Blood Glucose and Blood Pressure Measurements Using a Wrist Wearable Sensor
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-010799
NCT ID: NCT05904769
About this study
A non-invasive wrist-based photoplethysmography (PPG) sensor may detect changes in blood glucose level and blood pressure. The PPG signal may also be used to extrapolate a waveform that may be used as a surrogate for the cardiac QRS complex.
Aims, purpose, or objectives:
- Measure systolic and diastolic blood pressure detected by a wrist-based sensor and compare against standard of care noninvasive cuff blood pressure measurements and/or invasive arterial line measurements.
- Extrapolate a surrogate waveform for the cardiac QRS complex by training and validating against the reference electrocardiograph (ECG) waveform.
- Measure blood glucose levels detected by a wrist-based sensor and compare against fingerstick data obtained four times daily in hospitalized diabetic patients
- Measure blood glucose levels detected by a wrist-based sensor and compare against whole blood glucose identified in hospitalized patients undergoing anticipated blood glucose measurements
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Diabetic patients on insulin undergoing four times daily blood sugar checks as part of standard of care.
- Patients undergoing continuous monitoring for heart rate and blood pressure as part of their routine care.
- Patients undergoing catheter ablation for atrial fibrillation.
Exclusion Criteria:
- Patients unable to provide informed consent.
- Patients without arms as these are needed to wear the wrist-based sensor.
Eligibility last updated 10/11/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Narayan Kowlgi, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available