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Non-invasive Measurement with LIFELEAF Smartwatch for Diabetes
N/A
Recruiting
Led By Narayan Guru G. Kowlgi, MBBS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This trial tests if a smartwatch can accurately measure blood glucose, blood pressure, and heart rate.
Who is the study for?
This trial is for diabetic patients who regularly check their blood sugar four times a day and monitor heart rate and blood pressure routinely. It's also for those getting catheter ablation for atrial fibrillation. People not meeting these specific conditions cannot participate.Check my eligibility
What is being tested?
The study tests the LIFELEAF Smartwatch's ability to measure blood glucose, blood pressure, and ECG readings against standard medical devices used in healthcare settings.See study design
What are the potential side effects?
Since this trial involves non-invasive monitoring with a smartwatch, there are no direct side effects from the device itself like you might expect with medications or surgeries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood glucose level
Diastolic blood pressure
Systolic blood pressure
Trial Design
2Treatment groups
Experimental Treatment
Group I: Hospitalized Diabetic GroupExperimental Treatment1 Intervention
Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, will wear the LIFELEAF Smartwatch for the duration of their hospital stay.
Group II: Electrophysiologic (EP) GroupExperimental Treatment1 Intervention
Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,766,884 Total Patients Enrolled
21 Trials studying Diabetes
6,603 Patients Enrolled for Diabetes
Narayan Guru G. Kowlgi, MBBSPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am diabetic, use insulin, and check my blood sugar 4 times a day.I am able to understand and agree to the study's procedures and risks.I have arms to wear a wrist-based sensor.I am having a procedure to correct irregular heartbeats.
Research Study Groups:
This trial has the following groups:- Group 1: Hospitalized Diabetic Group
- Group 2: Electrophysiologic (EP) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open for the current clinical trial?
"The information on clinicaltrials.gov suggests that the medical research project, which was initially posted on June 1st 2023 and last modified a few days later, is not presently seeking participants. However, there are 183 other studies actively recruiting individuals at this juncture."
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