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

Insulin Resistance Clinical Trial

Official title: A Phase 1 Study to Assess the Safety and Efficacy of Embrace, De-tensioning Patch, in Subjects With Type 1 Diabetes and Lipohypertrophy (LH)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. However, before admission to the research center, unblinded CGM is worn for ~13 days (day 1 is discarded to avoid variability, day 2-7 bolus injections in Normal Tissue (NAT) and day 8-13 bolus injections in target LH) as outpatients. Subjects will discontinue their basal insulin for 2-3 days after the 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, reapplying the patch every week and avoiding any injections in the target LH lesion. Basal insulin is injected only in NAT away from the LH site. 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 (again, day 1 is discarded) 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. ;

Related Conditions & MeSH terms

• Insulin Resistance
• Lipohypertrophy

• NCT number: NCT06025513
• Study type: Interventional
• Source: Neodyne Biosciences, Inc.
• Contact: Jasper Jackson
• Phone: 1-800-519-7127
• Email: jjackson@neodynebio.com
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2024
• Completion date: February 2025