Type 2 DiabetesNCT07308925
Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.
A study testing real time Continuous Glucose Monitoring in people with Type 2 Diabetes, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- real time Continuous Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteColombia
- Study dates
- 31 Jan 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Hospital Universitario San Ignacio
Bogotá, 111121
Diana C Henao-Carrillo, Endocrinologyst, +57 601 5946161 ext. 2817, dchenao@husi.org.co
Adriana G Gómez-Velasquez, Nutricionist, +57 601 5946161 ext. 2817, algomez@husi.org.co
About this study
Official title: Effectiveness of Using Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.
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.
Read the 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
- Being tested
- real time Continuous Glucose Monitoring
- Keywords
- Type 2 Diabetes, Continuous Glucose Monitoring, Time in Range
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real time Continuous Glucose MonitoringDevice
Also called RT-CGM
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: real time Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 12 weeks
TAR
To compare percentage of time in hyperglycemia range >180 and >250 mg/dl
Measured: 12 weeks
TBR <70 mg/dl
To compare the proportion of patients with a %TBR <70 mg/dL to less than 4%
Measured: 12 weeks
TBR <54 mg/dl
To compare the proportion of patients with a %TBR <54 mg/dL to less than 1%
Measured: 12 weeks
Severe hypoglycemia
To compare the incidence of severe hypoglycemia, hospitalizations, and emergency department visits.
Measured: 12 weeks
Satisfaction with the device
To compare satisfaction with the device using the "Questionnaire on experience with glucose monitoring (C-EMC)" at the end of the follow-up.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start31 Jan 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor
- Investigators
- Diana C Henao-Carrillo, Endocrinologyst, Principal investigator, Hospital Universitario San Ignacio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308925
- Sponsor's protocol ID
- FM-CIE-1013-24
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.
- ClinicalTrials.gov ID
- NCT07308925
- Acronym / sponsor ID
- FM-CIE-1013-24
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Continuous Glucose Monitoring, Time in Range
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| 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 | 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real time Continuous Glucose MonitoringAlso: RT-CGM• 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 | RT-CGM |
Primary outcome
Time in Range
Time frame: 12 weeks
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.
6 secondary outcomes
Proportion of patients with a ≥5% increase in TIR
Time frame: 12 weeks
TAR
Time frame: 12 weeks
TBR <70 mg/dl
Time frame: 12 weeks
TBR <54 mg/dl
Time frame: 12 weeks
Severe hypoglycemia
Time frame: 12 weeks
Satisfaction with the device
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana C Henao-Carrillo, Endocrinologyst principal investigator
Hospital Universitario San Ignacio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real time Continuous Glucose Monitoring in people with Type 2 Diabetes, run by Hospital Universitario San Ignacio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana C Henao, Endocrinologyst (+57 601 5946161 ext. 2817, dchenao@husi.org.cp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.