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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

7 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Vincent Hospital and The University of Melbourne, Fitzroy, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter

Time frame: Four weeks of pump wear

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.

Sponsors and collaborators

Lead sponsor

Medtronic MiniMed, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Nov 15, 2012
Registry last updated: Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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