United Kingdom User Evaluation, MiniMed Paradigm® X54 System
X54User
1 other identifier
interventional
31
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2009
Shorter than P25 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 23, 2010
CompletedFirst Posted
Study publicly available on registry
December 28, 2010
CompletedResults Posted
Study results publicly available
February 14, 2011
CompletedJune 23, 2023
June 1, 2023
1 month
December 23, 2010
January 21, 2011
June 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Usability of the Training Material Meets Expectations
5 weeks
Study Arms (1)
X54 pump
EXPERIMENTALAll subjects transferred from current pump to X54
Interventions
Change from current insulin pump to new X54 pump
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Kings College Hospital
Denmark Hill, London, SE5 9RS, United Kingdom
Harrogate District Hospital
Harrogate, N. Yorkshire, HG2 7SX, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, Tyne and Wear, NE4 6BE, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Related Publications (1)
Choudhary P, Shin J, Wang Y, Evans ML, Hammond PJ, Kerr D, Shaw JA, Pickup JC, Amiel SA. Insulin pump therapy with automated insulin suspension in response to hypoglycemia: reduction in nocturnal hypoglycemia in those at greatest risk. Diabetes Care. 2011 Sep;34(9):2023-5. doi: 10.2337/dc10-2411.
PMID: 21868778DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Harold Torunsky
- Organization
- Medtronic Diabetes
Study Officials
- STUDY DIRECTOR
Scott W Lee, MD
Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 23, 2010
First Posted
December 28, 2010
Study Start
January 1, 2009
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
June 23, 2023
Results First Posted
February 14, 2011
Record last verified: 2023-06