Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 6:19 PM
Study NCT ID:
NCT01472406
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2011-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS)
Sponsor:
Sansum Diabetes Research Institute
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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).
* 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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: