Fault Detection, Zone MPC and DiAs System in T1D (ZoneMPC)
|ClinicalTrials.gov Identifier: NCT02773875|
Recruitment Status : Unknown
Verified May 2016 by B. Wayne Bequette, Rensselaer Polytechnic Institute.
Recruitment status was: Not yet recruiting
First Posted : May 16, 2016
Last Update Posted : May 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: Artificial pancreas system (Algorithm + CGM + pump)||Not Applicable|
Artificial Pancreas System with Fault Detection Algorithms: Roche Accu-Check Spirit Combo Insulin Pump, Dexcom G4P System with Share, Diabetes Assistant (DiAs) on Android phone, DiAs Web Monitoring (DWM)
- referred to as Remote Monitoring Server, MPC control algorithm, Health Monitoring System (HMS) algorithm. Sensor and infusion set fault detection algorithms will be applied offline with data obtained from server and notifications will be sent to the clinician.
Sensor-augmented insulin pump therapy: Subject will use their personal insulin pump and Dexcom G4P System with Share.
To determine the efficacy of the fault detection algorithm. The primary outcome is based on the amount of time the sensor glucose is >250 mg/dL in the 4 hours preceding detection of the infusion set failure during sensor augmented pump therapy vs. closed-loop control with fault detection alerts.
To determine the effectiveness of the sensor fault detection algorithm. To determine the efficacy of the Zone MPC controller by evaluating glycemic outcomes
Number of Subjects:
There will be 20 subjects recruited: 10 at Stanford and 10 at Denver (up to 36 subjects will be enrolled to reach 20 subjects completing the study)
Diagnosis and Main Inclusion Criteria:
Adult subjects between 18 and 55 years of age inclusive, diagnosed with type 1 diabetes.
This outpatient study will be conducted over 6 weeks as shown in the figure below. The 6-week period will consist of two 2-week blocks of prolonged infusion set wear with a 1-week sensor run-in period preceding each block. In each block, subjects will wear an infusion set for up to 7 days. A new infusion set will be inserted at the start of each week in the block. Following enrollment procedures, subjects will be randomized at a ratio of 1:1 to either use the AP system with fault detection algorithms (intervention) or sensor-augmented pump therapy (control) in the first block.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Crossover Study to Evaluate the Efficacy of Fault Detection Algorithms Using the ZoneMPC Algorithm and DiAs System in Adult Subjects With Type 1 Diabetes in the Outpatient Setting|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
No Intervention: Sensor Augmented Pump (control)
Use sensor augmented pump (SAP) for 3 weeks.
Experimental: Artificial Pancreas (intervention)
Artificial pancreas system (Algorithm + CGM + pump)--use the AP system for 3 weeks which consists of: (1) Fault detection and Zone MPC algorithm housed on the DiAs platform + (2) Roche insulin pump + (3) Dexcom CGM
Device: Artificial pancreas system (Algorithm + CGM + pump)
The AP system using fault detection algorithms will determine whether insulin infusion problems are occurring and may prevent severe hyperglycemia due to its predictive nature
- Amount of time sensor glucose levels are >250 mg/dl [ Time Frame: 4 hours after insulin infusion set failure ]Amount of time sensor glucose levels are >250 mg/dl in the control arm versus the experimental arm
- Effectiveness of sensor fault detection algorithm as defined by % of sensor failures caught by the system [ Time Frame: During 2 week intervention period ]Effectiveness of sensor fault detection algorithm as defined by % of sensor failures caught by the system
- Mean sensor glucose values [ Time Frame: 2 week intervention period versus 2 week control period ]mean sensor glucose values
- Percent of time in range between 70-180 mg/dl [ Time Frame: 2 week intervention period versus 2 week control period ]Percent of time in range between 70-180 mg/dl
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773875
|Contact: David Maahs, MD, PhD||David.Maahs@ucdenver.edu|
|Contact: Laurel Messer||Laurel.Messer@ucdenver.edu|