Measuring health vital signs and blood sugars with a wearable, noninvasive writstwatch

Not Applicable

• Registration Number: CTRI/2018/02/012074
• Lead Sponsor: ifePlus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

I.Adults aged 18-90 years and above who are either healthy adults, or

II.Carry diagnosis of Type 2 diabetes, high blood pressure, some form cardiac arrhythmia, and/or chronic obstructive pulmonary disease (COPD) (subjects with combinations of these conditions can also be included).

Group B: Subject should have history of at least one active cardiac arrhythmia including atrial fibrillation, atrial flutter/fibrillation, bigeminy / trigeminy, various types of heart block (first-degree, second-degree, third-degree), or other paroxysmal or sustained tachy- or brady-arrhythmias (other than sinus tachycardia or sinus bradycardia)

Group C: Subject should have known history of restrictive or obstructive airway/lung diseases such as interstitial lung disease, COPD, asthma or bronchitis

Exclusion Criteria

I.Patients not willing to give consent to participate in the study

II.Females of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods (double barrier methods or intrauterine device), unless they affirm that they are celibate and are willing to remain celibate for the duration of the study and to also have urinary hCG test (pregnancy test) checked on the morning of each study visit with result coming back negative for pregnancy prior to proceeding with the study visit.

III.Pregnant or lactating women.

IV.In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or plan to relocate during the study.

V. Inability to do light walking for up to 10 minutes;

VI. Inability to safely fast from midnight until noon (may drink water);

VII.History of Diabetic Ketoacidosis or Hyperosmolar Nonketotic Coma;

VIII.Sufficiently â??brittleâ?? diabetes where remaining off of diabetic medications (injectable insulin or oral medications) for the durations of the study visits would be deemed to pose a health concern;

IX.Most recently checked HbA1c >12.0;

X.Congestive heart failure (given that subjects will be administered fluids containing sodium for this initial study);

XI.Have a pacemaker or implantable cardioverter defibrillator;

XII.History of significant peripheral vascular disease in the upper extremities including stents, bypasses, or arteriovenous grafts involving arteries of the upper extremities, history of claudication in the upper extremities, or other circumstances that would preclude safely or reliably obtaining cuff BP in the left arm;

XIII.End-stage renal disease, hyperkalemia, cardiac arrhythmia, or patients taking medications or adhering to specific dietary regimens for the purposes of lowering potassium levels.

XIV.Any circumstances where consumption of two 591.5 mL bottles of Gatorade per visit would be deemed to be acutely and significantly deleterious to a subjectâ??s immediate health from the standpoints of sodium, potassium, and sugar intake.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
At study completion, the composite measurement data for each individual will be randomly sub-divided into learning and validation sets for creation of novel algorithms to attempt to non-invasively report vital signs and Fingerstick Blood Glucose levels for each participantTimepoint: Month 1, 2, 3 and 4

Secondary Outcome Measures

Name	Time	Method
- For patients with cardiac arrhythmias, will focus on whether PPG waveforms obtained by the LifeLeaf watch can detect and classify cardiac arrhythmia events occurring during the recording. <br/ ><br>- For patients with demonstrated obstructive/restrictive pulmonary diseases, investigation will focus on whether acute changes in PPG can be used as a surrogate to track acute changes in lung function represented by a clinically established parameter, called Tiffeneau-Pinelli index (FEV1/FVC ratio).Timepoint: Month 1, 2, 3 and 4