| CTRI Number |
CTRI/2026/02/103857 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Impact Of Point-of-care-testing of HbA1c On Glycemic Control In Patients of Non-Communicable Diseases Clinic Of A Health And Wellness Centre Of West Bengal, India: A Quasi-experimental Study |
|
Scientific Title of Study
|
Assessment Of Impact Of Point-of-care HbA1c Testing On Glycemic Control In People Living With Diabetes Attending A Health And Wellness Centre Of West Bengal, India: A Quasi-experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeevan Muktha Somashekara |
| Designation |
Academic Junior Resident |
| Affiliation |
AIIMS Kalyani |
| Address |
Department of CM & FM, 3rd floor, academic block 1, AIIMS Kalyani, NH 34 connector, Basantapur, Saguna, Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
7259118018 |
| Fax |
|
| Email |
jeevanmuktha18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Farhad Ahamed |
| Designation |
Additional professor |
| Affiliation |
AIIMS Kalyani |
| Address |
Department of CM & FM, 3rd floor, academic block 1, AIIMS Kalyani, NH 34 connector, Basantapur, Saguna, Kalyani
NH34 Connector, Basantapur, Saguna, Nadia
Kolkata
WEST BENGAL
741245
India |
| Phone |
9711813486 |
| Fax |
|
| Email |
farhad.cmfm@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jeevan Muktha Somashekara |
| Designation |
Academic Junior Resident |
| Affiliation |
AIIMS Kalyani |
| Address |
Department of CM & FM, 3rd floor, academic block 1, AIIMS Kalyani, NH 34 connector, Basantapur, Saguna, Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
7259118018 |
| Fax |
|
| Email |
jeevanmuktha18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Journal of Community Medicine and Indian Association of Preventive and Social Medicine,
Secretariate, Department of Community Medicine, Dr.Ram Manohar Lohia Institute of Medical Sciences, Lucknow, UP 226010 |
|
|
Primary Sponsor
|
| Name |
Jeevan Muktha Somashekara |
| Address |
Department of CM & FM, 3rd floor, Academic block 1, AIIMS Kalyani, NH 34 connector, Basantapur, Saguna, Kalyani, Nadia, 741245 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Farhad Ahamed |
All India Institute of Medical Sciences Kalyani |
Urban Primary health centre 1 and 2 of All India Institute of Medical Sciences Kalyani, Kalyani, Nadia, West Bengal
Kolkata
WEST BENGAL |
09711813486
jeevanmuktha18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Nil (Routine NCD care) |
Diabetics attending the NCD Clinic of the control UPHC. will undergo routine NCD care services and be followed up at 0,3 and 6 months. |
| Intervention |
Point of care HbA1c testing |
Diabetics attending the NCD Clinic of the intervention UPHC will undergo point of care HbA1c testing on the day of their visit before consulting the physician thrice (at 0, 3 and 6 months). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients attending the NCD Clinic of the selected UPHC with history of diabetes for atleast 6 months will be screened and recruited consecutively
Should be a patient registered in the NCD registry of the selected primary health centre |
|
| ExclusionCriteria |
| Details |
Those who do not provide consent
Those who do not have their previous medication records/ OPD slips of last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion change in diabetics with glycemic control |
At 0, 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compliance to blood investigation and medications |
0, 6 months |
| Patient satisfaction |
0, 3, 6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
23/02/2026 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background Lack fo compliance to blood investigations is one of the reasons for poor glycemic control among diabetics attending NCD clinics of HWCs. Point of care testing of HbA1c might be helpful in improving the blood investigation compliance and result in better glycemic control.
Objectives Primary To assess the impact of POC HbA1c testing on glycemic status of diabetics attending to the NCD clinics of HWC-UPHC of Kalyani, West Bengal secondary To assess the impact of POC HbA1c testing on patient satisfaction and compliance to blood investigations and medications
Methodology It will be a quasi-experimental study conducted in NCD clinics of two HWC-UPHCs of Kalyani, West Bengal considering one HWC-UPHC as intervention and other as control arm. Data on glycemic status (FBS, PPBS or HbA1c), compliance to blood investigations and medications and patient satisfaction will be collected apart from sociodemographic and comorbidity details at 0,3 and 6 months. Point of care HbA1c testing before physician consultation along with routine NCD care will be provided at 0, 3 and 6 months in the intervention HWC-UPHC while routine NCD care will be provided at control HWC-UPHC. The change in the proportion of diabetics under glycemic control will be determined and compared between the interventiona and control arms.
Expected outcomes Evidence will be generated regarding impact of POC HbA1c testing on glycemic status of diabetics attending to the NCD clinics of HWC-UPHC and will aid in formulating polies accordingly. |