User Evaluation of the MiniMed 640G Insulin Pump

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Medtronic Diabetes
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01991548
First received: November 18, 2013
Last updated: November 21, 2013
Last verified: November 2013

November 18, 2013
November 21, 2013
November 2013
February 2014   (final data collection date for primary outcome measure)
Likert scale [ Time Frame: Four weeks of pump wear ] [ Designated as safety issue: Yes ]
Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
Same as current
Complete list of historical versions of study NCT01991548 on ClinicalTrials.gov Archive Site
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User Evaluation of the MiniMed 640G Insulin Pump
A User Evaluation of the MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

This four center international study will include two United Kingdom National Health Service centers, and two centers in Melbourne, Australia. The objective of the study is to evaluate subject acceptance of a new insulin pump and transmitter together with the accompanying training materials. Descriptive data from participant questionnaires and device uploads will be evaluated.

Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of age upwards, who currently use an insulin pump in the management of their type 1 or type 2 diabetes, will be invited to participate. Each subject will be trained on the study device and then use it for approximately four weeks. During this time there will be three in-clinic visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of this period, they will revert back to their original insulin pump and complete a questionnaire on the study pump training materials, features and usability.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients within the research center diabetes population who currently use insulin pump for their diabetes therapy.

  • Type 1 Diabetes
  • Type 2 Diabetes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
February 2014
February 2014   (final data collection date for primary outcome measure)

Criteria for Inclusion: A subject is eligible for the user evaluation study if all of the following criteria are met:

  1. Subject is 7 years or older at time of screening
  2. Subject is current insulin pump user for at least 3 months
  3. Subject has the following CGM experience as determined by the Investigator:

    • Has experience and is able to insert/change sensor by herself/himself and
    • Has experience and can recharge the transmitter and
    • Has experience and can read sensor data in real-time on her/his pump screen
  4. Subject/legal representative has signed a Patient Informed Consent and is willing to comply with the study procedures;
  5. Subject is willing to complete study questionnaires throughout the study
  6. Must have the following clinical diagnosis:

1. Type 1 diabetes, for a minimum of 6 months prior to enrollment

Criteria for Exclusion: A subject is excluded from the user evaluation if any of the following criteria are met:

  1. Female subject has a positive urine pregnancy screening test.
  2. Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn
  3. Subject has any condition that, in the opinion of the Investigator or qualified Investigational Centre staff, may preclude him/her from participating in the study and completing study related procedures.
  4. Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Centre staff
  5. Subject is unable to tolerate tape adhesive in the area of sensor placement
  6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
  7. Subject has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled
  8. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks (CEP267 User Evaluation is not included in this exclusion criteria).
Both
7 Years and older
No
Contact: Bob Janowski, BA 818-576-5662 bob.janowski@medtronic.com
United Kingdom,   Australia
 
NCT01991548
CEP284
No
Medtronic Diabetes
Medtronic Diabetes
Not Provided
Not Provided
Medtronic Diabetes
November 2013

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