An interventional study of Inset II with Lantern Technology in Insulin Dependent Diabetes Mellitus 1, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2021-05-25.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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
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:
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Type 1 Diabetes by clinical definition
Exclusion Criteria:
The presence of any of the following is an exclusion for the study:
Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
Multi-slitted lantern infusion set
Device: Inset II with Lantern Technology
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.
Time to Infusion Set Failure
Time to when the infusion set fails and needs to be replaced.
Time frame: 10 days of infusion set wear
| Milestone | Lantern Infusion Set |
|---|---|
| Started | 24 |
| Completed | 22 |
| Not completed | 2 |
| Withdrew: Physician decision | 2 |
Time to when the infusion set fails and needs to be replaced.
| days | Lantern Infusion Set |
|---|---|
| Time to Infusion Set Failure | 8.0 ± 2.4 |
Collected over 10 days. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lantern Infusion Set | 0/24 (0%) | 0/24 (0%) | 12/24 (50%) |
| Event | Lantern Infusion Set |
|---|---|
| hyperglycemiaEndocrine disorders | 6/24 |
| adhesive failureSkin and subcutaneous tissue disorders | 4/24 |
| subcutaneous infectionSkin and subcutaneous tissue disorders | 1/24 |
| ketotosisEndocrine disorders | 1/24 |
Participants who completed the protocol are included in the analysis for baseline characteristics.
| Age, Continuous(years) | Lantern Infusion Set |
|---|---|
| Mean | 40.1 ± 14.3 |
| Sex: Female, Male(Participants) | Lantern Infusion Set |
|---|---|
| Female | 10 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | Lantern Infusion Set |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 21 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Lantern Infusion Set |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Lantern Infusion Set |
|---|---|
| United States | 22 |
| Diabetes Duration(years) | Lantern Infusion Set |
|---|---|
| Mean | 26.4 ± 12.2 |
| HbA1c(% glcosylated HBG:total HBG) | Lantern Infusion Set |
|---|---|
| Mean | 7.1 ± 0.8 |
| Total Daily Insulin Dose (Units)(units) | Lantern Infusion Set |
|---|---|
| Mean | 48.0 ± 16.7 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Stanford University