N/A
N=24
Longevity of Multi-Slitted Catheter With Lantern Technology
Insulin Dependent Diabetes Mellitus 1
Bottom Line
View on ClinicalTrials.gov: NCT03819634 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Time to Infusion Set Failure — 8.0 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inset II with Lantern Technology (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Infusion Set Failure |
8.0 | — |
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
Eligibility Criteria
Inclusion Criteria
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
- 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
Exclusion Criteria
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
- 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.
Data sourced from ClinicalTrials.gov (NCT03819634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.