Flash Glucose Monitoring in Reduction of Hypoglycaemia in Diabetic Patients with Chronic Kidney D… (NCT04016155) | Clinical Trial Compass
CompletedNot Applicable
Flash Glucose Monitoring in Reduction of Hypoglycaemia in Diabetic Patients with Chronic Kidney Disease
Hong Kong94 participantsStarted 2019-07-17
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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).