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出境医 / 临床实验 / Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics

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

Study Description
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
Layout table for study information
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
Arms and Interventions
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
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
Layout table for eligibility information
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

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
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 29, 2019
Results First Submitted Date  ICMJE March 30, 2021
Results First Posted Date  ICMJE June 7, 2021
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE June 14, 2019
Actual Primary Completion Date May 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2021) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • 20% (±20 mg/dL for SG <80) Agreement, by Age Group and Insertion Location [ Time Frame: 170 hours ]
    Guardian™ Sensor (3) values will be compared to YSI™* plasma glucose values during YSI™* FSTs. A within 20% mean agreement rate (±20 mg/dL when SG less than (<) 80 mg/dL), μ, between Guardian™ Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days will be evaluated
  • ±15 mg/dL Agreement, SG <70 mg/dL, by age group and insertion location [ Time Frame: 170 hours ]
    Guardian™ Sensor (3) values will be compared to YSI™* plasma glucose values during YSI™* FSTs. A within ±15 mg/dL mean agreement rate when SG less than (<) 70 mg/dL, μ, between Guardian™ Sensor (3) values and YSI™* plasma glucose values during YSI™* FST days will be evaluated
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics
Official Title  ICMJE Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Type 1 Diabetes Mellitus
  • Type2 Diabetes Mellitus
Intervention  ICMJE Device: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter
Continuous Glucose Monitoring and frequent sample testing
Study Arms  ICMJE 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.
Intervention: Device: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2020) 		335
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2019) 		460
Actual Study Completion Date  ICMJE May 13, 2020
Actual Primary Completion Date May 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966911
Other Study ID Numbers  ICMJE CIP324
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Diabetes
Study Sponsor  ICMJE Medtronic Diabetes
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medtronic Diabetes
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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