Use of the Guardian™ Connect System With Smart Connected Devices
1 other identifier
interventional
217
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2021
CompletedFirst Posted
Study publicly available on registry
March 22, 2021
CompletedStudy Start
First participant enrolled
April 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2023
CompletedResults Posted
Study results publicly available
December 10, 2024
CompletedDecember 10, 2024
November 1, 2024
2.5 years
March 18, 2021
September 30, 2024
November 14, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Time in Hypoglycemia
The overall mean percentage of time in hypoglycemia (SG \< 70 mg/dL)
Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Percentage of Time in Euglycemia
The overall mean percentage of time in euglycemia (SG 70-180 mg/dL)
Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Percentage of Time in Hyperglycemia
The overall mean percentage of time in hyperglycemia (SG \> 180 mg/dL)
Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Study Arms (1)
Guardian™ Connect system, InPen™ Basal smart cap, and smart insulin pens
EXPERIMENTALAll 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.
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Arkansas Diabetes and Endocrinology Center
Little Rock, Arkansas, 72211, United States
Loma Linda University Medical Center
Loma Linda, California, 92354-3811, United States
Mary and Dick Allen Diabetes Center
Newport Beach, California, 92663, United States
Salinas Valley Memorial Healthcare System
Salinas, California, 93901-4483, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045-2536, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852, United States
Rhode Island Hospital (Lifespan Clinical Research Center)
Providence, Rhode Island, 02903, United States
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, 38133, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78731, United States
Texas Diabetes and Endocrinology
Round Rock, Texas, 78681, United States
Rainer Clinical Research Center
Renton, Washington, 98057, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Binh Ngo (Clinical Research Director)
- Organization
- Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2021
First Posted
March 22, 2021
Study Start
April 6, 2021
Primary Completion
September 29, 2023
Study Completion
September 29, 2023
Last Updated
December 10, 2024
Results First Posted
December 10, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share