Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility

Trial ID or NCT#

NCT04714216

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility Study

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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 Criteria:
  1. * 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
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Investigator(s)

Michael Samuel Hughes
Instructor, Medicine - Endocrinology, Gerontology, & Metabolism Masters Student in Clinical Informatics Management, admitted Summer 2024

View on ClinicalTrials.gov