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

NCT ID: NCT01726621

Last Updated: 2016-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-12-31

Brief Summary

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Insulin dependent diabetics

Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter

Group Type: OTHER

Medtronic MiniMed 620G or 640G Insulin Pump

Intervention Type: DEVICE

Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pratik Choudhary, MBBS, MRCP

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

St Vincent Hospital and The University of Melbourne

Fitzroy, , Australia

The Royal Melbourne Hospital

Patkville, , Australia

Herlev Hospital

Herlev, , Denmark

Barcelona University Hospital

Barcelona, , Spain

University College Hospital

London, , United Kingdom

King's College London

London, , United Kingdom

Countries

Australia; Denmark; Spain; United Kingdom

Other Identifiers

CEP267

Identifier Type: -

Identifier Source: org_study_id