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CompletedNCT04379427Updated May 7, 2020

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

An interventional study of Sanmina Biosensor in Diabetes Mellitus, sponsored by Sciema UG. Completed at 1 site in Germany. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-07.

Sponsored by Sciema UG · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Mar 2019, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sciema UG is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Optimization and control 1

    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

  • Experimental
    Optimization and control 2

    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

  • Other
    Precision and accuracy

    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

  • DeviceSanmina Biosensor

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: approx. 240 minutes

  2. 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 (%).

    Time frame: approx. 240 minutes

  3. 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).

    Time frame: approx. 240 minutes

07

Study locations

1 site
  • Pfuetzner Science & Health Institute GmbH
    Mainz, Rhineland-Palatinate 55128, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04379427
Lead sponsor
Sciema UG
Collaborators
Sanmina
Responsible party
Sponsor
First posted
May 7, 2020
Start date
Mar 25, 2019
Primary completion
Nov 7, 2019
Completion
Apr 1, 2020
Last update
May 7, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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