Type 1 Diabetes MellitusNCT02662842
BD FlowSmart™ Subcutaneous Insulin Infusion Set User Preference and Claims Study
An observational study of Type 1 Diabetes Mellitus, run by Becton, Dickinson and Company at 4 sites in United States.
Trial summary
Continuous Subcutaneous Insulin Infusion (CSII) via insulin pump therapy has been shown to improve quality of life and glucose control in many patients with diabetes opting for this treatment modality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- FlowSmart Infusion Set and Current Infusion Set
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 75 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to Feb 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 75 subjects with type 1 diabetes currently on CSII will participate in the study
Who may be able to join
- Must be 18-75 years of age, inclusive
- Have type 1 diabetes
- Treating diabetes with CSII for at least 12 months
- Currently using a soft catheter infusion set that is inserted 90° to body surface
- Have HbA1c ≤ 9.0% (tested at enrollment)
- Willing to do self monitoring of blood glucose (SMBG) using the supplied BG meter
Show all 10Show fewer
- Able to read, write and follow instructions in English
- Able and willing to provide informed consent
- Willing to use each infusion set (both study and current) for 72 hours (3 days)
- Willing to use their usual insertion method (manual or mechanical inserter) with both infusion sets
Who cannot join
- Pregnant (pre-menopausal females only; tested at enrollment)
- Recent history (within 6 months) of unstable diabetes including ketoacidosis, hyperglycemia and/or hypoglycemia requiring hospitalization(self-reported)
- Physical conditions that restrict dexterity and may limit ability to perform study procedure (e.g., severe neuropathy or arthritis of the hands, self-reported)
- Any other condition the PI or designee deems to pose a risk to the subject in the study
- Currently taking steroidal medications (self-reported)
- Acutely ill as determined by the Principal Investigator.
Show all 13Show fewer
- Currently using an insulin infusion pump whose insulin reservoir is not compatible with either a Paradigm or Luer connector, such as Sooil Dana, Asante Snap, and Accu-Chek insight
- Currently using a disposable (patch) insulin pump, such as the Insulet Omnipod and the Valeritas V-Go
- Currently using a Teflon infusion set that is not inserted at a 90° angle, such as the Animas Comfort, Animas Inset 30, Medtronic Silhouette, or a steel infusion set, such as the Accu-Chek Rapid-D or Medtronic Sure-T
- Currently using Advanced Diabetes Research (ADR) reservoirs
- Currently participating in any other clinical investigations that conflicts with this one, or who have participated in a study with the same indication within the last 3 months and that the Principal Investigator or designee believes will conflict with outcomes or ability of the subject to complete all activities required in the study
- Participated in one or more of the following BD studies: DBC-14SCARL10 and DBC-14SCARL13
- Employed by, or currently serving as a contractor or consultant to BD or study site
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
AMCR Institute Inc.
Escondido, California, 92025
TKL Research
Fair Lawn, New Jersey, 07410
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
About this study
Official title: BD FlowSmart™ User Claims Study
Continuous Subcutaneous Insulin Infusion (CSII) via insulin pump therapy has been shown to improve quality of life and glucose control in many patients with diabetes opting for this treatment modality. Despite significant innovation and advancement in pump technology, insulin infusion sets have been an area where innovation has been significantly lacking with no clinical studies performed prior to product launches.
BD has developed a subcutaneous infusion set with FlowSmart™ Technology designed to address patient comfort, insulin delivery and flow interruptions. According to preliminary animal and clinical studies, this technology results in lower infusion pressure indicating more consistent insulin delivery.
Read more
The FlowSmart infusion set has been previously tested in prototype form with healthy non-diabetic subjects with the sets inserted by nurses, and with CSII-using patients who self-inserted the FlowSmart infusion set in a clinical research setting.
The purpose of this study is to determine if insulin pump users prefer using the BD FlowSmart infusion set compared to their current set with respect to insertion pain and wear comfort.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- FlowSmart Infusion Set, Current Infusion Set
- Keywords
- infusion set, continuous subcutaneous insulin infusion
- 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.
FlowSmart Infusion SetDevice
Use of set for subcutaneous insulin infusion, with set change every three days.
Current Infusion SetDevice
Use of set for subcutaneous insulin infusion, with set change every three days.
| Study group | Role | What they receive |
|---|---|---|
| FlowSmart Infusion set, then current set | Subjects will use the FlowSmart Infusion Set for a period of 9 to 11 days, then switch to their current infusion set for another period of 9 to 11 days. Subjects must use at least 3 sets during each Study Period then - Subjects will use their current infusion set for a period of 9 to 11 days, then switch to the FlowSmart infusion set for another period of 9 to 11 days. Subjects must use at least 3 sets during each Study Period. Receives: Device: FlowSmart Infusion Set; Device: Current Infusion Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative Infusion Set Insertion Pain
At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate which insertion set was less painful to insert, the BD Flowsmart or their current infusion set. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted average pain rating using a multiple comparison approach.
Measured: Comparative pain measure assessed at the end of Study Period 2, after 9-11 days use of each infusion set type
Comparative Infusion Set Wear Comfort
At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate which set was more comfortable to wear, the BD FlowSmart or their current infusion set. Only if reduced Pain (outcome 1) for FlowSmart if achieved will wear comfort be further analyzed. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted average comfort rating using a multiple comparison approach.
Measured: Comparative pain measure assessed at the end of Study Period 2, after 9-11 days use of each infusion set type
Secondary outcomes (1)
Overall Infusion Set Preference
At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate their preference for the BD Flowsmart compared to their current infusion set based on their recent experience. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted preference rating using a multiple comparison approach.
Measured: Assessed at the end of Study Period 2, after 9-11 days use of each infusion set type
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Laurence Hirsch, MD, Study director, Becton Dickinson, World Wide VP Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662842
- Sponsor's protocol ID
- DBC-15SCARL15
- Status last verified
- Apr 2017
- First submitted
- 19 Jan 2016
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BD FlowSmart™ User Claims Study
- ClinicalTrials.gov ID
- NCT02662842
- Acronym / sponsor ID
- DBC-15SCARL15
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- infusion set, continuous subcutaneous insulin infusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Jan 2016 (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.
Continuous Subcutaneous Insulin Infusion (CSII) via insulin pump therapy has been shown to improve quality of life and glucose control in many patients with diabetes opting for this treatment modality. Despite significant innovation and advancement in pump technology, insulin infusion sets have been an area where innovation has been significantly lacking with no clinical studies performed prior to product launches.
BD has developed a subcutaneous infusion set with FlowSmart™ Technology designed to address patient comfort, insulin delivery and flow interruptions. According to preliminary animal and clinical studies, this technology results in lower infusion pressure indicating more consistent insulin delivery.
The FlowSmart infusion set has been previously tested in prototype form with healthy non-diabetic subjects with the sets inserted by nurses, and with CSII-using patients who self-inserted the FlowSmart infusion set in a clinical research setting.
The purpose of this study is to determine if insulin pump users prefer using the BD FlowSmart infusion set compared to their current set with respect to insertion pain and wear comfort.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FlowSmart Infusion set, then current set | – | Device: FlowSmart Infusion Set, Device: Current Infusion SetSubjects will use the FlowSmart Infusion Set for a period of 9 to 11 days, then switch to their current infusion set for another period of 9 to 11 days. Subjects must use at least 3 sets during each Study Period then - Subjects will use their current infusion set for a period of 9 to 11 days, then switch to the FlowSmart infusion set for another period of 9 to 11 days. Subjects must use at least 3 sets during each Study Period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 75 subjects with type 1 diabetes currently on CSII will participate in the study
Key inclusion criteria (10 listed)
- Must be 18-75 years of age, inclusive
- Have type 1 diabetes
- Treating diabetes with CSII for at least 12 months
- Currently using a soft catheter infusion set that is inserted 90° to body surface
- Have HbA1c ≤ 9.0% (tested at enrollment)
Key exclusion criteria (13 listed)
- Pregnant (pre-menopausal females only; tested at enrollment)
- Recent history (within 6 months) of unstable diabetes including ketoacidosis, hyperglycemia and/or hypoglycemia requiring hospitalization(self-reported)
- Physical conditions that restrict dexterity and may limit ability to perform study procedure (e.g., severe neuropathy or arthritis of the hands, self-reported)
- Any other condition the PI or designee deems to pose a risk to the subject in the study
- Currently taking steroidal medications (self-reported)
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 |
|---|---|---|
| FlowSmart Infusion SetUse of set for subcutaneous insulin infusion, with set change every three days. | Device | FlowSmart Infusion set, then current set |
| Current Infusion SetUse of set for subcutaneous insulin infusion, with set change every three days. | Device | FlowSmart Infusion set, then current set |
Primary outcome
Comparative Infusion Set Insertion Pain
Time frame: Comparative pain measure assessed at the end of Study Period 2, after 9-11 days use of each infusion set type
At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate which insertion set was less painful to insert, the BD Flowsmart or their current infusion set. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted average pain rating using a multiple comparison approach.
Comparative Infusion Set Wear Comfort
Time frame: Comparative pain measure assessed at the end of Study Period 2, after 9-11 days use of each infusion set type
At the study visit after completing both study periods (Visit 3), subjects will use a 15 cm Visual Analog Scale (VAS) to indicate which set was more comfortable to wear, the BD FlowSmart or their current infusion set. Only if reduced Pain (outcome 1) for FlowSmart if achieved will wear comfort be further analyzed. Effects of infusion set type will be tested for statistical significance using linear mixed models adjusting for the effect of subject, study site and period. The model will be used to generate a two-sided 95% confidence interval for the adjusted average comfort rating using a multiple comparison approach.
1 secondary outcome
Overall Infusion Set Preference
Time frame: Assessed at the end of Study Period 2, after 9-11 days use of each infusion set type
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 13 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Laurence Hirsch, MD study director
Becton Dickinson, World Wide VP Diabetes Care
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Becton, Dickinson and Company at 4 sites 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 10 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: finished, as of the sponsor's last update on 13 Apr 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 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?
Comparative Infusion Set Insertion Pain (time frame: Comparative pain measure assessed at the end of Study Period 2, after 9-11 days use of each infusion set type). 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 13 Apr 2017.