Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility
Study Details
Study Description
Brief Summary
This single-arm stepwise feasibility study will test initial deployment of hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This single-arm stepwise feasibility study will test initial deployment of hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities to hospitalized patients admitted to the general medical/surgical floorwith diabetes (type 1 or type 2) requiring insulin therapy. All enrolled participants will be placed on HCL insulin therapy for 10 days or until hospital discharge (if less than 10 days) to determine functional operability of the system and its effect on glycemic control in the hospital setting. This study will generate preliminary data to inform the design of a large multi-institution randomized controlled trial to assess superiority of HCL compared to standard inpatient insulin therapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hybrid closed-loop (HCL) automated insulin delivery (AID) Hybrid closed-loop (HCL) automated insulin delivery (AID) using the Omnipod 5/Horizon HCL system with remote monitoring and device operation capabilities will be deployed to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy. |
Device: The Omnipod 5/Horizon HCL system
The Omnipod 5/Horizon HCL system, consists of a disposable insulin infusion pump (or "pod"), a built-in model predictive control (MPC) insulin dosing algorithm, and a remote Personal Diabetes Manager (PDM) interface, that interact with a Dexcom G6 continuous glucose monitor (CGM) to automatically control insulin delivery based upon real-time glucose values. The PDM component also enables remote interaction with the system, including glucose monitoring as well as insulin dosing management and adjustments.
|
Outcome Measures
Primary Outcome Measures
- Proportion of time spent in HCL after CGM sensor meets initial validation criteria [Until hospital discharge (up to 10 days )]
Proportion of time spent in HCL after CGM sensor meets initial validation criteria [sensor glucose value is within ±20% of POC values (for glucose levels ≥70 mg/dL) or ±20 mg/dL for POC glucose values <70 mg/dL].
- Percentage of time sensor glucose is within target glucose range [Until hospital discharge (up to 10 days )]
Percentage of time sensor glucose is within target glucose range [time-in-range (TIR)], defined as 70-180 mg/dL.
Secondary Outcome Measures
- Time from enrollment to start of HCL therapy (after initial CGM validation) [Until hospital discharge (up to 10 days )]
Time from enrollment to start of HCL therapy (after initial CGM validation) will be recorded
- Percentage of time with CGM readings [Until hospital discharge (up to 10 days )]
Percentage of time with CGM readings will be calculated
- Percentage of CGM values meeting accuracy criteria for bolus/correction insulin dosing [Until hospital discharge (up to 10 days )]
Percentage of CGM values meeting accuracy criteria for bolus/correction insulin dosing will be calculated
- Number of CGM readings within %15/15 of POC readings and within %20/20 of POC readings with the cut point at 70 mg/dL [Until hospital discharge (up to 10 days )]
Number of CGM readings within %15/15 of POC readings and within %20/20 of POC readings with the cut point at 70 mg/dL will be recorded
- Number of hypoglycemic (<70 mg/dL) episodes per patient [Until hospital discharge (up to 10 days )]
Number of hypoglycemic (<70 mg/dL) episodes per patient will be recorded
- Number clinically important hypoglycemic (<54 mg/dL) episodes per patient [Until hospital discharge (up to 10 days )]
Number clinically important hypoglycemic (<54 mg/dL) episodes per patient will recorded
- Percent time below range (TBR, <70mg/dL) [Until hospital discharge (up to 10 days )]
Percent time below range (TBR, <70mg/dL) will be recorded
- Percent time below range (<54 mg/dL) [Until hospital discharge (up to 10 days )]
Percent time below range (<54 mg/dL) will be recorded
- Percent time above range (TAR, >180 mg/dL) [Until hospital discharge (up to 10 days )]
Percent time above range (TAR, >180 mg/dL) will be recoreded
- Percent time in severe hyperglycemia (>250 mg/dL) [Until hospital discharge (up to 10 days )]
Percent time in severe hyperglycemia (>250 mg/dL) will be recorded
- Frequency of setting overall adjustments for clinically-important hypoglycemia (<54 mg/dL) [Until hospital discharge (up to 10 days )]
Frequency of setting overall adjustments for clinically-important hypoglycemia (<54 mg/dL) will be recorded
- Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL)to basal rate [Until hospital discharge (up to 10 days )]
Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL)to basal rate will be recorded
- Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL) to insulin carb ratio (ICR) [Until hospital discharge (up to 10 days )]
Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL) to insulin carb ratio (ICR) will be recorded
- Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL)to insulin sensitivity factor (ISF) [Until hospital discharge (up to 10 days )]
Frequency of setting adjustments for clinically-important hypoglycemia (<54 mg/dL)to insulin sensitivity factor (ISF) will be recorded
- Frequency of setting overall adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) [Until hospital discharge (up to 10 days )]
Frequency of setting overall adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) will be recorded
- Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to basal rate [Until hospital discharge (up to 10 days )]
Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to basal rate will be recorded
- Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to ICR [Until hospital discharge (up to 10 days )]
Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to ICR will be recorded
- Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to ISF [Until hospital discharge (up to 10 days )]
Frequency of setting adjustments for prolonged hyperglycemia (>250 mg/dL for >1 hour) to ISF will be recorded
- Total daily insulin (TDI) [Until hospital discharge (up to 10 days )]
Total daily insulin (TDI) will be calculated
- Total daily basal insulin (TBI) [Until hospital discharge (up to 10 days )]
Total daily basal insulin (TBI) will be calculated
- Total daily bolus meal/correction [Until hospital discharge (up to 10 days )]
Total daily bolus meal/correction will be recorded
- Number of hypoglycemic events that required assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions [Until hospital discharge (up to 10 days )]
Number of hypoglycemic events that required assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions will be recorded
- Number of Diabetic ketoacidosis events [Until hospital discharge (up to 10 days )]
Number of Diabetic ketoacidosis events will be recorded
- Patient Survey [Until hospital discharge (up to 10 days )]
Patient survey on HCL system use
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients ≥18 years of age with insulin-treated T1 or T2DM admitted to general (non-intensive care) medical-surgical hospital service requiring inpatient insulin therapy.
Exclusion Criteria:
-
Patients admitted the ICU or anticipated to require ICU transfer
-
Anticipated length of hospital stay <48 hours.
-
Evidence of hyperglycemic crises (diabetic ketoacidosis or hyperosmolar hyperglycemic state) at enrollment
-
Severely impaired renal function (eGFR < 30 ml/min/1.73m2) or clinically significant liver failure
-
Severe anemia with hemoglobin <7 g/dL
-
Evidence of hemodynamic instability
-
Hypoxia (SpO2 <95% on supplemental oxygen)
-
Pre-admission or inpatient total daily insulin dose >100 units
-
Mental condition rendering the participant unable to consent or answer questionnaires
-
Pregnant or breast feeding at time of enrollment
-
Unable or unwilling to use rapid-acting insulin analogs (Humalog, Admelog, Novolog or Apidra) during the study
-
Use of hydroxyurea or high-dose ascorbic acid (>1g/day)
-
COVID-19 infection or person under investigation (PUI) on isolation precautions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University School of Medicine | Stanford | California | United States | 94305 |
| 2 | Grady Health System (non-CRN) | Atlanta | Georgia | United States | 30322 |
| 3 | University of Virginia School of Medicine | Charlottesville | Virginia | United States | 22903 |
Sponsors and Collaborators
- Emory University
- Insulet Corporation
- Jaeb Center for Health Research
Investigators
- Principal Investigator: Francisco Pasquel, M.D., M.P.H, Emory University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00001835