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

NCT07308925 | Not Yet Recruiting FDA Device

• 1 other identifier: FM-CIE-1013-24
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Continuous Glucose Monitoring; Time in Range

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (6)

• Proportion of patients with a ≥5% increase in TIR

  12 weeks

• TAR

  12 weeks

• TBR <70 mg/dl

  12 weeks

• TBR <54 mg/dl

  12 weeks

• Severe hypoglycemia

  12 weeks

Study Arms (2)

isCGM

NO INTERVENTION

Usual Care + isCGM Group: Patients in this group will have the FreeStyle Libre 2 continuous interstitial glucose monitoring sensor (Abbott Diabetes Care Inc., Alameda, CA, USA) inserted. High glucose alarms (\>250 mg/dL) and low glucose alerts (\<70 mg/dL) will be programmed. They will also be instructed to perform at least eight scans daily to avoid data loss. All participants were instructed to replace their sensors according to the manufacturer's recommendations: every 15 days for isCGM.

RT-CGM

EXPERIMENTAL

• 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.

Device: real time Continuous Glucose Monitoring

Interventions

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.

Also known as: RT-CGM

RT-CGM

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead
• Pontificia Universidad Javeriana: collaborator

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, 111121, Colombia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Diana C Henao-Carrillo, Endocrinologyst

  Hospital Universitario San Ignacio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana C Henao, Endocrinologyst

CONTACT

+57 601 5946161; dchenao@husi.org.cp

Adriana L Gonzáles, Nutricionist

CONTACT

+57 601 5946161; algomez@husi.org.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open-label randomized clinical trial

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: December 30, 2025
• Study Start: January 31, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CO (1)