United Kingdom User Evaluation, MiniMed Paradigm® X54 System (X54User)

Medtronic

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 1

Treatments

Device: X54 insulin pump with low suspend feature

Study type

Interventional

Funder types

Industry

Identifiers

NCT01267175

ETP08-2625

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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;
Have an HbA1c value less than 9.0% recorded at the time of their last test (if no HbA1c value is available within three months of enrollment, an HbA1c should be performed prior to entry to verify inclusion criteria);
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 If a woman becomes pregnant during participation, she will be withdrawn;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).