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NCT06838819Not yet recruiting

CGM in Icodextrin PD

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

Source: ClinicalTrials.gov · Last updated 21 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
30 (estimated)
First submitted
17 Feb 2025
Start date
20 Feb 2025
Primary completion date
20 Aug 2026
Lead sponsor
Elaine Chow
NCT number
NCT06838819

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 20 Feb 2025 to the primary completion date, 20 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Planned for switching to hemodialysis or living donor transplant in the future 1 month
  • 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.
  • Continuous use of real-time CGM for personal diabetes management in the three months prior to screening (sensor use \>80% of time)

Other illness

  • 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.
  • 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.
  • Patients with history of pacemaker and prosthesis implantation.

Lab values

  • Poorly controlled diabetes mellitus with HbA1c\>11%

Other

  • Peritonitis within 1 month of screening
  • Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential
  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Medicine and Therapeutics, The Chinese University of Hong Kong
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.