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This program will provide patients with type 1 and high risk type 2 diabetes the safest hospitalization by using wireless continuous glucose monitoring devices (CGM) to track their glucose parameters in real-time similar to other continuously monitored vital signs. The CGM will inform a team of health professionals who will monitor the patients' progress, communicate recommendations, and be available for discussion when recommended targets are not achieved. Health teams will utilize sensor results in addition to existing electronic medical records data to evaluate progress and manage care.
All patients with type 1 or type 2 diabetes who meet study criteria will be invited to participate in the study. All patients included in the study will be followed by an advanced practice diabetes nurse for glucose management during their hospitalization. All patients included in the study will receive a CGM. Patients with type 2 diabetes will be randomized to control (blinded CGM glucose values to APN, care team and researchers) or intervention (CGM blood glucose values will be used to aid with glucose management during the hospitalization). In addition, a research only supplemental order set will be implemented for all study participants. The order set focuses on any glucose point of care test that is between 70-79 mg/dL or ≥ 250 at bedtime or before the 4 am usual care blood glucose check. The goal is to prevent hypoglycemia and hyperglycemia for all study patients. The advanced practice diabetes nurse will work with the physician in charge of the patient's care as well as the patient's care team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | For type 2 patients in the intervention group, CGM data will be viewed real-time. |
|
| Control | Experimental | For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-time CGM data | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL) | Percentage of time a person's blood glucose level stays within a specific range of 70-180 mg/dL | Up to 30 days |
| Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL) | Percentage of time a person's blood glucose level stays within a specific range on 70-200 mg/dL | Up to 30 days |
| Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL) | Percentage of time a person's blood glucose level stays within a specific range on 70-250 mg/dL | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Time in Hypoglycemia (<70 mg/dL) | Percentage of time a person's blood glucose level stays within a specific range < 70 mg/dL | Up to 30 days |
| Percentage Time in Hyperglycemia (>250 mg/dL) |
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Inclusion Criteria:
Expected length of hospital stay of at least 48 hours
One of the following:
Literate in English or Spanish
Exclusion Criteria (not all listed):
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| Name | Affiliation | Role |
|---|---|---|
| Athena Philis-Tsimikas, MD | Scripps Whittier Diabetes Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Whittier Diabetes Institute | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32855160 | Derived | Fortmann AL, Spierling Bagsic SR, Talavera L, Garcia IM, Sandoval H, Hottinger A, Philis-Tsimikas A. Glucose as the Fifth Vital Sign: A Randomized Controlled Trial of Continuous Glucose Monitoring in a Non-ICU Hospital Setting. Diabetes Care. 2020 Nov;43(11):2873-2877. doi: 10.2337/dc20-1016. Epub 2020 Aug 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Patients in the intervention group, CGM data will be viewed real-time. Real-time CGM data |
| FG001 | Control | Patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group. Real-time CGM data |
| FG002 | Observational T1D | Hospitalized patients with T1D placed on a CGM |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | For type 2 patients in the intervention group, CGM data will be viewed real-time. Real-time CGM data |
| BG001 | Control | For type 2 patients in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group. Real-time CGM data |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL) | Percentage of time a person's blood glucose level stays within a specific range of 70-180 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time during CGM use | Up to 30 days |
|
Length of time on study over a 2-year period
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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 | Intervention | Patients with T2D in the intervention group, CGM data will be viewed real-time. Real-time CGM data |
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The control group was not considered ethical for the T1D arm; therefore, no comparison data was available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Athena Philis-Tsimikas | Scripps Health | 858-678-7077 | philis-tsimikas.athena@scrippshealth.org |
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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 | Jan 9, 2020 | Aug 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Percentage of time a person's blood glucose level stays within a specific range > 250 mg/dL
| Up to 30 days |
| BG002 | Observational T1D | For type 1 patients in the observational group, CGM data will be viewed real-time. Real-time CGM data |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Missing data at hospital admission. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type 2 Diabetes Duration | Missing data at hospital admission. Explanation: Data not assessed in T1D observational arm | Mean | Standard Deviation | years |
|
| HbA1c at Hospital Admission | HbA1c was missing on patients | Median | Inter-Quartile Range | percentage |
|
| Point of Care (POC) Blood Glucose Testing at Hospital Admission | Missing data at hospital admission. | Median | Inter-Quartile Range | mg/dL |
|
| Serum Creatinine at Hospital Admission | Range not determined in this T1D observational arm | Median | Inter-Quartile Range | mg/dL |
|
| BMI | Missing data at hospital admission. Explanation: BMI not collected in this T1D observational arm | Median | Inter-Quartile Range | kg/m2 |
|
| Observational T1D |
For type 1 patients in the observational group, real-time CGM data was collected. |
|
|
|
| Primary | Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL) | Percentage of time a person's blood glucose level stays within a specific range on 70-200 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time during CGM use | Up to 30 days |
|
|
|
|
| Primary | Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL) | Percentage of time a person's blood glucose level stays within a specific range on 70-250 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time during CGM use | Up to 30 days |
|
|
|
|
| Secondary | Percentage Time in Hypoglycemia (<70 mg/dL) | Percentage of time a person's blood glucose level stays within a specific range < 70 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time during CGM use | Up to 30 days |
|
|
|
|
| Secondary | Percentage Time in Hyperglycemia (>250 mg/dL) | Percentage of time a person's blood glucose level stays within a specific range > 250 mg/dL | Posted | Median | Inter-Quartile Range | percentage of time during CGM use | Up to 30 days |
|
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Control | Patients with T2D in the control group, CGM data is blinded to all and only gathered for comparison purposes to intervention group. Real-time CGM data | 0 | 53 | 0 | 53 | 0 | 53 |
| EG002 | Observational T1D | For type 1 patients in the observational group, real-time CGM data was collected. | 0 | 47 | 0 | 47 | 0 | 47 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|