Use of the Guardian™ Connect System With Smart Connected Devices

November 14, 2024 updated by: Medtronic Diabetes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Diabetes and Endocrinology Center
    • California
      • Loma Linda, California, United States, 92354-3811
        • Loma Linda University Medical Center
      • Newport Beach, California, United States, 92663
        • Mary and Dick Allen Diabetes Center
      • Salinas, California, United States, 93901-4483
        • Salinas Valley Memorial Healthcare System
    • Colorado
      • Aurora, Colorado, United States, 80045-2536
        • Barbara Davis Center for Childhood Diabetes
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Atlanta Diabetes Associates
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions, Inc.
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes and Osteoporosis Center
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Endocrine and Metabolic Consultants
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital (Lifespan Clinical Research Center)
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
        • AM Diabetes And Endocrinology Center
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Diabetes and Endocrinology
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes and Endocrinology
    • Washington
      • Renton, Washington, United States, 98057
        • Rainer Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Time in Hypoglycemia
Time Frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in hypoglycemia (SG < 70 mg/dL)
Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Percentage of Time in Euglycemia
Time Frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in euglycemia (SG 70-180 mg/dL)
Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Percentage of Time in Hyperglycemia
Time Frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in hyperglycemia (SG > 180 mg/dL)
Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Diabetes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Actual)

September 29, 2023

Study Completion (Actual)

September 29, 2023

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes Mellitus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe