Status:
COMPLETED
Flash Glucose Monitoring in Reduction of Hypoglycaemia in Diabetic Patients with Chronic Kidney Disease
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Diabetes with Diabetic Chronic Kidney Disease (Diagnosis)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 identifie...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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).
- 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).
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2021
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04016155
Start Date
July 17 2019
End Date
April 8 2021
Last Update
March 5 2025
Active Locations (1)
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1
Prince of Wales Hospital
Shatin, Hong Kong