| CTRI Number |
CTRI/2026/03/105120 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
01/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Utilizing Mobile Health Technology to Optimize Diabetes Management in Pregnancy |
|
Scientific Title of Study
|
Utilizing mobile health technology to optimize diabetes management in pregnancy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shoiba Khanam |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College , AMU , Aligarh |
| Address |
Shahida Manzil, near Safa school, Dhaurra Mafi, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8360046120 |
| Fax |
|
| Email |
khanamshoiba815@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shoiba Khanam |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College , AMU , Aligarh |
| Address |
Shahida Manzil, near Safa school, Dhaurra Mafi, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8360046120 |
| Fax |
|
| Email |
khanamshoiba815@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shoiba Khanam |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College , AMU , Aligarh |
| Address |
Shahida Manzil, near Safa school, Dhaurra Mafi, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8360046120 |
| Fax |
|
| Email |
khanamshoiba815@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College AMU Aligarh |
|
|
Primary Sponsor
|
| Name |
Shoiba Khanam |
| Address |
Jawaharlal Nehru Medical college , Civil Lines , Medical Road , AMU , Aligarb |
| Type of Sponsor |
Government medical 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 |
| Shoiba khanam |
Department of Obstetrics and gynaecology AMU Aligarh |
Jawaharlal Nehru Medical College AMU Aligarh
Aligarh
UTTAR PRADESH |
8360046120
khanamshoiba815@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jawaharlal Nehru Medical College & Hospital, Faculty of Medicine, Aligarh Muslim University, Aligarh, U.P., India- 202002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O097||Supervision of high risk pregnancydue to social problems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Remote monitoring via telemedicine |
Utilizing telemedicine in control and management of gestational diabetes mellitus at home |
| Comparator Agent |
Usual antenatal care as per clinical guidelines |
Self-reported logs maintained with the assistance of mobile health technology |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women diagnosed with diabetes ( gestational & pre-existing)
Patient having access to and is familiar with a mobile phone.
Patient giving consent for their inclusion in the study. |
|
| ExclusionCriteria |
| Details |
Patient not giving consent.
Unable to use or access a mobile phone. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To asses the efficacy of monitoring and counselling through mobile technology on diabetes control during pregnancy .
To access effectiveness of mobile health technology in minimizing antenatal visits . |
To asses the efficacy of monitoring and counselling through mobile technology on diabetes control during pregnancy .
To access effectiveness of mobile health technology in minimizing antenatal visits . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyse cost effectiveness of the intervention done using telemedicine . |
|
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="54"
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 2 |
|
Date of First Enrollment (India)
|
23/03/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This trial has been conducted to establish the importance of telemedicine in management of gestational diabetes at home compared to standard care. Telemedicine has emerged as a very important aspect in healthcare during COVID era and has been beneficial to a lot of patients. This reduces in person visits and hence reading chances of hospital acquired infections. |