NCT06025513

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

Completed NA Last updated 7 August 2025

What this trial tests

NA trial testing Embrace Patch in Insulin Resistance in 29 participants. Completed in 13 March 2025.

Timeline

16 February 2024

Primary endpoint
18 December 2024

13 March 2025

Quick facts

Lead sponsor	Neodyne Biosciences, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	16 February 2024
Primary completion	18 December 2024
Estimated completion	13 March 2025
Sites	1 location across Germany

Drugs / interventions tested

• Embrace Patch

Conditions studied

• Insulin Resistance — all drugs for Insulin Resistance →
• Lipohypertrophy — all drugs for Lipohypertrophy →

Sponsor

Neodyne Biosciences, Inc.

Who can join

Adults 18 to 65, any sex, with Insulin Resistance or Lipohypertrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The DERMIS Study: Methodologies, Results, and Implications for the Future.
   Hirsch IB, Khakpour D, Joseph J, Shinohara MM, et al · · 2026 · cited 5× · PMID 39633523 · DOI 10.1177/19322968241298005