Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMBG | Active Comparator | Patients use their own glucometers as control |
|
| Flash CGMS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbott FreeStyle Libre | Device | Flash CGMS |
| |
| Patient Own SMBG |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elaine Chow | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Shatin | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
Market SMBG |
|
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 |