Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.

Detailed Description
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This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 24 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results. Total subject participation approximately 1 week for screening to completion. This includes approximately 24 hours usage of the investigation device in the clinical research center under close medical supervision.

Official Title
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Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Hypoglycemia-Hyperglycemia Minimizer System


Participation Criteria
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Eligibility Criteria
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Summary of Key inclusion/exclusion criteria: Inclusion Criteria: Age 21-65 years Type 1 diabetes mellitus for at least one year Using an insulin infusion pump for at least the past 6 months Exclusion Criteria: Pregnancy History of diabetic ketoacidosis (DKA) in the past six months History of severe hypoglycemia (seizure, unconsciousness) in the past 6 months Other Inclusion/Exclusion criteria apply. Please contact clinical study site for complete details.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>non-randomized, uncontrolled, feasibility study | Device: Hypoglycemia-Hyperglycemia Minimizer System<br>* Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting. | Measuring the response of the investigational device, including insulin delivery dosing changes in response to glucose changes. Also, the ability of the system to mitigate Hypoglycemia. | End of Study - in approximately 5 months from first subject enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evaluation | Measuring the following: the number and type of adverse events, including Adverse device effects, Serious Adverse Events, Unanticipated Adverse Device Effects, device malfunctions Resulting glucose data from 24 hour clinical research center visit | End of Study - in approximately 5 months from first subject enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes Mellitus, Artificial Pancreas