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Feasibility Evaluation of an Artificial Pancreas With Glucose Prediction Trust Index

NCT03092310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-07-12

No results posted yet for this study

Summary

The purpose of this pilot study is to establish that closed-loop insulin delivery with a target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms with a trust index of the predicted glucose value is safe and effective, to analyze and learn to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to inform a future larger study.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Artificial Pancreas Device

Artificial Pancreas Device

Sponsors & Collaborators

Principal Investigators

  • Jordan E Pinsker, MD · Sansum Diabetes Research Institute

  • Eyal Dassau, PhD · Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University

  • Francis J Doyle III, PhD · Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University

  • Alejandro Leguna, PhD · Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University

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
2017-03-20
Primary Completion
2017-12-20
Completion
2017-12-20
FDA Device
Yes

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 NCT03092310 on ClinicalTrials.gov