United Kingdom User Evaluation, MiniMed Paradigm® X54 System (X54User)

The user evaluation is to assess user acceptance and the quality of training materials for the MiniMed Paradigm® X54 System (X54 System) in preparation for commercial distribution of the new system.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: X54 insulin pump with low suspend feature

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Addenbrookes Hospital
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Royal Bournemouth Hospital
  • London
    • Denmark Hill, London, United Kingdom, SE5 9RS
      • Kings College Hospital
  • N. Yorkshire
    • Harrogate, N. Yorkshire, United Kingdom, HG2 7SX
      • Harrogate District Hospital
  • Tyne And Wear
    • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE4 6BE
      • Newcastle General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Are current 512/712, 515/715 or 522/722 MiniMed Paradigm Insulin Pump users, with or without CGM experience, and have at least three months experience with any one of these devices;
• Have signed an Informed Consent and are willing to comply with the user evaluation procedures;
• Have an HbA1c value less than 9.0% recorded at the time of their last test (if no HbA1c value is available within three months of enrollment, an HbA1c should be performed prior to entry to verify inclusion criteria);
• Are willing to use the Bolus Wizard feature;
• Agree to complete a diary for the duration of the study;
• Agree to complete a questionnaire at the conclusion of the study;
• Have been diagnosed with Type 1 Diabetes Mellitus by appropriate fasting or non fasting lab blood glucose values, c-peptide, insulin antibodies, prior documented DKA or good clinical picture at least six months prior to study start;
• Are 18 - 65 years of age;
• Have access to the internet and agree to upload the device per protocol

Exclusion Criteria:

• Is pregnant or planning to become pregnant during the course of the user evaluation. Pregnancy screening will be completed during the routine office visit prior to evaluation for the study. If a woman becomes pregnant during participation, she will be withdrawn;
• Suffers from a chronic debilitating condition;
• Has serious or unstable medical or psychological conditions (e.g., eating disorders, clinical depression, anxiety disorder) which, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study;
• Has impaired vision or hearing problems that could compromise the handling of the device;
• Has a history of tape allergies or skin conditions that could interfere with continued use of the system;
• Has the potential for lack of compliance or any other issue, in the opinion of the Investigator, that may preclude the subject from satisfactory participation in the study;
• Has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled;
• Is currently participating in an investigational study (drug or device).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: X54 pump; All subjects transferred from current pump to X54	Device: X54 insulin pump with low suspend feature; Change from current insulin pump to new X54 pump; Other Names: Veo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the X54 Insulin Pump Meets Expectations	Questionnaire completed at the end of the study measuring usability of the X54 insulin pump. Results scored on a Likert scale of 1 - 7, 1 being the least likely to use and 7 being the most likely to use.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the Training Material Meets Expectations	Questionnaire completed at the end of the study, measuring usability of the device training manual. Results scored on a Likert scale of 1 - 7, 1 being the least user friendly and 7 being the most user friendly.	5 weeks

Collaborators and Investigators

• Sponsor: Medtronic Diabetes
• Investigators: Study Director: Scott W Lee, MD, Medtronic

Publications and helpful links

General Publications

• Choudhary P, Shin J, Wang Y, Evans ML, Hammond PJ, Kerr D, Shaw JA, Pickup JC, Amiel SA. Insulin pump therapy with automated insulin suspension in response to hypoglycemia: reduction in nocturnal hypoglycemia in those at greatest risk. Diabetes Care. 2011 Sep;34(9):2023-5. doi: 10.2337/dc10-2411.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: December 23, 2010
• First Submitted That Met QC Criteria: December 27, 2010
• First Posted (Estimated): December 28, 2010

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: ETP08-2625