NCT07308925

Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.

Effectiveness of Using Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Hospital Universitario San Ignacio · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All patients diagnosed with type 2 diabetes (T2D) who meet the inclusion criteria will be identified (see inclusion and exclusion criteria). They will then be invited to participate in the study and asked to sign an informed consent form. Demographic data, baseline clinical characteristics, and clinical tests related to metabolic control will be collected. Visit 0 (V0): Informed consent signature and basal CGM system installation will be verified. Visit 1 (V1): CGM data will be downloaded. All enrolled patients will receive the same instructions for device use and management of high and low glucose levels, according to standard clinical procedures. Then, randomization will be performed by someone who is blinded to the clinical characteristics of each patient and is not part of the research group. The allocation given by this mechanism cannot be changed by the treating physicians. * Usual care + TR-CGM group: Patients in this group will receive a continuous interstitial glucose monitoring (CIGM) sensor via the FreeStyle Libre 2 Plus device and LibreLink app® (Abbott Diabetes Care, Inc., Alameda, CA). High alarms greater than 250 mg/dL and low glucose alerts less than 70 mg/dL will be programmed. All participants will be instructed to change their sensor according to the manufacturer's recommendations: every 15 days for the TR-CGM group. * Usual care + CIGM group: Patients in this group will receive a CIGM sensor using the FreeStyle Libre 2 device (Abbott Diabetes Care Inc., Alameda, CA, USA). High alarms \>250 mg/dL and low glucose alerts \<70 mg/dL will be programmed. Additionally, they will be instructed to perform at least eight scans daily to avoid data loss. All participants were instructed to change their sensors according to the manufacturer's recommendations: every 15 days for isCGM. Standard Care (Applies to Both Groups): All patients should be assessed by the diabetes clinic's nutrition service, which will provide basic dietary and physical activity recommendations. All patients will be instructed in basal and/or prandial insulin titration, as appropriate.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-01-31
• Primary completion: 2028-05-31
• Completion: 2028-12-30
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: Colombia

Regulatory

• FDA-regulated device study