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

May 13, 2016 updated by: B. Wayne Bequette, Rensselaer Polytechnic Institute

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

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

Study Overview

Status

Unknown

Conditions

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 hours after insulin infusion set failure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During 2 week intervention period
Mean sensor glucose values
Time Frame: 2 week intervention period versus 2 week control period
mean sensor glucose values
2 week intervention period versus 2 week control period
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
2 week intervention period versus 2 week control period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 16, 2016

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 13, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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