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Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices

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. Identifier: NCT04020822
Recruitment Status : Completed
First Posted : July 16, 2019
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
Medtronic Diabetes

Brief Summary:
The purpose of Phase 3 Group is to evaluate the impact of acetaminophen on the performance of Guardian Sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin requiring diabetes,18-75 years of age.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Device: Guardian Sensor (3) Not Applicable

Detailed Description:

The study is a multi-center, prospective single-arm design without controls. All subjects will be assigned to treatment for 11 days of sensor wear. Each subject will wear 4 Guardian Sensor (3)s, and each will be connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter. Subjects will not use sensor glucose values for diabetes management.

On days 1, 3, 5, and 6, subjects will be asked to measure blood glucose (BG) using a home glucose meter approximately every 20 minutes for 5 hours. Subjects will be asked to take one gram of acetaminophen orally on days 3, 5, and 6 of sensor wear.

On day 11, devices will be removed, data uploaded from the study meter and transmitter or recorder, skin assessment will be performed, and the subject's participation in the study will be completed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices - Phase 3 Group
Actual Study Start Date : July 29, 2019
Actual Primary Completion Date : August 27, 2019
Actual Study Completion Date : August 27, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Subjects Wearing Guardian Sensor (3)s
Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear.
Device: Guardian Sensor (3)
Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.

Primary Outcome Measures :
  1. Accuracy of sensor glucose after acetaminophen administration [ Time Frame: 6 days ]
    Accuracy (mean absolute relative difference) between the primary sensor values and meter BG values during the two hours [approximately 6 paired points per frequent sample testing event (FST)] after ingestion of acetaminophen. Primary sensor will be assigned to sensor number one (inserted in arm).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject is 18-75 years of age at time of screening
  2. A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator, for at least the last 12 months
  3. Subject is using insulin to treat their diabetes
  4. Subject agrees to comply with the study protocol requirements
  5. Subject is willing to perform self-monitoring of blood glucose approximately every 20 minutes during FST

Exclusion Criteria:

  1. Subject has history of allergy to acetaminophen or has been told by health care provider they may not ingest acetaminophen
  2. Subject reports history of liver cirrhosis or problems with liver that a health care provider told them they should not use acetaminophen because of liver disorder.
  3. Subject is unable to tolerate tape adhesive in the area of sensor placement
  4. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
  5. Subject is actively participating in or plans to enroll in an investigational study (drug or device), other than this study, wherein they have received treatment from an investigational drug or device
  6. Subject has a positive urine pregnancy test at time of screening
  7. 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
  8. Subject is unwilling to participate in study procedures.

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 identifier (NCT number): NCT04020822

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United States, Colorado
Barbara Davis Center for Diabetes
Aurora, Colorado, United States, 80045
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Sponsors and Collaborators
Medtronic Diabetes

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Responsible Party: Medtronic Diabetes Identifier: NCT04020822     History of Changes
Other Study ID Numbers: CIP318
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Medtronic Diabetes:
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases