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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorHospital Universitario San Ignacio

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • real time Continuous Glucose Monitoring

Treatment groups

108 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hospital Universitario San Ignacio

Lead sponsor

Pontificia Universidad Javeriana

Collaborator