Fault Detection, Zone MPC and DiAs System in T1D
Trial ID or NCT#
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
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
- 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 -
- 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 glargine) 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 -
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Trang Ly, MBBS PhD