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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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This study aims to compare inpatient glycemic control by measuring the percentage of time in the range of 70-180 mg/dl and the frequency of hypoglycemia between Dexcom G7 Continuous Glucose Monitoring (CGM) and Point of Care (POC) Blood Glucose Testing in poorly controlled subjects with Type 1 Diabetes Mellitus.
The main question it aims to answer is:
-Whether there is a difference between POC testing (standard of care) and Real-time CGM in glycemic control and hypoglycemic events during hospitalization:
The CDC reports that 1.6 million U.S. adults (5.7%) have type 1 diabetes (T1D), with hospitalization rates three times higher than the general population, primarily due to diabetes-related complications such as ketoacidosis and cardiovascular disease. A study at Emory University found that hospitalized T1D patients are younger, experience longer stays and more admissions, and face worse glycemic control and higher rates of hypoglycemia compared to type 2 diabetes (T2D) patients.
Point-of-care (POC) capillary glucose testing is the standard for monitoring hospitalized diabetes patients, but continuous glucose monitoring (CGM) offers more detailed glycemic profiles. Research, including trials using Dexcom CGM systems, has demonstrated CGM's superior ability to detect hypo- and hyperglycemia, reduce hypoglycemic events, and improve insulin therapy adjustments in T2D patients. However, no randomized controlled studies have evaluated the best glucose monitoring system for hospitalized T1D patients.
The proposed study aims to compare POC testing with Dexcom G7 CGM for guiding insulin therapy in hospitalized T1D patients. Researchers hypothesize that CGM will better prevent hypoglycemia and improve glycemic management during hospital stays, addressing a critical gap in evidence regarding glucose control's impact on T1D hospital outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) with intravenous or subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG < 400 mg/dl). Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded to the electronic medical record (EMR) system. The research team, together with the Primary care (PCP) team, will adjust daily insulin orders based on POC readings (standard of care). In addition, subjects will wear a 'blinded' CGM (no results will be visualized by patients, nursing staff, medicine, or research teams) during hospitalization for up to 10 days. |
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| Dexcom CGM | Experimental | Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) intravenously with subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG < 400 mg/dl). Subjects will wear a real-time Dexcom G7 CGM for up to 10 days. Insulin therapy will be titrated based on daily CGM reports, including mean glucose, glycemic excursions, hypoglycemia, and severe hyperglycemia > 180 and >250 mg/dl values. Participants will wear a Dexcom rtCGM for up to 10 days during hospitalization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G7 rtCGM | Device | The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a glucose monitoring system that continuously measures glucose in the interstitial fluid. It aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control | The total difference in blood sugar levels between the POC testing (standard of care) group and the rtCGM group throughout the hospitalization | Through study completion (Day 10 or the length of admission) |
| Clinically significant hypoglycemia <54 mg/dl | The difference between blood sugar levels in POC testing (standard of care) group and rtCGM group during hospitalization | Through study completion (Day 10 or the length of admission) |
| Measure | Description | Time Frame |
|---|---|---|
| Time above range | % time above Target Above range (TAR). Differences between the both groups will be calculated. (TAR, >250 mg/dl) | Through study completion (Day 10 or the length of admission) |
| Time below range |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant hypoglycemia | Number of clinically significant hypoglycemic episodes: <54 mg/dl | Through study completion (Day 10 or the length of admission) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Umpierrez, MD | Contact | 404-778-1665 | geumpie@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Recruiting | Atlanta | Georgia | 30303 | United States |
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Research design Adult subjects with T1D admitted to non-ICU medicine and surgery units and receiving insulin therapy will be randomized to either standard POC testing or Dexcom G7 CGM to guide insulin dose adjustments, with the POC group wearing a blinded CGM and the CGM group having insulin adjustments based on daily glucose profiles.
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| Capillary Blood glucose Testing (POC) | Diagnostic Test | POC glucose meters measure whole blood and convert the results to plasma glucose concentrations, which is the standardized form used in clinical practice. |
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% time in Below Target range (TBR). Differences between the both groups will be calculated.
Differences between the both groups will be calculated. (TBR, < 70 and 54 mg/dl)
| Through study completion (Day 10 or the length of admission) |
| Glycemic Variability [% Coefficient of Variation (%CV) | % coefficient of variation will be measured during the intervention phase, compared to control, as measured by CGM. | Through study completion (Day 10 or the length of admission) |
| Hypoglycemic events | Number of hypoglycemia events < 70 and 54 mg/dl | Through study completion (Day 10 or the length of admission) |
| Hyperglycemic events | Number of hypoglycemia events >250 mg/dl | Through study completion (Day 10 or the length of admission) |
| Nocturnal hypoglycemia | Number of hypoglycemic events (<70 and <54 mg/dl) between 22:00 and 06:00 | Through study completion (Day 10 or the length of admission) |
| Prolonged hypoglycemia | Number of events of Prolonged hypoglycemia < 70 mg/dl for more than 2 hours by CGM | Through study completion (Day 10 or the length of admission) |
| Hospital Complications | Hospital complications include a composite of acute kidney injury (doubling of serum creatinine >0.5 mg/dl from baseline), cardiovascular events, infections, and death | Through study completion (Day 10 or the length of admission) |
| Recurrent hypoglycemia | Number of recurrent hypoglycemic episodes (< 70 mg/dl) | Through study completion (Day 10 or the length of admission) |
| Recurrent hyperglycemia | Number of recurrent hyperglycemic episodes (>250 mg/dl) | Through study completion (Day 10 or the length of admission) |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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