Status:
COMPLETED
Use of the Guardian™ Connect System With Smart Connected Devices
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
2-80 years
Phase:
NA
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) w...
Detailed 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 participat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT04809285
Start Date
April 6 2021
End Date
September 29 2023
Last Update
December 10 2024
Active Locations (14)
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1
Arkansas Diabetes and Endocrinology Center
Little Rock, Arkansas, United States, 72211
2
Loma Linda University Medical Center
Loma Linda, California, United States, 92354-3811
3
Mary and Dick Allen Diabetes Center
Newport Beach, California, United States, 92663
4
Salinas Valley Memorial Healthcare System
Salinas, California, United States, 93901-4483