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.
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.
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.
Parallel
real time Continuous Glucose Monitoring
Device• 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.
Time in Range
To compare the efficacy defined as time in range between 70 - 180 mg/dl of the TR-CGM compared to isCGM in patients diagnosed with T2DM treated with insulin who use CGM as part of usual clinical practice in follow-up at the endocrinology unit of the San Ignacio University Hospital.
Proportion of patients with a ≥5% increase in TIR
Compare the proportion of patients with a ≥5% increase in TIR 70-180 mg/dl compared to the initial value.
TAR
To compare percentage of time in hyperglycemia range \>180 and \>250 mg/dl
TBR <70 mg/dl
To compare the proportion of patients with a %TBR \<70 mg/dL to less than 4%
TBR <54 mg/dl
To compare the proportion of patients with a %TBR \<54 mg/dL to less than 1%
Click on the lead sponsor to view all of their trials.
Hospital Universitario San Ignacio
Lead sponsor
Pontificia Universidad Javeriana
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
