Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS)

NCT01472406 | Completed Early Phase 1 DMC

• 1 other identifier: DK085628
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes. The device is a closed-loop between a DexCom™ SEVEN® PLUS (DexCom™ Corp, San Diego, CA) continuous glucose monitor (CGM) and a OneTouch® Ping® Glucose Monitoring System (Animas Corp, Westchester, PA) subcutaneous insulin delivery pump (CSII). The AP device is controlled by a zone-Model Predictive Control (zone-MPC) algorithm augmented by a safety algorithm named the Health Monitoring System (HMS). The clinical study will include 12 to 20 adults subjects aged 21 to 65 years old.

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitus; closed-loop artificial pancreas

Outcome Measures

Primary Outcomes (1)

• % of time within zone [80-140] mg/dL except 5 hours post-prandial and during exercise and 3 hours post-exercise

  Measures ability of AP device to maintain glucose level within a safe zone and to return to save zone following unannounced meals and exercises.

  24 hours

Secondary Outcomes (4)

• % of time within zone [80-140] mg/dL during night between 12:00 am and 7:00 am

  24 hours

• % of time within zone [70-180] mg/dL 5 hours after unannounced evening meal, and breakfast

  24 hours

• % of time within zone [70-150] mg/dL during the 30 min exercise

  24 hours

• % of time within zone [70-150] mg/dL during the 3 hours following exercise

  24 hours

Study Arms (1)

Closed-loop session

EXPERIMENTAL

The study consists of an evaluation of the Sansum Closed-loop Artificial Pancreas Device, insulin infusion pump, Continuous Glucose Monitor, zone-Model Predictive Control algorithm, and a Safety Health Monitoring System. during a 24-hour closed-loop in a clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA).

Device: Sansum Closed-Loop Artificial Pancreas; Device: Insulin infusion pump; Device: Continuous Glucose Monitor; Device: zone-Model Predictive Control algorithm; Device: Safety Health Monitoring System

Interventions

Sansum Closed-Loop Artificial Pancreas DEVICE

The Sansum Closed-loop Artificial Pancreas Device is the infrastructure that allows communication between the insulin pump, the CGM, the zone-MPC, and the HMS.

Also known as: Sansum AP

Closed-loop session

Insulin infusion pump DEVICE

The insulin pump, which has received 510k clearance (K080639), delivers insulin subcutaneously through an infusion set.

Closed-loop session

Continuous Glucose Monitor DEVICE

The CGM, which is an approved device (P050012), measures interstitial glucose.

Also known as: CGM

Closed-loop session

zone-Model Predictive Control algorithm DEVICE

The zone-MPC predicts future glucose values, based on CGM data, to regulate blood glucose level by increasing, decreasing, or stopping insulin infusion via an insulin infusion pump.

Also known as: zone-MPC

Closed-loop session

Safety Health Monitoring System DEVICE

The HMS predicts future glucose values, based on CGM data, to warn the Sansum Closed-loop Artificial Pancreas Device of values below 70 mg/dL.

Also known as: HMS

Closed-loop session

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months with commercially available rapid actin insulin
• The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
• Age 21 to 65 years
• For females, not currently known to be pregnant or nursing
• HbA1c between 5.0% and 10%, as measured with DCA2000 or equivalent device
• Willing to perform the calibration of the study CGMs using a finger stick only and willing to follow instructions for insulin pump and CGM wear.
• Willing to use the study CGM and study insulin pump during closed-loop.
• Able to and agrees to avoid the following medication starting 24 hours before sensor wear through completion of CRC visit: acetaminophen, prednisone, and pseudoephedrine.
• An understanding of and willingness to follow the protocol and sign the informed consent

You may not qualify if:

• Pregnancy (as determined by a positive blood pregnancy test performed in females of childbearing capacity during screening visit and urine test at time of admission for in-patient visit) or nursing mother.
• Diabetic ketoacidosis in the past 6 months prior to enrollment requiring emergency room visit or hospitalization
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
• Current treatment for a seizure disorder; Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist
• Cystic fibrosis
• Active infection
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as cognitive deficit.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write.
• Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
• Coronary artery disease or heart failure. Subjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist
• Presence of a known adrenal disorder
• Active coronary artery disease or heart failure
• 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. Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• University of California, Santa Barbara: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Related Publications (1)

• Harvey RA, Dassau E, Bevier WC, Seborg DE, Jovanovic L, Doyle FJ 3rd, Zisser HC. Clinical evaluation of an automated artificial pancreas using zone-model predictive control and health monitoring system. Diabetes Technol Ther. 2014 Jun;16(6):348-57. doi: 10.1089/dia.2013.0231. Epub 2014 Jan 28.

  PMID: 24471561 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Howard Zisser, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

• Francis J Doyle, PhD

  University of California, Santa Barbara

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 16, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

US (1)