Type 1 DiabetesPhase 1NCT02687256
Evaluation of Extended Infusion Set Wear Using Medtronic Extended Wear Sof-set Infusion Set
A Phase 1 study testing Extended Wear infusion set, Standard Infusion set and Heparin in people with Type 1 Diabetes, run by Stanford University at 1 site in United States.
Trial summary
This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong insulin infusion set wear up to 7 days in adults with Type 1 Diabetes. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Extended Wear infusion set, Standard Infusion set and Heparin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Nov 2017
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- 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 12 months
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
- Age 18 to 55 years
- Hemoglobin A1c level less than or equal to 8.5%
- Willing to use Novolog insulin while they are participating in the study
- Total daily insulin dose is at least 0.3 units/kg/day
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- For females, not currently known to be pregnant
- An understanding of and willingness to follow the protocol and sign the informed consent
- Willingness to wear the experimental insulin infusion sets throughout the study
- Must be able to understand spoken and written English
Who cannot join
- Diabetic ketoacidosis in the past 3 months
- blood urea nitrogen (BUN), Creatinine, or liver function test (ALT or AST) more than three times the upper limit of normal, or thrombocytopenia
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- Pregnant or lactating females
- Known tape allergies
- Current treatment for a seizure disorder
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- 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:
- 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
- Dialysis for renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set
This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.
Read the detailed description
This is a double blinded cross-over study. Subjects will be asked to wear infusion set either a standard infusion set or an extended wear infusion set. They will wear each infusion set twice, and the order of infusion set wear will be randomized with the first infusion set wear and then alternated over 4 weeks. By performing a cross over study using both experimental infusion sets and standard infusion sets, the investigators hope to see whether there is a benefit to using an extended wear infusion set.
- Conditions
- Type 1 Diabetes
- Being tested
- Extended Wear infusion set, Standard Infusion set, Heparin
- 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.
Extended Wear infusion setDevice
For two of the 4 weeks the Extended Wear insulin infusion set will be used.
Standard Infusion setDevice
Also called Minimed
For two of the 4 weeks the Standard infusion set will be used
HeparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Protocol 1: Standard then Extended Set | Experimental | Participants will wear the control (standard) infusion set for 1 week, then switch to the experimental Extended Wear infusion set in combination with Heparin 400 IU for 1 week, then will repeat the cycle for a total of 4 weeks. Receives: Device: Extended Wear infusion set; Device: Standard Infusion set; Drug: Heparin |
| Protocol 1: Extended then Standard Set | Experimental | Participants will wear the experimental Extended Wear infusion set in combination with Heparin 400 IU for 1 week, then switch to the control (standard) infusion set for 1 week, then will repeat the cycle for a total of 4 weeks. Receives: Device: Extended Wear infusion set; Device: Standard Infusion set; Drug: Heparin |
| Protocol 2 (Part 1): Sequence 1 | Experimental | Participants will wear the control (standard) infusion set for 1 week, then the Extended Wear infusion set with heparin at 40 IU (week 1), 80 IU (week 2), 120 IU (week 3), and 200 IU (week 4). Receives: Device: Extended Wear infusion set; Device: Standard Infusion set; Drug: Heparin |
| Protocol 2 (Part 1): Sequence 2 | Experimental | Participants will wear the Extended Wear infusion set with heparin at 40 IU (week 1), 80 IU (week 2), 120 IU (week 3), and 200 IU (week 4), then the control (standard) infusion set (week 5). Receives: Device: Extended Wear infusion set; Device: Standard Infusion set; Drug: Heparin |
| Protocol 2 (Part 1): Sequence 3 | Experimental | Participants will wear the Extended Wear infusion set with heparin at 80 IU (week 1), 120 IU (week 2), and 200 IU (week 3), then the control (standard) infusion set (week 4), then the Extended Wear infusion set with heparin at 40 IU (week 5). Receives: Device: Extended Wear infusion set; Device: Standard Infusion set; Drug: Heparin |
| Protocol 2 (Part 1): Sequence 4 | Experimental | Participants will wear the Extended Wear infusion set with heparin at 120 IU (week 1), and 200 IU (week 2), then the control (standard) infusion set (week 3), then the Extended Wear infusion set with heparin at 40 IU (week 4), and 80 IU (week 5). Receives: Device: Extended Wear infusion set; Device: Standard Infusion set; Drug: Heparin |
| Protocol 2 (Part 1): Sequence 5 | Experimental | Participants will wear the Extended Wear infusion set with heparin at 200 IU (week 1), then the control (standard) infusion set (week 2), then the Extended Wear infusion set with heparin at 40 IU (week 3), 80 IU (week 4), and 80 IU (week 5). Receives: Device: Extended Wear infusion set; Device: Standard Infusion set; Drug: Heparin |
| Protocol 2 (Part 2): Standard then Extended Set | Experimental | Participants will wear the control (standard) infusion set for 1 week, then switch to the experimental Extended Wear infusion set in combination with Heparin 80 IU for 1 week, then will repeat the cycle for a total of 4 weeks. Receives: Device: Extended Wear infusion set; Device: Standard Infusion set; Drug: Heparin |
| Protocol 2 (Part 1): Extended then Standard Set | Experimental | Participants will wear the experimental Extended Wear infusion set in combination with Heparin 80 IU for 1 week, then switch to the control (standard) infusion set for 1 week, then will repeat the cycle for a total of 4 weeks. Receives: Device: Extended Wear infusion set; Device: Standard Infusion set; Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to an infusion set failure due to an occlusion
Glucose >250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL, or ketones > or = 0.6 mg/dL with a glucose reading of >250 mg/dL (in the absence of illness), or a pump occlusion alarm
Measured: within 1 week
Secondary outcomes (1)
signs of infection at insulin infusion site
erythema or induration of > 1cm in diameter at injection site
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Bruce A. Buckingham, Stanford University
- Investigators
- Bruce Buckingham, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687256
- Sponsor's protocol ID
- IRB 36142
- Status last verified
- Jun 2018
- First submitted
- 9 Feb 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: To maintain the integrity of this research study, the subject is told they may not have access to any health information developed as part of this study until it is completed.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set
- ClinicalTrials.gov ID
- NCT02687256
- Acronym / sponsor ID
- IRB 36142
- Conditions
- Type 1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Mar 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 22 Feb 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.
This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.
Detailed description
This is a double blinded cross-over study. Subjects will be asked to wear infusion set either a standard infusion set or an extended wear infusion set. They will wear each infusion set twice, and the order of infusion set wear will be randomized with the first infusion set wear and then alternated over 4 weeks. By performing a cross over study using both experimental infusion sets and standard infusion sets, the investigators hope to see whether there is a benefit to using an extended wear infusion set.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Protocol 1: Standard then Extended Set | Experimental | Device: Extended Wear infusion set, Device: Standard Infusion set, Drug: HeparinParticipants will wear the control (standard) infusion set for 1 week, then switch to the experimental Extended Wear infusion set in combination with Heparin 400 IU for 1 week, then will repeat the cycle for a total of 4 weeks. |
| Protocol 1: Extended then Standard Set | Experimental | Device: Extended Wear infusion set, Device: Standard Infusion set, Drug: HeparinParticipants will wear the experimental Extended Wear infusion set in combination with Heparin 400 IU for 1 week, then switch to the control (standard) infusion set for 1 week, then will repeat the cycle for a total of 4 weeks. |
| Protocol 2 (Part 1): Sequence 1 | Experimental | Device: Extended Wear infusion set, Device: Standard Infusion set, Drug: HeparinParticipants will wear the control (standard) infusion set for 1 week, then the Extended Wear infusion set with heparin at 40 IU (week 1), 80 IU (week 2), 120 IU (week 3), and 200 IU (week 4). |
| Protocol 2 (Part 1): Sequence 2 | Experimental | Device: Extended Wear infusion set, Device: Standard Infusion set, Drug: HeparinParticipants will wear the Extended Wear infusion set with heparin at 40 IU (week 1), 80 IU (week 2), 120 IU (week 3), and 200 IU (week 4), then the control (standard) infusion set (week 5). |
| Protocol 2 (Part 1): Sequence 3 | Experimental | Device: Extended Wear infusion set, Device: Standard Infusion set, Drug: HeparinParticipants will wear the Extended Wear infusion set with heparin at 80 IU (week 1), 120 IU (week 2), and 200 IU (week 3), then the control (standard) infusion set (week 4), then the Extended Wear infusion set with heparin at 40 IU (week 5). |
| Protocol 2 (Part 1): Sequence 4 | Experimental | Device: Extended Wear infusion set, Device: Standard Infusion set, Drug: HeparinParticipants will wear the Extended Wear infusion set with heparin at 120 IU (week 1), and 200 IU (week 2), then the control (standard) infusion set (week 3), then the Extended Wear infusion set with heparin at 40 IU (week 4), and 80 IU (week 5). |
| Protocol 2 (Part 1): Sequence 5 | Experimental | Device: Extended Wear infusion set, Device: Standard Infusion set, Drug: HeparinParticipants will wear the Extended Wear infusion set with heparin at 200 IU (week 1), then the control (standard) infusion set (week 2), then the Extended Wear infusion set with heparin at 40 IU (week 3), 80 IU (week 4), and 80 IU (week 5). |
| Protocol 2 (Part 2): Standard then Extended Set | Experimental | Device: Extended Wear infusion set, Device: Standard Infusion set, Drug: HeparinParticipants will wear the control (standard) infusion set for 1 week, then switch to the experimental Extended Wear infusion set in combination with Heparin 80 IU for 1 week, then will repeat the cycle for a total of 4 weeks. |
| Protocol 2 (Part 1): Extended then Standard Set | Experimental | Device: Extended Wear infusion set, Device: Standard Infusion set, Drug: HeparinParticipants will wear the experimental Extended Wear infusion set in combination with Heparin 80 IU for 1 week, then switch to the control (standard) infusion set for 1 week, then will repeat the cycle for a total of 4 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 12 months
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
- Age 18 to 55 years
- Hemoglobin A1c level less than or equal to 8.5%
- Willing to use Novolog insulin while they are participating in the study
Key exclusion criteria (14 listed)
- Diabetic ketoacidosis in the past 3 months
- blood urea nitrogen (BUN), Creatinine, or liver function test (ALT or AST) more than three times the upper limit of normal, or thrombocytopenia
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- Pregnant or lactating females
- Known tape allergies
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 |
|---|---|---|
| Extended Wear infusion setFor two of the 4 weeks the Extended Wear insulin infusion set will be used. | Device | Protocol 1: Extended then Standard Set, Protocol 1: Standard then Extended Set, Protocol 2 (Part 1): Extended then Standard Set, Protocol 2 (Part 1): Sequence 1, Protocol 2 (Part 1): Sequence 2, Protocol 2 (Part 1): Sequence 3, Protocol 2 (Part 1): Sequence 4, Protocol 2 (Part 1): Sequence 5, Protocol 2 (Part 2): Standard then Extended Set |
| Standard Infusion setAlso: MinimedFor two of the 4 weeks the Standard infusion set will be used | Device | Protocol 1: Extended then Standard Set, Protocol 1: Standard then Extended Set, Protocol 2 (Part 1): Extended then Standard Set, Protocol 2 (Part 1): Sequence 1, Protocol 2 (Part 1): Sequence 2, Protocol 2 (Part 1): Sequence 3, Protocol 2 (Part 1): Sequence 4, Protocol 2 (Part 1): Sequence 5, Protocol 2 (Part 2): Standard then Extended Set |
| Heparin | Drug | Protocol 1: Extended then Standard Set, Protocol 1: Standard then Extended Set, Protocol 2 (Part 1): Extended then Standard Set, Protocol 2 (Part 1): Sequence 1, Protocol 2 (Part 1): Sequence 2, Protocol 2 (Part 1): Sequence 3, Protocol 2 (Part 1): Sequence 4, Protocol 2 (Part 1): Sequence 5, Protocol 2 (Part 2): Standard then Extended Set |
Primary outcome
Time to an infusion set failure due to an occlusion
Time frame: within 1 week
Glucose >250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL, or ketones > or = 0.6 mg/dL with a glucose reading of >250 mg/dL (in the absence of illness), or a pump occlusion alarm
1 secondary outcome
signs of infection at insulin infusion site
Time frame: 1 week
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 6 Jun 2018.
- Individual participant dataSharing planned: No. To maintain the integrity of this research study, the subject is told they may not have access to any health information developed as part of this study until it is completed.
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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 Buckingham, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Extended Wear infusion set, Standard Infusion set and Heparin in people with Type 1 Diabetes, run by Stanford University 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 10 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 6 Jun 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to an infusion set failure due to an occlusion (time frame: within 1 week). 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 6 Jun 2018.