Diabetes Mellitus Type INCT01775059
Collection of Performance Data From the Integrated Sensor and Infusion Set. TRIAL 4
A study testing Integrated sensor and infusion set. in people with Diabetes Mellitus Type I and Diabetes Mellitus Type II, run by Medtronic Diabetes R&D Denmark at 3 sites in Denmark.
Trial summary
This is a multi-center, non-randomized, and interventional study in which subjects will use the Integrated sensor and infusion set with MiniLink Transmitter and the Medtronic Paradigm® VEO™ insulin pump (Sensor augmented pump) for 15 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type I, Diabetes Mellitus Type II
- What is being tested?
- Integrated sensor and infusion set.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesDenmark
- Study dates
- Mar 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age or older at time of screening
- Subject has a clinical diagnosis of insulin requiring diabetes, as determined by investigator.
- Subject is currently using a Medtronic Paradigm Sensor Augmented insulin pump and has been so for a minimum of 3 months at time of enrollment.
- Subject has Continuous Glucose Monitoring experience (min 30% of CGM use within the month prior to enrollment).
- Subject has an average of 3 SMBG per day (verified via CareLink) during the month prior to enrollment.
- Subject is willing to wear the study devices for the duration of the study
- Subject is willing to perform frequent (min 7 per day) SMBGs during study device wear
- Subject is willing to keep a short diary during the device wear.
Who cannot join
- Female subject is pregnant, per urine pregnancy test performed at time of enrollment in women of child bearing age.
- Female subject plans to become pregnant during the course of the study.
- Subject is unable to tolerate tape adhesive in the area of the placement of the study device.
- Subject has any unresolved adverse skin condition in the area of the placement of the study device (e.g. psoriasis, rash, Staphylococcus infection).
- The subject is not deemed to be an appropriate candidate for the study by the investigator for any reason.
Trial locations and contacts
3 sites in 1 country.
Ulrik Pedersen-Bjergaard, MD contact
Denmark3 sites
Fredericia Hospital
Fredericia, 7000
Hans Gjessing, MD, hans.gjessing@slb.regionsyddanmark.dk
Hans Gjessing, MD
Hilleroed Hospital
Hilleroed, 3400
Ulrik Pedersen-Bjergaard, MD, ulrik.pedersen-bjergaard@regionh.dk
Ulrik Pedersen-Bjergaard, MD
Hvidovre Hospital
Hvidovre, 2650
Kirsten Norgaard, MD, kirsten.noergaard@regionh.dk
Kirsten Noergaard, MD
About this study
This is a multi-center, non-randomized, and interventional study in which subjects will use the Integrated sensor and infusion set with MiniLink Transmitter and the Medtronic Paradigm® VEO™ insulin pump (Sensor augmented pump) for 15 days.
The purpose of this study is to collect performance data on the Integrated sensor and infusion set for approximately 15 days, with the intention for each subject to wear 5 sets for 3 days each.
- Being tested
- Integrated sensor and infusion set.
- 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.
Integrated sensor and infusion set.Device
| Study group | Role | What they receive |
|---|---|---|
| Integrated sensor and infusion set. | Experimental | Not described Receives: Device: Integrated sensor and infusion set. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy endpoint
Agreement Rate (% within 20%) using VEO Pump
Measured: 5 months
Safety endpoint
Descriptive summary of SAE, Adverse events and Device complaints
Measured: 5 months
Secondary outcomes (1)
Accuracy endpoint
Agreement Rate (% within 20%) using re-analyzed Guardian® REAL-Time and Paradigm® REAL-Time algorithm data
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type IStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Diabetes R&D Denmark
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrik Pedersen-Bjergaard, MD, Principal investigator, Hilleroed Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775059
- Sponsor's protocol ID
- CEP 277
- Other IDs
- 2012102304
- Status last verified
- Jan 2013
- First submitted
- 21 Jan 2013
- Last updated
- 5 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Performance Data From the Integrated Sensor and Infusion Set. TRIAL 4
- ClinicalTrials.gov ID
- NCT01775059
- Acronym / sponsor ID
- CEP 277
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medtronic Diabetes R&D DenmarkIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (estimated)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, non-randomized, and interventional study in which subjects will use the Integrated sensor and infusion set with MiniLink Transmitter and the Medtronic Paradigm® VEO™ insulin pump (Sensor augmented pump) for 15 days.
The purpose of this study is to collect performance data on the Integrated sensor and infusion set for approximately 15 days, with the intention for each subject to wear 5 sets for 3 days each.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated sensor and infusion set. | Experimental | Device: Integrated sensor and infusion set. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is 18 years of age or older at time of screening
- Subject has a clinical diagnosis of insulin requiring diabetes, as determined by investigator.
- Subject is currently using a Medtronic Paradigm Sensor Augmented insulin pump and has been so for a minimum of 3 months at time of enrollment.
- Subject has Continuous Glucose Monitoring experience (min 30% of CGM use within the month prior to enrollment).
- Subject has an average of 3 SMBG per day (verified via CareLink) during the month prior to enrollment.
Key exclusion criteria (5 listed)
- Female subject is pregnant, per urine pregnancy test performed at time of enrollment in women of child bearing age.
- Female subject plans to become pregnant during the course of the study.
- Subject is unable to tolerate tape adhesive in the area of the placement of the study device.
- Subject has any unresolved adverse skin condition in the area of the placement of the study device (e.g. psoriasis, rash, Staphylococcus infection).
- The subject is not deemed to be an appropriate candidate for the study by the investigator for any reason.
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 |
|---|---|---|
| Integrated sensor and infusion set. | Device | Integrated sensor and infusion set. |
Primary outcome
Accuracy endpoint
Time frame: 5 months
Agreement Rate (% within 20%) using VEO Pump
Safety endpoint
Time frame: 5 months
Descriptive summary of SAE, Adverse events and Device complaints
1 secondary outcome
Accuracy endpoint
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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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.
Ulrik Pedersen-Bjergaard, MD contact
Ulrik Pedersen-Bjergaard, MD principal investigator
Hilleroed Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated sensor and infusion set. in people with Diabetes Mellitus Type I and Diabetes Mellitus Type II, run by Medtronic Diabetes R&D Denmark at 3 sites in Denmark.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrik Pedersen-Bjergaard, MD (ulrik.pedersen-bjergaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy endpoint (time frame: 5 months). The study lists 2 primary outcomes in all. 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 5 Feb 2013.