Actively Recruiting
Islet Transplantation in Patients With "Brittle" Type I Diabetes
Led by University of Chicago · Updated on 2025-12-09
20
Participants Needed
1
Research Sites
943 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to learn about the safety of islet transplantation for Type 1 diabetes mellitus, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.
CONDITIONS
Official Title
Islet Transplantation in Patients With "Brittle" Type I Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 18 to 70 years of age
- Able to provide written informed consent and comply with study procedures
- Clinical history consistent with Type 1 diabetes with onset before age 40
- Insulin dependence for at least 5 years at enrollment
- Sum of patient age and insulin-dependent duration of at least 28 years
- Absent stimulated c-peptide (<0.3 ng/mL) in response to a mixed meal tolerance test
- At least one severe hypoglycemic episode in the 12 months before enrollment, OR problematic hypoglycemia defined as two or more severe episodes per year or one episode with impaired awareness, extreme blood sugar swings, or major fear and behavior issues
- Intensive diabetes management with self-monitoring of glucose at least three times daily and three or more insulin injections daily or insulin pump therapy under specialist care with at least 3 evaluations in the past year
- Reduced awareness of hypoglycemia defined by Clarke score ≥4 OR HYPO score ≥90th percentile OR marked glycemic lability defined by LI score ≥90th percentile OR combination of Clarke score ≥4, HYPO score ≥75th percentile, and LI score ≥75th percentile within the last 6 months
You will not qualify if you...
- Body mass index (BMI) greater than 30 kg/m2 or weight less than 50 kg
- Insulin requirement greater than 1.0 IU/kg/day or less than 15 units/day
- Untreated proliferative diabetic retinopathy
- Blood pressure over 160 mmHg systolic or 100 mmHg diastolic
- Glomerular filtration rate less than 80 mL/min/1.73m2 or less than 70 mL/min/1.73m2 for strict vegetarians
- Presence or history of macroalbuminuria (>300 mg/g creatinine)
- Presence or history of panel-reactive anti-HLA antibodies above 30% or donor-specific anti-HLA antibodies
- For females: positive pregnancy test, currently breastfeeding, wishing to become pregnant during or after the study, or unwillingness to use effective contraception during and 4 months after the study
- For males: intent to father a child during or 4 months after the study, or unwillingness to use effective contraception
- Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis
- Known active alcohol or substance abuse
- Severe heart disease
- Known hypercoagulative state
- Symptomatic gallstones
- Acute or chronic pancreatitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
L
Lindsay Basto, RN, BSN
CONTACT
P
Piotr Witkowski, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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