Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2018 |
| Start Date: | November 2015 |
| End Date: | August 2018 |
The goal of this study is to test whether a dipeptidyl peptidase-4 inhibitor, compared with a
sulfonylurea, improves time in normal blood glucose range and reduces blood glucose
variability. Blood glucose is measured using a continuous glucose monitoring device.
sulfonylurea, improves time in normal blood glucose range and reduces blood glucose
variability. Blood glucose is measured using a continuous glucose monitoring device.
This is a proof-of-concept clinical trial testing the effects of linagliptin versus glipizide
on glucose variability among people with type 2 diabetes and stage 3-4 CKD. In a cross-over
design, each enrolled participant will receive 28 days of each study medication. Study
medications will be provided in a randomly assigned order without blinding. The primary study
outcome is glucose time in range, measured by blinded continuous glucose monitoring for the
last 6 days of each 28-day treatment period. Secondary outcomes include indices of glycemic
variability, hypoglycemia, and biomarkers of systemic inflammation, oxidative stress, and
albuminuria. The overall goal of this research is to identify safe and effective treatments
to control glycemia among patients with diabetes and CKD.
on glucose variability among people with type 2 diabetes and stage 3-4 CKD. In a cross-over
design, each enrolled participant will receive 28 days of each study medication. Study
medications will be provided in a randomly assigned order without blinding. The primary study
outcome is glucose time in range, measured by blinded continuous glucose monitoring for the
last 6 days of each 28-day treatment period. Secondary outcomes include indices of glycemic
variability, hypoglycemia, and biomarkers of systemic inflammation, oxidative stress, and
albuminuria. The overall goal of this research is to identify safe and effective treatments
to control glycemia among patients with diabetes and CKD.
Inclusion Criteria:
- Type 2 diabetes
- eGFR 15-59 mL/min/1.73 m2
- Hemoglobin A1c < 8%
- Age ≥ 18 years
- Current use of sulfonylurea
Exclusion Criteria:
- BMI > 40 kg/m2
- Actively using CGM for clinical care
- End stage renal disease needing dialysis
- Kidney transplant
- Pregnant or nursing
- Unable to provide informed consent
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