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

NCT04379427 | Completed

• 1 other identifier: SNM-NGM-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Optimization and control 1

EXPERIMENTAL

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

Device: Sanmina Biosensor

Optimization and control 2

EXPERIMENTAL

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

Device: Sanmina Biosensor

Precision and accuracy

OTHER

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

Device: Sanmina Biosensor

Interventions

Sanmina Biosensor DEVICE

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

Optimization and control 1; Optimization and control 2; Precision and accuracy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• years old and above;
• Anatomically suitable finger in discretion of the investigator

You may not qualify if:

• 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

Sponsors & Collaborators

• Sciema UG: lead
• Sanmina: collaborator

Study Sites (1)

Pfuetzner Science & Health Institute GmbH

Mainz, Rhineland-Palatinate, 55128, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 7, 2020
• Study Start: March 25, 2019
• Primary Completion: November 7, 2019
• Study Completion: April 1, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)