Phase
Condition
Diabetes And Hypertension
Diabetes Prevention
Diabetic Kidney Disease
Treatment
Continuous glucose monitor
Insulin Degludec
Dulaglutide
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Type 2 diabetes mellitus diagnosed for at least 6 months
Male or female age ≥ 18 years old and ≤ 75 years old.
Body mass index between 18 and 40 kg/m2 inclusive
HbA1c ≥ 6.5% and ≤ 9.0% at screening
Women who are not pregnant, lactating or planning a pregnancy during theirparticipation in the clinical study.
Patients with CKD stage 3 or 4 as defined by estimated glomerular filtration ratebetween 15-59 ml/min/m2 by the modified Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) equation at screening
Willingness, ability and commitment to comply with the testing, procedure andfollow-up outlined in this protocol including (but not limited to) and use ofpre-specified glucose monitoring devices.
In the opinion of the investigator, absence of any physical limitations, addictivediseases, or underlying medical conditions (including mental health) that maypreclude 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 continuous glucose monitor as judged by theinvestigator
Exclusion
Exclusion Criteria:
Type 1 diabetes
Currently pregnant, as demonstrated by a positive pregnancy test at screening orplanning pregnancy
Treatment with GLP-1 RA or insulin degludec in the past three months
Any active acute or chronic disease or condition that, in the opinion of theinvestigator, might interfere with the performance of this study.
Any active acute or chronic infectious disease that, in the opinion of theinvestigator, would pose an excessive risk to study staff.
Current use or recent exposure to any medication that in the opinion of theinvestigator could have an influence on the patient's ability to participate in thisstudy or on the performance of the test device.
Extensive skin changes/diseases that preclude wearing the CGM on normal skin at theproposed application sites (e.g., extensive psoriasis, recent burns or severesunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitisherpetiformis).
Have a known allergy to medical-grade adhesives
Known current or recent alcohol or drug abuse
Diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction inthe six months prior to screening
Patients on renal replacement therapy or likely require kidney transplant ordialysis during the study period
Currently participating in another investigational study protocol where the testingor results may interfere with study compliance, diagnostic results, or datacollection.
An identified protected vulnerable patient (including but not limited to those indetention, or a prisoner).
Study Design
Connect with a study center
Prince of Wales Hospital
Sha Tin,
Hong KongSite Not Available
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