Clinical trial NCT02463682: Early Feasibility Study of Zone-MPC and HMS With DiAs in the Outpatient Setting
Official title: Early Feasibility Study of a Zone-Model Predictive Control (MPC) Controller and a Health Monitoring System (HMS) With the Diabetes Assistant (DiAS) in the Outpatient Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Artificial Pancreas
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: University of California, Santa Barbara
name: Mayo Clinic
name: University of Virginia
name: University of Padova
First posted: 2015-06-04
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a feasibility study of an artificial pancreas (AP) system with our previously validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTraisl.gov: NCT01929798) integrated into the Diabetes Assistant (DiAs) system.

Detailed description: This is a feasibility study of an artificial pancreas (AP) system with our previously validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTraisl.gov: NCT01929798) integrated into the Diabetes Assistant (DiAs) system. The system will be evaluated on 2-3 subjects per site (n=6-9 subjects) for 2 weeks at 3 different sites (William Sansum Diabetes Center, University of Virginia, and Mayo Clinic, Rochester, MN). Basal rates will be adjusted in a run-to-run manner by study physicians prior to the closed-loop phase for a maximum of 3 weeks. Subjects will then complete 2 weeks at home use of the Zone-MPC/HMS system using the DIAs platform for a closed-loop feasibility trial. The purpose of this pilot study is to establish that safe day-and-night use of the Zone-MPC/HMS system integrated into the DiAs is achievable in the home environment, to analyze and learn to improve upon the run-to- run optimization process, and to collect efficacy data to inform a future larger study.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year and an insulin pump for at least 6 months
* 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:

* Admission for diabetic ketoacidosis in the 12 months prior to enrollment
* 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

Primary outcomes:
measure: Safety and efficacy of the system, as assessed by the composite outcome of time in range for glucose levels of 70-180 mg/dL and time < 70 mg/dL.
timeFrame: 1 Week
Secondary outcomes:
measure: Time in range for glucose 80-140 mg/dL
timeFrame: 1 Week
measure: Time in range for glucose during the nocturnal period
timeFrame: 1 week
measure: Time in Range Postprandial
timeFrame: 1 Week
measure: Markers of hypo- and hyperglycemia
timeFrame: 1 Week
measure: Insulin Doses Given
timeFrame: 1 Week
measure: Treatments for hypoglycemia
timeFrame: 1 week
measure: Number of alerts given by the HMS to prevent hypoglycemia
timeFrame: 2 Weeks
measure: Outside interventions needed
timeFrame: 2 Weeks
measure: Failure analysis of the devices/connectivity issues that may occur.
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: William Sansum Diabetes Center
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of California, Santa Barbara/William Sansum Diabetes Center
name: Francis J Doyle III, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Santa Barbara/William Sansum Diabetes Center
name: Eyal Dassau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sansum Diabetes Research Institute
name: Jordan E Pinsker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic, Rochester, MN
name: Ananda Basu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic, Rochester, MN
name: Yogish Kudva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Boris Kovatchev, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Sue Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Stephen Patek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Padova
name: Claudio Cobelli, PhD
role: PRINCIPAL_INVESTIGATOR
References: