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

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ClinicalTrials.gov Identifier: NCT03966911
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
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
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Subjects with diabetes wearing Guardian™ Sensor (3)
Subjects wear Guardian™ Sensor (3) over 7 days and participate in FSTs.
Device: Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter
Continuous Glucose Monitoring and frequent sample testing




Primary Outcome Measures :
  1. 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

  2. ±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



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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.

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
SoCal Diabetes Recruiting
Torrance, California, United States, 90505
Contact: Mary Halvorson    310-962-1808    halvorson@socaldiabetes.com   
Principal Investigator: Kevin Kaiserman, MD         
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: Catherine Morimoto, RC    925-930-7267    mmacarewich@diabloclinical.com   
Contact: Catherine Morimoto, RC    925-930-7267    cmorimoto@diabloclinical.com   
Principal Investigator: Mark Christiansen, MD         
United States, Washington
Rainer Clinical Research Center Recruiting
Renton, Washington, United States, 98057
Contact: Kristen Hughes    425-251-1720    khughes@rainier-research.com   
Principal Investigator: Ronald Brazg, MD         
Sponsors and Collaborators
Medtronic Diabetes

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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT03966911     History of Changes
Other Study ID Numbers: CIP324
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases