User Evaluation of the MiniMed 640G Insulin Pump

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Interventions: Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

• Registration Number: NCT01991548
• Lead Sponsor: Medtronic Diabetes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-25
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2015-08-28
• Status Verified: 2016-03
• Results First Submitted QC: 2017-05-11
• Last Update Submitted: 2017-05-11
• Results First Posted: 2017-05-15
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diabetic participants with study devices	MiniMed® 640G Insulin Pump and Guardian® Link Transmitter	-

Primary Outcome Measures

Name	Time	Method
User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter	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.

Trial Locations

Locations (4)

The Royal Melbourne Hospital; 🇦🇺 Patkville, Australia

University College Hospital; 🇬🇧 London, United Kingdom

St Vincent Hospital and The University of Melbourne; 🇦🇺 Fitzroy, Australia

King's College London; 🇬🇧 London, United Kingdom