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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK138366-01 | U.S. NIH Grant/Contract | View source | |
| 2025P012163 | Other Identifier | Emory IRB |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This randomized controlled trial will test the efficacy and safety of automated insulin delivery (AID) in hospitalized patients with diabetes (type 1 or type 2) requiring insulin therapy who are admitted to general medical/surgical floors.
The main objectives of this study are:
Participants will be:
Annually, over 8 million people in the United States are hospitalized due to diabetes. Among these patients, those with uncontrolled diabetes are at a significantly heightened risk for poor hospital outcomes. However, achieving glycemic targets within hospital settings proves challenging, as doing so often increases the risk of iatrogenic hypoglycemia. This is exacerbated by the variable insulin therapy requirements that arise during acute illnesses, such as unpredictable nutrition intake, illness severity, and the effects of various medications. These fluctuations pose a substantial challenge for healthcare providers tasked with caring for patients with diabetes.
The usage of diabetes technology may offer an opportunity to improve inpatient diabetes care, but best practices are not yet defined. The COVID-19 pandemic has highlighted how accelerated use of technologies (e.g., telemedicine, e-consults, and remote monitoring) helps healthcare systems adapt care delivery while minimizing exposure risk. Following the non-objection by the US Food and Drug Administration (FDA) to the use of CGM in the hospital, the investigators and others implemented the usage of remote real-time CGM to treat patients with COVID-19. Initial clinical trials using remote real-time CGM have shown modest improvements in hypoglycemia detection and prevention and minimal or no increases in time spent in the target range (TIR) in non-ICU patients.
The use of AID with remote insulin delivery and remote glucose monitoring is novel for the inpatient setting. The use of AID allows for 288 automated insulin dosing alterations per day, which is infeasible for hospital staff and could help proactively compensate for the multitude of factors affecting insulin requirements in the hospital. Preliminary data from AID trials with a single European AID system (using an insulin pump with tubing) have shown improvements in glycemic control in diverse populations without increasing the risk of hypoglycemia. However, these trials have limited involvement of patient care teams and the feasibility of hospital implementation and adoption is unknown.
Using single-use insulin patch-pumps (without tubing) may offer a unique opportunity for hospital use of AID; however, no randomized controlled data on the use of AID in the hospital is available in the US. Results from our recently completed pilot study show that using AID with remote CGM is feasible in the hospital and appears to be associated with good glycemic control.
In addition to improving glycemic control, this approach will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | The control group will follow the hospital's usual practice for subcutaneous insulin for glucose control. It will be managed by the admitting team with the assistance of an inpatient endocrine team. Participants will wear a real-time CGM for 10 days or until hospital discharge (if <10 days) |
|
| Intervention | Experimental | Participants in the intervention arm will be assigned to the Omnipod 5 AID system with integrated Dexcom CGM. These devices will communicate with a patient-specific smartphone secured within the patient room and remotely monitored by the nursing station. Nursing staff on medical-surgical units will provide insulin therapy using the investigational device for participants randomized to the intervention arm, including delivering insulin boluses, monitoring CGM values and trends, validating CGM accuracy against POC glucose, and performing routine device exchanges (Pod or CGM) when indicated AID therapy will continue for 10 days or until hospital discharge (if <10 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AID system with Remote Real-Time CGM | Device | The Omnipod 5 AID System is comprised of two components:
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Time spent in glucose target range | This will be captured by the percentage of time spent in glucose target range (TIR 70-180 mg/dl); | Up to 10 days (or hospital discharge if before 10 days) |
| Safety: Time spent below the target glucose range | This will be captured by the percentage of time spent below glucose range (TBR <54 mg/dl). | Up to 10 days (or hospital discharge if before 10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| TAR >250mg/dl | Percentage of time spent above 250 mg/dl | Up to 10 days (or hospital discharge if before 10 days) |
| TBR <70 mg/dl | Percentage of time spent below range (TBR <70 mg/dl) |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent above 180 mg/dl | Percentage of time spent above the glucose levels of 180 mg/dl | Up to 10 days (or hospital discharge if before 10 days) |
| Time spent between 70-99 mg/dl | Percentage of time spent between the range of 70-99 mg/dl |
Inclusion Criteria:
• Any person ≥18 years of age with diabetes mellitus (except cystic fibrosis- and pregnancy-related) admitted to general (non-ICU) medical-surgical hospital services which require inpatient insulin therapy (i.e.,TID or T2D with ≥2 glucose values ≥180mg/dl)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Pasquel, M.D., M.P.H | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| Grady Health System (non-CRN) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2025 | Nov 13, 2025 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 4, 2025 | Nov 13, 2025 | ICF_001.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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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Standard of Care Insulin Therapy + CGM | Combination Product | This includes the usage of subcutaneous insulin for glucose control. Participants will wear a real-time Continuous Monitoring (CGM) for 10 days or until hospital discharge (if <10 days). Treatment decisions will be based on POC testing with consideration of daily evaluation of CGM patterns. |
|
|
| Up to 10 days (or hospital discharge if before 10 days) |
| Mean hospitalization glucose | This will be calculated as the mean of total glucose levels during the hospital stay. | Up to 10 days (or hospital discharge if before 10 days) |
| Up to 10 days (or hospital discharge if before 10 days) |
| Glycemic events above 300 mg/dl | Number of Glycemic events above 300 mg/dl will be captured | Up to 10 days (or hospital discharge if before 10 days) |
| Glycemic events below 54 mg/dl | Number of Glycemic events below 54 mg/dl will be captured | Up to 10 days (or hospital discharge if before 10 days) |
| Number of hypoglycemic episodes (Glucose <40 mg/dl) | defined as an event that required assistance of another person due to altered consciousness to actively administer parenteral carbohydrate, glucagon, or other resuscitative actions. This means that the participant was impaired cognitively to the point that the participant was unable to drink or eat oral carbs (e.g. juice, crackers), was incoherent, disoriented, and/or combative, or experienced seizure or coma. | Up to 10 days (or hospital discharge if before 10 days) |
| Number of Diabetes-related Ketoacidosis Events | The number of Diabetes-related ketoacidosis (DKA) events across all participants. | Up to 10 days (or hospital discharge if before 10 days) |
| Number of hyperosmolar hyperglycemic syndrome (HHS) events | The number of hyperosmolar hyperglycemic syndrome (HHS) events across all participants. | Up to 10 days (or hospital discharge if before 10 days) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Virginia School of Medicine | Charlottesville | Virginia | 22903 | United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |