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.

NCT07668219 | Not Yet Recruiting DMC

• 1 other identifier: FM-CIE-0839-24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

• 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:
• Selection period (15 days): Blinded monitoring is performed to obtain baseline data.
• 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.

Conditions

Type 2 Diabetes; Kidney Disease; CGM; Time in Range

Keywords

Type 2 Diabetes; Kidney Disease; Continuous Glucose Monitoring; Time in range

Outcome Measures

Primary Outcomes (1)

• Time in range (TIR)

  Percentage of time in which glucose levels are maintained between 70 - 180 mg/dl.

  12 weeks

Secondary Outcomes (5)

• Time below range (TBR)

  12 weeks

• Time above range (TAR)

  12 weeks

• Glycemic Variability

  12 weeks

• Time in Tight Range (TITR)

  12 weeks

• HbA1c

  12 weeks

Other Outcomes (1)

• MARD (Mean Absolute Relative Difference)

  12 weeks

Study Arms (2)

Self-monitoring blood glucose

ACTIVE COMPARATOR

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

RT-CGM

EXPERIMENTAL

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

Interventions

Real time continuos glucose monitoring DEVICE

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

RT-CGM

self blood glucose monitoring DEVICE

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.

Self-monitoring blood glucose

Eligibility Criteria

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

You may qualify if:

• Age over 18 years
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, Cundinamarca, 111021, Colombia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Kidney Diseases

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Central Study Contacts

Ana M Gómez - Medina, Endocrinologyst

CONTACT

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

Diana Cristina Henao, MD

CONTACT

+57 601 5946161; dchenao@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

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: June 25, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)