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

A User Evaluation of the MiniMed® 620G and 640G Insulin Pumps and Guardian® Link Transmitter

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Intervention / Treatment: Device: Medtronic MiniMed 620G or 640G Insulin Pump

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Fitzroy, Australia, 3065
    • St Vincent Hospital and The University of Melbourne
  • Patkville, Australia, 3050
    • The Royal Melbourne Hospital
• Denmark
  • Herlev, Denmark
    • Herlev Hospital
• Spain
  • Barcelona, Spain, 08036
    • Barcelona University Hospital
• United Kingdom
  • London, United Kingdom, NW1 2PG
    • University College Hospital
  • London, United Kingdom, SE5 9NU
    • King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 95 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter	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.	Four weeks of pump wear

Collaborators and Investigators

• Sponsor: Medtronic Diabetes
• Investigators: Principal Investigator: Pratik Choudhary, MBBS, MRCP, King's College London

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 8, 2012
• First Submitted That Met QC Criteria: November 9, 2012
• First Posted (Estimate): November 15, 2012

Study Record Updates

• Last Update Posted (Estimate): April 18, 2016
• Last Update Submitted That Met QC Criteria: March 17, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: CEP267