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De-tensioning Patch, in Subjects With Type 1 Diabetes and Lipohypertrophy

NCT06025513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-08-07

No results posted yet for this study

Summary

This is a single-center, single-cohort, open, repeated-application study. Baseline assessments will include a Hyperinsulinemic clamp after injection of 0.15 U/kg body weight of insulin lispro in the target LH lesion, as well as a Mixed Meal Tolerance Test (MMTT) with pre-meal insulin injected into the LH lesion. Subjects will discontinue their basal insulin for 2-3 days after the Continuous glucose monitor (CGM) study ends, prior to admission to the research center ("wash-out"). After release from the research center, subjects will wear the Embrace over the target LH lesion for 16 weeks. At the beginning of week 17, the clamp and MMTT will be repeated, after which participants will again wear an unblinded CGM for \~6 days with injections only in the target LH lesion when applying an Embrace patch with a hole. A needle biopsy will be taken from the LH lesion at baseline and again at study completion.

Conditions

Interventions

DEVICE

Embrace Patch

Tension offloading skin patch

Sponsors & Collaborators

  • Neodyne Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Marc Stoffel, Doctor · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-16
Primary Completion
2024-12-18
Completion
2025-03-13
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT06025513 on ClinicalTrials.gov