Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.
Colombia108 participantsStarted 2026-01-31
Plain-language 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.
Who can participate
Age range35 Years
SexALL
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Inclusion Criteria:
* Minimum age of 35 years.
* HbA1c \>7.0%
* Treatment with one or more insulin injections.
* Stable medication regimen for the 3 months prior to study entry.
* Insulin treatment for ≥3 months with a stable dose prior to entry, with fasting blood glucose between 70 and 130 mg/dL.
* Availability of an NFC-enabled smartphone.
Exclusion Criteria:
* Pregnancy or planning to become pregnant during the study period.
* History of bariatric surgery within the year prior to study entry or plans to undergo bariatric surgery during the study.
* Having a condition that would likely require an MRI during the study period.
* Use of medications containing high doses of ascorbic acid (\>2000 mg/day), as it may falsely increase sensor readings.
* Concomitant illness or condition that may compromise patient safety, including, but not limited to, serious mental illness, a diagnosed or suspected eating disorder, or any long-term medical/unmanageable disorder.
* GFR less than 30 ml/min.
* Psychiatric condition that interferes with study-related tasks.
* Known (or suspected) significant allergy to medical-grade adhesives.