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| Name | Class |
|---|---|
| Pontificia Universidad Javeriana | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isCGM | No Intervention | 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. | |
| RT-CGM | Experimental | • 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| real time Continuous Glucose Monitoring | Device | • 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| TAR | To compare percentage of time in hyperglycemia range >180 and >250 mg/dl |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana C Henao, Endocrinologyst | Contact | +57 601 5946161 | 2817 | dchenao@husi.org.cp |
| Adriana L Gonzáles, Nutricionist | Contact | +57 601 5946161 | 2817 | algomez@husi.org.co |
| Name | Affiliation | Role |
|---|---|---|
| Diana C Henao-Carrillo, Endocrinologyst | Hospital Universitario San Ignacio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario San Ignacio | Bogotá | 111121 | Colombia |
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open-label randomized clinical trial
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| 12 weeks |
| TBR <70 mg/dl | To compare the proportion of patients with a %TBR <70 mg/dL to less than 4% | 12 weeks |
| TBR <54 mg/dl | To compare the proportion of patients with a %TBR <54 mg/dL to less than 1% | 12 weeks |
| Severe hypoglycemia | To compare the incidence of severe hypoglycemia, hospitalizations, and emergency department visits. | 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. | 12 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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