'm interested in participating in an islet transplant trial. What do I do next?

If you believe that you meet the criteria for participation in an islet transplant trial, the next step is to register to let us know that you are interested. First, answer the short list of questions. Once you enter this information into our system, you will either be asked to provide additional information or you will be informed why you do not meet the criteria to participate in one of the current clinical trials. Please keep in mind that if you do not meet the criteria to participate in a current clinical trial, your information will be kept in our database and you will be informed if you meet the criteria for a future clinical trial. If you have an urgent medical need, you may want to consider having a pancreas transplant.

If you are asked to enter additional information, please do so as accurately as possible. Once you have completed the entire form, we will review it in detail. If you meet the criteria for a current clinical trial, we will contact you to provide you with more specific details about the current clinical trials and to obtain additional information. Please note that we have had many people who meet the criteria contact us about participating in an islet transplant trial. As such, meeting all of the entry criteria does not guarantee that you will be selected for an islet transplant. If you do not meet the criteria or are not selected to participate in a current clinical trial, we will contact you to let you know this as well. If you do not meet the criteria, you may qualify for whole-organ pancreas transplantation, which is not in research phase and is now covered by Medicare. If you are interested in a pancreas transplant, please call 1-800-328-5465 for information and an application.

Please note that we have had many people who meet the criteria contact us about participating in an islet transplant trial. As such, meeting all of the entry criteria listed does not guarantee that you will be selected for an islet transplant.

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Why do I have to have diabetes for at least five years?

People participating in islet transplant trials at the current time need to have some complications as a result of their diabetes (the most frequent is recurrent hypoglycemia unawareness). In addition, you also need to be working closely with your physician to intensely manage your diabetes. Typically, people who have had diabetes for less than five years are extremely unlikely to have had enough time to have developed complications sufficient to meet inclusion criteria for the clinical trials.

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Why is there an age limit?

Currently, we must limit participation to people between the ages of 18 and 65. The FDA does not allow people under the age of 18 to participate at this time. As we collect additional data on the safety and efficacy of islet transplants in adults and young adults, we anticipate offering islet transplant clinical trials in people under the age of 18 in the future.

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Why is there a weight limit?

The most important factor in determining whether a transplant will be effective is the number of islets the islet transplant recipient receives. Larger people need more islets. At this time, it is only possible to consistently extract enough islets from a single pancreas for people who weigh less than 170 pounds. As techniques for isolating islets from the pancreas improve, this weight limit will gradually be relaxed.

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Why do I have to see my diabetes care team three times per year?

Islet transplantation is currently considered an experimental procedure and only available to a very select group of people who are continuing to have problems with their diabetes despite significant efforts to control it. People who are in contact with their diabetes care team frequently and still have problems such as hypoglycemia (low blood sugar) unawareness are particularly likely to benefit from islet transplants while they are still in the experimental stage. It is to your advantage to work closely with your diabetes care team to optimize your care to delay or prevent future complications.

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Why do I have to be using at least three insulin injections per day and checking my blood sugar at least three times per day?

The current “gold standard” of care for diabetes is intensive insulin therapy, which includes at least three insulin injections per day or the use of an insulin pump. Until we are able to demonstrate the safety and efficacy of islet transplantation, we can only offer it to people who are having problems despite their diligent efforts to intensively manage their blood sugar.

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Why is there a limit on the amount of insulin that is used?

The most important factor in determining whether a transplant will be effective is the number of islets the islet transplant recipient receives. Since an islet transplant may contain just enough islets to achieve insulin independence, it is important to optimize other factors that can affect the chance for success. It is believed that people with type 1 diabetes who are using more than 50 units of insulin may not respond efficiently to insulin (also known as "insulin resistance," not unlike that seen in patients with type 2 diabetes). Insulin resistance makes the transplanted islets work harder.

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How can I make an appointment?

The DIIT is not a clinic in which you can make an appointment. If you are interested in participating in an islet transplant trial, please complete the Clinical Trial Registration pages. If you meet study criteria and are selected to participate in a current clinical trial, we may invite you to come to the University of Minnesota for further screening.

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