Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-07 @ 10:30 AM
Study NCT ID:
NCT04379427
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Sciema UG
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: