Southern California Islet Consortium
 
 
 
ISLET TRANSPLANTATION ALONE IN PATIENTS WITH DIFFICULT TO CONTROL TYPE 1 DIABETES MELLITUS
 


PATIENT SELECTION CRITERIA

Patient Enrollment for Islet Transplantation Alone (ITA)
Patients with difficult to control type 1 diabetes without end-stage kidney disease, self- or physician-referred to participating transplant centers, will be offered enrollment in this study if they meet the inclusion criteria. Difficult to control diabetes is defined as wide swings in blood glucose that disrupt the patient's life and result in frequent episodes of hypoglycemia (low blood sugar) despite compliance with multiple daily insulin injections or proper use of insulin pump therapy and frequent blood glucose testing. Currently, most patients with type 1 diabetes will be more safely managed with insulin injections or pump therapy rather than being subjected to the side effects of the immune suppressing drugs that are needed for survival of transplanted islets. Thus, patients with good glycemic control on insulin pump therapy or multiple daily insulin injections will not be eligible for islet transplantation under this study at this time. However, in patients with diabetes that is complicated by frequent hypoglycemic comas or secondary complications, the benefits of islet transplantation outweigh the risks. In summary, patients qualifying for this study will be those that are unable to achieve safe and adequate glucose control on traditional insulin therapy, despite the fact that they are able to demonstrate a thorough understanding of diabetes management techniques and a capability to execute them.

Inclusion Criteria for ITA
To qualify for islet transplantation at the Southern California Islet Consortium, patients must meet the following criteria:
  1. Type 1 diabetes for at least 5 years
  2. Age 18 to 60 years
  3. Fasting C-peptide level less than or equal to 0.2 ng/ml and a glucagon stimulated C-peptide level less than or equal to 0.8 ng/ml
  4. No evidence of kidney failure
  5. No evidence of liver disease
  6. Frequent episodes of hypoglycemia (low blood sugar) with symptoms (i.e. loss of consciousness, headaches, anxiety, irritability, trembling, sweating) more than once per week, documented lack of awareness of hypoglycemic episodes (i.e. no symptoms with blood glucose less than 54 mg/dl) two or more times in the past two months, or hypoglycemic episodes that required the assistance of another person more than once per month or hospitalization more than once over the past 20 months
  7. Ability to comply with transplant follow-up treatment, including intake of anti-rejection drugs, frequent blood sugar monitoring, insulin pump therapy and other required tests.

Exclusion Criteria for ITA
Patients with any of the following conditions or situations will not be able to participate in the Southern California Islet Consortium islet transplant trial at this time:
  1. Significant liver disease, liver masses, evidence of high pressure within the liver, or significant untreated gallbladder disease (i.e. gallstones)
  2. Significant heart disease, including non-correctable coronary artery disease and/or recent heart attack (within last 12 months); extensive arterial disease of lower extremities not correctable by surgery or untreated diabetic eye disease
  3. Recent unresolved infection, including tuberculosis, HIV, Hepatitis B, Hepatitis C, CMV or positive skin test for TB
  4. Any history of cancer, except squamous or basal cancer of the skin and early detection of cancer of the uterine cervix (in situ cancer)
  5. Inability to comply with strict blood sugar control and insulin pump therapy
  6. Psychiatric illness that is untreated, or likely to interfere significantly with transplantation despite treatment
  7. Significant obesity (body mass index greater than 30)
  8. Presence of a chronic disease that must be treated with one or more of the following medications: glucocorticoids, thiazides, diazoxide, clonidine, bumetamide, halopindol, chlorpromazine, amitryptyline, desipramine, doxepin, imipramine, nortryptyline, diphenylhydantion, isoproterenol, levodopa, propanolol, indomethacin, morphine, L-asparaginase, cyclophosphamide, megestol acetate, isoniazid, nicotinic acid, cimetidine, heparin, nalidixic acid, or any other agents that may adversely influence blood sugar control
  9. Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective birth control measures for the duration of immunosuppressive therapy, and women presently breast feeding are ineligible due to the unknown effects of these drugs on the fetus and nursing infant
  10. Active alcohol or substance abuse, including cigarette smoking (must be abstinent for greater than 6 months)
  11. High cholesterol and/or triglycerides
  12. Anemia or other blood disorders that require medical attention
  13. Problems with blood clotting or use of blood thinners other than occasional use of aspirin

If you think you meet the conditions presented above and are interested in participating in this islet transplantation trial, please proceed to Instructions for Completing the Patient Information Form.

If you have questions regarding your eligibility for this trial, contact Linda Shevlin at (626) 359-8111 x62637.