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NCT04398030 · ClinicalTrials.gov registry record · NA
Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")
A NA study of Type 1 Diabetes and Diabetes Mellitus, Type 1, sponsored by Capillary Biomedical.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT04398030 is a NA study of Type 1 Diabetes and Diabetes Mellitus, Type 1 that has completed, run by Capillary Biomedical. The registered enrollment target is 7 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04398030, a NA study of Type 1 Diabetes and Diabetes Mellitus, Type 1, has completed, sponsored by Capillary Biomedical.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE coil-reinforced soft polymer indwelling cannula
- DEVICE soft Teflon indwelling catheter
Study Locations (1)
California
- AMCR Institute - Escondido
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-07-17 |
| Est. Completion | 2021-04-22 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04398030
The ClinicalTrials.gov registry entry for NCT04398030 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The listed sponsor is Capillary Biomedical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which coil-reinforced soft polymer indwelling cannula is the first listed.
NCT04398030 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04398030 about?
NCT04398030 is a clinical study titled "Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")". 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...
What is the current status of trial NCT04398030?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2020-07-17. Estimated completion is 2021-04-22.
What conditions does trial NCT04398030 study?
This clinical trial studies the following conditions: Type 1 Diabetes, Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT04398030?
The interventions under investigation include: coil-reinforced soft polymer indwelling cannula (DEVICE), soft Teflon indwelling catheter (DEVICE).
Who is sponsoring clinical trial NCT04398030?
This trial is sponsored by Capillary Biomedical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04398030 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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