A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients (NCT01897688) | Clinical Trial Compass
CompletedPhase 3
A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
United States10 participantsStarted 2012-06
Plain-language summary
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female patients age 18-65 years of age at consent
. Ability to provide written informed consent
. Mentally stable and able to comply with the procedures of the study protocol
. Patients with T1D and insulin-dependent for at least 5 years fulfilling the following criteria:
. Absent stimulated c-peptide (\<0.3 ng/mL) in response to a mixed meal tolerance test (MMTT; ensure 6 mL/kg body weight to a maximum of 360mL) measured at 60 and 90 min after the start of consumption
. Patients who have been followed by a qualified physician for diabetes management for a minimum of 12 months
. At least one episode of severe hypoglycemia in the past 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already been completed, would my doctor be able to access or share the safety and feasibility results, and what do those findings suggest about whether islet transplantation is a realistic option for someone in my situation?
2This study focused on people with Type 1 diabetes who also had severe hypoglycemic unawareness — how severe does my own hypoglycemia unawareness need to be before islet transplantation would even be worth considering as a path forward?
3Because this was a Phase 3 trial at a single center, does my doctor know whether the approach used here is now available more broadly, or would I need to travel to a specialized transplant center to pursue this treatment?
4Islet transplantation involves immune suppression to prevent rejection — given this trial's safety focus, what does my doctor think are the most serious risks I should weigh against my current struggles with hypoglycemia?
5Before considering something like islet transplantation, are there other treatments my doctor would recommend trying first, such as continuous glucose monitoring systems or closed-loop insulin delivery, that might address my hypoglycemia unawareness with less risk?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Feasibility of Islet Transplantation to Treat Type-1 Diabetes (T1D)
Timeframe: Two years after the final islet transplant.
. A Clarke score of 4 or more defining reduced awareness of hypoglycemia
Exclusion criteria
. Body mass index (BMI) \> 30
. Insulin requirement of \> 1.0 IU/kg/day
. HbA1c \> 10%
. Calculated glomerular filtration rate (GFR) \< 80mL/min for transplant-naïve patients (using subjects serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration equation CKD-EPI) or 50mL/min for previously transplanted patients currently on immunosuppression
. Macroalbuminuria \>300 mg/g creatinine
. Panel reactive anti-HLA antibodies\> 50% by flow cytometry
. For female subjects: positive pregnancy test, breast feeding or unwillingness to use effective contraceptive measures for the duration of the study.
. Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB)