Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller

NCT ID: NCT02280863

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-05-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adult Cohort

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.

Group Type: EXPERIMENTAL

Medtronic Hybrid Closed-loop System - Android Platform

Intervention Type: DEVICE

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.

Medtronic Hybrid Closed-loop Integrated System

Intervention Type: DEVICE

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

Adolescent Cohort

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.

Group Type: EXPERIMENTAL

Medtronic Hybrid Closed-loop Integrated System

Intervention Type: DEVICE

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

Interventions

Medtronic Hybrid Closed-loop System - Android Platform

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.

Intervention Type: DEVICE

Medtronic Hybrid Closed-loop Integrated System

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Bruce A. Buckingham

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce A Buckingham, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27191182 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30239219 (View on PubMed)

Other Identifiers

1-SRA-2014-238-

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB 29973

Identifier Type: OTHER

Identifier Source: secondary_id

IDE: G140086

Identifier Type: -

Identifier Source: org_study_id