Feasibility and Validation of the Fluispotter®, a Novel Intravenous System for Serial Blood Sampling

Launched by RIGSHOSPITALET, DENMARK · Jun 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Fluispotter®, which is designed to collect blood samples more easily and comfortably than traditional methods. The Fluispotter® is a wearable device that can take blood samples without needing a healthcare worker to be present, allowing samples to be collected during everyday activities like sleeping, working, or exercising. This trial aims to see how well the Fluispotter® works compared to standard blood sampling methods, particularly for adults with adrenal insufficiency related to pituitary disease.

To participate in the study, you need to be a healthy adult or someone with adrenal insufficiency caused by a pituitary condition. Healthy participants should not be on any regular medications, should not have any major medical issues, and must be able to understand instructions in Danish. Patients with adrenal insufficiency must have stable hormone therapy for at least three months and meet other health criteria. If you join the trial, you can expect to wear the device for 20 hours while your blood is collected automatically. This innovative approach may reduce the stress and complications of regular blood sampling, making it easier for everyone involved.

Gender

ALL

Eligibility criteria

• • Healthy subjects
• Inclusion Criteria:
• • Not receiving regular medication
• • Not receiving oral contraceptives or other oestrogens
• • No known endocrine or major medical diseases
• • No previous surgery of endocrine glands
• • No regular smoking
• • Not working nightshifts within the last 14 days before assessment
• • Able to understand verbal and written instructions in Danish
• • Able and willing to sign informed consent
• • A negative pregnancy test one-week prior to admission
• • Normal infection-, electrolyte- and coagulation-status assessed by standard blood samples
• • Patients Inclusion criteria
• • Adrenal insufficiency due to pituitary disease
• • No previous hormone producing pituitary adenomas
• • Not receiving oral contraception or other oestrogens
• • Stabil pituitary hormone replacement therapy, including hydrocortisone, for the previous three months
• • No cardiac, respiratory or lung disease.
• • No other disease that potentially requires additional hydrocortisone supplementation
• • No regular smoking
• • Not working nightshifts within the last 14 days before assessment
• • Able to understand verbal and written instructions in Danish
• • Able and willing to sign informed consent
• • A negative pregnancy test 1-week prior to admission
• • Normal infection-, electrolyte- and coagulations-status assessed by standard blood samples