Insulin Balanced Infusion System

Study Overview
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Brief Summary
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The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; study to develop a closed loop for use in intensive care units and surgery

Detailed Description
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The study is using an experimental design outpatient with individuals having treatment using an automated closed loop glucose control unit; glucoses are measured every 5 minutes using a intravenous glucose sensor and infusion of glucose and insulin are altered without manual intervention as directed by algorithm

Official Title
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Insulin Balanced Infusion System Control of Glucose

Conditions
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Hyperglycemia, Diabetes

Intervention / Treatment
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* Device: glucose and insulin infusions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 1 or type 2 diabetic individuals on insulin ages 21-85 with A1c 7-9.9% glucose at time of study > 150 mg/dl Exclusion Criteria: pregnancy renal or hepatic disease corticosteroids poor intravenous access anemia electrolyte abnormality

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 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
Interventional Model Description: Insulin and glucose infusion in closed loop control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin and glucose infusion<br>trial of experimental technique in outpatient setting; the group under study will be comprised of type 1 and type 2 diabetic individuals ; they will have automated treatment using algorithm which regulates balancing infusions of glucose and/or insulin intravenously without manual intervention; blood glucose target of 80-180 mg/dl will be guide for the automated system | Device: glucose and insulin infusions<br>* combined algorithm directed glucose and insulin infusion with 5 minute blood glucose measurements to direct glucose control; regular insulin and glucose are infused intravenously as adjusted by the algorithm without manual intervention in the group of diabetic individuals under study to adjust the glucose level to a target range of 80-180 mg/dl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose control in target range | blood glucose measurements in target range (80-125 mg/dl) | data will be evaluated within 6 months after completion of all 40 studies | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoglycemia | blood glucose <70 mg/dl | data will be evaluated within 6 months after all 40 studies are completed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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closed loop glucose control, intensive care glucose control