| CTRI Number |
CTRI/2021/08/035618 [Registered on: 12/08/2021] Trial Registered Prospectively |
| Last Modified On: |
18/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A single arm prospective observational study to analyze Type 2 Diabetes Glucose biomarkers with daily prick tests. |
|
Scientific Title of Study
|
A single arm prospective observational study to analyze Type 2 Diabetes Glucose biomarkers with daily prick tests on non-medicating type 2 diabetes patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGCTS/20/108 Version no 01 dated 09 Dec 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Gupta |
| Designation |
Principal Investigator |
| Affiliation |
Sunils Diabetic care n research centre |
| Address |
Sunils Diabetic care n research centre, 42 Lendra park, Ramdaspeth Nagpur-440010
Maharashtra, India
Nagpur
MAHARASHTRA
440010
India |
| Phone |
|
| Fax |
|
| Email |
drsunil492@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Gupta |
| Designation |
Principal Investigator |
| Affiliation |
Sunils Diabetic care n research centre |
| Address |
Sunils Diabetic care n research centre, 42 Lendra park, Ramdaspeth Nagpur-440010
Maharashtra, India
Nagpur
MAHARASHTRA
440010
India |
| Phone |
|
| Fax |
|
| Email |
drsunil492@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Gupta |
| Designation |
Principal Investigator |
| Affiliation |
Sunils Diabetic care n research centre |
| Address |
Sunils Diabetic care n research centre, 42 Lendra park, Ramdaspeth Nagpur-440010
Maharashtra, India
Nagpur
MAHARASHTRA
440010
India |
| Phone |
|
| Fax |
|
| Email |
drsunil492@gmail.com |
|
|
Source of Monetary or Material Support
|
| Klick Inc 175 Bloor Street East Suite 300, North Tower
Toronto, ON, M4W 3R8, Canada
|
|
|
Primary Sponsor
|
| Name |
Klick Inc |
| Address |
175 Bloor Street East
Suite 300, North Tower
Toronto, ON, M4W 3R8, Canada
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhijit Munshi |
Sunils Diabetic care n research centre |
42 Lendra Park, Ramdaspeth
Nagpur
MAHARASHTRA |
9822371703
drabhijitmunshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Arnejas Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are diagnosed with T2D must have a confirmation according to their latest medical records from a certified physician
No restrictions on gender or ethnicity will be implemented
Participants must speak English fluently (no restrictions on language accent)
Subjects willing to give written informed consent
Subjects able to comply with the study protocol
|
|
| ExclusionCriteria |
| Details |
Any person below the age of 18 years or above the age of 60 years
Suspected or confirmed pregnancy
Currently breastfeeding
Diagnosis of any known chronic or acute medical disease other than T2D (e.g., cardiovascular disease, respiratory disease, influenza, pneumonia, etc.)
Diagnosis of any known neurological disease or psychological disorder of any kind (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.)
Any implanted electrical medical device (e.g., pacemaker, insulin pump, deep brain stimulator, etc.)
Use of antibiotics in the three months prior to enrollment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glucose data after 3 weeks(21 days) |
3 weeks(21 days) |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/08/2021 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational study to analyze voice changes with glucose levels |