To compare GLP-1 RA plus basal insulin (BGLP) versus basal-bolus (BB) insulin regimens on glycemic variability (GV) and time in range (TIR) in diabetes patients CKD stage 3-4
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
Dulaglutide once weekly subcutaneous
Insulin degludec once daily
Dexcom G6 CGM system
Prince of Wales Hospital
Shatin, Hong Kong
Glycemic variability
% coefficient of variation on blinded CGM
Time frame: 16 weeks
percent time in range
percent time 3.9-10 mmol/l on CGM
Time frame: week 16 and 26
percent time below range
percent time below 3.9 mmol/l and below 3.0 mmol/l
Time frame: week 16 and 26
percent time above range
percent time above 10 mmol/l and 13.9 mmol/l
Time frame: week 16 and 26
HbA1c
HbA1c
Time frame: week 16 and 26
Self reported hypoglycemia
level 1,2 and 3 hypoglycemia, biochemically confirmed
Time frame: 26 weeks
Self monitored glucose profiles
Fasting and postprandial
Time frame: 26 weeks
Body weight
Body weight
Time frame: week 16 and 26
Insulin doses
Insulin doses
Time frame: week 16 and 26
eGFR
estimated glomerular filrate rate by CKD-EPI equation
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Time frame: week 16 and 26
uACR
urine albumin creatinine ratio
Time frame: week 16 and 26
Diabetes Treatment Satisfaction
Chinese version of Diabetes Treatment Satisfaction Questionnaire, higher score better
Time frame: week 16 and 26