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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

December 23, 2010
February 16, 2011
January 2009
February 2009   (final data collection date for primary outcome measure)
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.
Verify that the usability of the X54 insulin pump meets expectations [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Physicians will have the ability to review the uploaded data in the Medtronic CareLink Therapy Management System for Diabetes
Complete list of historical versions of study NCT01267175 on ClinicalTrials.gov Archive Site
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.
Evaluate the effectiveness of the training material provided [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
United Kingdom User Evaluation, MiniMed Paradigm® X54 System
United Kingdom User Evaluation, MiniMed Paradigm® X54 System

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Diabetes Mellitus, Type 1
Device: X54 insulin pump with low suspend feature
Change from current insulin pump to new X54 pump
Other Name: Veo
Experimental: X54 pump
All subjects transferred from current pump to X54
Intervention: Device: X54 insulin pump with low suspend feature
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
February 2009
February 2009   (final data collection date for primary outcome measure)

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).
Not Provided
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01267175
ETP08-2625
No
Scott Lee, MD, Medtronic
Medtronic Diabetes
Not Provided
Study Director: Scott W Lee, MD Medtronic
Medtronic Diabetes
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP