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Artificial Pancreas With Different Stress Assessments in the Outpatient Setting

NCT04142229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-12-01

No results posted yet for this study

Summary

This feasibility study is a randomized crossover trial that will compare the efficacy and safety of an automated insulin delivery (AID) system in patients with type 1 diabetes using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS), and will include different stress induction and assessments over a 4 week period.

Conditions

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.

OTHER

Sensor-Augmented Pump

Subjects will use their home insulin pump and a Dexcom G6 continuous glucose monitoring sensor.

Sponsors & Collaborators

Principal Investigators

  • Yogish Kudva, MBBS · Mayo Clinic

  • Eyal Dassau, PhD · Harvard University

  • Jordan 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
2019-10-25
Primary Completion
2020-11-06
Completion
2020-11-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT04142229 on ClinicalTrials.gov