Clinical Research
Clinical Trials in Abdominal Transplantation
Clinical trials within the Divison of Abdominal Transplantation include: Tolerance Induction, EVB-induced post-transplant lymphoma, and the following Stanford-based trials for liver, kidney, intestine, pacreas, diabetes, and hepatocellular carcinoma.
This page provides an auto-populated up-to-date list of Stanford Clinical Trials in: liver, kidney, intestine, pancreas, diabetes, hepatocellular carcinoma, and pediatric transplant.
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
This is a 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial. Upon completion of the NIH 3-month extension study, subjects will be invited to participate in a continued use phase with Control-IQ Technology, funded by Tandem Diabetes Care, until the equipment has received FDA approval for commercial use.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
- device: t:slim X2 with Basal-IQ & Dexcom G6 CGM
Eligibility
Inclusion Criteria:
1. Successful completion of the original 6-month RCT within the prior 14 days
2. For females, not currently known to be pregnant. If female and sexually active, must
agree to use a form of contraception to prevent pregnancy while a participant in the
study. A negative urine pregnancy test will be required for all females of
child-bearing potential. Participants who become pregnant will be discontinued from
the study. Also, participants who during the study develop and express the intention
to become pregnant within the timespan of the study will be discontinued.
3. For participants <18 years old, living with one or more parent/legal guardian
knowledgeable about emergency procedures for severe hypoglycemia and able to contact
the participant in case of an emergency.
4. Willingness to not use a personal CGM for the duration of the study
5. Investigator has confidence that the participant can successfully operate all study
devices and is capable of adhering to the protocol
6. Willingness to use only lispro (Humalog) or aspart (Novolog), and to use no other
insulin during the study.
7. Willingness not to start any new non-insulin glucose-lowering agent during the course
of the trial
Exclusion Criteria
1. Concurrent use of any non-insulin glucose-lowering agent other than metformin
(including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors,
sulfonylureas).
2. Hemophilia or any other bleeding disorder
3. A condition, which in the opinion of the investigator or designee, would put the
participant or study at risk
4. Participation in another pharmaceutical or device trial at the time of enrollment or
during the study
5. Employed by, or having immediate family members employed by Tandem Diabetes Care,
Inc., Dexcom, Inc., or TypeZero Technologies, LLC, or having a direct supervisor at
place of employment who is also directly involved in conducting the clinical trial (as
a study investigator, coordinator, etc.); or having a first-degree relative who is
directly involved in conducting the clinical trial
Ages Eligible for Study
14 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting