United Kingdom User Evaluation, MiniMed Paradigm® X54 System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-02-28

Brief Summary

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The user evaluation is to assess user acceptance and the quality of training materials for the MiniMed Paradigm® X54 System (X54 System) in preparation for commercial distribution of the new system.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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X54 pump

All subjects transferred from current pump to X54

Group Type EXPERIMENTAL

X54 insulin pump with low suspend feature

Intervention Type DEVICE

Change from current insulin pump to new X54 pump

Interventions

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X54 insulin pump with low suspend feature

Change from current insulin pump to new X54 pump

Intervention Type DEVICE

Other Intervention Names

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Veo

Eligibility Criteria

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Inclusion Criteria

* Are current 512/712, 515/715 or 522/722 MiniMed Paradigm Insulin Pump users, with or without CGM experience, and have at least three months experience with any one of these devices;
* Have signed an Informed Consent and are willing to comply with the user evaluation procedures;
* Are willing to use the Bolus Wizard feature;
* Agree to complete a diary for the duration of the study;
* Agree to complete a questionnaire at the conclusion of the study;
* Have been diagnosed with Type 1 Diabetes Mellitus by appropriate fasting or non fasting lab blood glucose values, c-peptide, insulin antibodies, prior documented DKA or good clinical picture at least six months prior to study start;
* Are 18 - 65 years of age;
* Have access to the internet and agree to upload the device per protocol

Exclusion Criteria

* Is pregnant or planning to become pregnant during the course of the user evaluation. Pregnancy screening will be completed during the routine office visit prior to evaluation for the study. If a woman becomes pregnant during participation, she will be withdrawn;
* Suffers from a chronic debilitating condition;
* Has serious or unstable medical or psychological conditions (e.g., eating disorders, clinical depression, anxiety disorder) which, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study;
* Has impaired vision or hearing problems that could compromise the handling of the device;
* Has a history of tape allergies or skin conditions that could interfere with continued use of the system;
* Has the potential for lack of compliance or any other issue, in the opinion of the Investigator, that may preclude the subject from satisfactory participation in the study;
* Has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled;
* Is currently participating in an investigational study (drug or device).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No