Feasibility Study of a Portable Artificial Pancreas System in Type 1 Diabetes Mellitus (T1DM) - Padova (HomeCTR1_2)
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).
|Type 1 Diabetes Mellitus||Device: Portable artificial pancreas system with Control-To-Range||Early Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study 1 of Outpatient Control-to-Range - System and Monitoring Testing|
- estimation of the failure rates of system components [ Time Frame: length of admission (hour 42) ]we will estimate the relative frequency of failures (#failures/opportunity of failure) of each following system components: CGM communication (1 failure opportunity every 5min), pump communication (1 failure opportunity every 5min), insulin dose computation (1 failure opportunity every 5min), user interface (1 failure opportunity every 1min).
- frequency analysis of lost or inaccurate CGM records [ Time Frame: length of admission (42 hours) ]number of CGM data points not received (or corrupted) by the device divided by the total number of possible CGM 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)
|Study Start Date:||September 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
|Experimental: Portable artificial pancreas system with Control-To-Range||
Device: Portable artificial pancreas system with Control-To-Range
We will test the new portable Control-To-Range system in clinical research center conditions for 10 hours followed by 18 hours of Control-To-Range in a hotel.
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 Juvenile Diabetes Research Foundation (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447992
|Azienda Ospedaliera E Universita Degli Study Di Padova|
|Padova, Veneto, Italy, 35128|
|Principal Investigator:||Angelo Avogaro, MD||University of Padova Hospital|
|Study Director:||Boris Kovatchev, PhD||University of Virginia|