Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Percentage of Time Sensor Glucose is Within Target Glucose Range
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Percentage of Time Sensor Glucose is Within Target Glucose Range
时间窗: 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.
Percentage of Time Spent in HCL After CGM Sensor Meets Initial Validation Criteria
时间窗: 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.
次要结局
- 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(Up to 10 days (or hospital discharge if before 10 days))
- Percent 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)(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))
- Frequency of Setting Adjustments for Clinically-important Hypoglycemia (<54 mg/dL) to Insulin Carb Ratio (ICR)(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))
- 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 CGM Values Meeting Accuracy Criteria for Bolus/Correction Insulin Dosing(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))
- Number of Hypoglycemic (<70 mg/dL) Episodes Per Patient-day(Up to 10 days (or hospital discharge if before 10 days))
- Frequency of Setting Overall Adjustments for Clinically-important Hypoglycemia (<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(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(Up to 10 days (or hospital discharge if before 10 days))
- Percent Time Below Range (TBR) of <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 Insulin Sensitivity Factor (ISF)(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(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(Up to 10 days (or hospital discharge if before 10 days))
- Number of Diabetic Ketoacidosis Events(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)(Up to 10 days (or hospital discharge if before 10 days))
- Total Daily Insulin (TDI)(Up to 10 days (or hospital discharge if before 10 days))
- Total Daily Basal Insulin (TBI)(Up to 10 days (or hospital discharge if before 10 days))
- Patient Perceptions of HCL System Use(At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days))
- Total Daily Bolus Meal/Correction(Up to 10 days (or hospital discharge if before 10 days))
- Number of Hypoglycemic Events That Required Assistance of Another Person(Up to 10 days (or hospital discharge if before 10 days))
- Patient Acceptability of HCL System(At time of device discontinuation (up to 10 days of use or hospital discharge if before 10 days))
研究者
Francisco Pasquel
Associate Professor
Emory University