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Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.
Sponsor: Hospital Universitario San Ignacio
Summary
The objective is to compare the efficacy of TR-CGM versus isCGM in patients diagnosed with T2D who are treated with insulin and use CGM, as defined by time in range between 70 and 180 mg/dL. An open-label clinical trial will be conducted. Patients with T2D who use intermittent glucose monitoring and insulin with poor metabolic control will be included. They will be randomized to continue with isCGM or RT-CGM. The primary outcome: %TIR 70-180 mg/dL.
Official title: Effectiveness of Using Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.
Key Details
Gender
All
Age Range
35 Years - Any
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2026-01-31
Completion Date
2028-12-30
Last Updated
2025-12-30
Healthy Volunteers
No
Conditions
Interventions
real time Continuous Glucose Monitoring
• Usual care + TR-CGM group: Patients in this group will undergo insertion of a continuous interstitial glucose monitoring (CGM) sensor using the FreeStyle Libre 2 Plus device and LibreLink app® (Abbott Diabetes Care, Inc., Alameda, CA, USA). The sensor will be programmed with high glucose alarms (\>250 mg/dL) and low glucose alerts (\<70 mg/dL). All participants will be instructed to replace their sensor according to the manufacturer's recommendations: every 15 days for TR-CGM.
Locations (1)
Hospital Universitario San Ignacio
Bogotá, Colombia