An interventional study of real time Continuous Glucose Monitoring in Type 2 Diabetes, sponsored by Hospital Universitario San Ignacio. Not yet recruiting at 1 site in Colombia. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Hospital Universitario San Ignacio · Not applicable, Interventional, and Treatment
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.
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 108 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Hospital Universitario San Ignacio is the lead sponsor of 25 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
• 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
• 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
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
TAR
To compare percentage of time in hyperglycemia range \>180 and \>250 mg/dl
Time frame: 12 weeks
TBR <70 mg/dl
To compare the proportion of patients with a %TBR \<70 mg/dL to less than 4%
Time frame: 12 weeks
TBR <54 mg/dl
To compare the proportion of patients with a %TBR \<54 mg/dL to less than 1%
Time frame: 12 weeks
Severe hypoglycemia
To compare the incidence of severe hypoglycemia, hospitalizations, and emergency department visits.
Time frame: 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.
Time frame: 12 weeks
Start is estimated for Jan 2026; primary completion for May 2028, 28 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 28 months is above that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Hospital Universitario San Ignacio