Use of the Guardian™ Connect System With Smart Connected Devices

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT04809285

Run by

Medtronic MiniMed, Inc.

People needed

217

Starts

2021-04-06

Expected to finish

2023-09-29

Last updated by the study team

2024-12-10

Who can join

Age: 2 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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