Use of the Guardian™ Connect System With Smart Connected Devices
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04809285|
Recruitment Status : Recruiting
First Posted : March 22, 2021
Last Update Posted : November 25, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of the Guardian™ Connect System With Smart Connected Devices|
|Actual Study Start Date :||April 6, 2021|
|Estimated Primary Completion Date :||August 31, 2023|
|Estimated Study Completion Date :||August 31, 2023|
Experimental: 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.
Device: 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.
- Percentage of Time in Range [ Time Frame: Up to 9 months ]Percentage of Time in Range (SG <70 mg/dL, 70-180 mg/dL, and >180 mg/dL)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||2 Years to 80 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04809285
|Contact: Jesse Burnsfirstname.lastname@example.org|
|United States, Arkansas|
|Arkansas Diabetes and Endocrinology Center||Active, not recruiting|
|Little Rock, Arkansas, United States, 72211|
|United States, California|
|Loma Linda University Medical Center||Active, not recruiting|
|Loma Linda, California, United States, 92354-3811|
|Mary and Dick Allen Diabetes Center||Recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Brittany Dennis Brittany.Dennis@hoag.org|
|Principal Investigator: David Ahn, MD|
|Salinas Valley Memorial Healthcare System||Completed|
|Salinas, California, United States, 93901-4483|
|United States, Colorado|
|Barbara Davis Center for Childhood Diabetes||Recruiting|
|Aurora, Colorado, United States, 80045-2536|
|Contact: Emily Fivekiller 303-724-8977 email@example.com|
|Principal Investigator: Robert Slover, MD|
|United States, Georgia|
|Atlanta Diabetes Associates||Recruiting|
|Atlanta, Georgia, United States, 30318|
|Contact: Sara Bartolanzo 404-927-4792 firstname.lastname@example.org|
|Principal Investigator: Bruce Bode, MD|
|Endocrine Research Solutions, Inc.||Recruiting|
|Roswell, Georgia, United States, 30076|
|Contact: Jessica Tapia 678-878-4750 email@example.com|
|Principal Investigator: John Reed, MD|
|United States, Idaho|
|Rocky Mountain Diabetes and Osteoporosis Center||Recruiting|
|Idaho Falls, Idaho, United States, 83404|
|Contact: Rochelle Christensen firstname.lastname@example.org|
|Principal Investigator: David Liljenquist, MD|
|United States, Maryland|
|Endocrine and Metabolic Consultants||Recruiting|
|Rockville, Maryland, United States, 20852|
|Contact: Corina Bagasao 301-770-7373 email@example.com|
|Principal Investigator: Michael Dempsey, MD|
|United States, Rhode Island|
|Rhode Island Hospital (Lifespan Clinical Research Center)||Not yet recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Amy Palmisciano 401-793-8788 APalmisciano@Lifespan.org|
|Principal Investigator: Amanda Fernandes, MD|
|United States, Tennessee|
|AM Diabetes and Endocrinology Center||Recruiting|
|Bartlett, Tennessee, United States, 38133|
|Contact: Brittany Lewis firstname.lastname@example.org|
|Principal Investigator: Kashif Latif, MD|
|United States, Texas|
|Texas Diabetes and Endocrinology||Active, not recruiting|
|Austin, Texas, United States, 78731|
|Texas Diabetes and Endocrinology||Recruiting|
|Round Rock, Texas, United States, 78681|
|Contact: Jaking Scales 512-334-3505 ext 2 email@example.com|
|Principal Investigator: Luis Casaubon, MD|
|United States, Washington|
|Rainer Clinical Research Center||Active, not recruiting|
|Renton, Washington, United States, 98057|
|Responsible Party:||Medtronic Diabetes|
|Other Study ID Numbers:||
|First Posted:||March 22, 2021 Key Record Dates|
|Last Update Posted:||November 25, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||Yes|
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases
Physiological Effects of Drugs