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

24 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Continuous glucose monitoring-derived metrics
Tidsram: During period of 14 day CGM wear
CGM derived time in ranges
During period of 14 day CGM wear

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
HbA1c
Tidsram: 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
Tidsram: Baseline through to month 12
24-hour dialysate and ultrafiltration volume,
Baseline through to month 12
Residual renal function
Tidsram: From baseline through 12 months
Defined by 24-hour urine volume
From baseline through 12 months
Hospitalization for hyperglycemic or hypoglycemic emergencies
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) overall score
Baseline
Quality of life specific to kidney disease
Tidsram: Baseline
Kidney Disease Quality of Life-36 questionnaire (KDQOL-36) total score
Baseline
CGM user satisfaction
Tidsram: Baseline and month 3
Total score from 10-item CGM user satisfaction questionnaire
Baseline and month 3

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Elaine Chow

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

31 augusti 2026

Primärt slutförande (Beräknad)

1 juni 2028

Avslutad studie (Beräknad)

1 september 2028

Studieregistreringsdatum

Först inskickad

21 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

24 augusti 2026

Första postat (Faktisk)

27 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GLANCE-PD

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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