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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379427
• Other study ID #: SNM-NGM-001
• Status: Completed
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2020
• Source: Sciema UG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2020
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Sanmina Biosensor
non-invasive blood glucose measurement using the Sanmina Biosensor referenced with the invasive reference blood glucose device YSI 2400 Plus.

Locations

Country	Name	City	State
Germany	Pfuetzner Science & Health Institute GmbH	Mainz	Rhineland-Palatinate

Sponsors (2)

Lead Sponsor	Collaborator
Sciema UG	Sanmina

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance and accuracy of glucose levels	performance and accuracy of the Sanmina biosensors (wearable and finger clip) in monitoring glucose levels (mg/dL) during a standardized meal experiment. Measurements (during the meal experiment) of the Sanmina biosensor will be compared to the capillary blood glucose reference method YSI STAT 2300 (glucose, in mg/dL).	approx. 240 minutes
Primary	Performance and accuracy of pO2	performance and accuracy of the Sanmina biosensors (wearable and finger clip) in monitoring pO2 (%) during a standardized meal experiment. PO2-measurements (during the meal experiment) of the Sanmina biosensor will be compared to the patient monitor (%).	approx. 240 minutes
Primary	Performance and accuracy of heart rate	performance and accuracy of the Sanmina biosensors (wearable and finger clip) in monitoring heart rate (pulse/min) during a standardized meal experiment. Heart rate measurements (during the meal experiment) of the Sanmina biosensor will be compared to the patient monitor heart rate(pulse/min).	approx. 240 minutes