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Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting

NCT03767790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-08-08

No results posted yet for this study

Summary

The objective of this randomized crossover clinical trial is to 1) assess the efficacy and safety of an automated insulin delivery (AID) system using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS) in people with type 1 diabetes, and 2) assess the impact of different meal macronutrient content on glucose control when using AID and SAP.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

iAPS

The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.

Sponsors & Collaborators

  • Harvard University

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • Sansum Diabetes Research Institute

    lead OTHER

Principal Investigators

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

  • David Eisenberg, MD · Harvard School of Public Health (HSPH)

  • Jordan E Pinsker, MD · Sansum Diabetes Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-03
Primary Completion
2019-06-27
Completion
2019-06-27
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 NCT03767790 on ClinicalTrials.gov