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Fault Detection, Zone MPC and DiAs System in T1D (ZoneMPC)

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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
Sponsor:
Collaborators:
Stanford University
University of Colorado, Denver
Harvard University
University of California, San Diego
University of California, Santa Barbara
Information provided by (Responsible Party):
B. Wayne Bequette, Rensselaer Polytechnic Institute

Tracking Information
First Submitted Date  ICMJE May 11, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date May 16, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fault Detection, Zone MPC and DiAs System in T1D
Official Title  ICMJE 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
Brief Summary This is a randomized crossover study testing the efficacy of the Fault Detection algorithms using the Zone MPC algorithm and DiAs artificial pancreas platform in adult patients with type 1 diabetes. The trial will last for 6 weeks for each individual subject, with three weeks using the AP algorithm and three weeks using sensor augmented pump in a randomized order
Detailed Description

Investigational Device:

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.

Control Arm:

Sensor-augmented insulin pump therapy: Subject will use their personal insulin pump and Dexcom G4P System with Share.

Primary Objective:

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.

Secondary Objectives:

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.

Trial Design:

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Device: Artificial pancreas system (Algorithm + CGM + pump)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 13, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Clinical diagnosis of type 1 diabetes for at least 12 months
  2. Daily insulin therapy for at least 12 months
  3. Age between 18.0 to 55.0 years of age
  4. Use of an insulin pump for at least 3 months
  5. Subject comprehends English
  6. Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test
  7. Total daily insulin requirement ≥ 0.3 units/kg/day
  8. Subject has an adult companion, age > 18 years, who lives with the subject, has access to where they sleep, is willing to be in the house when the subject is sleeping and willing to attend to the subject if there are safety concerns -

Exclusion Criteria:

  1. Diabetic ketoacidosis in the past 6 months
  2. Hypoglycemic seizure or loss of consciousness in the past 6 months
  3. Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine)
  4. Subjects using other anti-diabetic medications other than insulin (oral or injectable) at the time of enrollment. Any prior use of other anti-diabetic medications must be washed out for at least 8 weeks prior to enrollment.
  5. Current use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  6. Subject has a medical disorder that in the judgment of the investigator will affect completion of any aspect of the protocol
  7. Subject is currently participating in another investigational device or drug study within 30 days or 5-half-lives of the drug.
  8. Subject has a history of any cardiac or vascular disorder including, but not limited to, myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease
  9. Subject has a history of hepatic disease
  10. Subject has renal failure on dialysis
  11. Systolic blood pressure > 160 mmHg on screening visit
  12. Diastolic blood pressure > 90 mmHg on screening visit
  13. Subjects with inadequately treated thyroid disease or celiac disease
  14. Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
  15. Subject has received inpatient psychiatric treatment in the past 6 months
  16. Subject consumes more than an average of 4 standard alcoholic drinks/day in the last 30 days
  17. Subject has an active skin condition that would affect sensor placement
  18. Subject is unable to avoid acetaminophen for the duration of the study
  19. Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
  20. Subject is currently on beta blocker medication -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773875
Other Study ID Numbers  ICMJE IDE G150122
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party B. Wayne Bequette, Rensselaer Polytechnic Institute
Study Sponsor  ICMJE Rensselaer Polytechnic Institute
Collaborators  ICMJE
  • Stanford University
  • University of Colorado, Denver
  • Harvard University
  • University of California, San Diego
  • University of California, Santa Barbara
Investigators  ICMJE Not Provided
PRS Account Rensselaer Polytechnic Institute
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP