Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility

NCT04714216 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00001835
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus

Keywords

Automated insulin delivery; Hybrid closed-loop system; Inpatient insulin therapy

Outcome Measures

Primary Outcomes (2)

• Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria

  The percentage of time spent in HCL after CGM sensor met initial validation criteria of sensor glucose value being within ±20% of point of care (POC) values (for glucose levels ≥70 mg/dL) or ±20 mg/dL for POC glucose values \<70 mg/dL.

  Up to 10 days (or hospital discharge if before 10 days)

• Percentage of Time Sensor Glucose is Within Target Glucose Range

  The percentage of time that the sensor glucose measurement is within the target glucose range of 70-180 mg/dL.

  Up to 10 days (or hospital discharge if before 10 days)

Secondary Outcomes (26)

• Time From Enrollment to Start of HCL Therapy (After Initial CGM Validation)

  Up to 10 days (or hospital discharge if before 10 days)

• Percentage of Time With CGM Readings

  Up to 10 days (or hospital discharge if before 10 days)

• Percentage of CGM Values Meeting Accuracy Criteria for Bolus/Correction Insulin Dosing

  Up to 10 days (or hospital discharge if before 10 days)

• Percentage of CGM Readings Within %15/15 of POC Readings and Within %20/20 of POC Readings With the Cut Point at 70 mg/dL

  Up to 10 days (or hospital discharge if before 10 days)

• Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient

  Up to 10 days (or hospital discharge if before 10 days)

Study Arms (1)

Hybrid closed-loop (HCL) automated insulin delivery (AID)

EXPERIMENTAL

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

Interventions

The Omnipod 5/Horizon HCL system DEVICE

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.

Hybrid closed-loop (HCL) automated insulin delivery (AID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Insulet Corporation: collaborator
• Jaeb Center for Health Research: collaborator

Study Sites (3)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Grady Health System (non-CRN)

Atlanta, Georgia, 30322, United States

Location

University of Virginia School of Medicine

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Francisco J. Pasquel
• Organization: Emory University

fpasque@emory.edu

404-778-1695

Study Officials

• Francisco Pasquel, M.D., M.P.H

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: June 29, 2021
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)