Pilot Study 1 of Outpatient Control-to-Range - System and Monitoring Testing
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01470807|
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : November 29, 2012
A single arm, single treatment study is proposed to assess the feasibility of a portable artificial pancreas system outside of a hospital based clinical research center.
Adult T1DM patients will use a newly developed platform in conjunction with a subcutaneous insulin infusion pump and a continuous glucose monitor for 18 hours is quasi free conditions (hotel).
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: portable artificial pancreas system with CTR algorithms||Not Applicable|
Automated closed-loop control (CLC), known as "artificial pancreas" (AP) can have tremendous impact on the health and lives of people with type 1 diabetes (T1D). Our inter-institutional and international research team has been on the forefront of CLC developments since the beginning of the JDRF Artificial Pancreas initiative in 2006. Thus far, we have conducted three closed-loop control clinical trials (totaling 60 subjects with T1D), which demonstrated significantly more time in an acceptable "target" blood glucose range during CLC, and significantly fewer hypoglycemic events during CLC compared to open loop. Our overall objective is to sequentially test, validate, obtain regulatory approval for, and deploy at home, a closed-loop Control-to-Range (CTR) system comprised of two algorithmic components: a Safety Supervision Module (SSM) and an automated Range Correction Module (RCM). The SSM will monitor the safety of the subject's continuous subcutaneous insulin infusion pump (CSII) to prevent hypoglycemia, and will also monitor the integrity of continuous glucose monitor (CGM) data for signal sensor deviations or loss of sensitivity. The RCM will be responsible for the optimal regulation of postprandial hyperglycemic excursions through correction boluses.
The first phase to address our overall objective is a pilot study that will test the ability of a cell-phone-based system to (1) run CTR in an outpatient setting, and (2) be remotely monitored. Specifically, this pilot study entails a hybrid hotel/hospital design targeting adults with T1D that are experienced insulin pump users. Subjects will spend one night in a local hotel, during which the phone-based system will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur. Subjects will spend the following day in the hospital, where CTR will be activated, and challenged with meals and a CGM sensor replacement . Subjects will then spend a second night in the hotel for continued evaluation of remote system monitoring, along with outpatient testing of the CTR system run on the phone-based system. This series of admissions will address the first major hurdles that need to be overcome for home deployment of a closed loop CTR system:
Specific Aim 1: The phone-based CTR system can be remotely monitored by nurses/physicians/technicians to confirm appropriate functioning outside of the hospital setting.
Specific Aim 2: The CTR can be deployed outside of the hospital setting.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of a Portable Artificial Pancreas System in Type 1 Diabetes|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Experimental: portable artificial pancreas system with CTR algorithms
This is the only arm of the study and concerns all patients.
Device: portable artificial pancreas system with CTR algorithms
The investigators will test the new portable CTR system in CRC conditions for 10h followed by 18h of CTR in a hotel.
- estimation of the failure rates of system components [ Time Frame: length of admission (hour 42) ]the investigators will estimate the frequency of failures (#failures/day) of each following system components: CGM communication, pump communication, insulin dose computation, user interface.
- frequency analysis of lost or inaccurate CGM records [ Time Frame: length of admission (42 hours) ]number of CGM data point not received by the device divided by the total number of possible data points to be received.
- percent time of active CTR [ Time Frame: length of admission (42h) ]number of minutes the Control-To-Range system was functioning properly (computation of insulin infusion, and insulin actually delivered) divided by the maximum number of minutes the CTR system should have been active (as per protocol)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470807
|University of Padova|
|Principal Investigator:||Claudio Cobelli, Ph.D.||University of Padova|
|Study Chair:||Boris Kovatchev, Ph.D.||University of Virginia|