United Kingdom User Evaluation, MiniMed Paradigm® X54 System

Study Overview
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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.

Official Title
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United Kingdom User Evaluation, MiniMed Paradigm® X54 System

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: X54 insulin pump with low suspend feature


Participation Criteria
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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; 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 If a woman becomes pregnant during participation, she will be withdrawn; Suffers from a chronic debilitating condition; Has serious or unstable medical or psychological conditions (e.g., eating disorders, clinical depression,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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: X54 pump<br>All subjects transferred from current pump to X54 | Device: X54 insulin pump with low suspend feature<br>* Change from current insulin pump to new X54 pump<br>* Other names: Veo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the X54 Insulin Pump Meets Expectations | Questionnaire completed at the end of the study measuring usability of the X54 insulin pump. Results scored on a Likert scale of 1 - 7, 1 being the least likely to use and 7 being the most likely to use. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the Training Material Meets Expectations | Questionnaire completed at the end of the study, measuring usability of the device training manual. Results scored on a Likert scale of 1 - 7, 1 being the least user friendly and 7 being the most user friendly. | 5 weeks |