Efficacy of the Use of Real-time Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes and Stage 3 and 4 Chronic Kidney Disease.

• Rationale: Glucose control in patients with kidney disease is challenging, as traditional metrics can be unreliable and there is a high risk of hypoglycemia (low blood sugar). Although RT-CGM has shown benefits in other groups, its efficacy in patients with advanced kidney damage needs to be validated to improve their quality of life and prevent disease progression.
• Main objective: To determine whether the use of RT-CGM is more effective than usual care (capillary blood glucose monitoring with a glucometer) in maintaining patients within an optimal glucose range (70-180 mg/dL) over a three-month period.
• Study population: We plan to include 30 patients over 18 years of age with type 2 diabetes and chronic kidney disease (with a glomerular filtration rate less than 60 ml/min), who use insulin and are not on renal replacement therapy such as dialysis.

• Methodology: The study is a randomized clinical trial consisting of two phases:

  1. Selection period (15 days): Blinded monitoring is performed to obtain baseline data.
  2. Treatment period (90 days): Patients are divided into two groups: the intervention group, which will use the CGM-RT with alarms configured for high and low levels, and the control group, which will continue with traditional fingerstick monitoring.
• Metrics to be evaluated: In addition to time in range, researchers will analyze episodes of hypoglycemia and hyperglycemia, glycemic variability, glycated hemoglobin (HbA1c) levels, and device accuracy.
• Ethical and logistical considerations: The study complies with international and national regulations, guaranteeing the confidentiality and autonomy of the participants. The project has a 24-month timeline and a detailed budget to cover medical personnel, monitoring sensors (Sinocare i3), and laboratory tests.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes; Time in Range; Kidney Disease; CGM
• Intervention / Treatment: Device: self blood glucose monitoring; Device: Real time continuos glucose monitoring

Detailed Description

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.

• 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 within these ranges.
• 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana M Gómez - Medina, Endocrinologyst; Phone Number: 2817 +57 601 5946161; Email: agomez@husi.org.co
• Study Contact Backup: Name: Diana Cristina Henao, MD; Phone Number: 2817 +57 601 5946161; Email: dchenao@husi.org.co

Study Locations

• Colombia
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 111021
      • Hospital Universitario San Ignacio
      • Contact: Ana M Gómez Medina, MD; Phone Number: 2817 +57 601 5946161; Email: agomez@husi.org.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

4.2.1 Inclusion Criteria

• Age over 18 years
• Chronic kidney disease defined as a glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m², in at least two measurements within the six months prior to inclusion.
• Treatment with basal insulin, basal-bolus regimen, or co-formulation with or without oral antidiabetic agents, with or without a GLP-1 analogue, with stable treatment for the last 3 months.

4.2.2 Exclusion Criteria

• Type 1 diabetes.
• Severe cognitive impairment or dysfunction that prevents device management.
• Chronic kidney disease on renal replacement therapy (peritoneal dialysis or hemodialysis).
• Patients with a history of kidney transplantation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Self-monitoring blood glucose; 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; 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.
Experimental: RT-CGM; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range (TIR)	Percentage of time in which glucose levels are maintained between 70 - 180 mg/dl.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time below range (TBR)	Percentage of time in which glucose levels are maintained below 54 mg/dl and 70 mg/dl	12 weeks
Time above range (TAR)	Percentage of time in which glucose levels are maintained above 180 mg/dl and 250 mg/dl	12 weeks
Glycemic Variability	Percentage coefficient of variation	12 weeks
Time in Tight Range (TITR)	Percentage of time that glucose is between 70-140 mg/dL.	12 weeks
HbA1c	Glycated hemoglobin percentage	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MARD (Mean Absolute Relative Difference)	The difference between the measurement of the device and the reference measurement, expressed as a percentage of the mean.	12 weeks

Collaborators and Investigators

• Sponsor: Hospital Universitario San Ignacio

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: June 19, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Type 2 Diabetes; Kidney Disease; Time in range
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Kidney Diseases; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Blood Glucose Self-Monitoring
• Other Study ID Numbers: FM-CIE-0839-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No