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

Animas Corporation13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

Hypoglycemia-Hyperglycemia Minimizer SystemDEVICE

Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Outcomes

Primary Outcomes

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.

Time frame: End of Study - in approximately 5 months from first subject enrolled

Secondary Outcomes

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

Time frame: End of Study - in approximately 5 months from first subject enrolled

Data from ClinicalTrials.gov

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