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

Animas

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes

Treatments: Device: Predictive Low Glucose Minimizer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01919385

3108873,

Details and patient eligibility

About

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

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

Enrollment: 12 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

type 1 diabetes

Experimental group

Description:

Predictive Low Glucose Minimizer (PLGM) System

Treatment:

Device: Predictive Low Glucose Minimizer