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Flash Glucose Monitoring in Reduction of Hypoglycaemia in Diabetic Patients with Chronic Kidney Disease

NCT04016155 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-03-05

No results posted yet for this study

Summary

This will be a single centre study at the Prince of Wales Hospital, Hong Kong. Patients will be identified from an existing registry of diabetes patients with CKD. Potential subjects will be identified from patients attending diabetes, general medical and renal clinics.

Following informed consent, patients will undergo screening where baseline HbA1c, renal function will be measured along withcomprehensive medical and drug history to confirm eligibility. All eligible patients will be fitted with a blinded CGM (Medtronic iPro2 professional CGM) on week-1 for baseline glucose profiles for capturing baseline CGM profile. In case of blinded CGM sensor loss or malfunction, the sensor will be replaced once. Patients with at least 50% sensor data during the blinded wear period will proceed to randomization.

At week 0, patients will be randomized to the flash glucose monitoring or SMBG. Both groups will receive standardised education on diabetes self-management, prevention and treatment of hypoglycaemia. This will be accordance with the usual practice at the study site. In the FGM group, patients will receive training on insertion, operation of the device with access to the device software for viewing of ambulatory glucose profiles. Patients will be advised to confirm blood glucose readings with SMBG in the event of hypoglycaemic symptoms, if FGM displays glucose \<3.9mmol or in event of glucose instability.

Patients randomized to the control group will perform SMBG using dedicated blood glucose meter at least twice daily.

Blinded CGM will again be worn in both groups at week 16 for assessment of primary and secondary outcomes.

Subjects will compete a hypoglycaemia diary for documenting symptomatic or asymptomatic hypoglycaemia during the study period.

Questionnaires on hypoglycaemia unawarenesss, fear of hypoglycaemia and patient-reported outcomes will be completed at baseline, week 8 and week 16 in both groups.

Conditions

  • Diabetes with Diabetic Chronic Kidney Disease (Diagnosis)

Interventions

DEVICE

Abbott FreeStyle Libre

Flash CGMS

DEVICE

Patient Own SMBG

Market SMBG

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Elaine Chow · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2021-04-08
Completion
2021-04-08

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04016155 on ClinicalTrials.gov