Clinical trial NCT02280863: Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
Official title: Hybrid Closed-Loop Studies With Medtronic PID Controller- Hotel HCL Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 24
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 feedback (PID-IFB) optimized to function in a hybrid mode with closed-loop control operating during the day and night.

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 days. All participants with diabetes and the parent/ guardian of participants \< 18 years of age will be asked to stay overnight in a hotel while the HCL PID-IFB system is on and to remain close to Stanford University during the day. For participants \> 18 years of age, designated remote monitors will be asked to receive alerts for low/ high glucose levels.

Enrolled participants will be asked to complete evaluations to describe their user experience/ evaluation of the system.Each participant had a companion (parent/ legal guardian of participants \< 18 years of age, or the designate remote monitor for participants \> 18 years of age) who will consent to monitor the participant and complete an evaluation, but will not be considered enrolled in the study.

Eligibility criteria: 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

Primary outcomes:
measure: Count of Participants With no More Than One Meter Glucose Value <50 mg/dL and no Values <40 mg/dL, no More Than Two Episodes With Meter Glucose Values Remaining >300 mg/dL for More Than 1 Hour, and no Ketonemia, Seizures, or Loss of Consciousness
timeFrame: Up to 10 days
Secondary outcomes:
measure: Mean Glucose Values
timeFrame: Up to 10 days
measure: Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts
timeFrame: Up to 10 days
measure: Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort
timeFrame: Up to 10 days
measure: Percentage of Time Within Glucose Range of 70-180 mg/dL
timeFrame: Up to 10 days
measure: Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL
timeFrame: Up to 10 days
measure: Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts
timeFrame: Up to 10 days
measure: Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort
timeFrame: Up to 10 days
measure: Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface
timeFrame: Up to 10 days
measure: Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: UC Denver- Barbara Davis Center for Childhood Diabetes
state: Colorado
city: New Haven
country: United States
facility: Yale University- Department of Pediatric Endocrinology
state: Connecticut
Study officials:
affiliation: Stanford University
name: Bruce A Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ly TT, Weinzimer SA, Maahs DM, Sherr JL, Roy A, Grosman B, Cantwell M, Kurtz N, Carria L, Messer L, von Eyben R, Buckingham BA. Automated hybrid closed-loop control with a proportional-integral-derivative based system in adolescents and adults with type 1 diabetes: individualizing settings for optimal performance. Pediatr Diabetes. 2017 Aug;18(5):348-355. doi: 10.1111/pedi.12399. Epub 2016 May 18.
citation: Adams RN, Tanenbaum ML, Hanes SJ, Ambrosino JM, Ly TT, Maahs DM, Naranjo D, Walders-Abramson N, Weinzimer SA, Buckingham BA, Hood KK. Psychosocial and Human Factors During a Trial of a Hybrid Closed Loop System for Type 1 Diabetes Management. Diabetes Technol Ther. 2018 Oct;20(10):648-653. doi: 10.1089/dia.2018.0174. Epub 2018 Sep 21.