International Diabetes Closed Loop (iDCL) Trial: Research Site Training Protocol

Not Recruiting

Trial ID: NCT02844517


The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.

Official Title

Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol

Stanford Investigator(s)

Bruce Buckingham
Bruce Buckingham

Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus


Inclusion Criteria

   1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least
   one year and using insulin for at least 1 year

   2. Use of an insulin pump for at least 6 months with established parameters for basal
   rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3

   3. Age 14.0 to <75.0 years

   4. HbA1c level <10.5% at screening

   5. 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 serum or urine pregnancy test will be required for all premenopausal
   women who are not surgically sterile. Subjects who become pregnant will be
   discontinued from the study. Also, subjects who during the study develop and express
   the intention to become pregnant within the timespan of the study will be

   6. Have care partner committed to participating in all training activities, knowledgeable
   at all times of the participants location, and being present and available to provide
   assistance when the system is being used at night

   7. Willingness, if using the closed-loop system, to stop closed-loop when taking
   acetaminophen and avoid closed-loop for at least 4 hours afterward

   8. Willingness to suspend use of any personal CGM for the duration of the clinical trial
   once the study CGM is in use

   9. Willingness to establish network connectivity on a daily basis either via local Wi-Fi
   network or via a study-provided cellular service

10. Investigator has confidence that the subject can successfully operate all study
   devices and is capable of adhering to the protocol

11. Currently using no insulins other than one of the following rapid-acting insulins at
   the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin
   glulisine (Apidra)

12. Total daily insulin dose (TDD) less than 100 U/day

Exclusion Criteria

   1. More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to

   2. More than one episode of severe hypoglycemia involving seizure of loss of
   consciousness in the 6 months prior to enrollment

   3. Medical need for chronic acetaminophen

   4. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists,
   Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and

   5. Hemophilia or any other bleeding disorder

   6. A condition, which in the opinion of the investigator or designee, would put the
   participant or study at risk

   7. Participation in another pharmaceutical or device trial at the time of enrollment or
   during the study

   8. Employed by, or having immediate family members employed by TypeZero Technologies, LLC


device: Artificial Pancreas

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Bruce Buckingham, MD