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

Primary Purpose

Type 1 Diabetes

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Artificial pancreas system (Algorithm + CGM + pump)

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring artificial pancreas

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of type 1 diabetes for at least 12 months
Daily insulin therapy for at least 12 months
Age between 18.0 to 55.0 years of age
Use of an insulin pump for at least 3 months
Subject comprehends English
Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test
Total daily insulin requirement ≥ 0.3 units/kg/day
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:

Diabetic ketoacidosis in the past 6 months
Hypoglycemic seizure or loss of consciousness in the past 6 months
Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine)
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.
Current use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study
Subject has a medical disorder that in the judgment of the investigator will affect completion of any aspect of the protocol
Subject is currently participating in another investigational device or drug study within 30 days or 5-half-lives of the drug.
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
Subject has a history of hepatic disease
Subject has renal failure on dialysis
Systolic blood pressure > 160 mmHg on screening visit
Diastolic blood pressure > 90 mmHg on screening visit
Subjects with inadequately treated thyroid disease or celiac disease
Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
Subject has received inpatient psychiatric treatment in the past 6 months
Subject consumes more than an average of 4 standard alcoholic drinks/day in the last 30 days
Subject has an active skin condition that would affect sensor placement
Subject is unable to avoid acetaminophen for the duration of the study
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
Subject is currently on beta blocker medication -

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Sensor Augmented Pump (control)

Artificial Pancreas (intervention)

Arm Description

Use sensor augmented pump (SAP) for 3 weeks.

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

Outcomes

Primary Outcome Measures

Amount of time sensor glucose levels are >250 mg/dl

Amount of time sensor glucose levels are >250 mg/dl in the control arm versus the experimental arm

Secondary Outcome Measures

Effectiveness of sensor fault detection algorithm as defined by % of sensor failures caught by the system

Mean sensor glucose values

mean sensor glucose values

Percent of time in range between 70-180 mg/dl

Full Information

NCT ID

NCT02773875

First Posted

May 11, 2016

Last Updated

May 13, 2016

Sponsor

Rensselaer Polytechnic Institute

Collaborators

Stanford University, University of Colorado, Denver, Harvard University, University of California, San Diego, University of California, Santa Barbara

1. Study Identification

Unique Protocol Identification Number

NCT02773875

Brief Title

Fault Detection, Zone MPC and DiAs System in T1D

Acronym

ZoneMPC

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 Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rensselaer Polytechnic Institute

Collaborators

Stanford University, University of Colorado, Denver, Harvard University, University of California, San Diego, University of California, Santa Barbara

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

artificial pancreas

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sensor Augmented Pump (control)

Arm Type

No Intervention

Arm Description

Use sensor augmented pump (SAP) for 3 weeks.

Arm Title

Artificial Pancreas (intervention)

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Artificial pancreas system (Algorithm + CGM + pump)

Intervention Description

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

Primary Outcome Measure Information:

Title

Amount of time sensor glucose levels are >250 mg/dl

Description

Amount of time sensor glucose levels are >250 mg/dl in the control arm versus the experimental arm

Time Frame

4 hours after insulin infusion set failure

Secondary Outcome Measure Information:

Title

Effectiveness of sensor fault detection algorithm as defined by % of sensor failures caught by the system

Description

Effectiveness of sensor fault detection algorithm as defined by % of sensor failures caught by the system

Time Frame

During 2 week intervention period

Title

Mean sensor glucose values

Description

mean sensor glucose values

Time Frame

2 week intervention period versus 2 week control period

Title

Percent of time in range between 70-180 mg/dl

Description

Percent of time in range between 70-180 mg/dl

Time Frame

2 week intervention period versus 2 week control period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of type 1 diabetes for at least 12 months Daily insulin therapy for at least 12 months Age between 18.0 to 55.0 years of age Use of an insulin pump for at least 3 months Subject comprehends English Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test Total daily insulin requirement ≥ 0.3 units/kg/day 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: Diabetic ketoacidosis in the past 6 months Hypoglycemic seizure or loss of consciousness in the past 6 months Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine) 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. Current use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study Subject has a medical disorder that in the judgment of the investigator will affect completion of any aspect of the protocol Subject is currently participating in another investigational device or drug study within 30 days or 5-half-lives of the drug. 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 Subject has a history of hepatic disease Subject has renal failure on dialysis Systolic blood pressure > 160 mmHg on screening visit Diastolic blood pressure > 90 mmHg on screening visit Subjects with inadequately treated thyroid disease or celiac disease Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol Subject has received inpatient psychiatric treatment in the past 6 months Subject consumes more than an average of 4 standard alcoholic drinks/day in the last 30 days Subject has an active skin condition that would affect sensor placement Subject is unable to avoid acetaminophen for the duration of the study 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 Subject is currently on beta blocker medication -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Maahs, MD, PhD

David.Maahs@ucdenver.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Laurel Messer

Laurel.Messer@ucdenver.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29390915

Citation

Howsmon DP, Baysal N, Buckingham BA, Forlenza GP, Ly TT, Maahs DM, Marcal T, Towers L, Mauritzen E, Deshpande S, Huyett LM, Pinsker JE, Gondhalekar R, Doyle FJ 3rd, Dassau E, Hahn J, Bequette BW. Real-Time Detection of Infusion Site Failures in a Closed-Loop Artificial Pancreas. J Diabetes Sci Technol. 2018 May;12(3):599-607. doi: 10.1177/1932296818755173. Epub 2018 Feb 1.

Results Reference

derived

PubMed Identifier

28584075

Citation

Forlenza GP, Deshpande S, Ly TT, Howsmon DP, Cameron F, Baysal N, Mauritzen E, Marcal T, Towers L, Bequette BW, Huyett LM, Pinsker JE, Gondhalekar R, Doyle FJ 3rd, Maahs DM, Buckingham BA, Dassau E. Application of Zone Model Predictive Control Artificial Pancreas During Extended Use of Infusion Set and Sensor: A Randomized Crossover-Controlled Home-Use Trial. Diabetes Care. 2017 Aug;40(8):1096-1102. doi: 10.2337/dc17-0500. Epub 2017 Jun 5. Erratum In: Diabetes Care. 2017 Sep 8;:

Results Reference

derived

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Fault Detection, Zone MPC and DiAs System in T1D

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