| CTRI Number |
CTRI/2025/08/093568 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [behavioural Modification] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of an Adaptive Diabetes Management Guide on blood sugar control and quality of life in adults with type 2 diabetes |
|
Scientific Title of Study
|
The Impact Of Adaptive Diabetes Management Guide On Improving Glycemic Control And Quality Of Life In Patients With Type-2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalangutkar Gajanan Kashiram |
| Designation |
Ph. D (Scholar) |
| Affiliation |
Institute of Nursing Education |
| Address |
Institute of Nursing Education
Bambolim Goa
North Goa
GOA
403202
India |
| Phone |
9823320760 |
| Fax |
|
| Email |
gajanankalangutkar123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yogesh Kumar |
| Designation |
Professor |
| Affiliation |
Teerthankar Mahaveer College of Nursing |
| Address |
Teerthankar College of Nursing
Bagarpur, Delhi Road
Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9813893463 |
| Fax |
|
| Email |
dryogesh.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Yogesh Kumar |
| Designation |
Professor |
| Affiliation |
Teerthankar Mahaveer College of Nursing |
| Address |
Teerthankar College of Nursing
Bagarpur, Delhi Road
Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9813893463 |
| Fax |
|
| Email |
dryogesh.nursing@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Institute of Nursing Education Bambolim North Goa 403202 |
| Part Time PhD Scholar at Teerthankar Mahaveer College of Nursing Moradabad UP 244001 |
|
|
Primary Sponsor
|
| Name |
Institute of Nursing Education |
| Address |
Institute of Nursing Education, Bambolim Goa 403202 |
| Type of Sponsor |
Other [[Government Nursing College]] |
|
|
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 |
| Gajanan K Kalangutkar |
Goa Medical College and Hospital |
Room no 3, Ground floor, Institute of Nursing Education, Bambolim Goa
North Goa
GOA |
09823320760
gajanankalangutkar123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Goa Medical College Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Teerthankar Mahaveer Dental College & Research Certre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adaptive Diabetes Management Guide (ADMG) |
Experimental: Adaptive Diabetes Management Guide (structured, nurse-led, algorithm-supported program, 24 weeks).
|
| Comparator Agent |
Standard usual care protocol |
Usual care (routine OPD care + one-time leaflet). |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Type - 2 Diabetes Mellitus Patients
Patient who knows to read English, Hindi, Marathi, Konkani
Patients willing to participate in study |
|
| ExclusionCriteria |
| Details |
Type -2 diabetes Mellitus patients with co-morbidities
Patients not consenting for study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic Control Fasting Blood Sugar Levels, Random Blood Sugar Levels, Hb A1C |
After 3 Months and 6 Months Intervals of Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Quality of Life |
After 3 months of intervention and 6 Months of Intervention |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="3"
Months="0"
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
|
Quantitative Research approach will be used in this study involving experimental research design Research protocol will be prepared and presented for ethical clearance to Institutional ethical committee Ethical clearance will be obtained from Institutional Ethical Committee Pilot study will be conducted and necessary modification will be carried out Participants will be selected using probability sampling technique - simple Random technique Validated Questionnaire will be administered to study participants to assess glycemic control and quality of life Pretest will be administered to both Intervention and control group Adaptive Diabetes Management Guide will be given and necessary guidance will be provided to understand and implement in daily routine to intervention group Control group will receive routine treatment Post test will be administered in both the group at 3 month and 6 Month interval Collected data will be analysed using descriptive and inferential statistics Research finding will be documented and submitted to University as prerequisite of Doctorate degree Research findings will be published in indexed journal
|