Flash Glucose Monitoring in Reduction of Hypoglycaemia in Diabetic Patients With Chronic Kidney Disease

This is an interventional diagnostic trial for Diabetes With Diabetic Chronic Kidney Disease (Diagnosis) Read More

Inclusion Criteria:

1. Type I or II diabetes mellitus diagnosed for at least 6 months
2. Male or female age ≥ 18 years old and ≤ 75 years old.
3. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
4. Patients with CKD stage 3b, 4 or 5 as defined by estimated glomerular filtration rate less than 45ml/min/m2
5. History of at least 1 episode of non-severe or severe hypoglycaemia in the 12 months prior to screening
6. 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.
7. Willingness to perform SMBG during the study period
8. 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.
9. Written informed consent to participate in the study provided by the patient.
10. Willing and capable of use of a flash glucose monitor as judged by the investigator

Exclusion Criteria:

1. HbA1C >8.5% at screening
2. 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.
3. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
4. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
5. 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.
6. 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).
7. Have a known allergy to medical-grade adhesives
8. Known current or recent alcohol or drug abuse
9. Diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction in the six months prior to screening
10. Patients on renal replacement therapy
11. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
12. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).