Ignite Creation Date:
2024-05-06 @ 2:41 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04398030
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2020-05-08
Brief Title:
Pharmacokinetics PK Pharmacodynamics PD of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion CSII in Type 1 Diabetes Mellitus T1DM Patients PEXIS
Sponsor:
Capillary Biomedical Inc
Organization:
Capillary Biomedical Inc
Study Overview
Official Title:
Randomized Crossover Euglycemic Clamp Study in Adult Patients With T1DM to Assess Pharmacokinetics and Pharmacodynamics of Subcutaneously Infused Insulin Using an Investigational Extended Wear Continuous Subcutaneous Insulin Infusion Cannula Compared to a Commercial Infusion Set
Status:
COMPLETED
Status Verified Date:
2022-08
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 study has been designed as a prospectively enrolled randomized sequence 2-way crossover study of device performance tolerability and safety of an investigational insulin infusion set using a coil-reinforced soft polymer indwelling cannula versus a commercial insulin infusion set using a soft Teflon indwelling cannula during two 7-day home use periods with 4 in-clinic euglycemic clamp sessions during each of the 7-day periods After a wash-out period subjects will cross over into the investigational or control group respectively
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R44DK110969-02 | NIH | None | httpsreporternihgovquickSearch2R44DK110969-02 |