Diabetes MellitusNCT01288729
Duration of Infusion Set Function: Quick-Set Teflon Catheter Versus Sure-T Steel Infusion Set Catheter
A study testing Sure-T Steel Infusion Set Catheter and Quick-Set Teflon Catheter in people with Diabetes Mellitus, run by Stanford University.
Trial summary
This is an open-label cross over study looking to compare the length of infusion set wear between a teflon catheter (Quick-Set) or a steel (Sure-T) catheter. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Sure-T Steel Infusion Set Catheter and Quick-Set Teflon Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jul 2011
- 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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 3 months
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age 12 to 45 years
- For females, not currently known to be pregnant
- An understanding of and willingness to follow the protocol and sign the informed consent
- Hemoglobin A1c level less than or equal to 10%
- Medtronic Continuous subcutaneous insulin infusion pump
- Must be able to understand spoken or written English
Who cannot join
- Diabetic ketoacidosis in the past 6 months
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
- Current treatment for a seizure disorder
- Cystic fibrosis
- Active infection
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
Show all 10Show fewer
- Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
- Presence of a known adrenal disorder
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
- Abuse of alcohol
About this study
Official title: Duration of Infusion Set Function: A Study Comparing the Quick-Set Teflon Catheter vs Sure-T Steel Infusion Set Catheter
This is an open-label cross over study looking to compare the length of infusion set wear between a teflon catheter (Quick-Set) or a steel (Sure-T) catheter.
Read the detailed description
Currently infusion sets are approved for 2-3 days of wear. In this study subjects will wear each infusion set for up to 7 days or until the infusion set fails. Subjects will alternate between wearing the Quick-Set Teflon catheter and the Sure-T steel catheter each week. They will wear each infusion set twice.
For the study, subjects will be provided with an investigational Medtronic Real-Time Continuous Glucose Monitor (CGM) Enlite Sensor/Serter to help identify, serious hyperglycemia or hypoglycemia during the study. This sensor is not yet FDA approved, but is similar to commercially available sensors. If the sensor detects a high or low glucose, subject must obtain a fingerstick glucose to confirm the result. In the study, all insulin dose and other treatment decisions will be made using glucose meter results, and will not be based on sensor results. Subjects will be instructed on how to identify infusion set failures.
Infusion set failure are defined as: 1) Blood ketones greater than 0.6 mmol/L, 2) Evidence of infection at the infusion site (such as redness of more than 4 mm), or 3) Blood glucose that does not decrease by at least 50 mg/dL within 1 hour of a correction bolus to treat a blood glucose greater than 300 mg/dL.
Subjects will follow-up weekly in one of our test centers for a total of five visits.
At home subjects will be asked to keep a log recording measurements of redness and induration at the infusion site when it is changed prior to the study visit.
- Conditions
- Diabetes Mellitus
- Being tested
- Sure-T Steel Infusion Set Catheter, Quick-Set Teflon Catheter
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sure-T Steel Infusion Set CatheterDevice
Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
Quick-Set Teflon CatheterDevice
Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Steel Cathetar, then Teflon | Experimental | Participants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set. Receives: Device: Sure-T Steel Infusion Set Catheter; Device: Quick-Set Teflon Catheter |
| Group 2 - Teflon Cathetar, the Steel | Experimental | Participants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set. Receives: Device: Sure-T Steel Infusion Set Catheter; Device: Quick-Set Teflon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Wear of Infusion Site
Comparison of the length of wear (hours) of Sure-T Steel Infusion Set Catheter versus Quick-Set Teflon Catheter. Infusion sets are currently approved for wear 2-3 days (24-72 hours). Participants wore each set for up to 7 days twice. Outcome measure is presented according to the intervention (Steel or Teflon catheter).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce A. Buckingham, Stanford University
- Investigators
- Bruce A. Buckingham, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288729
- Sponsor's protocol ID
- SU-01272011-7439
- Status last verified
- Jan 2017
- First submitted
- 31 Jan 2011
- Last updated
- 27 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Patel PJ, Benasi K, Ferrari G, Evans MG, Shanmugham S, Wilson DM, Buckingham BA. Randomized trial of infusion set function: steel versus teflon. Diabetes Technol Ther. 2014 Jan;16(1):15-9. doi: 10.1089/dia.2013.0119. Epub 2013 Oct 3.
PubMed 24090124
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Infusion Set Function: A Study Comparing the Quick-Set Teflon Catheter vs Sure-T Steel Infusion Set Catheter
- ClinicalTrials.gov ID
- NCT01288729
- Acronym / sponsor ID
- SU-01272011-7439
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Feb 2011 (estimated)
- Results
- Posted 27 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label cross over study looking to compare the length of infusion set wear between a teflon catheter (Quick-Set) or a steel (Sure-T) catheter.
Detailed description
Currently infusion sets are approved for 2-3 days of wear. In this study subjects will wear each infusion set for up to 7 days or until the infusion set fails. Subjects will alternate between wearing the Quick-Set Teflon catheter and the Sure-T steel catheter each week. They will wear each infusion set twice.
For the study, subjects will be provided with an investigational Medtronic Real-Time Continuous Glucose Monitor (CGM) Enlite Sensor/Serter to help identify, serious hyperglycemia or hypoglycemia during the study. This sensor is not yet FDA approved, but is similar to commercially available sensors. If the sensor detects a high or low glucose, subject must obtain a fingerstick glucose to confirm the result. In the study, all insulin dose and other treatment decisions will be made using glucose meter results, and will not be based on sensor results. Subjects will be instructed on how to identify infusion set failures.
Infusion set failure are defined as: 1) Blood ketones greater than 0.6 mmol/L, 2) Evidence of infection at the infusion site (such as redness of more than 4 mm), or 3) Blood glucose that does not decrease by at least 50 mg/dL within 1 hour of a correction bolus to treat a blood glucose greater than 300 mg/dL.
Subjects will follow-up weekly in one of our test centers for a total of five visits.
At home subjects will be asked to keep a log recording measurements of redness and induration at the infusion site when it is changed prior to the study visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Steel Cathetar, then Teflon | Experimental | Device: Sure-T Steel Infusion Set Catheter, Device: Quick-Set Teflon CatheterParticipants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set. |
| Group 2 - Teflon Cathetar, the Steel | Experimental | Device: Sure-T Steel Infusion Set Catheter, Device: Quick-Set Teflon CatheterParticipants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 3 months
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age 12 to 45 years
- For females, not currently known to be pregnant
- An understanding of and willingness to follow the protocol and sign the informed consent
Key exclusion criteria (10 listed)
- Diabetic ketoacidosis in the past 6 months
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
- Current treatment for a seizure disorder
- Cystic fibrosis
- Active infection
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 |
|---|---|---|
| Sure-T Steel Infusion Set CatheterParticipants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time | Device | Group 1 - Steel Cathetar, then Teflon, Group 2 - Teflon Cathetar, the Steel |
| Quick-Set Teflon CatheterParticipants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time | Device | Group 1 - Steel Cathetar, then Teflon, Group 2 - Teflon Cathetar, the Steel |
Primary outcome
Length of Wear of Infusion Site
Time frame: 5 weeks
Comparison of the length of wear (hours) of Sure-T Steel Infusion Set Catheter versus Quick-Set Teflon Catheter. Infusion sets are currently approved for wear 2-3 days (24-72 hours). Participants wore each set for up to 7 days twice. Outcome measure is presented according to the intervention (Steel or Teflon catheter).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24090124Patel PJ, Benasi K, Ferrari G, Evans MG, Shanmugham S, Wilson DM, Buckingham BA. Randomized trial of infusion set function: steel versus teflon. Diabetes Technol Ther. 2014 Jan;16(1):15-9. doi: 10.1089/dia.2013.0119. Epub 2013 Oct 3.
- 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.
Bruce A. Buckingham principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Sure-T Steel Infusion Set Catheter and Quick-Set Teflon Catheter in people with Diabetes Mellitus, run by Stanford University.
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 10 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 27 Feb 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?
Yes. Results are posted in the registry (first posted 27 Feb 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?
Length of Wear of Infusion Site (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01288729, which also lists 1 linked publication.
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 27 Feb 2017.