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

This study has been completed.
Sponsor:
Information provided by:
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01267175
First received: December 23, 2010
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Device: X54 insulin pump with low suspend feature
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: United Kingdom User Evaluation, MiniMed Paradigm® X54 System

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • Usability of the X54 Insulin Pump Meets Expectations [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Usability of the Training Material Meets Expectations [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: X54 pump
All subjects transferred from current pump to X54
Device: X54 insulin pump with low suspend feature
Change from current insulin pump to new X54 pump
Other Name: Veo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267175

Locations
United Kingdom
Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Kings College Hospital
Denmark Hill, London, United Kingdom, SE5 9RS
Harrogate District Hospital
Harrogate, N. Yorkshire, United Kingdom, HG2 7SX
Newcastle General Hospital
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE4 6BE
Guy's Hospital
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Medtronic Diabetes
Investigators
Study Director: Scott W Lee, MD Medtronic
  More Information

No publications provided by Medtronic Diabetes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott Lee, MD, Medtronic
ClinicalTrials.gov Identifier: NCT01267175     History of Changes
Other Study ID Numbers: ETP08-2625
Study First Received: December 23, 2010
Results First Received: January 21, 2011
Last Updated: February 16, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 30, 2014