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Use of the Guardian™ Connect System With Smart Connected Devices

Primary Purpose

Type 1 Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus

Eligibility Criteria

2 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arkansas Diabetes and Endocrinology Center
  • Loma Linda University Medical Center
  • Mary and Dick Allen Diabetes CenterRecruiting
  • Salinas Valley Memorial Healthcare System
  • Barbara Davis Center for Childhood DiabetesRecruiting
  • Atlanta Diabetes AssociatesRecruiting
  • Endocrine Research Solutions, Inc.Recruiting
  • Rocky Mountain Diabetes and Osteoporosis CenterRecruiting
  • Endocrine and Metabolic ConsultantsRecruiting
  • Rhode Island Hospital (Lifespan Clinical Research Center)
  • AM Diabetes and Endocrinology CenterRecruiting
  • Texas Diabetes and Endocrinology
  • Texas Diabetes and EndocrinologyRecruiting
  • Rainer Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Guardian™ Connect system, InPen™ Basal smart cap, and smart insulin pens

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Time in Range
Percentage of Time in Range (SG <70 mg/dL, 70-180 mg/dL, and >180 mg/dL)

Secondary Outcome Measures

Full Information

First Posted
March 18, 2021
Last Updated
November 22, 2022
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT04809285
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guardian™ Connect system, InPen™ Basal smart cap, and smart insulin pens
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app
Intervention Description
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 Measure Information:
Title
Percentage of Time in Range
Description
Percentage of Time in Range (SG <70 mg/dL, 70-180 mg/dL, and >180 mg/dL)
Time Frame
Up to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesse Burns
Phone
818-576-3289
Email
jesse.p.burns@medtronic.com
Facility Information:
Facility Name
Arkansas Diabetes and Endocrinology Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354-3811
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mary and Dick Allen Diabetes Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Dennis
Email
Brittany.Dennis@hoag.org
First Name & Middle Initial & Last Name & Degree
David Ahn, MD
Facility Name
Salinas Valley Memorial Healthcare System
City
Salinas
State/Province
California
ZIP/Postal Code
93901-4483
Country
United States
Individual Site Status
Completed
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Fivekiller
Phone
303-724-8977
Email
emily.fivekiller@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Robert Slover, MD
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Bartolanzo
Phone
404-927-4792
Email
sbartolanzo@atlantadiabetes.com
First Name & Middle Initial & Last Name & Degree
Bruce Bode, MD
Facility Name
Endocrine Research Solutions, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Tapia
Phone
678-878-4750
Email
jtapia@gmail.com
First Name & Middle Initial & Last Name & Degree
John Reed, MD
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rochelle Christensen
Email
rochelle.christensen@idahomed.com
First Name & Middle Initial & Last Name & Degree
David Liljenquist, MD
Facility Name
Endocrine and Metabolic Consultants
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corina Bagasao
Phone
301-770-7373
Email
acbagasao.endocrine@gmail.com
First Name & Middle Initial & Last Name & Degree
Michael Dempsey, MD
Facility Name
Rhode Island Hospital (Lifespan Clinical Research Center)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Palmisciano
Phone
401-793-8788
Email
APalmisciano@Lifespan.org
First Name & Middle Initial & Last Name & Degree
Amanda Fernandes, MD
Facility Name
AM Diabetes and Endocrinology Center
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Lewis
Email
blewis@amdiabetes.net
First Name & Middle Initial & Last Name & Degree
Kashif Latif, MD
Facility Name
Texas Diabetes and Endocrinology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Diabetes and Endocrinology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaking Scales
Phone
512-334-3505
Ext
2
Email
jscales@tderesearch.com
First Name & Middle Initial & Last Name & Degree
Luis Casaubon, MD
Facility Name
Rainer Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of the Guardian™ Connect System With Smart Connected Devices

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