Diabetes Mellitus, Type 1Phase 4X54UserNCT01267175

United Kingdom User Evaluation, MiniMed Paradigm® X54 System

A Phase 4 study testing X54 insulin pump with low suspend feature in people with Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc. at 6 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: X54 insulin pump with low suspend feature
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 6 sitesUnited Kingdom
Study dates: Jan 2009to Feb 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Show all 9Show fewer

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

Who cannot join

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).

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United Kingdom6 sites

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

Other trials in United Kingdom

About this study

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.

Conditions: Diabetes Mellitus, Type 1
Being tested: X54 insulin pump with low suspend feature
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

X54 insulin pump with low suspend featureDevice
Also called Veo
Change from current insulin pump to new X54 pump

Study groups in NCT01267175
Study group	Role	What they receive
X54 pump	Experimental	All subjects transferred from current pump to X54 Receives: Device: X54 insulin pump with low suspend feature

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 weeks

Secondary outcomes (1)

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.
Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Feb 2009

First posted28 Dec 2010 (estimated)
Study startJan 2009
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01267175
Sponsor's protocol ID: ETP08-2625
Acronym: X54User
Status last verified: Jun 2023
First submitted: 23 Dec 2010
Last updated: 23 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 21868778

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: United Kingdom User Evaluation, MiniMed Paradigm® X54 System
ClinicalTrials.gov ID: NCT01267175
Acronym / sponsor ID: X54User / ETP08-2625
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 28 Dec 2010 (estimated)
Results: Posted 14 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
X54 pump	Experimental	Device: X54 insulin pump with low suspend featureAll subjects transferred from current pump to X54

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
X54 insulin pump with low suspend featureAlso: VeoChange from current insulin pump to new X54 pump	Device	X54 pump

Primary outcome

Usability of the X54 Insulin Pump Meets Expectations
Time frame: 5 weeks
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.

1 secondary outcome

Usability of the Training Material Meets Expectations
Time frame: 5 weeks

Results and safety

Results posted to the registry on 14 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
X54 Pump	31	29

Primary outcome: Usability of the X54 Insulin Pump Meets Expectations

Time frame: 5 weeks. Mean (Standard Deviation). Unit: Scores on a scale

Measure	X54 Pump n = 31
Value	5.9 (1.56)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Unanticipated Device related Adverse Events were required to be reported over the 15 week observation period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
X54 Pump	0 of 31 (0%)	0 of 31 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21868778Choudhary 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.

Related trials for Diabetes Mellitus, Type 1

Recruiting
C-Carbs: A CGM-guided Approach to Teaching Carb Awareness
Type 1 Diabetes
RecruitingPhase 3
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
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Not yet recruitingPhase 3
CKM For Safe Use of SGLT2i in Type 1 Diabetes
Type 1 Diabetes (T1D)
Active, not recruitingPhase 1
Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen
Diabetes Mellitus
RecruitingPhase 3
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Diabetes Mellitus, Type 1

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott W Lee, MD study director

Medtronic

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing X54 insulin pump with low suspend feature in people with Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc. at 6 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability of the X54 Insulin Pump Meets Expectations (time frame: 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01267175, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.