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NCT Number: NCT06838819

CGM in Icodextrin PD

Assessment of performance (precision and accuracy) of Simplera™ CGM as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis with icodextrin

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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 for at least 3 months
  • On continuous ambulatory peritoneal dialysis (CAPD) or APD for at least 2 months
  • On icodextrin PD solutions for at least 1 month or planned for switching to icodextrin PD solutions within 3 months of screening
  • 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 of screening
  • Planned for switching to hemodialysis or living donor transplant in the future 1 month
  • Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential
  • 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.
  • 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
  • Patients with history of pacemaker and prosthesis implantation.
  • Continuous use of real-time CGM for personal diabetes management in the three months prior to screening (sensor use >80% of time)

Treatment and study plan

Continuous Glucose Monitoring System

Device

Medtronic Simplera™

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 value

  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 Time Frame: 2 weeks and

  7. Correlation between CGM metrics, HbA1c and fructosamine

    Time frame: 2 weeks

    Correlation between CGM metrics, HbA1c and fructosamine

  8. Correlation between CGM metrics and SMBG

    Time frame: 2 weeks

    Correlation between CGM metrics and SMBG

Study contacts

Contact information is provided by the study sponsor or research team.

Elaine Chow Clinical Associate Professor, MBChB

CONTACT

[email protected]

+85235051549

Sponsors and collaborators

Lead sponsor

Elaine Chow

Other

Collaborators

  • Medtronic MiniMed, Inc.

Registry information

Official study title

Evaluation of Accuracy of Medtronic Simplera™ CGM in Patients on Icodextrin-containing Peritoneal Dialysis Regimens

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

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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