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Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study

NCT04320069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-11-13

Study results available
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Summary

Subjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.

Conditions

Interventions

DEVICE

Omnipod Horizon™ Automated Glucose Control System

Omnipod Horizon™ Automated Glucose Control System use in Manual Mode

Sponsors & Collaborators

  • Insulet Corporation

    lead INDUSTRY

Principal Investigators

  • Jordan Pinsker, MD · Sansum Diabetes Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-09
Primary Completion
2020-09-29
Completion
2020-09-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT04320069 on ClinicalTrials.gov