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Study Assessing an Insulin Pump-controlling Algorithm to Minimize Hypo and Hyper in Type 1 During CRC Setting

NCT ID: NCT01638299

Last Updated: 2012-09-21

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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 Mellitus

Keywords

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Type 1 Diabetes Mellitus Artificial Pancreas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypo-Hyper Minimizer (HHM) System

Group Type EXPERIMENTAL

Hypo-Hyper Minimizer (HHM) System

Intervention Type DEVICE

Adjustment of Insulin dosing during meal time

Interventions

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Hypo-Hyper Minimizer (HHM) System

Adjustment of Insulin dosing during meal time

Intervention Type DEVICE

Other Intervention Names

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Insulin delivery

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
* Histoey of severe hypoglycemia (Seizure, unconsciousnesss) 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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Henry Anhalt, DO

Role: STUDY_DIRECTOR

Animas Corporation

Locations

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Samsum Diabetes Reserach Inst.

Santa Barbara, California, United States

Site Status

UVA Diabetes Technology Center

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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3076823, V3.0

Identifier Type: -

Identifier Source: org_study_id