Efficacy of the Use of Real-time Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes and Stage 3 and 4 Chronic Kidney Disease.

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Conditions studied: Type 2 Diabetes, Kidney Disease, CGM, Time in Range

In brief

* Rationale: Glucose control in patients with kidney disease is challenging, as traditional metrics can be unreliable and there is a high risk of hypoglycemia (low blood sugar). Although RT-CGM has shown benefits in other groups, its efficacy in patients with advanced kidney damage needs to be validated to improve their quality of life and prevent disease progression. * Main objective: To determine whether the use of RT-CGM is more effective than usual care (capillary blood glucose monitoring with a glucometer) in maintaining patients within an optimal glucose range (70-180 mg/dL) over a three-month period. * Study population: We plan to include 30 patients over 18 years of age with type 2 diabetes and chronic kidney disease (with a glomerular filtration rate less than 60 ml/min), who use insulin and are not on renal replacement therapy such as dialysis. * Methodology: The study is a randomized clinical trial consisting of two phases: 1. Selection period (15 days): Blinded monitoring is performed to obtain baseline data. 2. Treatment period (90 days): Patients are divided into two groups: the intervention group, which will use the CGM-RT with alarms configured for high and low levels, and the control group, which will continue with traditional fingerstick monitoring. * Metrics to be evaluated: In addition to time in range, researchers will analyze episodes of hypoglycemia and hyperglycemia, glycemic variability, glycated hemoglobin (HbA1c) levels, and device accuracy. * Ethical and logistical considerations: The study complies with international and national regulations, guaranteeing the confidentiality and autonomy of the participants. The project has a 24-month timeline and a detailed budget to cover medical personnel, monitoring sensors (Sinocare i3), and laboratory tests.

Key facts

Study ID
NCT07668219
Run by
Hospital Universitario San Ignacio
People needed
30
Starts
2026-11-01
Expected to finish
2027-05-30
Last updated by the study team
2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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