Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics

The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus; Type2 Diabetes Mellitus
• Intervention / Treatment: Device: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter

Detailed Description

The study is a multi-center, prospective, single-sample correlational design without controls. The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).

• Study Type: Interventional
• Enrollment (Actual): 335
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Escondido, California, United States, 92026
      • AMCR Institue
    • Santa Barbara, California, United States, 93105
      • Sansum Diabetes Research Institute
    • Torrance, California, United States, 90505
      • SoCal Diabetes
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
    • Walnut Creek, California, United States, 92025
      • Diablo Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center - Adults
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center for Childhood Diabetes (Pediatric)
  • Florida
    • Tampa, Florida, United States, 33613
      • University of South Florida
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Diabetes and Osteoporosis Center
  • Iowa
    • Des Moines, Iowa, United States, 50265
      • IDERC
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic (Rochester MN)
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • AM Diabetes & Endocrinology Center
  • Texas
    • Austin, Texas, United States, 78749
      • Texas Diabetes and Endocrinology
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virgina
  • Washington
    • Renton, Washington, United States, 98057
      • Rainer Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Individual is 2 - 80 years of age at time of enrollment
2. A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
3. Adequate venous access as assessed by investigator or appropriate staff
4. Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity ratio. Subjects without ratios may participate under observation only

Exclusion Criteria:

1. Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual.
2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
4. Subject is female and has a positive pregnancy screening test
5. Female of child bearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator
6. Subject is female and plans to become pregnant during the course of the study
7. Subject has had a hypoglycemic seizure within the past 6 months prior to enrollment
8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
10. Subject has a history of a seizure disorder
11. Subject has central nervous system or cardiac disorder resulting in syncope
12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
13. Subject has a hematocrit (Hct) lower than the normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents)
14. Subject has a history of adrenal insufficiency
15. Subject is a member of the research staff involved with the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Subjects with diabetes wearing Guardian™ Sensor (3); Subjects wear Guardian™ Sensor (3) and Guardian™ Connect Transmitter over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data.	Device: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter; Continuous Glucose Monitoring and frequent sample testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Readings Within 20% Agreement	Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™*) reference value (within 20 mg/dL if sensor values < 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI.	7 days (170 hours)

Collaborators and Investigators

• Sponsor: Medtronic Diabetes

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 14, 2019
• Primary Completion (ACTUAL): May 13, 2020
• Study Completion (ACTUAL): May 13, 2020

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (ACTUAL): May 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CIP324

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