Status:
COMPLETED
Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility
Lead Sponsor:
Emory University
Collaborating Sponsors:
Insulet Corporation
Jaeb Center for Health Research
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 d...
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 d...
Eligibility Criteria
Inclusion
- Patients ≥18 years of age with insulin-treated T1 or Type 2 diabetes mellitus (T2DM) admitted to general (non-intensive care) medical-surgical hospital service requiring inpatient insulin therapy.
Exclusion
- 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)
- Coronavirus Disease 2019 (COVID-19) infection or person under investigation (PUI) on isolation precautions
Key Trial Info
Start Date :
June 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04714216
Start Date
June 29 2021
End Date
August 11 2022
Last Update
April 23 2024
Active Locations (3)
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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