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Impact of Two Medtronic Infusion Sets on Lipohypertrophy in Type 1 Diabetes (T1DM) Patients Thought to Have LH

NCT06074965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-10-10

No results posted yet for this study

Summary

This is an observational study using ultrasound (US) and palpation to assess the impact of infusion sets on lipohypertrophy (LH) in an infusion set crossover study.

Conditions

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Lipohypertrophy

Interventions

DEVICE

Medtronic Extended Infusion Set

Each subject will be given 2 types of infusion sets to wear and change sets per label use (3 days for Medtronic Quick-set™ and 7 days for Medtronic Extended).

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Azienda Ospedaliera San Camillo Forlanini

    lead OTHER

Principal Investigators

  • Claudio Tubili · Azienda Ospedaliera San Camillo Forlanini

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2023-05-23
Completion
2023-05-23

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06074965 on ClinicalTrials.gov