Type 1 DiabetesNCT01991548
User Evaluation of the MiniMed 640G Insulin Pump
A study testing MiniMed® 640G Insulin Pump and Guardian® Link Transmitter in people with Type 1 Diabetes and Type 2 Diabetes, run by Medtronic MiniMed, Inc. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- MiniMed® 640G Insulin Pump and Guardian® Link Transmitter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2013to Nov 2014
- Phase
- Interventional
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Criteria for Inclusion: A subject is eligible for the user evaluation study if all of the following criteria are met:
- 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
Criteria for Exclusion: A subject is excluded from the user evaluation if any of the following criteria are met:
- 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 If a woman becomes pregnant during participation, she will be withdrawn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
- 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).
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia2 sites
St Vincent Hospital and The University of Melbourne
Fitzroy, 3050
The Royal Melbourne Hospital
Patkville, 3050
United Kingdom2 sites
University College Hospital
London, NW1 2PG
King's College London
London, SE5 9NU
About this study
Official title: A User Evaluation of the MiniMed® 640G Insulin Pump and Guardian® Link Transmitter
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
- Being tested
- MiniMed® 640G Insulin Pump and Guardian® Link Transmitter
- Keywords
- Insulin pump
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniMed® 640G Insulin Pump and Guardian® Link TransmitterDevice
| Study group | Role | What they receive |
|---|---|---|
| Diabetic participants with study devices | Other | Not described Receives: Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks of pump wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
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.
- Other trials for Type 1 DiabetesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991548
- Sponsor's protocol ID
- CEP284
- Status last verified
- Mar 2016
- First submitted
- 18 Nov 2013
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A User Evaluation of the MiniMed® 640G Insulin Pump and Guardian® Link Transmitter
- ClinicalTrials.gov ID
- NCT01991548
- Acronym / sponsor ID
- CEP284
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Insulin pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic participants with study devices | Other | Device: MiniMed® 640G Insulin Pump and Guardian® Link Transmitter |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| MiniMed® 640G Insulin Pump and Guardian® Link Transmitter | Device | Diabetic participants with study devices |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiniMed® 640G Insulin Pump and Guardian® Link Transmitter in people with Type 1 Diabetes and Type 2 Diabetes, run by Medtronic MiniMed, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2017). 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?
User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter (time frame: Four weeks of pump wear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2017.