Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility
NCT ID: NCT04714216
Last Updated: 2024-04-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2021-06-29
2022-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
* Coronavirus Disease 2019 (COVID-19) infection or person under investigation (PUI) on isolation precautions
18 Years
ALL
No
Sponsors
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Insulet Corporation
INDUSTRY
Jaeb Center for Health Research
OTHER
Emory University
OTHER
Responsible Party
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Francisco Pasquel
Associate Professor
Principal Investigators
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Francisco Pasquel, M.D., M.P.H
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Grady Health System (non-CRN)
Atlanta, Georgia, United States
University of Virginia School of Medicine
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY00001835
Identifier Type: -
Identifier Source: org_study_id
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