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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01726621
• Other study ID #: CEP267
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2012
• Last updated: April 11, 2014
• Start date: March 2013

Study information

• Verified date: November 2013
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Australia	St Vincent Hospital and The University of Melbourne	Fitzroy
Australia	The Royal Melbourne Hospital	Patkville
Denmark	Herlev Hospital	Herlev
Spain	Barcelona University Hospital	Barcelona
United Kingdom	King's College London	London
United Kingdom	University College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Countries where clinical trial is conducted

Australia,  Denmark,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does user acceptance of the new MiniMed 620G and 640G insulin pumps and Guardian Link transmitter meet expectations?	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	Yes
Secondary	Do the training materials provided with the products meet the needs of the participants?	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.	One month	No