An interventional study of Real time continuos glucose monitoring and self blood glucose monitoring in Type 2 Diabetes, Kidney Disease and CGM, sponsored by Hospital Universitario San Ignacio. Not yet recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Hospital Universitario San Ignacio · Not applicable, Interventional, and Treatment
Methodology: The study is a randomized clinical trial consisting of two phases:
Patients diagnosed with type 2 diabetes mellitus and chronic kidney disease treated at the San Ignacio University Hospital in the outpatient clinic who meet the inclusion criteria will be identified. Once identified, they will be invited to participate in this study and will undergo the informed consent process, which will include, for those who accept, completing and signing the informed consent document (Appendix 1). It is clarified that the only intervention to be evaluated will be real-time continuous glucose monitoring; the patient's therapy will not be modified. The study will comprise a selection period and a treatment period.
4.3.1 Selection Period Potential subjects will sign an informed consent form before undergoing any procedure related to the study. During this phase, blinded continuous glucose monitoring will be performed to obtain baseline metabolic control data for 15 days prior to randomization. During this period, participants will be instructed to measure capillary blood glucose according to standard clinical practice. During this follow-up period, seven daily blood glucose readings will be taken to evaluate the device's accuracy in all patients.
4.3.2 Treatment Period Once the blinded monitoring data has been downloaded, randomization will begin. A simple, computer-generated randomization code will be used, managed centrally by a person who will not be aware of each patient's clinical characteristics. The assignment determined by this mechanism cannot be changed by the treating physicians.
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 30 is below 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.
4.2.2 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.
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.
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.
Control group: Continuous glucose monitoring will be installed, blinded to measure baseline glycemic control metrics and at the end of the study. Patients assigned to the control group will receive routine nursing education on glucometer use, frequency of capillary blood glucose monitoring, and recommendations for managing hypoglycemic episodes. Capillary glucose data will be reviewed monthly by a physician trained in diabetes management, who will make appropriate adjustments to therapy if subjects experience hypoglycemic events (\<54 mg/dL and \<70 mg/dL) or recurrent hyperglycemic events (\>180 mg/dL), according to basal and prandial insulin titration recommendations.
Device: self blood glucose monitoring
Description: Intervention group (users of real-time continuous glucose monitoring). Participants in the intervention group will be instructed on the use of real-time continuous glucose monitoring. This training will be provided by nursing staff and will include instruction on device use, alarm management, and recommendations for responding to hypoglycemic episodes reported by the device. Alarms will be configured as follows: High Glucose Alert ≥240 mg/dL and Low Glucose Alert ≤70 mg/dL. Data uploaded to the platform by the device will be reviewed monthly by a physician trained in diabetes management, who will make appropriate adjustments to therapy if participants experience hypoglycemic episodes (\<54 mg/dL and \<70 mg/dL) or recurrent hyperglycemic episodes (\>180 mg/dL), according to basal and prandial insulin titration recommendations. This group will be instructed to confirm readings below 70 mg/dL and above 240 mg/dL with capillary blood glucose monitoring to evaluate the device's
Device: Real time continuos glucose monitoring
Intervention group (users of real-time continuous glucose monitoring). Participants in the intervention group will be instructed on the use of real-time continuous glucose monitoring. This training will be provided by nursing staff and will include instruction on device use, alarm management, and recommendations for responding to hypoglycemic episodes reported by the device. Alarms will be configured as follows: High Glucose Alert ≥240 mg/dL and Low Glucose Alert ≤70 mg/dL. Data uploaded to the platform by the device will be reviewed monthly by a physician trained in diabetes management, who will make appropriate adjustments to therapy if participants experience hypoglycemic episodes (\<54 mg/dL and \<70 mg/dL) or recurrent hyperglycemic episodes (\>180 mg/dL), according to basal and prandial insulin titration recommendations. This group will be instructed to confirm readings below 70 mg/dL and above 240 mg/dL with capillary blood glucose monitoring to evaluate the device's accuracy withi
Control group: Continuous glucose monitoring will be installed, blinded to measure baseline glycemic control metrics and at the end of the study. Patients assigned to the control group will receive routine nursing education on glucometer use, frequency of capillary blood glucose monitoring, and recommendations for managing hypoglycemic episodes. Capillary glucose data will be reviewed monthly by a physician trained in diabetes management, who will make appropriate adjustments to therapy if subjects experience hypoglycemic events (\<54 mg/dL and \<70 mg/dL) or recurrent hyperglycemic events (\>180 mg/dL), according to basal and prandial insulin titration recommendations.
Time in range (TIR)
Percentage of time in which glucose levels are maintained between 70 - 180 mg/dl.
Time frame: 12 weeks
Time below range (TBR)
Percentage of time in which glucose levels are maintained below 54 mg/dl and 70 mg/dl
Time frame: 12 weeks
Time above range (TAR)
Percentage of time in which glucose levels are maintained above 180 mg/dl and 250 mg/dl
Time frame: 12 weeks
Glycemic Variability
Percentage coefficient of variation
Time frame: 12 weeks
Time in Tight Range (TITR)
Percentage of time that glucose is between 70-140 mg/dL.
Time frame: 12 weeks
HbA1c
Glycated hemoglobin percentage
Time frame: 12 weeks
MARD (Mean Absolute Relative Difference)
The difference between the measurement of the device and the reference measurement, expressed as a percentage of the mean.
Time frame: 12 weeks
Plan to share: No — The datasets generated and/or analyzed during the current study will not be publicly available because they contain clinical data from patients being monitored at Hospital Universitario San Ignacio.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitario San Ignacio