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

NCT01726621 | Completed Results

• 1 other identifier: CEP267
• Study Type: interventional
• Target: 55
• Locations: 4 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Insulin dependent diabetics

OTHER

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

Interventions

Medtronic MiniMed 620G or 640G Insulin Pump DEVICE

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

Insulin dependent diabetics

Eligibility Criteria

• Age: 7 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (6)

St Vincent Hospital and The University of Melbourne

Fitzroy, 3065, Australia

Location

The Royal Melbourne Hospital

Patkville, 3050, Australia

Location

Herlev Hospital

Herlev, Denmark

Location

Barcelona University Hospital

Barcelona, 08036, Spain

Location

University College Hospital

London, NW1 2PG, United Kingdom

Location

King's College London

London, SE5 9NU, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Medtronic MiniMed, Inc

julie.sekella@medtronic.com

8185765171

Study Officials

• Pratik Choudhary, MBBS, MRCP

  King's College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 15, 2012
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 18, 2016
• Results First Posted: April 18, 2016

Record last verified: 2016-03

Locations

AU (2); GB (2); DK (1); ES (1)