User Evaluation of the MiniMed 640G Insulin Pump

This four center international study will include two United Kingdom National Health Service centers, and two centers in Melbourne, Australia. The objective of the study is to evaluate subject acceptance of 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 four 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 and older

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.

Criteria for Inclusion: A subject is eligible for the user evaluation study if all of the following criteria are met:

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 CGM 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/legal representative has signed a Patient Informed Consent and is willing to comply with the study procedures;
Subject is willing to complete study questionnaires throughout the study
Must have the following clinical diagnosis:

Type 1 diabetes, for a minimum of 6 months prior to enrollment

Criteria for Exclusion: A subject is excluded from the user evaluation if any of the following criteria are met:

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 Centre 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 Centre staff
Subject is unable to tolerate tape adhesive in the area of sensor placement
Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
Subject has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled
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 (CEP267 User Evaluation is not included in this exclusion criteria).

Treatment and study plan

MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

Device

Primary outcomes

User Acceptance of the New MiniMed 640G Insulin Pump 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 subject acceptance of the MiniMed 640G, Guardian Link Transmitter, and the training materials. A response of 4 or greater will be considered positive on a Likert scale for training materials and product acceptance.

Sponsors and collaborators

Lead sponsor

Medtronic MiniMed, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Nov 25, 2013
Registry last updated: May 15, 2017

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.

Published trials that share one or more normalized conditions with this study.

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