DiabetesNCT02382536
Monitoring the Infusion Pressure in Insulin Infusion Sets in Healthy Adults
An observational study of Diabetes, run by Becton, Dickinson and Company at 1 site in United States.
Trial summary
The purpose of this study is to compare the in-line fluid pressure (pressure of the fluid going through the tubing) and leakage (observation of fluid on and around the device) during and after subcutaneous infusion using two types of infusion sets. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- BD Scarlett Infusion set and Medtronic QuickSet Infusion Set
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2014
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be between the ages of 18-75 years of age (inclusive)
- In stable health status with no acute or significant illness, in the opinion of the investigator.
- Able to read, write and follow study instructions in English.
- Able and willing to provide informed consent.
- Able and willing to complete all study procedures.
Who cannot join
- Pregnant (self-attestation)
- BMI > 35
- Currently taking anti-platelet therapy or anticoagulants (Use of up to 81 mg per day of aspirin is permitted)
- History of bleeding disorder or easy bruising
- Known blood borne infections
- Diabetes on insulin therapy
Show all 14Show fewer
- History of recurrent dermatological condition or skin disorder (e.g. psoriasis, eczema)
- Gross skin anomalies and abnormalities (e.g. scars, stretch marks, discolorations, tattoos, superficial masses, other) located at or very close to the intended infusion sites on the abdomen
- Subjects with excessive hair on the abdomen who are unwilling to have excessive hair removed by Site Staff
- Fear of needles, history of symptomatic low blood pressure or history of fainting (syncope) during hypodermic injections
- History of allergic reaction to adhesives, metals, latex, or plastics.
- Any other condition the PI or designee deems to pose a risk to the subject in the study.
- Currently participating in any other clinical investigation that conflicts with this one, or who have participated in a study with the same indication within the prior 30 days that the Principal Investigator or designee believes will conflict with outcomes or ability of the subject to complete all activities required in this study.
- Employed by, or currently serving as a contractor or consultant to BD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infusion Pressure Delivering Insulin Diluent - BD's Scarlett vs. Medtronic's (MDT) Quickset in Healthy Adults
The purpose of this study is to compare the in-line fluid pressure (pressure of the fluid going through the tubing) and leakage (observation of fluid on and around the device) during and after subcutaneous infusion using two types of infusion sets. One infusion set is investigational, developed by BD, and the other is the Quick-set (Medtronic), which is commercially available. These infusion sets will be used with a commercially available insulin pump to deliver insulin diluent (an inactive liquid with no medication) for approximately 4 1/2 hours. During this time pressure and leakage will be continuously monitored.
Read the detailed description
This is a single center, open label study.
Each subject is to receive up to 4 basal/bolus diluent infusions in the abdomen with the BD Scarlett and the Medtronic Quick-set®; 2 Scarlett infusion sets and 2 Quick-set infusion sets. The order of device placement will be randomized.
After insertion, insulin diluent will be delivered at a rate of 0.01 mL/hour (equivalent in volume and rate to 1.0 unit/hour of U-100 insulin) via the insulin pump for a minimum of 3 hours. After 3 hours of basal infusion, a bolus of 0.1 mL (equivalent to 10 units) will be delivered via the insulin pump and basal infusion continued for a minimum of 1 additional hour.
At the end of the final basal infusion period, the infusion set tubing will be clamped to mimic an occlusion event and allowed to run until either an occlusion alert ("no delivery") is signaled by the pump, or a minimum of 30 minutes, whichever comes first. Infusion pressure data will be collected during the entire infusion period, including the time the tubing is clamped. After removal of the device from the body, the presence of fluid on the application site skin (Leakage) will be determined by visual assessment then measured using gravimetric analysis, if applicable.
- Conditions
- Diabetes
- Being tested
- BD Scarlett Infusion set, Medtronic QuickSet Infusion Set
- Keywords
- Diabetes, Insulin therapy, insulin pump, Infusion sets
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD Scarlett Infusion setDevice
Each subject will receive subcutaneous infusion from two investigational BD Scarlet infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours.
Medtronic QuickSet Infusion SetDevice
Each subject will receive subcutaneous infusion from two Medtronic infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Infusion set | Each subject will receive a total of 4 simultaneous subcutaneous infusions of insulin diluent, two using the investigational device (BD Scarlett Infusion Set) and two using the the comparator (Medtronic QuickSet Infusion Set). Receives: Device: BD Scarlett Infusion set; Device: Medtronic QuickSet Infusion Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-line fluid pressure
Infusion pressure profiles will be measured by an inline pressure transducer and recorded by a data logger. Pressure profiles will be evaluated by type of infusion set. The occurrence of pressure events (continuous pressure rises or flow interruptions of at least 30 minutes) will be assessed.
Measured: Continuous measure for 4-5 hours after insertion
Secondary outcomes (1)
Leakage
Upon removal of the infusion set, the infusion site and device will be checked for fluid leakage. If leakage is observed, the infusion site device hub/skin interface will be swabbed for fluid with a pre-weighed swab. The swab will be re-weighed to determine the amount of fluid. Fluid collected at infusion site and the device/skin interface will not be classified as leakage if the measured volume is less than 0.005 mL (equivalent to 0.5 units U-100 insulin).
Measured: Immediately upon device removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillip LaStella, MD, Principal investigator, TKL Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382536
- Sponsor's protocol ID
- DBC-14SCARL06
- Status last verified
- Feb 2017
- First submitted
- 27 Feb 2015
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusion Pressure Delivering Insulin Diluent - BD's Scarlett vs. Medtronic's (MDT) Quickset in Healthy Adults
- ClinicalTrials.gov ID
- NCT02382536
- Acronym / sponsor ID
- DBC-14SCARL06
- Conditions
- Diabetes
- Keywords
- Diabetes, Insulin therapy, insulin pump, Infusion sets
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Mar 2015 (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.
The purpose of this study is to compare the in-line fluid pressure (pressure of the fluid going through the tubing) and leakage (observation of fluid on and around the device) during and after subcutaneous infusion using two types of infusion sets. One infusion set is investigational, developed by BD, and the other is the Quick-set (Medtronic), which is commercially available. These infusion sets will be used with a commercially available insulin pump to deliver insulin diluent (an inactive liquid with no medication) for approximately 4 1/2 hours. During this time pressure and leakage will be continuously monitored.
Detailed description
This is a single center, open label study.
Each subject is to receive up to 4 basal/bolus diluent infusions in the abdomen with the BD Scarlett and the Medtronic Quick-set®; 2 Scarlett infusion sets and 2 Quick-set infusion sets. The order of device placement will be randomized.
After insertion, insulin diluent will be delivered at a rate of 0.01 mL/hour (equivalent in volume and rate to 1.0 unit/hour of U-100 insulin) via the insulin pump for a minimum of 3 hours. After 3 hours of basal infusion, a bolus of 0.1 mL (equivalent to 10 units) will be delivered via the insulin pump and basal infusion continued for a minimum of 1 additional hour.
At the end of the final basal infusion period, the infusion set tubing will be clamped to mimic an occlusion event and allowed to run until either an occlusion alert ("no delivery") is signaled by the pump, or a minimum of 30 minutes, whichever comes first. Infusion pressure data will be collected during the entire infusion period, including the time the tubing is clamped. After removal of the device from the body, the presence of fluid on the application site skin (Leakage) will be determined by visual assessment then measured using gravimetric analysis, if applicable.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infusion set | – | Device: BD Scarlett Infusion set, Device: Medtronic QuickSet Infusion SetEach subject will receive a total of 4 simultaneous subcutaneous infusions of insulin diluent, two using the investigational device (BD Scarlett Infusion Set) and two using the the comparator (Medtronic QuickSet Infusion Set). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be between the ages of 18-75 years of age (inclusive)
- In stable health status with no acute or significant illness, in the opinion of the investigator.
- Able to read, write and follow study instructions in English.
- Able and willing to provide informed consent.
- Able and willing to complete all study procedures.
Key exclusion criteria (14 listed)
- Pregnant (self-attestation)
- BMI > 35
- Currently taking anti-platelet therapy or anticoagulants (Use of up to 81 mg per day of aspirin is permitted)
- History of bleeding disorder or easy bruising
- Known blood borne infections
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 |
|---|---|---|
| BD Scarlett Infusion setEach subject will receive subcutaneous infusion from two investigational BD Scarlet infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours. | Device | Infusion set |
| Medtronic QuickSet Infusion SetEach subject will receive subcutaneous infusion from two Medtronic infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours. | Device | Infusion set |
Primary outcome
In-line fluid pressure
Time frame: Continuous measure for 4-5 hours after insertion
Infusion pressure profiles will be measured by an inline pressure transducer and recorded by a data logger. Pressure profiles will be evaluated by type of infusion set. The occurrence of pressure events (continuous pressure rises or flow interruptions of at least 30 minutes) will be assessed.
1 secondary outcome
Leakage
Time frame: Immediately upon device removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Phillip LaStella, MD principal investigator
TKL Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Becton, Dickinson and Company at 1 site in United States.
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 5 inclusion and 14 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In-line fluid pressure (time frame: Continuous measure for 4-5 hours after 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 9 Feb 2017.