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CTRI Number  CTRI/2024/10/075038 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Telemedicine follow up in uncontrolled Diabetes Mellitus Type 2 
Scientific Title of Study   A pilot randomised controlled trial comparing telephonic message based follow up versus standard of care in patients with uncontrolled Type 2 Diabetes Mellitus in Medicine OPD 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krupa Devakumar 
Designation  PG registrar 
Affiliation  Christian Medical College, Vellore 
Address  Medicine II office, Room No. 202, Radiotherapy block, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9905641929  
Fax    
Email  krupadevakumar1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vignesh Kumar Chandiraseharan 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Medicine II office, Room 202, Radiotherapy Block, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8778879558  
Fax    
Email  vigneshmmc02@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Krupa Devakumar 
Designation  PG registrar 
Affiliation  Christian Medical College, Vellore 
Address  Medicine II office, Room 202, Radiotherapy block, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9905641929  
Fax    
Email  krupadevakumar1995@gmail.com  
 
Source of Monetary or Material Support  
Thesis Research Fund Christian Medical College, Vellore 
 
Primary Sponsor  
Name  Christian Medical College, Vellore 
Address  Christian Medical College, Vellore Pin 632004 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krupa Devakumar  Christian Medical College, Vellore  Department of Medicine, Christian Medical College, Ida Scudder Road, Vellore 632004
Vellore
TAMIL NADU 
9905641929

krupadevakumar1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD (IRB), OFFICE OF RESEARCH, CHRISTIAN MEDICAL COLLEGE, VELLORE, INDIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard of care  The comparator arm will receive the current standard of care which includes dietary advice provided by the physician and/or dietician, diabetes education provided by the physician and/or diabetic nurse educator, pharmacological therapy including biguanides, sulphonylureas, DPP IV inhibitors, SGLT 2 inhibitors, Thiazolidinediones, GLP 1 analogues depending on patient’s profile, comorbidities, allergies and adverse effects.  
Intervention  Telephonic message follow up  The intervention group will receive telephonic message based follow up (upto 2 messages a week for 12 weeks) in addition to standard care. The messages will be in one of the following languages: Tamil English Hindi Malayalam Telugu Bengali It will be based on the patient’s preference. This is based on the transtheoretical model of behavioural change  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Pragmatic trial 
 
ExclusionCriteria 
Details  No consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in HbA1c  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Hba1c at 6 months
Patient satisfaction at 3 months
quality of life at 3 months
Knowledge, attitude and practices at 3 months
Depression rates at 3 months 
3 months
6 months 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   21/10/2024 
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="1"
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  

Diabetes mellitus is a complex metabolic illness marked by elevated blood sugar levels due to issues with insulin secretion or action. It affects around 422 million people worldwide, particularly impacting low- and middle-income countries and causing 1.5 million deaths annually. The cases of Diabetes in India have been steadily increasing and rural Tamil Nadu experiencing a nearly threefold increase.


Studies indicate that digital tools for health coaching and education can help improve diabetes control measures, such as HbA1c, weight loss, and blood glucose levels. One effective intervention is telephone follow-up after a hospital visit, as phones are widely used and do not require additional equipment. This method involves health-related messages and motivational calls to encourage medication adherence and lifestyle changes. The study aims to show that such telephonic follow-up interventions can improve HbA1c levels and reduce LDL cholesterol, blood pressure, and depression within three months.

    The study focuses on general medicine outpatients in Tamil Nadu with HbA1c levels exceeding 8, comparing the effectiveness of standard treatment alone versus standard treatment supplemented with telephonic follow-up. The intervention group receives six weekly messages and a phone call at six weeks from the principal investigator, with messages provided in Tamil or English based on patient preference. Patients must be over 18, easily reachable by phone, and consent to participate. Exclusion criteria are not specified. The comparator group receives standard treatment following department practices. 


   The main goal of this study is to see if telemedicine follow-up for patients is as effective as standard care in managing HbA1c levels (a measure of blood sugar) at 3 months. Secondary goals include comparing HbA1c levels at 6 months, assessing patient satisfaction with telemedicine at 3 months, quality of life and comparing the prevalence of depression at 3 months between the telemedicine and standard care groups.


 
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