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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
94
Flash CGMS
Market SMBG
Prince of Wales Hospital
Shatin, Hong Kong
Difference in time in hypoglycaemia
Compare the difference in time in hypoglycaemia (\<3.9mmol/l) on blinded CGM between intervention and control groups
Time frame: week 16
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
Time frame: week 16
Glycated haemoglobin
Change in HbA1c
Time frame: week 16
Incidence of hypoglycaemia
Numbers of hypoglycaemic episode reported by study subjects
Time frame: week 16
Patient compliance to Flash CGMS
Frequency of sensor scans and time duration of sensor wear
Time frame: week 16
Change in Diabetic treatment
Physician directed change in diabetes treatment (including insulin dosage)
Time frame: 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.
Time frame: week 16
Hypoglycaemia awareness
Measure by questionnaire: Gold Score Hypoglycaemia awareness (Total 7 grading, lowest score indicates better outcome)
Time frame: 16 weeks
Treatment satisfaction
Measured by questionnaire: IDTSQs (Total 8 questions with total score 0-48, highest score indicates better outcome)
Time frame: 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".
Time frame: 16 weeks
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