Insulin Dependent Diabetes Mellitus 1LanternNCT03819634
Longevity of Multi-Slitted Catheter With Lantern Technology
A study testing Inset II with Lantern Technology in people with Insulin Dependent Diabetes Mellitus 1, run by Stanford University at 1 site in United States.
Trial summary
To determine time to set failure when the Convatec Inset II with Lantern technology (Convatec Lantern) infusion set with multi-slitted catheter is worn for up to 10 days Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Insulin Dependent Diabetes Mellitus 1
- What is being tested?
- Inset II with Lantern Technology
- 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
- 25 Jan 2019to 20 Apr 2019
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 Diabetes by clinical definition
- Age 22 and over
- On tethered insulin pump therapy for at least 3 months using Lispro or Aspart insulin.
- Hemoglobin A1c level less than or equal to 9%
- Eating more than 60 grams of carbohydrate each day
- For females, not currently known to be pregnant
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- Understanding and willingness to follow the protocol and sign informed consent
- Willingness to wear the experimental infusion sets
- Willingness to have photographs taken of their infusion sites
- Ability to speak, read and write in the language of the investigators
Who cannot join
- The presence of any of the following is an exclusion for the study:
- Diabetic ketoacidosis in the past 3 months
- Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
- Pregnant or lactating
- Known tape allergies
- Active infection
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- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- Known cardiovascular events in the last 6 months
- Known acute proliferative diabetic retinopathy
- Known adrenal disorder
- Current treatment for a seizure disorder
- Inpatient psychiatric treatment in the past 6 months
- Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication.
- Use of SGLT inhibitor
- Suspected drug or alcohol abuse
- Dialysis or end stage kidney disease
- Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longevity of Multi-Slitted Catheter, the Convatec Inset II With Lantern Technology
To determine time to set failure when the Convatec Inset II with Lantern technology (Convatec Lantern) infusion set with multi-slitted catheter is worn for up to 10 days
Read the detailed description
This is a pilot study to obtain preliminary data to determine the time to set failure when the Lantern infusion set is worn for up to 10 days. The study is not intended for registration purposes or to support a 510(k) submission. The study will be conducted at one site: Stanford University.
This study will enroll 24 subjects (as per FDA approval) to establish the maximum length of Lantern infusion set wear when 80% of sets are still functional (excluding accidental "pull-outs"). Each participant will place the set and wear it for 10 days or until set failure and data will be collected on the cause of set failure. If a set is accidentally pulled out, it can be replaced by the subject. Failures are based on:
- Presence of serum ketones with hyperglycemia
- Unexplained hyperglycemia
- Signs of infection at the infusion site
- Pump occlusion alarm
- Adhesive failure
Since infusion set failures will occur after variable lengths of wear, regularly scheduled visits are unlikely to capture the day of an infusion set failure. Instead the subject will be taught how to insert the set, measure erythema and induration with a ruler marked in millimeters and to take a picture of the infusion site. Subjects will be instructed to text the study team when they remove their infusion set and to send a picture of the infusion site and measurements. If there is any evidence of an infection (≥10 mm of erythema or induration), they will be asked to come in that day for an unscheduled visit.
- Conditions
- Insulin Dependent Diabetes Mellitus 1
- Being tested
- Inset II with Lantern Technology
- 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.
Inset II with Lantern TechnologyDevice
Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.
| Study group | Role | What they receive |
|---|---|---|
| Lantern infusion set | Experimental | Multi-slitted lantern infusion set Receives: Device: Inset II with Lantern Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Infusion Set Failure
Time to when the infusion set fails and needs to be replaced.
Measured: 10 days of infusion set wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start25 Jan 2019
- Primary completion20 Apr 2019
- Study completion20 Apr 2019
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 Insulin Dependent Diabetes Mellitus 1Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To determine length of infusion set wear for up to a maximum of 10 days
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- ConvaTec Inc.
- Responsible party
- Principal investigator, Bruce Buckingham, Stanford University
- Investigators
- Bruce A Buckingham, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819634
- Sponsor's protocol ID
- IRB #45812
- Acronym
- Lantern
- Status last verified
- May 2021
- First submitted
- 24 Jan 2019
- Last updated
- 25 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lal RA, Hsu L, Zhang J, Schondorff PK, Heschel M, Buckingham B. Longevity of the novel ConvaTec infusion set with Lantern technology. Diabetes Obes Metab. 2021 Aug;23(8):1973-1977. doi: 10.1111/dom.14395. Epub 2021 Apr 18.
PubMed 33822472
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longevity of Multi-Slitted Catheter, the Convatec Inset II With Lantern Technology
- ClinicalTrials.gov ID
- NCT03819634
- Acronym / sponsor ID
- Lantern / IRB #45812
- Conditions
- Insulin Dependent Diabetes Mellitus 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- ConvaTec Inc.
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine time to set failure when the Convatec Inset II with Lantern technology (Convatec Lantern) infusion set with multi-slitted catheter is worn for up to 10 days
Detailed description
This is a pilot study to obtain preliminary data to determine the time to set failure when the Lantern infusion set is worn for up to 10 days. The study is not intended for registration purposes or to support a 510(k) submission. The study will be conducted at one site: Stanford University.
This study will enroll 24 subjects (as per FDA approval) to establish the maximum length of Lantern infusion set wear when 80% of sets are still functional (excluding accidental "pull-outs"). Each participant will place the set and wear it for 10 days or until set failure and data will be collected on the cause of set failure. If a set is accidentally pulled out, it can be replaced by the subject. Failures are based on:
- Presence of serum ketones with hyperglycemia
- Unexplained hyperglycemia
- Signs of infection at the infusion site
- Pump occlusion alarm
- Adhesive failure
Since infusion set failures will occur after variable lengths of wear, regularly scheduled visits are unlikely to capture the day of an infusion set failure. Instead the subject will be taught how to insert the set, measure erythema and induration with a ruler marked in millimeters and to take a picture of the infusion site. Subjects will be instructed to text the study team when they remove their infusion set and to send a picture of the infusion site and measurements. If there is any evidence of an infection (≥10 mm of erythema or induration), they will be asked to come in that day for an unscheduled visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To determine length of infusion set wear for up to a maximum of 10 days
| Arm | Type | Receives |
|---|---|---|
| Lantern infusion set | Experimental | Device: Inset II with Lantern TechnologyMulti-slitted lantern infusion set |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Type 1 Diabetes by clinical definition
- Age 22 and over
- On tethered insulin pump therapy for at least 3 months using Lispro or Aspart insulin.
- Hemoglobin A1c level less than or equal to 9%
- Eating more than 60 grams of carbohydrate each day
Key exclusion criteria (17 listed)
- Diabetic ketoacidosis in the past 3 months
- Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
- Pregnant or lactating
- Known tape allergies
- 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 |
|---|---|---|
| Inset II with Lantern TechnologyEach participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump. | Device | Lantern infusion set |
Primary outcome
Time to Infusion Set Failure
Time frame: 10 days of infusion set wear
Time to when the infusion set fails and needs to be replaced.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33822472Lal RA, Hsu L, Zhang J, Schondorff PK, Heschel M, Buckingham B. Longevity of the novel ConvaTec infusion set with Lantern technology. Diabetes Obes Metab. 2021 Aug;23(8):1973-1977. doi: 10.1111/dom.14395. Epub 2021 Apr 18.
- 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, 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 study testing Inset II with Lantern Technology in people with Insulin Dependent Diabetes Mellitus 1, 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 17 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 25 May 2021. 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?
Yes. Results are posted in the registry (first posted 25 May 2021). 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?
Time to Infusion Set Failure (time frame: 10 days of infusion set wear). 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 NCT03819634, 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 25 May 2021.