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Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial

NCT03195140 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2023-12-08

Study results available
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Summary

A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth \> 6 years old with type 1 diabetes (T1D).

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Predictive Low Glucose Suspend

Application of Predictive Low Glucose Suspend

Sponsors & Collaborators

  • Jaeb Center for Health Research

    collaborator OTHER

  • Tandem Diabetes Care, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce Buckingham, MD · Stanford University

  • Vance Swanson · Tandem Diabetes Care, Inc.

  • John Lum, MS · JCHR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-11
Primary Completion
2018-02-06
Completion
2018-02-06
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03195140 on ClinicalTrials.gov