Type 2 DiabetesNCT07668219
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.
A study testing Real time continuos glucose monitoring and self blood glucose monitoring in people with Type 2 Diabetes and Kidney Disease, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Kidney Disease, CGM
- What is being tested?
- Real time continuos glucose monitoring and self blood glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- Nov 2026to 30 May 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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, Cundinamarca, 111021
Ana M Gómez Medina, MD, +57 601 5946161 ext. 2817, agomez@husi.org.co
About this study
- 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Kidney Disease, CGM, Time in Range
- Being tested
- Real time continuos glucose monitoring, self blood glucose monitoring
- Keywords
- Type 2 Diabetes, Kidney Disease, Continuous Glucose Monitoring, Time in range
- Medical subject headings
- Diabetes Mellitus, Type 2, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real time continuos glucose monitoringDevice
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
self blood glucose monitoringDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Real time continuos glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range (TIR)
Percentage of time in which glucose levels are maintained between 70 - 180 mg/dl.
Measured: 12 weeks
Secondary outcomes (5)
Time below range (TBR)
Percentage of time in which glucose levels are maintained below 54 mg/dl and 70 mg/dl
Measured: 12 weeks
Time above range (TAR)
Percentage of time in which glucose levels are maintained above 180 mg/dl and 250 mg/dl
Measured: 12 weeks
Glycemic Variability
Percentage coefficient of variation
Measured: 12 weeks
Time in Tight Range (TITR)
Percentage of time that glucose is between 70-140 mg/dL.
Measured: 12 weeks
HbA1c
Glycated hemoglobin percentage
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 posted25 Jun 2026
- Study startNov 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion30 May 2027 (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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668219
- Sponsor's protocol ID
- FM-CIE-0839-24
- Status last verified
- Jun 2026
- First submitted
- 28 Jan 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07668219
- Acronym / sponsor ID
- FM-CIE-0839-24
- Conditions
- Type 2 Diabetes, Kidney Disease, CGM, Time in Range
- Keywords
- Type 2 Diabetes, Kidney Disease, Continuous Glucose Monitoring, Time in range
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 25 Jun 2026 (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.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-monitoring blood glucose | Active comparator | Device: self blood glucose monitoringControl 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. |
| RT-CGM | Experimental | Device: Real time continuos glucose monitoringDescription: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 continuos glucose monitoringIntervention 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 | Device | RT-CGM |
| self blood glucose monitoringControl 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-monitoring blood glucose |
Primary outcome
Time in range (TIR)
Time frame: 12 weeks
Percentage of time in which glucose levels are maintained between 70 - 180 mg/dl.
5 secondary outcomes
Time below range (TBR)
Time frame: 12 weeks
Time above range (TAR)
Time frame: 12 weeks
Glycemic Variability
Time frame: 12 weeks
Time in Tight Range (TITR)
Time frame: 12 weeks
HbA1c
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 25 Jun 2026.
- Individual participant dataSharing planned: 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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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.
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 continuos glucose monitoring and self blood glucose monitoring in people with Type 2 Diabetes and Kidney Disease, 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?
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 25 Jun 2026. 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 Ana M Gómez - Medina, Endocrinologyst (+57 601 5946161 ext. 2817, agomez@husi.org.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (TIR) (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 25 Jun 2026.