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Use of the Guardian™ Connect System With Smart Connected Devices

NCT04809285 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2024-12-10

Study results available
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Summary

The purpose of this study is to collect sensor, insulin, sleep, activity and food/meal data for a minimum of 90 days of device wear (Phase 1) and up to a maximum of 9 months of device wear (Phase 2) with optional insulin injection video capture and/or menstrual cycle tracking and/or cardiac monitoring in subjects with insulin requiring diabetes 2-80 years of age.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app

Guardian™ Connect system consists of Guardian™ Connect app, Guardian™ Connect transmitter, and Guardian Sensor (3), will be working with InPen™ Basal smart cap and smart insulin pens and InPen™ Diabetes Management app for multiple daily injections. The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2023-09-29
Completion
2023-09-29
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 NCT04809285 on ClinicalTrials.gov