Diabetes Mellitus, Type 1NCT03242005
The PSIQS Study - User Experience With Pro-Set
A study testing MiniMed® Pro-set® and MiniMed® Quick-set® in people with Diabetes Mellitus, Type 1, run by Becton, Dickinson and Company.
Trial summary
Open label, randomized 2-period cross-over study comparing two continuous subcutaneous insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed® Quick-set® Read more about this study
- Who is it for?
- Ages 13 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- MiniMed® Pro-set® and MiniMed® Quick-set®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Feb 2018
- 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 13 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be between 13 and 70 years of age (inclusive)
- Must have been previously diagnosed with type 1 diabetes mellitus
- Must be using one of the following Medtronic insulin pumps with the Paradigm connector (note 670G excluded) for at least 6 months prior to enrollment. These pumps must have the ability to upload data to Medtronic CareLink Therapy Management software.
- MiniMed Paradigm Revel™ Insulin Pump - models 523 (1.8 mL reservoir) and 723 (3 mL reservoir)
- MiniMed 530G Pump - models 551 (1.8 mL reservoir) and 751 (3 mL reservoir)
- MiniMed 630G System
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- Must have been using the Medtronic Enlite CGM for at least 3 months prior to enrollment, and are currently doing so
- Must routinely insert their own infusion set (may be inserted manually or with an inserter or with an integrated set/inserter, i.e. Mio)
- If instructed, must be willing to insert all assigned infusion sets with a mechanical inserter
- Must have another form of insulin delivery available (i.e. vial and syringe or pen and pen needle)
- Must agree to continue using current Medtronic Enlite CGM throughout the study
- Willing to have insulin pump, BGM and CGM data downloaded into Medtronic CareLink Therapy Management Software (requires subject CareLink logon ID and password)
- In stable health status with no acute or significant illness, in the opinion of the investigator or designee
- Able to read, write and follow instructions in English
- Able and willing to provide informed consent
- Able and willing to comply with study procedures
Who cannot join
- Pregnant (self-attestation) or nursing
- Currently using a body-worn patch insulin infusion pump, e.g. Omnipod or V-Go
- Currently using the Medtronic Model 670G pump and associated CGM
- Current or past participation in previous BD Study DBC-16SCARL21
- History of bleeding disorder or easy bruising.
- Currently taking anti-platelet therapy or anticoagulants (use of up to 81 mg per day of aspirin is permitted).
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- Known blood borne infections.
- History of recurrent dermatological condition or skin disorder (e.g. psoriasis, eczema, pre-existing dermatitis).
- Skin abnormalities, anomalies or conditions (e.g. sunburn, tattoos, extensive scarring, lipohypertrophy) located at or very close to the intended insertion site.
- Physical condition that restricts dexterity and may limit ability to perform study procedures (i.e. severe neuropathy or arthritis of the hands; self-reported)
- Currently participating in any other clinical investigation that conflicts with this study
- Employed by, or currently serving as a contractor or consultant to BD, Medtronic or study site
- Any other condition the investigator or designee deems to pose an unacceptable risk to the subject in the study
About this study
Official title: The PSIQS Study - User Experience With the Pro-Set Over Intended Wear of 3 Days With New Instructions and Requirement to be Inserted With the Quick-Serter
Open label, randomized 2-period cross-over study comparing two continuous subcutaneous insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed® Quick-set®
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- MiniMed® Pro-set®, MiniMed® Quick-set®
- 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.
MiniMed® Pro-set®Device
Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy.
MiniMed® Quick-set®Device
Utilization of the MiniMed® Quick-set® to administer the subject's current insulin therapy.
| Study group | Role | What they receive |
|---|---|---|
| Pro-set® vs. Quick-set® | Experimental | Subjects will be randomized to start with one of the study subcutaneous insulin administration sets (MiniMed® Pro-set® or MiniMed® Quick-set®). After completing the first study period,subjects will be placed in the alternative group according to the cross-over study design. Receives: Device: MiniMed® Pro-set®; Device: MiniMed® Quick-set® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia
Measured: 6 hours from time of insertion
Secondary outcomes (4)
Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; > 400mg/dl.
Measured: 6 hours from time of insertion
Compare Pro-set® vs. Quick- set® for set removals due to set failure; hyperglycemia >250mg/dl.
Measured: 72 hours of set wear that occurs at 6 hours or later after insertion
Compare Pro-set® vs. Quick- set® for set removals at less than 60 hours post insertion.
Measured: 60 hours post insertion
Compare Pro-set® vs. Quick- set® for duration of wear
Measured: % reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study startSep 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Why it stopped: Sponsor decision to not proceed with study - no subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242005
- Sponsor's protocol ID
- DBC-17SCARL23
- Status last verified
- Sep 2017
- First submitted
- 4 Aug 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- 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 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PSIQS Study - User Experience With the Pro-Set Over Intended Wear of 3 Days With New Instructions and Requirement to be Inserted With the Quick-Serter
- ClinicalTrials.gov ID
- NCT03242005
- Acronym / sponsor ID
- DBC-17SCARL23
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision to not proceed with study - no subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 8 Aug 2017 (actual)
- 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.
Open label, randomized 2-period cross-over study comparing two continuous subcutaneous insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed® Quick-set®
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pro-set® vs. Quick-set® | Experimental | Device: MiniMed® Pro-set®, Device: MiniMed® Quick-set®Subjects will be randomized to start with one of the study subcutaneous insulin administration sets (MiniMed® Pro-set® or MiniMed® Quick-set®). After completing the first study period,subjects will be placed in the alternative group according to the cross-over study design. |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Must be between 13 and 70 years of age (inclusive)
- Must have been previously diagnosed with type 1 diabetes mellitus
- Must be using one of the following Medtronic insulin pumps with the Paradigm connector (note 670G excluded) for at least 6 months prior to enrollment. These pumps must have the ability to upload data to Medtronic CareLink Therapy Management software.
- Must have been using the Medtronic Enlite CGM for at least 3 months prior to enrollment, and are currently doing so
- Must routinely insert their own infusion set (may be inserted manually or with an inserter or with an integrated set/inserter, i.e. Mio)
Key exclusion criteria (13 listed)
- Pregnant (self-attestation) or nursing
- Currently using a body-worn patch insulin infusion pump, e.g. Omnipod or V-Go
- Currently using the Medtronic Model 670G pump and associated CGM
- Current or past participation in previous BD Study DBC-16SCARL21
- History of bleeding disorder or easy bruising.
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® Pro-set®Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy. | Device | Pro-set® vs. Quick-set® |
| MiniMed® Quick-set®Utilization of the MiniMed® Quick-set® to administer the subject's current insulin therapy. | Device | Pro-set® vs. Quick-set® |
Primary outcome
Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia
Time frame: 6 hours from time of insertion
4 secondary outcomes
Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; > 400mg/dl.
Time frame: 6 hours from time of insertion
Compare Pro-set® vs. Quick- set® for set removals due to set failure; hyperglycemia >250mg/dl.
Time frame: 72 hours of set wear that occurs at 6 hours or later after insertion
Compare Pro-set® vs. Quick- set® for set removals at less than 60 hours post insertion.
Time frame: 60 hours post insertion
Compare Pro-set® vs. Quick- set® for duration of wear
Time frame: % reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing MiniMed® Pro-set® and MiniMed® Quick-set® in people with Diabetes Mellitus, Type 1, run by Becton, Dickinson and Company.
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 16 inclusion and 13 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: withdrawn, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia (time frame: 6 hours from time of insertion). 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 14 Sep 2017.