Early Feasibility Study of Zone-MPC and HMS With DiAs in the Outpatient Setting
NCT ID: NCT02463682
Last Updated: 2016-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
9 participants
INTERVENTIONAL
2015-05-31
2015-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy
NCT01714505
Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy (Italy)
NCT01727817
Inpatient Closed Loop Glucose Control With the Gen 2 GlucoSTAT
NCT04227626
Inpatient Use of Personal Continuous Glucose Monitor (CGM) to Improve Diabetes Mellitus Control
NCT07006480
Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)
NCT01763567
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sensor-Augmented Pump Open-Loop Care (Week 1)
The subjects Sensor-Augmented Pump Open-Loop Care for the first week of the study before any adjustments to pump settings.
CGM and Insulin Pump
Dexcom G4 Platinum CGM with Share AP Receiver Roche Accu-Chek insulin pump
Closed-Loop Control System with Zone MPC and HMS
The artificial pancreas system will be allowed to employ its Model Predictive Control algorithm to make decisions about insulin delivery based on measured glucose levels. The Health Monitoring System algorithm uses the same CGM data as the MPC control algorithm but utilizes a separate algorithm for trending and predictions of future glucose values. Using a redundant and independent algorithm is an important safety feature of the overall AP device.
Closed-Loop Control System
The devices that will be used in the Closed-Loop Control System include the following components:
DiAs - a smart-phone medical platform; Dexcom Dexcom G4 Platinum connected to DiAs via Bluetooth CGM receiver; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Zone-MPC and HMS algorithms running on DiAs (MPC and HMS)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CGM and Insulin Pump
Dexcom G4 Platinum CGM with Share AP Receiver Roche Accu-Chek insulin pump
Closed-Loop Control System
The devices that will be used in the Closed-Loop Control System include the following components:
DiAs - a smart-phone medical platform; Dexcom Dexcom G4 Platinum connected to DiAs via Bluetooth CGM receiver; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Zone-MPC and HMS algorithms running on DiAs (MPC and HMS)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Willing to wear the study CGM device for the duration of the study
* Age ≥21 to \<65 years
* HbA1c \<10.0%; if HbA1c \<6.0% then total daily insulin must be ≥0.5 U/kg
* For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
* Demonstration of proper mental status and cognition for the study
* Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes
* Hypoglycemia awareness as demonstrated by a Clarke Hypoglycemia Unawareness score of 2 or lower
* Access to internet and cell phone service at home, and a computer for downloading device data
* Availability of care partner committed to participating in training activities, knowledgeable at all times of the participant's location, and being present and available to provide assistance when system is being used at night
* Commitment to maintaining uninterrupted availability via cell phone and avoiding any overnight travel for the duration the period using the closed-loop system
* An understanding of and willingness to follow the protocol and sign the informed consent
Exclusion Criteria
* Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
* History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist
* Coronary artery disease or heart failure, unless written clearance is received from a cardiologist
* History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
* Cystic fibrosis
* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
* Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
* Presence of a known adrenal disorder
* Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
* Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty
* Active gastroparesis
* If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
* Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L); testing required within three months prior to admission for subjects with a goiter or who are on thyroid hormone replacement, and within one year otherwise
* Abuse of alcohol or recreational drugs
* Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)
* A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
* Current use of the following drugs and supplements:
* Acetaminophen
* Any medication being taken to lower blood glucose, such as Pramlintide, Metformin,GLP-1 Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose
* Beta blockers
* Oral or injectable glucocorticoids
* Any other medication that the investigator believes is a contraindication to the subject's participation
21 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, Santa Barbara
OTHER
Mayo Clinic
OTHER
University of Virginia
OTHER
University of Padova
OTHER
Sansum Diabetes Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francis J Doyle III, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Santa Barbara/William Sansum Diabetes Center
Eyal Dassau, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Santa Barbara/William Sansum Diabetes Center
Jordan E Pinsker, MD
Role: PRINCIPAL_INVESTIGATOR
Sansum Diabetes Research Institute
Ananda Basu, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic, Rochester, MN
Yogish Kudva, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic, Rochester, MN
Boris Kovatchev, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Sue Brown, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Stephen Patek, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Claudio Cobelli, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Padova
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
William Sansum Diabetes Center
Santa Barbara, California, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
99796-JPIN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.