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
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Sanmina Biosensor
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Pfuetzner Science & Health Institute GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Optimization and control 1
Optimization and control 2
Precision and accuracy
Arm 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.
The second study part/arm includes 12 patients and 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.
Outcomes
Primary Outcome Measures
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).
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 (%).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04379427
First Posted
April 29, 2020
Last Updated
May 4, 2020
Sponsor
Sciema UG
Collaborators
Sanmina
1. Study Identification
Unique Protocol Identification Number
NCT04379427
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sciema UG
Collaborators
Sanmina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optimization and control 1
Arm Type
Experimental
Arm 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.
Arm Title
Optimization and control 2
Arm Type
Experimental
Arm 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.
Arm Title
Precision and accuracy
Arm Type
Other
Arm Description
During the third study part with enrolment of 36 patients, the precision and accuracy of the final Sanmina biosensor algorithm will be demonstrated.
Intervention Type
Device
Intervention Name(s)
Sanmina Biosensor
Intervention Description
non-invasive blood glucose measurement using the Sanmina Biosensor referenced with the invasive reference blood glucose device YSI 2400 Plus.
Primary Outcome Measure Information:
Title
Performance and accuracy of glucose levels
Description
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).
Time Frame
approx. 240 minutes
Title
Performance and accuracy of pO2
Description
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 (%).
Time Frame
approx. 240 minutes
Title
Performance and accuracy of heart rate
Description
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).
Time Frame
approx. 240 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Pfuetzner Science & Health Institute GmbH
City
Mainz
State/Province
Rhineland-Palatinate
ZIP/Postal Code
55128
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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