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Safety and Feasibility Evaluation of the APS APP

NCT03504046 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-09-05

No results posted yet for this study

Summary

This clinical trial is a safety and feasibility study to assess the performance of artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the APS APP platform.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Artificial Pancreas App

The portable Artificial Pancreas System App (APS APP) is an artificial pancreas system comprised primarily of an insulin pump, a continuous glucose monitor (CGM), and a cellular phone device to connect the components.

Sponsors & Collaborators

Principal Investigators

  • Eyal Dassau, PhD · Harvard University

  • Jordan Pinsker, MD · Sansum Diabetes Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2018-09-04
Completion
2018-09-04
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03504046 on ClinicalTrials.gov