Type 2 Diabetes Clinical Trial
Official title:
A User Evaluation of the MiniMed® 620G and 640G Insulin Pumps and Guardian® Link Transmitter
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.
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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