CTRI/2018/02/012074
Not Yet Recruiting
N/A
Observational, Non-invasive study to measure the Vital signs and Fingerstick Blood Glucose levels using the LifeLeaf Wristwatch
ifePlus0 sites0 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ifePlus
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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);
Outcomes
Primary Outcomes
Not specified
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