Clinical trial NCT01267175: United Kingdom User Evaluation, MiniMed Paradigm® X54 System
Official title: United Kingdom User Evaluation, MiniMed Paradigm® X54 System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2010-12-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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 If a woman becomes pregnant during participation, she will be withdrawn;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).

Primary outcomes:
measure: Usability of the X54 Insulin Pump Meets Expectations
timeFrame: 5 weeks
Secondary outcomes:
measure: Usability of the Training Material Meets Expectations
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
city: Denmark Hill
country: United Kingdom
facility: Kings College Hospital
state: London
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
state: N. Yorkshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle General Hospital
state: Tyne And Wear
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
affiliation: Medtronic
name: Scott W Lee, MD
role: STUDY_DIRECTOR
References:
citation: 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.