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

Randomised Controlled Trial of Flash Glucose Monitoring in Reduction of Hypoglycaemia in Diabetes Patients with Chronic Kidney Disease

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.

Study Overview

• Status: Completed
• Conditions: Diabetes with Diabetic Chronic Kidney Disease (Diagnosis)
• Intervention / Treatment: Device: Patient Own SMBG; Device: Abbott FreeStyle Libre

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Sha Tin, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Type I or II diabetes mellitus diagnosed for at least 6 months
2. Male or female age ≥ 18 years old and ≤ 75 years old.
3. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
4. Patients with CKD stage 3b, 4 or 5 as defined by estimated glomerular filtration rate less than 45ml/min/m2
5. History of at least 1 episode of non-severe or severe hypoglycaemia in the 12 months prior to screening
6. Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) and use of pre-specified glucose monitoring devices.
7. Willingness to perform SMBG during the study period
8. 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 suitable study candidate.
9. Written informed consent to participate in the study provided by the patient.
10. Willing and capable of use of a flash glucose monitor as judged by the investigator

Exclusion Criteria:

1. HbA1C >8.5% at screening
2. Currently pregnant, as demonstrated by a positive pregnancy test at screening or planning pregnancy. Women of childbearing potential will also be asked to adopt adequate contraceptive measures throughout the study period, and to notify the study staff immediately if discovered pregnant. Participants who are unwilling to comply with these measures will be excluded.
3. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
4. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
5. 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.
6. Extensive skin changes/diseases that preclude wearing the FGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
7. Have a known allergy to medical-grade adhesives
8. Known current or recent alcohol or drug abuse
9. Diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction in the six months prior to screening
10. Patients on renal replacement therapy
11. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
12. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SMBG; Patients use their own glucometers as control	Device: Patient Own SMBG; Market SMBG
Experimental: Flash CGMS	Device: Abbott FreeStyle Libre; Flash CGMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in time in hypoglycaemia	Compare the difference in time in hypoglycaemia (<3.9mmol/l) on blinded CGM between intervention and control groups	week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM indices	Time-in-range (4-10mmol/l), time-in-hyperglycaemia (>10mmol), low blood glucose index, glycaemic variability (coefficient of variation). These CGM indices are defined in accordance with the latest International Consensus on Use of CGM	week 16
Glycated haemoglobin	Change in HbA1c	week 16
Incidence of hypoglycaemia	Numbers of hypoglycaemic episode reported by study subjects	week 16
Patient compliance to Flash CGMS	Frequency of sensor scans and time duration of sensor wear	week 16
Change in Diabetic treatment	Physician directed change in diabetes treatment (including insulin dosage)	week 16
Patient quality-of-life	Measures by questionnaire: Diabetes Distress Scale (DDS; total score from 17-102), comprising 3 subscales namely emotional, physician, regimen / social support. A lower score indicates better outcome.	week 16
Hypoglycaemia awareness	Measure by questionnaire: Gold Score Hypoglycaemia awareness (Total 7 grading, lowest score indicates better outcome)	16 weeks
Treatment satisfaction	Measured by questionnaire: IDTSQs (Total 8 questions with total score 0-48, highest score indicates better outcome)	16 weeks
Fear of hypoglycaemia	Measured by questionnaire: Hypoglycemia Fear Survey II (comprising 2 subscales namely behaviour (15 items) and worry (18 items). Each item has 5 categorical selection from "never" to "always".	16 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Elaine Chow, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): April 8, 2021
• Study Completion (Actual): April 8, 2021

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Renal Insufficiency; Hypoglycemia; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: FlashDKD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No