Clinical trial NCT04809285: Use of the Guardian™ Connect System With Smart Connected Devices
Official title: Use of the Guardian™ Connect System With Smart Connected Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 217
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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 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.

Eligibility criteria: Inclusion Criteria

1. Individual is 2-80 years of age at time of consent.
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

1. Subject is using a syringe and unwilling or unable to use insulin pen(s).
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.

Primary outcomes:
measure: Percentage of Time in Hypoglycemia
timeFrame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
measure: Percentage of Time in Euglycemia
timeFrame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
measure: Percentage of Time in Hyperglycemia
timeFrame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Diabetes and Endocrinology Center
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Newport Beach
country: United States
facility: Mary and Dick Allen Diabetes Center
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Healthcare System
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Providence
country: United States
facility: Rhode Island Hospital (Lifespan Clinical Research Center)
state: Rhode Island
city: Bartlett
country: United States
facility: AM Diabetes and Endocrinology Center
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Renton
country: United States
facility: Rainer Clinical Research Center
state: Washington
Study officials:
References: