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Use of the Guardian™ Connect System With Smart Connected Devices

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ClinicalTrials.gov Identifier: NCT04809285
Recruitment Status : Recruiting
First Posted : March 22, 2021
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of the Guardian™ Connect System With Smart Connected Devices
Actual Study Start Date : April 6, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Eileen Sneeden 818-576-5203 eileen.sneeden@medtronic.com

Locations
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United States, Arkansas
Arkansas Diabetes and Endocrinology Center Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Spencer Francis    501-850-8285    spenf@medvestinc.com   
Principal Investigator: James Thrasher, MD         
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354-3811
Contact: Christopher Jacobson    909-558-3022    cjacobson@llu.edu   
Principal Investigator: Kevin Codorniz, MD         
Salinas Valley Memorial Healthcare System Recruiting
Salinas, California, United States, 93901-4483
Contact: Juan Morales    831-759-3051    jmorales3@svmh.com   
Principal Investigator: Nicolas Kissell, MD         
United States, Colorado
Barbara Davis Center for Childhood Diabetes Recruiting
Aurora, Colorado, United States, 80045-2536
Contact: Emily Fivekiller    303-724-8977    emily.fivekiller@cuanschutz.edu   
Principal Investigator: Robert Slover, MD         
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Contact: Lizzie Huckaby    404-355-4393    LHuckaby@atlantadiabetes.com   
Principal Investigator: Bruce Bode, MD         
Endocrine Research Solutions, Inc. Recruiting
Roswell, Georgia, United States, 30076
Contact: Jessica Tapia    678-878-4750    jtapia@gmail.com   
Principal Investigator: John Reed, MD         
United States, Tennessee
AM Diabetes and Endocrinology Center Recruiting
Bartlett, Tennessee, United States, 38133
Contact: Lesley Draffin    901-384-0065    ldraffin@amdiabetes.net   
Principal Investigator: Kashif Latif, MD         
United States, Texas
Texas Diabetes and Endocrinology Recruiting
Austin, Texas, United States, 78731
Contact: Emmanuel Lopez    512-334-3505 ext 3    elopez@texasdiabetes.com   
Principal Investigator: Lindsay Harrison, MD         
Texas Diabetes and Endocrinology Recruiting
Round Rock, Texas, United States, 78681
Contact: Dawn Montoya    512-334-3505 ext 2    dmontoya@texasdiabetes.com   
Principal Investigator: Luis Casaubon, MD         
United States, Washington
Rainer Clinical Research Center Recruiting
Renton, Washington, United States, 98057
Contact: Lisa Aaker    425-251-1720    laaker@rainier-research.com   
Principal Investigator: Ronald Brazg, MD         
Sponsors and Collaborators
Medtronic Diabetes
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT04809285    
Other Study ID Numbers: CIP331
First Posted: March 22, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs