User Evaluation of the MiniMed 640G Insulin Pump

NCT01991548 | Completed Results FDA Device

• 1 other identifier: CEP284
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 4

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Insulin pump

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diabetic participants with study devices

OTHER

Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter

Interventions

MiniMed® 640G Insulin Pump and Guardian® Link Transmitter DEVICE

Diabetic participants with study devices

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (4)

St Vincent Hospital and The University of Melbourne

Fitzroy, 3050, Australia

Location

The Royal Melbourne Hospital

Patkville, 3050, Australia

Location

University College Hospital

London, NW1 2PG, United Kingdom

Location

King's College London

London, SE5 9NU, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Medtronic Diabetes

818-576-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); GB (2)