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

NCT ID: NCT01919385

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-09-30

Brief Summary

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

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

Conditions

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Type 1 Diabetes

Keywords

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Type 1 diabetes Insulin Pump

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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type 1 diabetes

Predictive Low Glucose Minimizer (PLGM) System

Group Type EXPERIMENTAL

Predictive Low Glucose Minimizer

Intervention Type DEVICE

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.

Interventions

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Predictive Low Glucose Minimizer

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.

Intervention Type DEVICE

Other Intervention Names

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type 1 diabetes

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Animas Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Zisser, MD

Role: PRINCIPAL_INVESTIGATOR

Samsum Diabetes Reserach Inst.

Locations

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Samsum Diabetes Reserach Inst.

Santa Barbara, California, United States

Site Status

Countries

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United States

References

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Finan DA, Dassau E, Breton MD, Patek SD, McCann TW Jr, Kovatchev BP, Doyle FJ 3rd, Levy BL, Venugopalan R. Sensitivity of the Predictive Hypoglycemia Minimizer System to the Algorithm Aggressiveness Factor. J Diabetes Sci Technol. 2015 Jun 30;10(1):104-10. doi: 10.1177/1932296815593292.

Reference Type DERIVED
PMID: 26134834 (View on PubMed)

Other Identifiers

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3108873,

Identifier Type: -

Identifier Source: org_study_id