Diabetes with Diabetic Chronic Kidney Disease (Diagnosis)NCT04016155
Flash Glucose Monitoring in Reduction of Hypoglycaemia in Diabetic Patients with Chronic Kidney Disease
A study testing Abbott FreeStyle Libre and Patient Own SMBG in people with Diabetes with Diabetic Chronic Kidney Disease (Diagnosis), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes with Diabetic Chronic Kidney Disease (Diagnosis)
- What is being tested?
- Abbott FreeStyle Libre and Patient Own SMBG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 Jul 2019to 8 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type I or II diabetes mellitus diagnosed for at least 6 months
- Male or female age ≥ 18 years old and ≤ 75 years old.
- Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- Patients with CKD stage 3b, 4 or 5 as defined by estimated glomerular filtration rate less than 45ml/min/m2
- History of at least 1 episode of non-severe or severe hypoglycaemia in the 12 months prior to screening
- 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.
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- Willingness to perform SMBG during the study period
- 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.
- Written informed consent to participate in the study provided by the patient.
- Willing and capable of use of a flash glucose monitor as judged by the investigator
Who cannot join
- HbA1C >8.5% at screening
- 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.
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
- 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.
- 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).
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- Have a known allergy to medical-grade adhesives
- Known current or recent alcohol or drug abuse
- Diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction in the six months prior to screening
- Patients on renal replacement therapy
- Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
- An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Abbott FreeStyle Libre, Patient Own SMBG
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott FreeStyle LibreDevice
Flash CGMS
Patient Own SMBGDevice
Market SMBG
| Study group | Role | What they receive |
|---|---|---|
| SMBG | Active comparator | Patients use their own glucometers as control Receives: Device: Patient Own SMBG |
| Flash CGMS | Experimental | Not described Receives: Device: Abbott FreeStyle Libre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in time in hypoglycaemia
Compare the difference in time in hypoglycaemia (<3.9mmol/l) on blinded CGM between intervention and control groups
Measured: week 16
Secondary outcomes (9)
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
Measured: week 16
Glycated haemoglobin
Change in HbA1c
Measured: week 16
Incidence of hypoglycaemia
Numbers of hypoglycaemic episode reported by study subjects
Measured: week 16
Patient compliance to Flash CGMS
Frequency of sensor scans and time duration of sensor wear
Measured: week 16
Change in Diabetic treatment
Physician directed change in diabetes treatment (including insulin dosage)
Measured: 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.
Measured: week 16
Hypoglycaemia awareness
Measure by questionnaire: Gold Score Hypoglycaemia awareness (Total 7 grading, lowest score indicates better outcome)
Measured: 16 weeks
Treatment satisfaction
Measured by questionnaire: IDTSQs (Total 8 questions with total score 0-48, highest score indicates better outcome)
Measured: 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".
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start17 Jul 2019
- Primary completion8 Apr 2021
- Study completion8 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes with Diabetic Chronic Kidney Disease (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Chow, Chinese University of Hong Kong
- Investigators
- Elaine Chow, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016155
- Sponsor's protocol ID
- FlashDKD
- Status last verified
- Jan 2021
- First submitted
- 25 Jun 2019
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Flash Glucose Monitoring in Reduction of Hypoglycaemia in Diabetes Patients with Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04016155
- Acronym / sponsor ID
- FlashDKD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMBG | Active comparator | Device: Patient Own SMBGPatients use their own glucometers as control |
| Flash CGMS | Experimental | Device: Abbott FreeStyle Libre |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Type I or II diabetes mellitus diagnosed for at least 6 months
- Male or female age ≥ 18 years old and ≤ 75 years old.
- Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- Patients with CKD stage 3b, 4 or 5 as defined by estimated glomerular filtration rate less than 45ml/min/m2
- History of at least 1 episode of non-severe or severe hypoglycaemia in the 12 months prior to screening
Key exclusion criteria (12 listed)
- HbA1C >8.5% at screening
- 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.
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott FreeStyle LibreFlash CGMS | Device | Flash CGMS |
| Patient Own SMBGMarket SMBG | Device | SMBG |
Primary outcome
Difference in time in hypoglycaemia
Time frame: week 16
Compare the difference in time in hypoglycaemia (<3.9mmol/l) on blinded CGM between intervention and control groups
9 secondary outcomes
CGM indices
Time frame: week 16
Glycated haemoglobin
Time frame: week 16
Incidence of hypoglycaemia
Time frame: week 16
Patient compliance to Flash CGMS
Time frame: week 16
Change in Diabetic treatment
Time frame: week 16
Patient quality-of-life
Time frame: week 16
Hypoglycaemia awareness
Time frame: 16 weeks
Treatment satisfaction
Time frame: 16 weeks
Fear of hypoglycaemia
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Chow principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbott FreeStyle Libre and Patient Own SMBG in people with Diabetes with Diabetic Chronic Kidney Disease (Diagnosis), run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in time in hypoglycaemia (time frame: week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.