Inpatient Closed-loop Glucose Control

Study Overview
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Brief Summary
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The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.

Detailed Description
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The goal of this first-in-man trial is to test the safety and efficacy of the automated, closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin sensitive subjects with type 2 diabetes (TTD > 1u/kg/day), and subjects with type 2 diabetes and substantial insulin resistance (<2 u/kg/day). The results of this study will help to design future studies, exploring the use of the closed-loop system for BG control in hospitalized patients, including those with diabetes or hyperglycemia of critical illness.

Official Title
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Subcutaneous Continuous Glucose Monitoring and Intravenous Dosing of Insulin and Dextrose for Automated Glycemic Control in the Inpatient Setting

Conditions
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Diabetes Mellitus, Hyperglycemia

Intervention / Treatment
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* Device: Closed-loop blood glucose control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects with type 1 diabetes Age 21 to 75 with clinical type 1 diabetes for at least one year Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins Total daily dose (TDD) of insulin that is < 1 u/kg Subjects with type 2 diabetes Age 21 to 75 with clinical type 2 diabetes for at least one year Diabetes managed using NPH as the basal insulin, which may be supplemented with regular or rapid-acting insulin Total daily dose (TDD) of insulin that is > 1 u/kg/day but < 2 u/kg/day or > 2 u/kg/day Exclusion Criteria: Pregnancy Renal insufficiency Cancer Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia Acute illness or exacerbation of chronic illness at the time of the study procedure Use of non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications other than metformin History of allergy or adverse reaction to aspirin, peptic ulcers or bleeding disorders Known history of coronary artery disease, TIA or stroke History of seizures Transaminitis Stage 2 hypertension at the time of screening

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed-loop blood glucose control<br>Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is > 1 u/kg or > 2 u/kg. | Device: Closed-loop blood glucose control<br>* The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg).<br>* Other names: InPatient Closed-Loop Blood Glucose Control Device.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. |  | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol |  | 12 hours | 
| Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements |  | 12 hours | 
| Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl |  | 12 hours | 
| Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm |  | 12 hours | 
| Number of BG Events < 70 mg/dl as Determined by the CGM |  | 12 hours | 
| Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl |  | 12 hours | 
| Insulin Dosing (u/kg) |  | 12 hours | 
| Dextrose Dosing (g/kg) |  | 12 hours | 
| Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard. | The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closed-loop blood glucose control, Continuous glucose monitoring, Bionic pancreas, Artificial pancreas