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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP1-ra plus basal insulin (BGLP) | Experimental | Dulaglutide and insulin degludec in combination with CGM |
|
| Basal bolus insulin (BB) | Active Comparator | Insulin aspart/lispro and insulin degludec in combination with CGM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulaglutide | Drug | Dulaglutide once weekly subcutaneous |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic variability | % coefficient of variation on blinded CGM | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| percent time in range | percent time 3.9-10 mmol/l on CGM | week 16 and 26 |
| percent time below range | percent time below 3.9 mmol/l and below 3.0 mmol/l |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C555680 | dulaglutide |
| C571886 | insulin degludec |
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| Insulin Degludec |
| Drug |
Insulin degludec once daily |
|
| Continuous glucose monitor | Device | Dexcom G6 CGM system |
|
| week 16 and 26 |
| percent time above range | percent time above 10 mmol/l and 13.9 mmol/l | week 16 and 26 |
| HbA1c | HbA1c | week 16 and 26 |
| Self reported hypoglycemia | level 1,2 and 3 hypoglycemia, biochemically confirmed | 26 weeks |
| Self monitored glucose profiles | Fasting and postprandial | 26 weeks |
| Body weight | Body weight | week 16 and 26 |
| Insulin doses | Insulin doses | week 16 and 26 |
| eGFR | estimated glomerular filrate rate by CKD-EPI equation | week 16 and 26 |
| uACR | urine albumin creatinine ratio | week 16 and 26 |
| Diabetes Treatment Satisfaction | Chinese version of Diabetes Treatment Satisfaction Questionnaire, higher score better | week 16 and 26 |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |