Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
Trial ID or NCT#
NCT02280863
Status
NOT RECRUITING
Purpose
The primary objective of this study is to evaluate the safety and efficacy of the Medtronic hybrid closed-loop (HCL) system utilizing the proportional-integral-derivative algorithm with insulin feedback (PID-IFB) optimized to function in a hybrid mode with closed-loop control operating during the day and night.
Official Title
Hybrid Closed-Loop Studies With Medtronic PID Controller- Hotel HCL Study
Eligibility Criteria
Ages Eligible for Study: 14 Years to 40 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- - Clinical diagnosis of type 1 diabetes (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.) - Daily insulin therapy for at least one year - Age between 14.0 to 40.0 years of age. The first 9 subjects (between all 3 centers) will be over 18 years old. - Subject has performed an average of at least 3 meter glucose readings per day in the preceding 2 weeks - Subject has used a downloadable insulin pump for at least 3 months - Subject comprehends written English - Female patients who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD - Female patients must have a negative urine pregnancy test - Informed Consent Form signed by the subject and/or parent and assent signed by the subject if < age 18 - Parent/guardian (for subjects < 18 years) and subject understand the study protocol and agree to comply with it. Both parents must sign if possible. - Total daily insulin requirement greater than 0.4 units/kg/day over the preceding two weeks. - No expectation that subject will be moving out of the area of the clinical center during the study. - Adults will need to be working within 20 minutes of our research staff during the day. - A person willing to fulfill the role of a remote monitor (such as parent, spouse or significant other).
Exclusion Criteria:
- - Subject has a medical disorder that in the judgment of the investigator will affect the wearing of the devices or the completion of any aspect of the protocol - Diabetic ketoacidosis in the past month - History of seizure or loss of consciousness in the last 6 months - Subject has a respiratory condition such as asthma, treated with systemic or inhaled corticosteroids in the previous 6 months or cystic fibrosis - Subject has a history of any cardiac or vascular disorder such as myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease - Subject has a history of liver or kidney disease (other than microalbuminuria) - Systolic blood pressure > 140 mmHg on screening visit - Diastolic blood pressure > 90 mmHg on screening visit - Subject has active Graves' disease - Subjects with inadequately treated thyroid disease or celiac disease - Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol - Either the subject or the subject's primary caregiver has received inpatient psychiatric treatment in the past 6 months - Subject has a history of diagnosed medical eating disorder - Subject has a history of known illicit drug abuse - Subject has a history of known prescription drug abuse - Subject has a history of current alcohol abuse - Subject has a history of visual impairment which would not allow subject to participate - Subject has an active skin condition that would affect sensor placement - Subject has adhesive allergies - Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine) - Subjects requiring other anti-diabetic medications other than insulin (oral or injectable) - 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 - Subject is currently on beta blocker medication - Subject is currently participating in another investigational study (drug or device) - Subject is deemed by the investigator to be unwilling or unable to follow the protocol
Investigator(s)
Bruce Buckingham
Endocrinologist
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus
Contact us to find out if this trial is right for you.
Contact
Bruce Buckingham, MD
(650) 723-5791
View on ClinicalTrials.gov
