CGM in Icodextrin PD

Launched by ELAINE CHOW · Feb 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a device called Simplera™ Continuous Glucose Monitor (CGM) to see how well it measures blood sugar levels in people with diabetes who are on a specific type of dialysis called peritoneal dialysis (PD) using icodextrin. The goal is to compare the accuracy of the Simplera™ CGM with a well-established lab method for measuring glucose.

To be eligible for this study, participants must be adults aged 18 to 75 with either type 1 or type 2 diabetes who have been on peritoneal dialysis for at least two months and using icodextrin for at least one month. They should also be willing to follow the study's procedures, including regular check-ups and using the glucose monitor as directed. Participants in the trial can expect to have their glucose levels monitored closely and to contribute to important research that could help improve diabetes management for others in similar situations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Type 1 or 2 diabetes mellitus for at least 3 months
• • 2. On continuous ambulatory peritoneal dialysis (CAPD) or APD for at least 2 months
• • 3. On icodextrin PD solutions for at least 1 month or planned for switching to icodextrin PD solutions within 3 months of screening
• • 4. Male or female age ≥ 18 years old and ≤ 75 year old.
• • 5. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
• • 6. 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.
• • 7. Willingness to abstain from swimming during their participation in the measurement phase.
• • 8. 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.
• • 9. Written informed consent to participate in the study provided by the patient.
• Exclusion Criteria:
• • 1. Poorly controlled diabetes mellitus with HbA1c\>11%
• • 2. Peritonitis within 1 month of screening
• • 3. Planned for switching to hemodialysis or living donor transplant in the future 1 month
• • 4. Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential
• • 5. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
• • 6. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
• • 7. 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.
• • 8. 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).
• • 9. Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
• • 10. Blood donation of more than 500 ml within the last three months
• • 11. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
• • 12. Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.
• • 13. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
• • 14. Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period
• • 15. Patients with history of pacemaker and prosthesis implantation.
• • 16. Continuous use of real-time CGM for personal diabetes management in the three months prior to screening (sensor use \>80% of time)