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Continuous Glucose Monitoring and Clinical Outcomes in Diabetes on Peritoneal Dialysis (GLANCE-PD)

24. august 2026 opdateret af: Elaine Chow

Glycemic Assessment Based on Continuous Glucose Monitoring and Clinical Outcomes in People With Diabetes on Peritoneal Dialysis: a Multi-centered Prospective Study

This prospective, multicenter observational study will evaluate glucose profiles using continuous glucose monitoring (CGM) in 100 adults with diabetes receiving peritoneal dialysis (PD) or planning to start PD within 3 months. The study will examine associations between CGM metrics and PD regimen, glucose-lowering treatment, conventional glycemic markers, dialysis-related measures, and clinical outcomes including glycemic emergencies, hospitalizations, cardiovascular events, and mortality over 12 months.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Medicine and Therapeutics, The Chinese University of Hong Kong
        • Kontakt:
        • Underforsker:
          • Jack Kit Chung Ng

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults with diabetes and stage 5 chronic kidney disease who are receiving peritoneal dialysis or are planned to initiate peritoneal dialysis within 3 months.

Beskrivelse

Inclusion criteria:

  1. Stage 5 CKD patients

    1. who have received PD for at least 3 months, OR
    2. who are planned for PD within the next 3 months.
  2. Age 18-80 years old
  3. Known history of type 1 or type 2 diabetes for at least 3 months
  4. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
  5. 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.
  6. Willingness to abstain from swimming during their participation in the measurement phase.
  7. 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.
  8. Written informed consent to participate in the study provided by the patient.

Exclusion criteria:

  1. Patients who are planning to switch to hemodialysis or renal transplant in the coming 3 months
  2. Life expectancy <6 months
  3. Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites
  4. HbA1c > 11% at enrolment
  5. Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential.
  6. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
  7. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
  8. 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.
  9. Have a known allergy to medical-grade adhesives or known hypersensitivity to any of the products used in the study.
  10. Have MRI scan, CT scan, or diathermy scheduled during the proposed period of sensor wearing during the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
peritoneal dialysis group
Adults with diabetes and stage 5 chronic kidney disease who have been receiving peritoneal dialysis for at least 3 months at enrollment.
Enhed: Continuous glucose monitoring system
Sibionics GS3 CGM
pre-peritoneal dialysis group
Adults with diabetes and stage 5 chronic kidney disease who are planned to initiate peritoneal dialysis within 3 months after enrollment.
Enhed: Continuous glucose monitoring system
Sibionics GS3 CGM

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Continuous glucose monitoring-derived metrics
Tidsramme: During period of 14 day CGM wear
CGM derived time in ranges
During period of 14 day CGM wear

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HbA1c
Tidsramme: Baseline to end of study period month 12
HbA1c by venous blood
Baseline to end of study period month 12
24-hour dialysate and ultrafiltration volume
Tidsramme: Baseline through to month 12
24-hour dialysate and ultrafiltration volume,
Baseline through to month 12
Residual renal function
Tidsramme: From baseline through 12 months
Defined by 24-hour urine volume
From baseline through 12 months
Hospitalization for hyperglycemic or hypoglycemic emergencies
Tidsramme: From baseline through 12 months
Incidence of hospitalization due to hyperglycemic or hypoglycemic emergencies during follow-up
From baseline through 12 months
Hospitalizations, cardiovascular events, and all-cause mortality
Tidsramme: From baseline through 12 months
Incidence of all-cause hospitalization, major cardiovascular events, and all-cause mortality during follow-up
From baseline through 12 months
Dietary intake during CGM wear
Tidsramme: During the 14-day CGM wear period
Dietary intake assessed using a 3-day food diary
During the 14-day CGM wear period
Health-related quality of life
Tidsramme: Baseline
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) overall score
Baseline
Quality of life specific to kidney disease
Tidsramme: Baseline
Kidney Disease Quality of Life-36 questionnaire (KDQOL-36) total score
Baseline
CGM user satisfaction
Tidsramme: Baseline and month 3
Total score from 10-item CGM user satisfaction questionnaire
Baseline and month 3

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Elaine Chow

Efterforskere

  • Ledende efterforsker: Elaine Chow, Department of Medicine and Therapeutics, The Chinese University of Hong Kong

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. august 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

21. august 2026

Først indsendt, der opfyldte QC-kriterier

24. august 2026

Først opslået (Faktiske)

27. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GLANCE-PD

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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