Use of the Guardian™ Connect System With Smart Connected Devices

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of the Guardian™ Connect System With Smart Connected Devices

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app


Participation Criteria
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Eligibility Criteria
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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 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 is currently using or is willing to use the Guardian Connect system during the study. 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 has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, Staphylococcus infection). 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 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guardian™ Connect system, InPen™ Basal smart cap, and smart insulin pens<br>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. | Device: Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Time in Range | Percentage of Time in Range (SG <70 mg/dL, 70-180 mg/dL, and >180 mg/dL) | Up to 9 months |