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User Evaluation of the MiniMed 640G Insulin Pump

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01991548
First received: November 18, 2013
Last updated: May 11, 2017
Last verified: March 2016
  Purpose

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.


Condition Intervention
Type 1 Diabetes Type 2 Diabetes Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A User Evaluation of the MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • 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.


Enrollment: 52
Study Start Date: November 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Diabetic participants with study devices Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

  Eligibility

Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT01991548

Locations
Australia
St Vincent Hospital and The University of Melbourne
Fitzroy, Australia, 3050
The Royal Melbourne Hospital
Patkville, Australia, 3050
United Kingdom
University College Hospital
London, United Kingdom, NW1 2PG
King's College London
London, United Kingdom, SE5 9NU
Sponsors and Collaborators
Medtronic Diabetes
  More Information

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01991548     History of Changes
Other Study ID Numbers: CEP284
Study First Received: November 18, 2013
Results First Received: August 28, 2015
Last Updated: May 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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

Keywords provided by Medtronic Diabetes:
Insulin pump

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017