Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility

March 26, 2024 updated by: Francisco Pasquel, Emory University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 floor with 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Francisco Pasquel, M.D., M.P.H
  • Phone Number: 4047781695
  • Email: fpasque@emory.edu

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Grady Health System (non-CRN)
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
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
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time From Enrollment to Start of HCL Therapy (After Initial CGM Validation)
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The time from enrollment to start of HCL therapy, after initial CGM validation, was recorded.
Up to 10 days (or hospital discharge if before 10 days)
Percentage of Time With CGM Readings
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The percentage of time during study participation with CGM readings was calculated.
Up to 10 days (or hospital discharge if before 10 days)
Percentage of CGM Values Meeting Accuracy Criteria for Bolus/Correction Insulin Dosing
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The percentage of CGM values meeting accuracy criteria for bolus/correction insulin dosing was calculated.
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
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The percentage of CGM values within 15% or 15 mg/dL (%15/15) and within 20% or 20 mg/dL (%20/20) of POC reference values for blood glucose, using a cut point at 70 mg/dL. The reference values are derived from a total of 597 paired CGM and reference capillary glucose values.
Up to 10 days (or hospital discharge if before 10 days)
Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The number of hypoglycemic (<70 mg/dL) episodes per patient.
Up to 10 days (or hospital discharge if before 10 days)
Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient-day
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The number of hypoglycemic (<70 mg/dL) episodes per patient-day in hospital.
Up to 10 days (or hospital discharge if before 10 days)
Number Clinically Important Hypoglycemic (<54 mg/dL) Episodes Per Patient
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The number clinically important hypoglycemic (<54 mg/dL) episodes per patient.
Up to 10 days (or hospital discharge if before 10 days)
Percent Time Below Range (TBR) of <70mg/dL
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The percent time below range (TBR), defined as blood glucose <70mg/dL.
Up to 10 days (or hospital discharge if before 10 days)
Percent Time Below Range (TBR) of <54 mg/dL
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The percentage of time below range (TBR) of <54 mg/dL.
Up to 10 days (or hospital discharge if before 10 days)
Percent Time Above Range (TAR) of >180 mg/dL
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The percentage of time above range (TAR) of >180 mg/dL.
Up to 10 days (or hospital discharge if before 10 days)
Percent Time in Severe Hyperglycemia (>250 mg/dL)
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The percentage of time in severe hyperglycemia, defined as >250 mg/dL.
Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Overall Adjustments for Clinically-important Hypoglycemia (<54 mg/dL)
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The frequency of setting adjustments across all participants for clinically-important hypoglycemia, defined as <54 mg/dL.
Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Basal Rate
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The frequency of setting adjustments across all participants for clinically-important hypoglycemia (<54 mg/dL) to basal rate.
Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Carb Ratio (ICR)
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The frequency of setting adjustments across all participants for clinically-important hypoglycemia (<54 mg/dL) to insulin carb ratio (ICR).
Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Sensitivity Factor (ISF)
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The frequency of setting adjustments across all participants for clinically-important hypoglycemia (<54 mg/dL) to insulin sensitivity factor (ISF).
Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Overall Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour)
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The frequency of setting adjustments across all participants for prolonged hyperglycemia, defined as blood glucose >250 mg/dL for over one hour.
Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to Basal Rate
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The frequency of setting adjustments across all participants for prolonged hyperglycemia, defined as blood glucose >250 mg/dL for over one hour, to basal rate.
Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ICR
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The frequency of setting adjustments across all participants for prolonged hyperglycemia, defined as >250 mg/dL for over one hour, to ICR.
Up to 10 days (or hospital discharge if before 10 days)
Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ISF
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The frequency of setting adjustments across all participants for prolonged hyperglycemia, defined as blood glucose >250 mg/dL for over one hour, to ISF.
Up to 10 days (or hospital discharge if before 10 days)
Total Daily Insulin (TDI)
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The total daily insulin (TDI) was calculated.
Up to 10 days (or hospital discharge if before 10 days)
Total Daily Basal Insulin (TBI)
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The total daily basal insulin (TBI) was calculated.
Up to 10 days (or hospital discharge if before 10 days)
Total Daily Bolus Meal/Correction
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The total daily bolus meal/correction was recorded
Up to 10 days (or hospital discharge if before 10 days)
Number of Hypoglycemic Events That Required Assistance of Another Person
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The number of hypoglycemic events across all participants that required assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions.
Up to 10 days (or hospital discharge if before 10 days)
Number of Diabetic Ketoacidosis Events
Time Frame: Up to 10 days (or hospital discharge if before 10 days)
The number of diabetic ketoacidosis (DKA) events across all participants.
Up to 10 days (or hospital discharge if before 10 days)
Patient Acceptability of HCL System
Time Frame: At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)
To assesses acceptability of the HCL system participants responded to the statement "Overall, I liked using the Omnipod 5/Horizon system to treat my blood sugar in the hospital" with five (5) options to choose from: Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, and Strongly Disagree. The responses were not assigned a score, rather the number of participants for each response were examined.
At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)
Patient Perceptions of HCL System Use
Time Frame: At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)
Participants were asked to provide their perceptions of the HCL system with four questions that were responded to with "Yes" or "No". Responses are assigned a score and a summary score is not calculated, rather the number of participants responding "Yes" or "No" to each of the individual questions is examined.
At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jaeb Center for Health Research
Insulet Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francisco Pasquel, M.D., M.P.H, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00001835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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