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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| embrace patch treatment | Experimental | Insulin PK/PD before and after treatment with embrace patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embrace Patch | Device | Tension offloading skin patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standard pharmacokinetics/pharmacodynamics (PK/PD) endpoints as applicable after injection of a rapid-acting mealtime insulin | Area under the glucose infusion rate curve (AUCGIR),0-4h: area under the glucose infusion rate curve from 0 to 4 hrs after injection of a 0.15 units/kg body weight dose of insulin lispro | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of embrace on lipohypertrophic tissue could result in beneficial effects on volume and subsequent remodeling of the lipohypertrophic tissue histology. | To investigate the effect of four months of treatment with embrace® on volume (mL) of the target lipohypertrophic lesion comparing baseline to EoT in trial participants with type 1 diabetes and lipohypertrophy. To investigate the effect of four months of natural healing of a LH comparator lesion volume (mL) from baseline to EoT in trial participants with type 1 diabetes and lipohypertrophy. Measurements will be taken by ultrasound. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Stoffel, Doctor | Profil Institut für Stoffwechselforschung GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil | Neuss | Germany |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Pre / Post comparison with device treatment for 16 weeks.
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| From enrollment to the end of treatment of 16 weeks. |