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

24. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Medicine and Therapeutics, The Chinese University of Hong Kong
        • Ta kontakt med:
        • Underetterforsker:
          • Jack Kit Chung Ng

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.
Enhet: 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.
Enhet: Continuous glucose monitoring system
Sibionics GS3 CGM

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Elaine Chow

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

31. august 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

21. august 2026

Først innsendt som oppfylte QC-kriteriene

24. august 2026

Først lagt ut (Faktiske)

27. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GLANCE-PD

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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