Clinical trial NCT05931926: Feasibility and Validation of the Fluispotter®, a Novel Intravenous System for Serial Blood Sampling
Official title: Feasibility and Validation of the Fluispotter®, a Novel Intravenous System for Serial Blood Sampling
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Adrenal Insufficiency
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with secondary pituitary insufficiency

Brief summary: The purpose of this study is to test the Fluispotter® technology: A novel system for collection of serial venous samples, which may overcome some of the problems associated with repeated sampling or 20-hour collection of blood samples using standard procedures. The Fluispotter® is the first fully automated, wearable device for obtaining serial blood samples from humans. It is designed to function without operator intervention. The wearable device and - when in place - painless sampling allow sampling during different situations e.g., during sleep, work, play or exercise - whatever the sampling situation requires, including sampling not possible today using wet samples e.g. during everyday activities. Further, it reduces the number of man-hours needed for serial sampling, and minimizes the risks of sample loss, wrong timing, misidentification and contamination.

The primary purpose of this investigator-initiated study is to assess the feasibility, including benefits and harms, of the Fluispotter®, a novel method for serial blood sampling, versus standard blood sampling. The planned setting is a test of the Fluispotter® is a 20-hour period in healthy adults and in adults with secondary adrenal insufficiency due to pituitary disease.

Detailed description: Background In an every-day endocrine setting the dynamic response of hormones is assessed for the diagnosis and evaluation of several conditions such as adrenal insufficiency, Cushing's disease, acromegaly, and growth hormone insufficiency. These procedures require repeated venous sampling. A novel system for collection of serial samples, the Fluispotter®, may overcome some of these problems associated with repeated sampling or 20-hour collection of blood samples. The Fluispotter® is the first fully automated, wearable device for obtaining serial blood samples from humans. It is designed to function without operator intervention. The wearable device and - when in place - painless sampling allow sampling during different situations e.g., during sleep, work, play or exercise - whatever the sampling situation requires, including sampling not possible today using wet samples e.g. during everyday activities. Further, it reduces the number of man-hours needed for serial sampling, and minimizes the risks of sample loss, wrong timing, misidentification and contamination. The dried blood spot technology used in the Fluispotter® was tested for cortisol by comparing with plasma samples and the interassay accuracy and precision were reported to less than 10% across a range of different haematocrit values.

Aim The primary purpose of this investigator-initiated study is to assess the feasibility, including benefits and harms, of the Fluispotter®, a novel method for serial blood sampling, versus standard blood sampling. The planned setting is a test of the Fluispotter® is a 20-hour period in healthy adults and in adults with secondary adrenal insufficiency due to pituitary disease.

The primary outcome for this study is feasibility. This will be assessed using a standardized questionnaire for both staff and participants including items regarding duration of the insertion procedure, ease of insertion, number of re-insertions during the 20-hour study, number of occlusions. Participants will also be asked about perception of pain during insertion, overall acceptance of insertion, acceptance of catheter during the 20-hour admission, and for an overall preference between the new method and conventional blood sampling. In addition, participants will be contacted one week after admission regarding problems related to catheter insertion such as haematomas, pain, infection.

Secondary outcomes will be to assess the validity of cortisol concentrations measured by Dried Blood Spot technology, i.e. the Fluispotter®, compared to the standard blood sampling technique in a clinical setting. Also, Study 1 will compare diurnal cortisol profiles in healthy adults and patients with secondary adrenal insufficiency as well as assessing if the Fluispotter® performs the planned sampling.

Participants In Study 1 a total of 20 individuals will be included, 10 of whom (5 healthy women and 5 healthy men) will constitute the healthy adults and will be recruited through media advertisements.

Five women and 5 men diagnosed with secondary adrenal insufficiency due to pituitary disease will be recruited as patients.These 10 participants will constitute the patient group

The intervention takes place at the Department of Endocrinology and Metabolism at Rigshospitalet, Copenhagen, Denmark.

Sampling Sampling from the Fluispotter® is automatic and does not require attendance from staff. The Fluispotter® will be programmed for 20 samplings at 11:00 am, 13:00 p.m., 17:00 p.m., 21:00 p.m., 23:00 p.m., 00:50 a.m., 02:00 a.m., 02:50 a.m., 04:00 a.m., 04:30 a.m., 05:00 a.m., 05:30 a.m., 06:00 a.m., 06:15 a.m., 06:30 a.m., 06:45 a.m., 07:00 a.m., 07:15 a.m., 07:30 a.m. and 08:00 a.m. The cassettes containing the dried blood spots will be stored at -80◦C until analysis.

Also, eighteen samples from the venous catheter will be drawn at 11:00 am, 13:00 p.m., 17:00 p.m., 21:00 p.m., 23:00 p.m., 01:00 a.m., 03:00 a.m., 04:00 a.m., 04:30 a.m., 05:00 a.m., 05:30 a.m., 06:00 a.m., 06:15 a.m., 06:30 a.m., 06:45 a.m., 07:00 a.m., 07:15 a.m., 07:30 a.m. and 08:00 a.m.

One week after admission the patients will be scheduled for a post-intervention interview. At this visit the patients' arms will be checked for haematomas and the patients will be asked about possible health problems occurring which have arisen after the admission.

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

Primary outcomes:
measure: Feasibility - subjects
timeFrame: Day 2-7
Secondary outcomes:
measure: Number of succesfull samples by the Fluispotter
timeFrame: Day 2
measure: Feasibility - operator
timeFrame: Day 1
Other outcomes:
measure: Increase of cortisol due to sampling stress
timeFrame: through study completion, an average of 1 year
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Ulla Feldt-Rasmussen, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ollerenshaw JD, Schroder M, Velschow S. A novel device for serial venous blood sampling in a canine model. J Pharmacol Toxicol Methods. 2022 Mar-Apr;114:107155. doi: 10.1016/j.vascn.2022.107155. Epub 2022 Jan 14.
citation: Adhikari KB, Rohde M, Velschow S, Feldt-Rasmussen U, Johannesen J, Johnsen AH. Fluispotter, a novel automated and wearable device for accurate volume serial dried blood spot sampling. Bioanalysis. 2020 May;12(10):665-681. doi: 10.4155/bio-2020-0048. Epub 2020 Jun 3.