Self-testing potassium levels using a capillary blood device

GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.

This study is testing a new device that lets people check their own potassium levels in their blood to see how well it works for both patients and healthy volunteers.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CardioRenal (industry)
• Locations: 6 sites (Grenoble and 5 other locations)
• Trial ID: NCT05975632 on ClinicalTrials.gov

What this trial studies

This multicenter, open, prospective interventional study investigates the accuracy and user proficiency of a self-testing device for measuring potassium levels in capillary blood. The study involves both calibration and comparison phases, where blood samples will be collected from patients and healthy volunteers, including those on dialysis. Participants will be trained to use the CardioRenal device for self-testing after receiving instructions. The goal is to assess the device's performance across a range of potassium concentrations.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older, both healthy individuals and those with a history of dyskalemia, who are willing to perform self-testing.

Not a fit: Patients with a medical history of seizure disorders, various forms of hemolytic anemia, or other specified conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could empower patients to monitor their potassium levels more effectively, leading to better management of their health.

How similar studies have performed: Other studies have shown promise in self-testing approaches for various health metrics, suggesting potential success for this novel application.

Eligibility criteria

Inclusion Criteria for subjects not on dialysis:

* Male/female subject, aged 18+ years ;
* Signing a written informed consent ;
* Willing to perform the self-test after viewing the instruction for use;
* Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Inclusion Criteria for hemodialysis patients:

* Male/female subject, aged 18+ years ;
* Medical history of dyskalemia ;
* Signing a written informed consent ;
* Willing to perform the self-test after viewing the instruction for use;
* Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Non-inclusion Criteria for subjects not on dialysis:

* Medical history of seizure (epilepsy)
* Known inherited hemolytic anemia
* Autoimmune hemolytic anemia
* Infectious Hemolytic anemia
* Prosthetic Cardiac valves
* Hemolytic uremic syndrome
* Peripheral edema
* Dehydration
* Peripheral Arterial Obstructive Disease (PAOD) stage 4
* Raynaud syndrome
* Known evolutive cancers
* Subjects who are pregnant or breast-feeding
* Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken
* Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
* Subject who is prohibited from participation in the study after consulting the Ministry of Health National File (e.g. indemnities \> 6000 euros for a 12-months period)

Non-inclusion Criteria for hemodialysis patients:

* Medical history of seizure (epilepsy)
* Known inherited hemolytic anemia
* Autoimmune hemolytic anemia
* Infectious Hemolytic anemia
* Prosthetic Cardiac valves
* Hemolytic uremic syndrome
* Peripheral edema
* Dehydration
* Peripheral Arterial Obstructive Disease (PAOD) stage 4
* Raynaud syndrome
* Known evolutive cancers
* Subjects who are pregnant or breast-feeding
* Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken
* Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
* Subject who is prohibited from participation in the study after consulting the Ministry of Health National File (e.g. indemnities \> 6000 euros for a 12-months period)

Where this trial is running

Grenoble and 5 other locations

• Centre d'Investigation Clinique — Grenoble, France (RECRUITING)
• CHU Grenoble-Alpes — Grenoble, France (RECRUITING)
• Agduc La Tronche — La Tronche, France (RECRUITING)
• Diaverum — Marseille, France (NOT_YET_RECRUITING)
• Hôpital Saint Joseph — Marseille, France (NOT_YET_RECRUITING)
• Biogroup — Meylan, France (RECRUITING)

Study contacts

• Principal investigator: Pierre-Louis Carron, MD — CHU Grenoble-Alpes Service de Nephrologie
• Study coordinator: Maurice BERENGER, PhD

Conditions: Potassium Measurement, self-test, capillary collection, in-vitro diagnostic medical device