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User Evaluation of the MiniMed 640G Insulin Pump

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01991548
First Posted: November 25, 2013
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Diabetes
November 18, 2013
November 25, 2013
August 28, 2015
May 15, 2017
May 15, 2017
November 2013
November 2014   (Final data collection date for primary outcome measure)
User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter [ Time Frame: Four weeks of pump wear ]
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 subject acceptance of the MiniMed 640G, Guardian Link Transmitter, and the training materials. A response of 4 or greater will be considered positive on a Likert scale for training materials and product acceptance.
Likert scale [ Time Frame: Four weeks of pump wear ]
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.
Complete list of historical versions of study NCT01991548 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Type 1 Diabetes
  • Type 2 Diabetes
Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter
Diabetic participants with study devices
Intervention: Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
November 2014
November 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).
Sexes Eligible for Study: All
7 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United Kingdom
 
 
NCT01991548
CEP284
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Plan to Share IPD: No
Medtronic Diabetes
Medtronic Diabetes
Not Provided
Not Provided
Medtronic Diabetes
March 2016

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