Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller

NCT02280863 | Completed Results DMC

• 3 other identifiers: IDE: G1400861-SRA-2014-238-IRB 29973
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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: 1. No more than one meter glucose value \<50 mg/dL and no values \<40 mg/dL 2. 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 3. No ketonemia \>1.0 mmol/L, while the system is functional unless related to an intercurrent illness or infusion set failure 4. No seizures or loss of consciousness while system is on and functional

  Up to 10 days

Secondary Outcomes (9)

• Mean Glucose Values

  Up to 10 days

• Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts

  Up to 10 days

• Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort

  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

Study Arms (2)

Adult Cohort

EXPERIMENTAL

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; Device: Medtronic Hybrid Closed-loop Integrated System

Adolescent Cohort

EXPERIMENTAL

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

Interventions

Medtronic Hybrid Closed-loop System - Android Platform 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.

Adult Cohort

Medtronic Hybrid Closed-loop Integrated System 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; Adult Cohort

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (3)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

UC Denver- Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

Yale University- Department of Pediatric Endocrinology

New Haven, Connecticut, 06520, United States

Location

Related Publications (2)

• 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.

  PMID: 27191182 RESULT

• 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.

  PMID: 30239219 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Bruce Buckingham, MD
• Organization: Stanford University

buckingham@stanford.edu

Study Officials

• Bruce A Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: November 3, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 3, 2018
• Results First Posted: July 3, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (3)