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Not yet recruiting NCT06838819

CGM in Icodextrin PD

— Observational Diabetes Mellitus (Diagnosis) End Stage Renal Disease (ESRD) Dialysis Continuous Glucose Monitoring

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continuous glucose monitoring system.
Who it may be relevant to
Registry conditions: Diabetes Mellitus (Diagnosis), End Stage Renal Disease (ESRD), Dialysis, Continuous Glucose Monitoring. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Device Continuous glucose monitoring system
    Medtronic Simplera™

Primary outcome measures

  • Mean absolute relative difference (MARD) [Time frame: 5 minutes]
Secondary outcome measures (8)
  • Median absolute relative difference (MedARD) [Time frame: 5 minutes]
  • Consensus Error grid analysis [Time frame: 5 minutes]
  • Percent accuracy [Time frame: 5 minutes]
  • Hypoglycemia detection rates [Time frame: 15 minutes]
  • Hyperglycemia detection rates [Time frame: 15 minutes]
  • User satisfaction [Time frame: 2 weeks]
  • Correlation between CGM metrics, HbA1c and fructosamine [Time frame: 2 weeks]
  • Correlation between CGM metrics and SMBG [Time frame: 2 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Hong Kong · 1 center
  • Department of Medicine and Therapeutics, The Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT06838819 · IcoSimplera

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗