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User Evaluation of the MiniMed 640G Insulin Pump

NCT01991548 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2017-05-15

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-11-30
Completion
2014-11-30
FDA Device
Yes

Countries

  • Australia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991548 on ClinicalTrials.gov