NCT02773875

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

May 11, 2016

Last Update Submit

May 13, 2016

Conditions

Type 1 Diabetes

Keywords

artificial pancreas

Outcome Measures

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

    4 hours after insulin infusion set failure

Secondary Outcomes (3)

  • 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

    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

Study Arms (2)

Sensor Augmented Pump (control)

NO INTERVENTION

Use sensor augmented pump (SAP) for 3 weeks.

Artificial Pancreas (intervention)

EXPERIMENTAL

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

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

Artificial Pancreas (intervention)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 29390915DERIVED

  • 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.

    PMID: 28584075DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Central Study Contacts

David Maahs, MD, PhD

CONTACT

David.Maahs@ucdenver.edu

Laurel Messer

CONTACT

Laurel.Messer@ucdenver.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Chemical & Biological Engineering Associate Director of Process Technologies

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 16, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

May 16, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share