Use of the Guardian™ Connect System With Smart Connected Devices

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    500
  • sponsor
    Medtronic Diabetes
Updated on 13 October 2022
diabetes
insulin
injection of insulin

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.

Description

The study is a multi-center, prospective single-arm design without controls. All subjects will participate for a minimum of 90 days (Phase 1) and some subjects 18 years of age or older will participate for up to 9 months (Phase 2). All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study.

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.

Details
Condition Type 1 Diabetes Mellitus
Treatment Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app
Clinical Study IdentifierNCT04809285
SponsorMedtronic Diabetes
Last Modified on13 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Individual is 2-80 years of age at time of consent
A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator for
at least the last 6 months for subjects 2-6 years of age
at least the last 12 months for subjects 7-80 years of age
Subject is on multiple daily injection therapy (3 or more insulin injections per day
Subject is currently using or is willing to use the Guardian Connect system during the study
one of which is a long acting insulin injection), is currently using or is
willing and can afford to use insulin pen(s) and pen cartridge(s)
Subject agrees to comply with the study protocol requirements
For adult subjects: Subject is capable of providing legal consent without a legal authorized representative

Exclusion Criteria

Subject is using a syringe and unwilling or unable to use insulin pen(s)
Subject is using an insulin pump
Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the Guardian Connect system during the study
Subject is using hydroxyurea at time of screening or plans to use it during the study
Subject will not tolerate tape adhesive in the area of device placement as assessed by a qualified provider
Subject is actively participating in or plans to enroll in an investigational study (e.g. drug or device), other than this study, wherein they have received treatment from an investigational drug or device
Subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, Staphylococcus infection)
Subject has a positive urine pregnancy test at time of screening
Subject is female, sexually active without the use of contraception, able to become pregnant or plans to become pregnant during the course of the study
Subject is unwilling to participate in study procedures
Subject is directly involved in the study as research staff
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