Clinical trial NCT04714216: Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility
Official title: Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Automated insulin delivery
Hybrid closed-loop system
Inpatient insulin therapy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Insulet Corporation
name: Jaeb Center for Health Research
First posted: 2021-01-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Percentage of Time Sensor Glucose is Within Target Glucose Range
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
Secondary outcomes:
measure: Time From Enrollment to Start of HCL Therapy (After Initial CGM Validation)
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Percentage of Time With CGM Readings
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Percentage of CGM Values Meeting Accuracy Criteria for Bolus/Correction Insulin Dosing
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: 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
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient-day
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Number Clinically Important Hypoglycemic (<54 mg/dL) Episodes Per Patient
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Percent Time Below Range (TBR) of <70mg/dL
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Percent Time Below Range (TBR) of <54 mg/dL
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Percent Time Above Range (TAR) of >180 mg/dL
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Percent Time in Severe Hyperglycemia (>250 mg/dL)
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Frequency of Setting Overall Adjustments for Clinically-important Hypoglycemia (<54 mg/dL)
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Basal Rate
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Carb Ratio (ICR)
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Sensitivity Factor (ISF)
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Frequency of Setting Overall Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour)
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to Basal Rate
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ICR
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Frequency of Setting Adjustments for Prolonged Hyperglycemia (>250 mg/dL for >1 Hour) to ISF
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Total Daily Insulin (TDI)
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Total Daily Basal Insulin (TBI)
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Total Daily Bolus Meal/Correction
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Number of Hypoglycemic Events That Required Assistance of Another Person
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Number of Diabetic Ketoacidosis Events
timeFrame: Up to 10 days (or hospital discharge if before 10 days)
measure: Patient Acceptability of HCL System
timeFrame: At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)
measure: Patient Perceptions of HCL System Use
timeFrame: At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Atlanta
country: United States
facility: Grady Health System (non-CRN)
state: Georgia
city: Charlottesville
country: United States
facility: University of Virginia School of Medicine
state: Virginia
Study officials:
affiliation: Emory University
name: Francisco Pasquel, M.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
References: