Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia

Phase 1CompletedNCT01919385

Animas Corporation12 enrolled

Overview

This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.

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 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Predictive Low Glucose MinimizerDEVICE

This study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Age 21-65 years * Type 1 diabetes mellitus for at least one year * Currently 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

Locations (1)

Samsum Diabetes Reserach Inst.

Santa Barbara, California, United States

Outcomes

Primary Outcomes

Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting

Evaluating the ability of the system to predict a fall or rise in glucose values below or above a low glucose threshold, and take the corresponding appropriate action of reducing or suspending insulin delivery in order to keep the subject's glucose above this threshold, or resuming insulin delivery at the current basal rate upon the increase of glucose above this threshold. Ability of the system to issue timely and accurate warnings.

Time frame: 1 week after subject is enrolled in the study

Secondary Outcomes

Capturing the number of Adverse Events as a measure of assessing subject safety

Understand the System's ability to safely keep the subject glucose levels within designated threshold. The subject and the device will be continuously monitored by the Principle Investigator and Algorithm Engineer to ensure proper function of the device and subject safety. All Adverse Events will be captured on the CRF.

Time frame: 1 week after subject is enrolled in the study

Data from ClinicalTrials.gov

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