Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS)
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.
Type 1 Diabetes Mellitus
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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Artificial Pancreas Device Feasibility Study for Type 1 Diabetes Patients Using Model-predictive Control and Health Monitoring System Algorithms With an Approved Subcutaneous Insulin Delivery Pump and Subcutaneous Continuous Glucose Monitor|
- % of time within zone [80-140] mg/dL except 5 hours post-prandial and during exercise and 3 hours post-exercise [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Measures ability of AP device to maintain glucose level within a safe zone and to return to save zone following unannounced meals and exercises.
- % of time within zone [80-140] mg/dL during night between 12:00 am and 7:00 am [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Measures ability of AP device to maintain glucose level with a safe zone during the night and prevent hypoglycemia
- % of time within zone [70-180] mg/dL 5 hours after unannounced evening meal, and breakfast [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Measures ability of AP device to react to small meal and to prevent glucose level from dangerous excursions.
- % of time within zone [70-150] mg/dL during the 30 min exercise [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Measures ability of AP device to maintain safe glucose level during 30 minutes of non-strenuous exercise
- % of time within zone [70-150] mg/dL during the 3 hours following exercise [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Measures ability of AP device to address exercise and to prevent glucose level from dangerous excursions
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Closed-loop session
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
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.
Other Name: Sansum APDevice: Insulin infusion pump
The insulin pump, which has received 510k clearance (K080639), delivers insulin subcutaneously through an infusion set.Device: Continuous Glucose Monitor
The CGM, which is an approved device (P050012), measures interstitial glucose.
Other Name: CGMDevice: zone-Model Predictive Control algorithm
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.
Other Name: zone-MPCDevice: Safety Health Monitoring System
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.
Other Name: HMS
The study consists of an evaluation of the Artificial Pancreas device during a 24-hour closed-loop in a clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA). The 24-hour period includes:
- 2 unannounced meals (evening dinner and breakfast);
- 1 period of 30 minutes of exercise at 50% of the predicted heart rate reserve (HRR) preceded with a snack and followed by a snack 3 hours later (on Day 2);
- complete night from 12:00 am to 7:00 am; The subject will arrive at approximately 4:00 pm to the CRC (clinical research center), the closed-loop will be initiated at approximately 4:30 pm that same day and continued until 4:30 pm the next day. A physician will be monitoring the patient with the artificial Pancreas (AP) device at all time.
The proposed study will evaluate the performance of the AP device in predicting the fall and rise of glucose values and in regulating insulin delivery to mitigate extreme blood glucose variations during the following challenges:
- following unannounced meals,
- during a nocturnal period, and
- during a period of active exercise.
The goal is to demonstrate that the AP device is able to maintain the subject blood glucose within a safe range at all times. One of the objectives of the study will be to measure the percent of time spent in the following zones:
- [80-140] mg/dL at all times unless described otherwise
- [80-140] mg/dL during the nocturnal period
- [70-180] mg/dL postprandial, for 5 hours following the unannounced meals
- [70-150] mg/dL during and for 3 hours following exercise It is anticipated that following the planned challenges, glucose value might increase temporarily beyond those ranges. These excursions will be reviewed and analyzed (value and duration) and the study will determine how the AP device mitigates those excursions and maintains glucose levels within a safe and acceptable range. The clinical study will also review any event that occur during the course of the 24-hour closed-loop: hypoglycemic events, hyperglycemic events, outside intervention, other Adverse Event, Serious Adverse Events, Unanticipated Adverse Device Effect, and device complaints for the commercial devices used. The safety of the patient will remain the primary goal. The goal of the AP device is to operate without outside intervention even when challenged by meals or exercise unless the outside intervention is requested by the Health Monitoring System (HMS).
|Contact: Howard Zisser, MD||805-682-7640 ext firstname.lastname@example.org|
|Contact: Eyal Dassau, Ph.D.||email@example.com|
|United States, California|
|Sansum Diabetes Research Institute||Recruiting|
|Santa Barbara, California, United States, 93105|
|Contact: Howard Zisser, MD 805-682-7640 ext 255 firstname.lastname@example.org|
|Contact: Wendy Bevier, PhD 805-682-7640 ext 207 email@example.com|
|Sub-Investigator: Lois Jovanovic, MD|
|Sub-Investigator: Eyal Dassau, PhD|
|Sub-Investigator: Francis Doyle, Ph.D.|
|Principal Investigator:||Howard Zisser, MD||Sansum Diabetes Research Institute|
|Study Director:||Francis J Doyle, PhD||University of California, Santa Barbara|