Measurement Algorithm Control and Optimization With Subsequent Performance Evaluation of Sanmina Non-invasive Biosensors During a Standardized Meal Test in Patients With Diabetes Mellitus Type 1 and Type 2

Sciema UG

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Sanmina Biosensor

Study type: Interventional

Funder types: Other

Identifiers

NCT04379427

SNM-NGM-001

Details and patient eligibility

About

Measurement algorithm control and optimization with subsequent performance evaluation of Sanmina biosensors in monitoring of glucose, heart rate (HR), and SpO2 in patients with type 1 and type 2 diabetes during a standardized meal experiment.

Full description

• This study is a combined, open label, prospective, comparative single-center study.
• The study is separated in 3 consecutive study parts. The first 2 study parts include 12 patients each. In the third study part 36 patients will be enrolled. Study part 1 and 2 will be used for optimization and control of the measurement algorithms of the Sanmina biosensors. During the third study part with enrolment of 36 patients, the precision and accuracy of the final Sanmina biosensor algorithm will be demonstrated. The study conduct for all 60 participants of all 3 study parts will be exactly the same. In all groups of participants, the Sanmina finger clip and wearable non-invasive monitoring biosensor will be individually introduced and assigned. During the study visit at the study site, a standardized meal will be given to the participants. At eleven time points before and after the standardized meal, glucose, heart rate, and pO2 will be measured using the Sanmina finger clip and wearable non-invasive monitoring biosensor. The measurement time points are -30, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min. The measurements will be compared to capillary blood glucose measurements by YSI Stat 2300 and StatStrip (glucose), and parallel measurements of the heart rate and the pO2 using a patient monitor. Further the exact skin colour will be evaluated using a skin colour card.

Enrollment: 60 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Type 1 or Type 2 diabetic subjects or healthy probands
• Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
• 18 years old and above;
• Anatomically suitable finger in discretion of the investigator

Exclusion criteria

• Does not meet inclusion criteria;
• Any conditions that may hamper good visual contact between the finger or wrist and sensor, such as raised birthmarks, scars, tattoos;
• Pregnancy;
• Nursing mothers;
• Any skin scratch(es), damage, over dry, long nails on the measured finger;
• Unsuitable finger with the device might be excluded if recognized during the trial;
• Medication containing nitrates

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Optimization and control 1

Experimental group

Description:

The first study part/arm includes 12 patients and will be used for optimization and control of the measurement algorithms of the Sanmina biosensors.

Treatment:

Device: Sanmina Biosensor

Optimization and control 2

Experimental group

Description:

The second study part/arm includes 12 patients and will be used for optimization and control of the measurement algorithms of the Sanmina biosensors.

Treatment:

Device: Sanmina Biosensor

Precision and accuracy

Other group

Description:

During the third study part with enrolment of 36 patients, the precision and accuracy of the final Sanmina biosensor algorithm will be demonstrated.

Treatment:

Device: Sanmina Biosensor