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

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Hypoglycemia-Hyperglycemia Minimizer System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01401751

3076823

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Single Arm

Other group

Description:

non-randomized, uncontrolled, feasibility study

Treatment:

Device: Hypoglycemia-Hyperglycemia Minimizer System