Use of the Guardian™ Connect System With Smart Connected Devices
NCT ID: NCT04809285
Last Updated: 2024-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
217 participants
INTERVENTIONAL
2021-04-06
2023-09-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Guardian™ Connect system, InPen™ Basal smart cap, and smart insulin pens
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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).
4. Subject is currently using or is willing to use the Guardian Connect system during the study.
5. Subject agrees to comply with the study protocol requirements.
6. For adult subjects: Subject is capable of providing legal consent without a legal authorized representative.
Exclusion Criteria
2. Subject is using an insulin pump.
3. Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the Guardian Connect system during the study.
4. Subject is using hydroxyurea at time of screening or plans to use it during the study.
5. Subject will not tolerate tape adhesive in the area of device placement as assessed by a qualified provider.
6. Subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, Staphylococcus infection).
7. 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.
8. Subject has a positive urine pregnancy test at time of screening.
9. 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.
10. Subject is unwilling to participate in study procedures.
11. Subject is directly involved in the study as research staff.
2 Years
80 Years
ALL
No
Sponsors
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Medtronic Diabetes
INDUSTRY
Responsible Party
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Locations
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Arkansas Diabetes and Endocrinology Center
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Mary and Dick Allen Diabetes Center
Newport Beach, California, United States
Salinas Valley Memorial Healthcare System
Salinas, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, United States
Rhode Island Hospital (Lifespan Clinical Research Center)
Providence, Rhode Island, United States
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
Texas Diabetes and Endocrinology
Round Rock, Texas, United States
Rainer Clinical Research Center
Renton, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CIP331
Identifier Type: -
Identifier Source: org_study_id