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The purpose of this study is to determine if patient's own Continuous Glucose Monitor (CGMs) worn in the non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucose measurement, and to determine if alerts given by CGMs worn in the non-ICU hospital would prevent episodes of hyperglycemia and hypoglycemia.
All patients admitted to the hospital in inpatient or observation status and having a Continuous Glucose Monitor (CGMs) attached will be screened and identified by providers and nurses. An order will be placed by providers to continue patient's home CGM use in the hospital. "CGM patient agreement" describing the hospital policy for use of CGMs will be provided to the patient for signature. Patients will be encouraged to continue to wear their CGMs in the hospital unless their presence interferes with patients' medical care. CGM presence will be recorded by nursing in patient chart under LDA (lines, drains, airway) section. Patients will be approached by the research staff and will be offered enrollment in the study. A research consent will be reviewed with patients and will be provided for signature. Patients will be asked to continue to use their home CGMs in the hospital. If CGM sensor will reach the end of life, patients have the option to place a new sensor and to follow manufacturer recommendations for calibration and setting. Patients are responsible to provide their own sensors, transmitters and readers during the hospitalization period. If it is determined that the current sensor will interfere with hospital medical and surgical care (MRI testing, procedure at the site), patients will be asked to remove the CGM sensor and transmitter. Patients will have the option to replace the sensor after the procedure if they so desire.
Patients will continue to monitor their glucose level via CGM. For flash sensors, patients will be asked to scan their sensor at least every 8 and as needed. CGMs that require calibration will be calibrated by the patients using hospital glucometer readings. .
Patients alerted by their CGM about low glucose levels or fast downward or upward trending will have to notify their nursing staff. A POC blood glucose check will be done by nursing staff to confirm the alert or the trend. Treatment decisions will be made based on POC readings.
During hospitalization patients will continue to have their blood glucose checked with POC glucometers per hospital policy.
Treatment of diabetes and the associated complications, dosing of insulin, change from PO to insulin treatment and back to PO medications during hospitalization or at discharge will be done by the admitting team with help from the inpatient Endocrinology Consultation Service.
Decisions about insulin dosing or other diabetes treatments will be made based on hospital glucometer readings, and not based on CGM readings alone.
Patients will be asked to give the research team "provider access" to their cloud CGM software, or to allow the team to download their CGM data prior to discharge if their reading devices do not automatically synchronize with the cloud software.
CGM data will be compared with POC glucometer readings obtained in the hospital at approximately the same time. Different patient variables (demographics, comorbidities, labs and vitals, administered medications) will be collected from electronic health record and will be evaluated to determine if they interfere with CGM readings. The accuracy of CGM for glucose measurement in the hospital will be calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Patients | Experimental | Patients with diabetes mellitus admitted to the hospital and using a CGM will be encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels will be communicated to the nursing staff. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor (CGM) | Device | CGM data will be downloaded prior to discharge and it will be compared with hospital glucometer readings taken at the same time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD) | The absolute relative difference (ARD) was defined as the absolute difference between control - point of care (POC) glucose reading and the corresponding CGM reading divided by POC glucose reading and expressed as percentage. ARD was calculated as mean absolute relative difference (MARD) with standard deviation. MARD was calculated between matched pairs of POC (point of care) glucose readings and the closest CGM reading. MARD was summarized as mean (standard deviation) or median (range) for glucose readings <70 mg/dl, 70-180 mg/dL, >180 mg/dl, 181-250mg/dl, >250 mg/dl respectively. | From date of enrollment and until discharge from the hospital up to 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Recorded Hypoglycemia Episodes | The incidence of hypoglycemic episodes | From date of enrollment and until discharge from the hospital up to 30 days. |
| CGM Recorded Duration of Hypoglycemic Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Dumitrascu, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40229126 | Derived | Dumitrascu AG, Perry M, Chindris AM, Chirila RM, Boone RJ, Blumenfeld SG, Hodge DO, White LJ, Gnanapandithan K, De La Cruz DA, Pagan RJ, Smerina M, Gavrancic T, Cortes MP, Murawska Baptista A, Wilson JR. Real-World Performance of Personal Continuous Glucose Monitors During Hospitalization. Diabetes Technol Ther. 2025 Aug;27(8):613-622. doi: 10.1089/dia.2024.0639. Epub 2025 Apr 14. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM Patients | Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff. Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM Patients | Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff. Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Continuous Glucose Monitors (CGM) Accuracy - Mean Absolute Relative Difference (MARD) | The absolute relative difference (ARD) was defined as the absolute difference between control - point of care (POC) glucose reading and the corresponding CGM reading divided by POC glucose reading and expressed as percentage. ARD was calculated as mean absolute relative difference (MARD) with standard deviation. MARD was calculated between matched pairs of POC (point of care) glucose readings and the closest CGM reading. MARD was summarized as mean (standard deviation) or median (range) for glucose readings <70 mg/dl, 70-180 mg/dL, >180 mg/dl, 181-250mg/dl, >250 mg/dl respectively. | 3316 total CGM-POC readings pairs were collected. Those 3316 POC-CGM reading pairs were further broken down into the following categories based on the POC value: CGM-POC Pairs with POC<70 mg/dL, CGM-POC Pairs with POC between 70-180 mg/dL, CGM-POC Pairs with POC between 181-250mg/dl, CGM-POC Pairs with POC>250 mg/dl, respectively. | Posted | Mean | Standard Deviation | MARD percentage | From date of enrollment and until discharge from the hospital up to 30 days. | CGM-POC pairs | CGM-POC pairs |
Adverse events were collected from the time of informed consent through end of study participation, approximately 60 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CGM Patients | Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff. Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adrian Dumitrascu M.D. | Mayo Clinic | 904-956-0081 | Dumitrascu.Adrian@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2020 | May 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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CGM recorded duration of hypoglycemic episodes
| From date of enrollment and until discharge from the hospital up to 30 days. |
| CGM Recorded Hyperglycemic Episodes | The incidence of hyperglycemic episodes | From date of enrollment and until discharge from the hospital up to 30 days. |
| CGM Recorded Duration of Hyperglycemic Episodes | The duration of hyperglycemic episodes | From date of enrollment and until discharge from the hospital up to 30 days. |
| Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters | The correlation between MARD point of care (POC) and Creatinine, Glomerular Filtration Rate (GFR), Bicarbonate, Hemoglobin (Hb), Mean Arterial Pressure (MAP), and Peripheral Oxygen Saturation (SpO2). The Spearman's rank correlation method was used to calculate the correlation coefficient. | From date of enrollment and until discharge from the hospital up to 30 days. |
| In Hospital Mortality | Mortality during index hospitalization | From date of enrollment and until discharge from the hospital up to 30 days. |
| Hospitalization Length of Stay | Duration of hospital stay in hours | From date of enrollment and until discharge from the hospital up to 30 days. |
| Mortality Rate at 30 Days | Mortality rate at 30 days post discharge from the hospital | From date of enrollment up to 60 days. |
| Number of Re-hospitalization Events at the Same Institution Within 30 Days From the Discharge Date of the Preceding Admission. | Number of re-hospitalization events that occurred at the same institution within 30 days from the discharge date of the preceding admission. | From date of enrollment up to 60 days. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | CGM Patients | Patients with diabetes mellitus admitted to the hospital and using a CGM were encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels were communicated to the nursing staff. Continuous Glucose Monitor (CGM): CGM data was downloaded prior to discharge and it was compared with hospital glucometer readings taken at the same time. |
|
|
| Secondary | CGM Recorded Hypoglycemia Episodes | The incidence of hypoglycemic episodes | Posted | Mean | Standard Deviation | Hypoglycemic Episodes | From date of enrollment and until discharge from the hospital up to 30 days. |
|
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| Secondary | CGM Recorded Duration of Hypoglycemic Episodes | CGM recorded duration of hypoglycemic episodes | Posted | Mean | Standard Deviation | Minutes | From date of enrollment and until discharge from the hospital up to 30 days. |
|
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|
|
| Secondary | CGM Recorded Hyperglycemic Episodes | The incidence of hyperglycemic episodes | Posted | Mean | Standard Deviation | Hyperglycemic Episodes | From date of enrollment and until discharge from the hospital up to 30 days. |
|
|
|
| Secondary | CGM Recorded Duration of Hyperglycemic Episodes | The duration of hyperglycemic episodes | Posted | Mean | Standard Deviation | Minutes | From date of enrollment and until discharge from the hospital up to 30 days. |
|
|
|
|
| Secondary | Variation in Mean Absolute Relative Difference (MARD) in Relation to Pharmacological and Physiological Parameters | The correlation between MARD point of care (POC) and Creatinine, Glomerular Filtration Rate (GFR), Bicarbonate, Hemoglobin (Hb), Mean Arterial Pressure (MAP), and Peripheral Oxygen Saturation (SpO2). The Spearman's rank correlation method was used to calculate the correlation coefficient. | Posted | Number | Correlation Coefficient | From date of enrollment and until discharge from the hospital up to 30 days. |
|
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| Secondary | In Hospital Mortality | Mortality during index hospitalization | Posted | Count of Participants | Participants | From date of enrollment and until discharge from the hospital up to 30 days. |
|
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| Secondary | Hospitalization Length of Stay | Duration of hospital stay in hours | Posted | Median | Inter-Quartile Range | Hours | From date of enrollment and until discharge from the hospital up to 30 days. |
|
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| Secondary | Mortality Rate at 30 Days | Mortality rate at 30 days post discharge from the hospital | Posted | Count of Participants | Participants | From date of enrollment up to 60 days. |
|
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| Secondary | Number of Re-hospitalization Events at the Same Institution Within 30 Days From the Discharge Date of the Preceding Admission. | Number of re-hospitalization events that occurred at the same institution within 30 days from the discharge date of the preceding admission. | Posted | Count of Units | Hospitalizations Events | From date of enrollment up to 60 days. | Hospitalizations Events | Hospitalizations Events |
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| 2 |
| 142 |
| 0 |
| 142 |
| 0 |
| 142 |
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Hypoglycemic Episodes <70 mg/dL
| Superiority |
Hypoglycemic Episodes <70 mg/dL
| Superiority |
Hyperglycemic Episodes >250 mg/dL
| Superiority |
| Title | Measurements |
|---|---|
|
| Hb |
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| MAP |
|
| SpO2 |
|
139GFR
| Superiority |
| Spearman Correlation coefficients | 0.22 | Bicarbonate | Superiority |
| Spearman Correlation coefficients | 0.48 | Hemoglobin | Superiority |
| Spearman Correlation coefficients | 0.77 | MAP | Superiority |
| Spearman Correlation coefficients | 0.0516 | SpO2 | Superiority |