Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID: NCT02280863
Run by: Stanford University
People needed: 24
Starts: 2014-07-01
Expected to finish: 2015-05-01
Last updated by the study team: 2018-07-03

Who can join

Age: 14 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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).

You may not qualify if…

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

Where it is running

Stanford University Medical Center — Stanford, California, United States
UC Denver- Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
Yale University- Department of Pediatric Endocrinology — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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