Status:
COMPLETED
Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
Lead Sponsor:
Stanford University
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
14-40 years
Phase:
NA
Brief Summary
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 feedba...
Detailed Description
Study participants will be asked to use the CGM and the study insulin pump provided for approximately 4 to 5 days prior to initiation of the HCL PID-IFB system in a hotel setting for another 4 to 5 da...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02280863
Start Date
July 1 2014
End Date
May 1 2015
Last Update
July 3 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University Medical Center
Stanford, California, United States, 94305
2
UC Denver- Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
3
Yale University- Department of Pediatric Endocrinology
New Haven, Connecticut, United States, 06520