MedTrace Logo

Crossover Feasibility Study of Portable AP Device With Zone-MPC and HMS and Adapted I:C and Basal Insulin

NCT01929798 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-10-21

No results posted yet for this study

Summary

The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1 diabetes using an insulin pump and rapid acting insulin. This proposed study is designed to compare closed-loop control with or without optimization of initialization parameters related to basal insulin infusion rates and insulin to carbohydrate (I:C) ratios for meals and snacks.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

portable Artificial Pancreas

The artificial pancreas system will be allowed to employ its Model Predictive Control algorithm to make decisions about insulin delivery based on measured glucose levels.

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • University of California, Santa Barbara

    collaborator OTHER

  • University of Padova

    collaborator OTHER

  • Sansum Diabetes Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01929798 on ClinicalTrials.gov