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N/A N=24 Treatment

Longevity of Multi-Slitted Catheter With Lantern Technology

Insulin Dependent Diabetes Mellitus 1

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

OutcomeResultp-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.

View full record on ClinicalTrials.gov →

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.

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