Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Type 1 Diabetes and Diabetes Mellitus, Type 1, sponsored by Capillary Biomedical.
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 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint will be compared between the treatment groups.
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 |
What the finished NCT04398030 record still lists
NCT04398030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04398030's enrollment target sits among peer trials
7 194th of 198 higher than 4 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
REAL-Fam Feasibility Study for Youth Diabetes Management
RECRUITING · NA
-
AIDANET Pediatrics
RECRUITING · NA
-
A Study Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes
RECRUITING · NA
-
Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery
RECRUITING · NA
-
EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes
RECRUITING · NA
-
Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI