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Completed

NCT Number: NCT04714216

Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine, Stanford, California, United States

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About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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).

  15. 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).

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. Total Daily Insulin (TDI)

    Time frame: Up to 10 days (or hospital discharge if before 10 days)

    The total daily insulin (TDI) was calculated.

  21. 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.

  22. 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

  23. 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.

  24. 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.

  25. 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.

  26. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Insulet Corporation
  • Jaeb Center for Health Research

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 19, 2021
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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