User Evaluation of the MiniMed 620G and 640G Insulin Pumps

This study is currently recruiting participants.
Verified November 2013 by Medtronic Diabetes
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01726621
First received: November 8, 2012
Last updated: April 11, 2014
Last verified: November 2013
  Purpose

This six center international study will include two United Kingdom National Health Service centers, two centers in Melbourne, Australia and one center each in Denmark and Spain. The objective of the study is to evaluate subject acceptance of the 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 six 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: Medtronic MiniMed 620G or 640G Insulin Pump

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A User Evaluation of the MiniMed® 620G and 640G Insulin Pumps and Guardian® Link Transmitter

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • Does user acceptance of the new MiniMed 620G and 640G insulin pumps and Guardian Link transmitter meet expectations? [ 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 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.


Secondary Outcome Measures:
  • Do the training materials provided with the products meet the needs of the participants? [ Time Frame: One month ] [ Designated as safety issue: No ]
    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 training materials. A response of 4 or greater on the Likert scale will be considered positive for the training materials and indicate acceptance.


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Insulin dependent diabetics
Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter
Device: Medtronic MiniMed 620G or 640G Insulin Pump
Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Subject is 7 years or older at time of screening
  • Subject is current insulin pump user for at least 3 months
  • Subject has the following Continuous Glucose Monitoring 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
  • Subject has signed a Patient Informed Consent form and is willing to comply with the study procedures;
  • Subject is willing to complete study questionnaires throughout the study
  • Must have one of the following clinical diagnosis:

    • Type 1 diabetes, for a minimum of 6 months prior to enrollment
    • Insulin requiring type 2 diabetes, for a minimum of 6 months prior to enrollment

Exclusion Criteria:

  • Female subject has a positive urine pregnancy screening test.
  • Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn
  • Subject has any condition that, in the opinion of the Investigator or qualified Investigational Center staff, may preclude him/her from participating in the study and completing study related procedures.
  • Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Center staff
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726621

Locations
Australia
St Vincent Hospital and The University of Melbourne Active, not recruiting
Fitzroy, Australia, 3065
The Royal Melbourne Hospital Active, not recruiting
Patkville, Australia, 3050
Denmark
Herlev Hospital Active, not recruiting
Herlev, Denmark
Spain
Barcelona University Hospital Recruiting
Barcelona, Spain, 08036
Contact: Marga Gimenez       GIMENEZ@clinic.ub.es   
Principal Investigator: Ignacio Conget         
United Kingdom
King's College London Active, not recruiting
London, United Kingdom, SE5 9NU
University College Hospital Active, not recruiting
London, United Kingdom, NW1 2PG
Sponsors and Collaborators
Medtronic Diabetes
Investigators
Principal Investigator: Pratik Choudhary, MBBS, MRCP King's College London
  More Information

No publications provided

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01726621     History of Changes
Other Study ID Numbers: CEP267
Study First Received: November 8, 2012
Last Updated: April 11, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014