insulin-dependent diabetes mellitus Diabetes Mellitus, Type 1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) A patient needs insulin treatment because of significantly reduced endogenous insulin. 2) Uncontrol blood glucose under the treatment by a diabetes specialist. 3) Under 75 years old 4) The patient, the family, and the attending physician agree with islet transplantation after the informed consent about both pancreatic transplantation and islet transplantation. 5) More than 5 years have passed since the onset of the disease.
Exclusion criteria
Exclusion criteria: 1) severe heart and/or liver disease 2) alcoholism 3) infection 4) malignant disease 5) severe obesity (BMI>25kg/m2) 6) retinopathy 7) other severe illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c<7.4% a year after islet transplantation and percentage of recipients without hypoglycemia 90 to 365 days after islet transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c<7.4% two year after islet transplantation and no hypoglycemia 90 to 730 days after islet transplantation no hypoglycemia 90 to 730 days after islet transplantation HbA1c<7.4% two year after islet transplantation HbA1c<6.9% two year after islet transplantation Insulin independent two year after islet transplantation | — |
Countries
Japan
Contacts
Shinshu University Hospital