Fault Detection, Zone MPC and DiAs System in T1D

Not Recruiting

Trial ID: NCT02506764


This is a randomized crossover study testing the efficacy of the Fault Detection algorithms using the Zone MPC algorithm and DiAs artificial pancreas platform in adult patients with type 1 diabetes. The trial will last for 6 weeks for each individual subject, with three weeks using the AP algorithm and three weeks using sensor augmented pump in a randomized order

Official Title

A Randomized Crossover Study to Evaluate the Efficacy of Fault Detection Algorithms Using the ZoneMPC Algorithm and DiAs System in Adult Subjects With Type 1 Diabetes in the Outpatient Setting

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 of type 1 diabetes for at least 12 months

   2. Daily insulin therapy for at least 12 months

   3. Age between 18.0 to 55.0 years of age

   4. Use of an insulin pump for at least 3 months

   5. Subject comprehends English

   6. Females of childbearing potential must use an adequate method of contraception and
   have a negative pregnancy test

   7. Total daily insulin requirement ≥ 0.3 units/kg/day

   8. Subject has an adult companion, age > 18 years, who lives with the subject, has access
   to where they sleep, is willing to be in the house when the subject is sleeping and
   willing to attend to the subject if there are safety concerns -

Exclusion Criteria:

   1. Diabetic ketoacidosis in the past 6 months

   2. Hypoglycemic seizure or loss of consciousness in the past 6 months

   3. Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or

   4. Subjects using other anti-diabetic medications other than insulin (oral or injectable)
   at the time of enrollment. Any prior use of other anti-diabetic medications must be
   washed out for at least 8 weeks prior to enrollment.

   5. Current use of other medications, which in the judgment of the investigator would be a
   contraindication to participation in the study

   6. Subject has a medical disorder that in the judgment of the investigator will affect
   completion of any aspect of the protocol

   7. Subject is currently participating in another investigational device or drug study
   within 30 days or 5-half-lives of the drug.

   8. Subject has a history of any cardiac or vascular disorder including, but not limited
   to, myocardial infarction, unstable angina, coronary artery bypass surgery, coronary
   artery stenting, transient ischemic attack, cerebrovascular accident, angina,
   congestive heart failure, arrhythmia or thromboembolic disease

   9. Subject has a history of hepatic disease

10. Subject has renal failure on dialysis

11. Systolic blood pressure > 160 mmHg on screening visit

12. Diastolic blood pressure > 90 mmHg on screening visit

13. Subjects with inadequately treated thyroid disease or celiac disease

14. Subject has a neurologic disorder that in the judgment of the investigator will affect
   completion of the protocol

15. Subject has received inpatient psychiatric treatment in the past 6 months

16. Subject consumes more than an average of 4 standard alcoholic drinks/day in the last
   30 days

17. Subject has an active skin condition that would affect sensor placement

18. Subject is unable to avoid acetaminophen for the duration of the study

19. Current use of oral/inhaled glucocorticoids or other medications, which in the
   judgment of the investigator would be a contraindication to participation in the study

20. Subject is currently on beta blocker medication -


device: Artificial pancreas system (Algorithm + CGM + pump)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Trang Ly, MBBS PHD