Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06025513
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-08-23
Brief Title:
De-tensioning Patch in Subjects With Type 1 Diabetes and Lipohypertrophy
Sponsor:
Neodyne Biosciences Inc
Organization:
Neodyne Biosciences Inc
Study Overview
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
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center single-cohort open repeated-application study Baseline assessments will include a Hyperinsulinemic clamp after injection of 015 Ukg 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
Detailed Description:
This is a single-center single-cohort open repeated-application study Baseline assessments will include a Hyperinsulinemic clamp after injection of 015 Ukg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None