User Evaluation of the MiniMed 640G Insulin Pump

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Intervention / Treatment: Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Fitzroy, Australia, 3050
    • St Vincent Hospital and The University of Melbourne
  • Patkville, Australia, 3050
    • The Royal Melbourne Hospital
• United Kingdom
  • London, United Kingdom, NW1 2PG
    • University College Hospital
  • London, United Kingdom, SE5 9NU
    • King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

1. Subject is 7 years or older at time of screening
2. Subject is current insulin pump user for at least 3 months

3. 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
4. Subject/legal representative has signed a Patient Informed Consent and is willing to comply with the study procedures;
5. Subject is willing to complete study questionnaires throughout the study
6. Must have the following clinical diagnosis:

1. 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:

1. Female subject has a positive urine pregnancy screening test.
2. Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn
3. 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.
4. Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Centre staff
5. Subject is unable to tolerate tape adhesive in the area of sensor placement
6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
7. Subject has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled
8. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Diabetic participants with study devices	Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter	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.	Four weeks of pump wear

Collaborators and Investigators

• Sponsor: Medtronic Diabetes

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Insulin pump
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: CEP284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes