User Evaluation of the MiniMed 640G Insulin Pump

• ClinicalTrials.gov Identifier: NCT01991548
• Recruitment Status: Completed
• First Posted: November 25, 2013
• Results First Posted: May 15, 2017
• Last Update Posted: May 15, 2017
• Sponsor: Medtronic Diabetes
• Information provided by (Responsible Party): Medtronic Diabetes

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes; Type 2 Diabetes	Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A User Evaluation of the MiniMed® 640G Insulin Pump and Guardian® Link Transmitter
• Study Start Date: November 2013
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Locations

Australia

St Vincent Hospital and The University of Melbourne

Fitzroy, Australia, 3050

The Royal Melbourne Hospital

Patkville, Australia, 3050

United Kingdom

University College Hospital

London, United Kingdom, NW1 2PG

King's College London

London, United Kingdom, SE5 9NU

Sponsors and Collaborators

Medtronic Diabetes

More Information

• Responsible Party: Medtronic Diabetes
• ClinicalTrials.gov Identifier: NCT01991548
• Other Study ID Numbers: CEP284
• First Posted: November 25, 2013
• Results First Posted: May 15, 2017
• Last Update Posted: May 15, 2017
• Last Verified: March 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Medtronic Diabetes:

Insulin pump

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs