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Status unknownNCT02773875ZoneMPCUpdated May 16, 2016

Fault Detection, Zone MPC and DiAs System in T1D

An interventional study of Artificial pancreas system (Algorithm + CGM + pump) in Type 1 Diabetes, sponsored by Rensselaer Polytechnic Institute. Status unknown. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-05-16.

Sponsored by Rensselaer Polytechnic Institute · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • artificial pancreas
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Rensselaer Polytechnic Institute is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 -
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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)

Interventions

  • DeviceArtificial 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 hours after insulin infusion set failure

Secondary outcomes

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

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

    Time frame: During 2 week intervention period

  2. Mean sensor glucose values

    mean sensor glucose values

    Time frame: 2 week intervention period versus 2 week control period

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

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

    Time frame: 2 week intervention period versus 2 week control period

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 29390915 ↗
  • 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 Nov;40(11):1606. doi: 10.2337/dc17-er11a. PubMed 28584075 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02773875
Lead sponsor
Rensselaer Polytechnic Institute
Collaborators
Stanford University, University of Colorado, Denver, Harvard University, University of California, San Diego, University of California, Santa Barbara
Responsible party
B. Wayne Bequette (Professor, Department of Chemical & Biological Engineering Associate Director of Process Technologies, Rensselaer Polytechnic Institute) — Principal investigator
First posted
May 16, 2016
Start date
May 2016
Primary completion
Nov 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
May 16, 2016

Study contacts

David Maahs, MD, PhD
Contact
David.Maahs@ucdenver.edu
Laurel Messer
Contact
Laurel.Messer@ucdenver.edu

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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