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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03966911
Recruitment Status : Completed
First Posted : May 29, 2019
Results First Posted : June 7, 2021
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Type2 Diabetes Mellitus Device: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics
Actual Study Start Date : June 14, 2019
Actual Primary Completion Date : May 13, 2020
Actual Study Completion Date : May 13, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Readings Within 20% Agreement [ Time Frame: 7 days (170 hours) ]
    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.


Eligibility Criteria
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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 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.
Contacts and Locations
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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): NCT03966911


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

Documents provided by Medtronic Diabetes:
Study Protocol  [PDF] September 26, 2019
Statistical Analysis Plan  [PDF] September 30, 2019

More Information
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT03966911    
Other Study ID Numbers: CIP324
First Posted: May 29, 2019    Key Record Dates
Results First Posted: June 7, 2021
Last Update Posted: June 7, 2021
Last Verified: May 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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases