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CTRI Number  CTRI/2022/08/044808 [Registered on: 22/08/2022] Trial Registered Prospectively
Last Modified On: 23/03/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Development of an Algorithm for Ultrahuman Health Platform  
Scientific Title of Study   Development of an Algorithm to Assess Metabolic Health of Non-diabetic and Pre-diabetic South-Asian Population Using Continuous Glucose Monitoring Systems and Ultrahuman Health Platform  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suresh Kumar Karri 
Designation  Sr. Project Manager 
Affiliation  Triomics Healthcare Pvt Ltd 
Address  Level 5, Green Boulevard, Block C, Sector 62 Noida Uttar Pradesh 201 301 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9739798272  
Fax    
Email  suresh.karri@triomics.in  
 
Details of Contact Person
Scientific Query
 
Name  Suresh Kumar Karri 
Designation  Sr. Project Manager 
Affiliation  Triomics Healthcare Pvt Ltd 
Address  Level 5, Green Boulevard, Block C, Sector 62 Noida Uttar Pradesh 201 301 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9739798272  
Fax    
Email  suresh.karri@triomics.in  
 
Details of Contact Person
Public Query
 
Name  Suresh Kumar Karri 
Designation  Sr. Project Manager 
Affiliation  Triomics Healthcare Pvt Ltd 
Address  Level 5, Green Boulevard, Block C, Sector 62 Noida Uttar Pradesh 201 301 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9739798272  
Fax    
Email  suresh.karri@triomics.in  
 
Source of Monetary or Material Support  
Ultrahuman Healthcare Pvt Ltd 45/3, Residency Rd, Shanthala Nagar, Ashok Nagar, Bengaluru, Karnataka 560025 
 
Primary Sponsor  
Name  Ultrahuman Healthcare Pvt Ltd 
Address  1st Floor Gopala Krishna Complex, #45/3 Residency Road, Bangalore, Karnataka, India - 560025 
Type of Sponsor  Other [A preventive healthcare technology] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R P Rajesh  Aadhavvan Diabetes & Research Centre  No.3, 5th Street, Eswar Nagar, Kodambakkam, Chennai - 600024
Chennai
TAMIL NADU 
9629394222

doctorrpr@gmail.com 
Dr Prabhat Ranjan Sinha  Aakash Healthcare Private Limited Hospital  Plot Road No. 201, Sector-3, Dwarka, New Delhi -110075
South West
DELHI 
9811709628

drprabhatsinha@yahoo.com 
Dr Neeta Deshpande  Belgaum Diabetes Centre  Ground and second floor, maruti street, Belgaum- 590001
Belgaum
KARNATAKA 
9880271313

neetarohit@gmail.com 
Dr Banshi Saboo  Diacare Research  1,2 Gandhi Park, near nehrunagar, Ambawadi, Ahmedabad- 380015
Ahmadabad
GUJARAT 
8375079880

banshisaboo@hotmail.com 
Dr Suresh S M  Dr. Suresh Diacare  No 723B, 11th Main Rd, 3rd Block, Rajajinag, Bengaluru 560010
Bangalore
KARNATAKA 
9844011862

sureshhospital@gmail.com 
Dr BVSN Raju  Induss Hospital  Opposite Kothapet Fruit Market Kothapet, Sri Sai Shivani Complex, HUDA Complex, Saroornagar 500035
Hyderabad
TELANGANA 
9440383778

vsnarayanraju10@gmail.com 
Dr Sriharee Kulkarni  Kulkarnis Medzone  Kulkarrni Medzone, G D Naidu Hall, Mohan Matrix,, 450, 12th Cross Rd, near Vidya Bharathi School, Mahalakshmipuram
Bangalore
KARNATAKA 
9480427359

drsriharee@gmail.com 
Dr Pankaj Aneja  Naveda Healthcare Center  A-1/81, Sector - 8, Rohini, Delhi 110085
North West
DELHI 
9811117266

drpankajaneja@gmail.com 
Dr Hamsraj Alva  Vinaya Hospital and Research Centre (a unit of KIMS)  Karangalpady, Mangaluru-575003
Dakshina Kannada
KARNATAKA 
9343562622

hansalva2001@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Aakash Healthcare Private Limited  Approved 
Bangalore Ethics Committee  Approved 
Bangalore Ethics Committee  Approved 
Diabetes centre ethics committee  Approved 
Ethics committee Vinaya Hospital  Approved 
Independent ethics committee  Approved 
Independent ethics committee - Universal Ethics Committee  Approved 
Induss Hospital Institutional Ethics Committee  Approved 
Shrey hospital Instituitional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Non-diabetic and prediabetic participants. 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  General inclusion criteria for healthy and prediabetic population:
Subjects within the age group of 25-50 years.
Subjects willing to participate in the study.
BMI within 20 – 30 kg per m2
Willing to comply to the advised use of CGM, activity tracker, CGM reader and the UH Application.
Inclusion criteria for healthy population:
Fasting blood glucose level at screening 79-99 mg/dl
HbA1c range 4.0-5.6 percentage
2-hour plasma glucose during 75-g OGTT below 140 mg/dL (less than 7.8 mmol/L)
Inclusion criteria for prediabetic population:
Fasting blood glucose level at screening 100-125 mg/dl OR
HbA1c range 5.7-6.4 percentage OR
2-hour plasma glucose during 75-g OGTT 140–199 mg/dL (7.8–11.0 mmol/L)
 
 
ExclusionCriteria 
Details  History of acute or subacute infection in the last three months.
History of chronic illnesses and autoimmune conditions.
Subjects on antimicrobial drug agents, including antibiotics, antivirals, or antifungals
Subjects pre-diagnosed with Type 1 Diabetes
Subjects pre-diagnosed with Type 2 Diabetes Mellitus according to the ADA (American Diabetes Association) criteria.
Subjects with anemia [less than male 13 grams per dL and females less than 12 grams per dL]
Documented known medical history of any impaired renal and liver function.
Subjects diagnosed with cardiac disease, including angina, heart failure, arrhythmias, valvular heart disease, or congenital heart disease.
Subjects with regular alcohol consumption of more than eight drinks per week and 15 drinks per week in women and men, respectively.
Enrolment in any kind of weight reduction program in the last six months
Unexplained intentional or unintentional weight loss of more than 10 percent of average weight in the previous six months
Subjects currently on diet plans such as keto, low carb and intermittent fasting.
Pregnant and lactating females
Out of range results in any of the screening tests carried out for blood glucose measurements (FBG, HbA1c and OGTT tests) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
CGM-based glucose indices over 14 days of period
Mean glucose levels described by a 24-hour profile during 2 weeks
Time in glucose ranges
Glycaemic variability as measured by the standard deviation, coefficient of variation, MAGE 
Day 1 and Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in FBS from day 0 to day 15
Assessing the correlations between the biomarkers and metabolic health metrics, the key relationships to explore are:
Glucose variability indices and sleep duration
Glucose variability indices and stress (as measured by cortisol)
Glucose variability indices and inflammation (as measured by Hs-CRP)
Glucose variability indices and gut microbiome index
Glucose variability indices and urine metabolites
Glucose variability indices and physical activity (limited to step count and heart rate) 
Day 0 and Day 14 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/08/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   In this prospective observational study, eligible subjects willing to participate in the study will be screened, and the subjects meeting the eligibility criteria will be enrolled in the study. Based on the ADA criteria of Screening and Diagnostic Tests for Prediabetes, the subjects will be assigned to either group A (healthy non-diabetic subjects) or group B (pre-diabetic subjects). After the screening of the subjects, urine, stool, and blood samples will be collected for baseline investigations. All the enrolled subjects will be provided with the CGM device and trained by the on-site staff on applying it to their arms. The CGM data-collection period will be 14 days (2 weeks). Based on GV Indices, Activity & Sleep data, the UH platform will provide Nudges related to GV Indices trend. Participants can modify their diet & activities accordingly. The glucose readings will be collected by the Abbott freestyle libre CGM device, which will be scanned with the subject’s phone and the supplied Abbott CGM reader. The daily food consumption will be logged on the UH application. The activity tracker will log the physical activities, sleeping, and waking time. All participants will be provided with the necessary training to familiarize themselves with the App’s features and use.  
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