Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hybrid Closed-Loop Studies With Medtronic PID Controller- Hotel HCL Study

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Medtronic Hybrid Closed-loop System - Android Platform
* Device: Medtronic Hybrid Closed-loop Integrated System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult Cohort<br>Medtronic Hybrid Closed-Loop System will be used by adults for five days in open-loop (sensor augmented pump) and five days in closed-loop. The first 8 Adults use the Android Platform. | Device: Medtronic Hybrid Closed-loop System - Android Platform<br>* A continuous glucose sensor and insulin delivery system designed for continuous closed-loop control with the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm using an Android controller.<br>Device: Medtronic Hybrid Closed-loop Integrated System<br>* A fully integrated continuous glucose sensor and insulin delivery system designed for continuous closed-loop control with the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm<br>|
| Experimental: Adolescent Cohort<br>Medtronic Hybrid Closed-Loop System will be used by adolescents for four days in open-loop (sensor augmented pump) and four days in closed-loop. | Device: Medtronic Hybrid Closed-loop Integrated System<br>* A fully integrated continuous glucose sensor and insulin delivery system designed for continuous closed-loop control with the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Our definition of a subject successfully participating in a cohort is: 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 that are unrelated to an infusion set failure No ketonemia >1.0 mmol/L, while the system is functional unless related to an intercurrent illness or infusion set failure No seizures or loss of consciousness while system is on and functional | Up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Glucose Values | Mean glucose values are reported as assessed by continuous glucose monitoring (CGM; subcutaneous sensor, day and night values). | Up to 10 days | 
| Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts | Mean glucose values are reported as assessed by fingerstick glucose meter value. | Up to 10 days | 
| Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort | Median an glucose values are reported as assessed by fingerstick glucose meter value. | Up to 10 days | 
| Percentage of Time Within Glucose Range of 70-180 mg/dL |  | Up to 10 days | 
| Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL |  | Up to 10 days | 
| Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts |  | Up to 10 days | 
| Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort |  | Up to 10 days | 
| Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface |  | Up to 10 days | 
| Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort |  | Up to 10 days |