AzTrials
AzTrials

Type 1 DiabetesZoneMPCNCT02773875

Fault Detection, Zone MPC and DiAs System in T1D

A study testing Artificial pancreas system (Algorithm + CGM + pump) in people with Type 1 Diabetes, run by Rensselaer Polytechnic Institute.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Artificial pancreas system (Algorithm + CGM + pump)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
May 2016to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 -

Who cannot join

  • 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
Show all 20Show fewer
  • 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 -

Trial locations and contacts

No sites are listed yet.

David Maahs, MD, PhD contact

David.Maahs@ucdenver.edu

Laurel Messer contact

Laurel.Messer@ucdenver.edu

About this study

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

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.

Conditions
Type 1 Diabetes
Being tested
Artificial pancreas system (Algorithm + CGM + pump)
Keywords
artificial pancreas
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial pancreas system (Algorithm + CGM + pump)Device

    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 groups in NCT02773875
Study groupRoleWhat they receive
Sensor Augmented Pump (control)No interventionUse sensor augmented pump (SAP) for 3 weeks.
Artificial Pancreas (intervention)ExperimentalArtificial 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
Receives: Device: Artificial pancreas system (Algorithm + CGM + pump)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 hours after insulin infusion set failure

Secondary outcomes (3)

  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

    Measured: During 2 week intervention period

  2. Mean sensor glucose values

    mean sensor glucose values

    Measured: 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

    Measured: 2 week intervention period versus 2 week control period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionNov 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02773875
Sponsor's protocol ID
IDE G150122
Acronym
ZoneMPC
Status last verified
May 2016
First submitted
11 May 2016
Last updated
16 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 28584075

Questions about this trial

What is this clinical trial studying?

A study testing Artificial pancreas system (Algorithm + CGM + pump) in people with Type 1 Diabetes, run by Rensselaer Polytechnic Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact David Maahs, MD, PhD (David.Maahs@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of time sensor glucose levels are >250 mg/dl (time frame: 4 hours after insulin infusion set failure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02773875, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in