An observational study in Diabetes, sponsored by DyAnsys, Inc.. Completed at 1 site in India. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by DyAnsys, Inc. · Observational
A study population with impaired fasting glucose levels, impaired glucose tolerance levels and diabetes (with or without complications) along with healthy patients will be chosen as participants. Their vital signs and their ECG (electrocardiograph) will be recorded during their only visit. Data analysis will be performed using the vital signs parameters. The RR intervals from the ECG will be analyzed by 5 different techniques to determine the best technique that stratifies the subjects the most accurately.
The Autonomic Nervous System (ANS) is a fundamental part of the nervous system in the body. And yet, there is no technique to test or measure the health and functioning of a person's autonomic nervous system.This type of study will determine the most accurate methodology to test the autonomic nervous system through heart rate variability (HRV) monitoring and gain vital information to distinguish patient groups in the diabetic population.
There is no gold standard for measuring autonomic dysfunction. Currently the method of power spectral analysis is finding very wide usage. It Is known that power spectral analysis does not discriminate the two subsystems of the ANS well. There are other beat to beat methodologies that have not yet gained traction. The reason for conducting this trial is to take a group of subjects in various stages of impaired fasting glucose, impaired glucose tolerance and diabetes (with and without complications) and determine which methodology stratifies these subjects most accurately.
Our study aims to introduce a new measurement method named the 'Beat to Beat' (BB) method for gauging autonomic dysfunction in patients. The investigators hope to observe that the average beat to beat method (BB) score could help discriminating diabetic patients into the following five distinct groups from the pilot study:
By showing that this measurement bears no relationship to the other four vital signs parameters (heart rate, blood oxygenation, blood pressure, body temperature), it will prove the necessity of this measurement in addition to the four vital signs for distinguishing patient groups among the diabetic population.
166 studies on the registry are indexed under Autonomic Nervous System Diseases; 36 are open to participants now.
This study's enrollment of 175 is above the median of 90 across 51 observational studies indexed under Autonomic Nervous System Diseases.
Browse Autonomic Nervous System Diseases studies →DyAnsys, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults of either sex with various stages of impaired fasting glucose tolerance levels and diabetes (with or without complications) will be considered as study population.
Exclusion Criteria:
Normal Glucose Tolerance (NGT) is defined as a plasma glucose concentration i.e \< 140 mg/dl. IFG is defined by an elevated fasting plasma glucose (FPG) concentration i.e ≥ 100 and \< 126 mg/dl. IGT is defined by an elevated post-prandial plasma glucose concentration i.e ≥140 and \< 200 mg/dl. Presence of confirmed diabetes (HbA1c level \> 6.4 %) without complications i.e no neuropathy, no retinopathy, no nephropathy etc. Presence of confirmed diabetes (HbA1c level \> 6.4 %) with at least one of the above complications.
Other: Device Name: ANSiscope
Heart rate variability measurement and vital signs monitoring will be performed on all subjects.
Determination of autonomic dysfunction by subject
The ANSiScope Plus will be used to determine the BB (beat to beat) score through heart rate variability measurements.
Time frame: The measurement will happen in a single visit i.e 1 day.
Establish the absence of any relationship of autonomic dysfunction (AD) to any other vital signs parameters.
Investigate the importance of measuring the autonomic dysfunction in the presence of other vital signs measurements (heart rate, body temperature, blood oxygenation and blood pressure)
Time frame: The measurement will happen in a single visit i.e 1 day.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Autonomic Nervous System Diseases→
DyAnsys, Inc.