NCT04125160

Brief Summary

The aim is to investigate the correlation between mean glucose measured by continuous glucose monitoring (CGM) and mean glucose estimated from glycated haemoglobin A1c (HbA1c) in persons with type 2 diabetes undergoing peritoneal dialysis compared with patients with type 2 diabetes and normal renal function. Furthermore, the aim is to compare CGM and HbA1c with glycated albumin and fructosamine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

November 12, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

October 10, 2019

Last Update Submit

September 28, 2020

Conditions

HbA1cPeritoneal DiseasesGlycated AlbuminFructosamineContinuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

  • HbA1c evaluated by the total mean glucose from continuous glucose monitoring

    Difference between the two groups in the ratio of mean glucose measured by continuous glucose monitoring (measured over 16 days) divided by the estimated mean blood glucose from HbA1c (measured at the final visit). For each person at least 12 days of CGM must be completed.

    16 days

Secondary Outcomes (11)

  • Glycated albumin

    16 days

  • Fructosamine

    16 days

  • Standard deviation

    16 days

  • Coefficient variation

    16 days

  • Low Blood Glucose Index

    16 days

  • +6 more secondary outcomes

Study Arms (2)

Type 2 diabetes and peritoneal dialysis

Case group with type 2 diabetes undergoing peritoneal dialysis for at least 3 months.

Device: Continuous glucose monitoringDiagnostic Test: Glycaemic markers

Type 2 diabetes and eGFR above 60ml/min

Control group with type 2 diabetes and no nephropathy (defined as eGFR above 60ml/min and UACR below 300mg/g).

Device: Continuous glucose monitoringDiagnostic Test: Glycaemic markers

Interventions

Continuous glucose monitoringDEVICE

Continuous glucose monitoring over 16 days

Type 2 diabetes and eGFR above 60ml/minType 2 diabetes and peritoneal dialysis
Glycaemic markersDIAGNOSTIC_TEST

Measurement of HbA1c, glycated albumin and fructosamine.

Type 2 diabetes and eGFR above 60ml/minType 2 diabetes and peritoneal dialysis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Total of 52 participants with 26 in each group. Case group: 26 patients on peritoneal dialysis with type 2 diabetes. Control group: 26 patients with type 2 diabetes and normal renal function (defined as eGFR \>60 ml/min and with Urine Albumin-to-Creatinine Ratio below 300mg/g. The patients are recruited from the department of Endocrinology or Nephrology at Rigshospitalet, from Herlev Hospital department of Nephrology, Steno Diabetes Center Copenhagen, Hillerød Hospital department of Nephrology and Roskilde Hospital department of Nephrology.

You may qualify if:

  • Type 2 diabetes\*
  • BMI 17.5-50 kg/m2
  • Receiving antidiabetic treatment
  • Peritoneal dialysis treatment for a minimum of 3 months

You may not qualify if:

  • Type 1 diabetes
  • Acute or chronic pancreatitis
  • Intermittent treatment with steroid during study period (defined as more than two days)
  • Haemoglobin \< 5.5 mmol / l
  • Hypertriglyceridemia (≥ 10mmol / L)
  • Hyperbilirubinemia (≥ 35 μmol / L)
  • Pregnant or breast-feeding
  • Blood transfusion within the last 3 months
  • Blood transfusion during the investigation period
  • Splenectomy
  • High alcohol consumption (defined as more than 21 units per week)
  • Vitamin E supplement
  • Ribavirin treatment
  • Interferon Alpha treatment
  • Positive for haemoglobinopathy (examined for haemoglobinopathy if patients come from Africa, Mediterranean, Middle East, Iran, Iraq, India, Pakistan or Southeast Asia)
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Herlev Hospital

Copenhagen, 2100, Denmark

Location

Rigshospitalet department of endocrinology

Copenhagen, Denmark

Location

Hillerød Hospital

Hillerød, 3400, Denmark

Location

Rigshospitalet department of nephrology

København Ø, 2100, Denmark

Location

Roskilde Hospital

Roskilde, Denmark

Location

MeSH Terms

Conditions

Peritoneal Diseases

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, DMSc, Head of Nephrology

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

November 12, 2019

Primary Completion

September 3, 2020

Study Completion

September 3, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations

DK(5)