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Completed

NCT Number: NCT04776811

Evaluation of Accuracy of Guardian Sensor 3 in Diabetes Patients on Peritoneal Dialysis

Assessment of performance (precision and accuracy) of Guardian Sensor™ 3 as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis.

Completed

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 or 2 diabetes mellitus diagnosed for at least 3 months
  • On continuous ambulatory peritoneal dialysis (CAPD) for at least 3 months
  • Male or female age ≥ 18 years old and ≤ 75 year old.
  • Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
  • Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
  • Willingness to abstain from swimming during their participation in the measurement phase.
  • In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
  • Written informed consent to participate in the study provided by the patient.

Exclusion criteria

  • Poorly controlled diabetes mellitus with HbA1c>11%
  • Peritonitis within 1 month
  • On icodextrin PD solutions
  • Planned for switching to hemodialysis or living donor transplant in future 3 months
  • Currently pregnant, as demonstrated by a positive pregnancy test at screening
  • Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
  • Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
  • Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
  • Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
  • Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
  • Blood donation of more than 500 ml within the last three months
  • Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.

13 Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.

  • An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
  • Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period 16. Patients with history of pacemaker and prosthesis implantation.

Treatment and study plan

Continuous Glucose Monitoring System

Device

Medtronic Guardian Connect with Guardian Sensor 3

Primary outcomes

  1. Mean absolute relative difference (MARD)

    Time frame: 5 minutes

    MARD of sensor versus YSI glucose

Secondary outcomes

  1. Median absolute relative difference (MedARD)

    Time frame: 5 minutes

    MedARD of sensor versus YSI glucose

  2. Consensus Error grid analysis

    Time frame: 5 minutes

    % sensor values in regions A and B

  3. Percent accuracy

    Time frame: 5 minutes

    System readings within 15%, 20%, 30%, 40% and greater than 40% of YSI values

  4. Hypoglycemia detection rates

    Time frame: 15 minutes

    True and false hypoglycemia notification rate, correct and missed hypoglycemia detection rate

  5. Hyperglycemia detection rates

    Time frame: 15 minutes

    True and false hyperglycemia notification rate, correct and missed hyperglycemia detection rates

  6. User satisfaction

    Time frame: 2 weeks

    Diabetes Satisfaction Treatment Questionnaire score

  7. Correlation between CGM metrics, HbA1c and fructosamine

    Time frame: 2 weeks

    Correlation between CGM metrics, HbA1c and fructosamine

Sponsors and collaborators

Lead sponsor

Elaine Chow

Other

Collaborators

  • Medtronic MiniMed, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2021
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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