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CTRI Number  CTRI/2016/03/006777 [Registered on: 31/03/2016] Trial Registered Retrospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [mobile phone based text messaging reminders ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of Automated Mobile Phone Text Messaging in improving glucose control in new diabetic patients 
Scientific Title of Study   A Pilot Study on the effectiveness of using Automated Mobile Phone Text Messaging in improving Glycaemic Control among Newly Detected Type 2 Diabetic Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IDRFARH001  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A Ramachandran 
Designation  President 
Affiliation  India Diabetes Research Foundation 
Address  No 28 Marshalls Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone  9841080605  
Fax    
Email  research@ardiabetes.org  
 
Details of Contact Person
Scientific Query  
Name  Dr A Ramachandran 
Designation  President 
Affiliation  India Diabetes Research Foundation 
Address  No 28 Marshalls Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone  9841080605  
Fax    
Email  research@ardiabetes.org  
 
Details of Contact Person
Public Query  
Name  Dr Satheesh K 
Designation  Senior Research Officer 
Affiliation  India Diabetes Research Foundation 
Address  No 28 Marshalls Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone  9842363895  
Fax    
Email  satresearch01@gmail.com  
 
Source of Monetary or Material Support  
India Diabetes Research Foundation No 28 Marshalls road Egmore Chennai 600008 Tamil Nadu India 
 
Primary Sponsor  
Name  India Diabetes Research Foundation 
Address  No 28 Marshalls road Egmore Chennai 600008 Tamil Naadu India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr D V L Narasimham  City Diabetes Centre  Department of Diabetology No 29 8 40/4 CHDG Street Suryaraopet, Vijayawada
Krishna
ANDHRA PRADESH 		 9848111775

manashwini97@gmail.com 
Dr Kandula Sai  Diabetes Care Hospital  Department of Diabetology, No 46 22 6 Danavaipet Rajahmundry
East Godavari
ANDHRA PRADESH 		 9949569559

sai_kandula@rediffmail.com 
Dr Vinitha Ramachandran  Dr A Ramachandans Diabetes Hospitals  Department of Diabetology No 110 Anna Salai Guindy
Chennai
TAMIL NADU 		 9841045133

vinitha7@hotmail.com 
Dr Nanditha Arun  Dr A Ramachandrans Diabetes Hospitals  Department of Diabetology No 28 Marshalls Road Egmore
Chennai
TAMIL NADU 		 9841002813

nanditha_2005@hotmail.com 
Dr Durga Prasad  Gayathri Hospital  Department of Diabetology No 484 & 485 VV Mahal Road Beside Bank of Baroda Tirupati
Chittoor
ANDHRA PRADESH 		 9966408588

jd.durga@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandrans Diabetes Hospitals/Chennai/Dr D V L Narasimham   Approved 
Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandrans Diabetes Hospitals/Chennai/Dr Durga Prasad  Approved 
Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandrans Diabetes hospitals/Chennai/Dr Kandula Sai  Approved 
Ethics Committee of India Diabetes Research Foundation and Dr A Ramachandrans Diabetes Hospitals/Chennai/Dr Vinitha Ramachandran  Approved 
Ethics Committee of India Diabetes Research Foundation and Dr A Ramchandrans Diabetes Hospitals/Chennai/Dr Nanditha Arun  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Newly Diagnosed Type 2 Diabetes Patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mobile phone based text messaging reminders   Text messages on lifestyle modification(Increased physical activity and healthy diet habits), medication adherence and diabetes awareness will be sent to the participants thrice a week at their preferred time. Total duration of SMS intervention will be for 24 months 
Comparator Agent  Standard Care  Advise on personalised diet, exercise, medication adherence and diabetes awareness at each visit (every 6 months) for 24 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Newly diagnosed Type 2 Diabetes patients not receiving any medication for diabetes.
2.Patients who consent to participate in the study.
3.Both sexes of age 20 to 60 years.
4.Having HbA1c level greater than or equal to 6.5% (48 mmol/mol) on diagnosis.
5.Willing to report periodically for investigations during the study period
6. Ability to read and understand messages.
 
 
ExclusionCriteria 
Details  1.Type 1 Diabetes
2.Major illness - such as Cancer, Cardiovascular Disease, Chronic liver or kidney disease and complications related with diabetes on diagnosis of diabetes.
3.Disorders with cognitive impairment, severe depression or mental imbalance.
4.Physical disability that would prevent regular physical activity.
5.Participants unwilling to participate in the study.
6.Participants who do not possess a mobile phone.
7.Participants not able to read and understand text messages.
8.Participants below the age of 20 years and above the age of 60 years. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in glycaemic outcome measured by HbA1c(less than or equal to 7.0% (53mmol/mol))   12 and 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in BMI  12 and 24 months 
Reduction in Blood Pressure  12 and 24 months 
Changes in Fasting and Post postprandial plasma glucose  12 and 24 months 
Changes in Lipid Profile  12 and 24 months 
Improvement in quality of life  12 and 24 months 
Acceptance of text messaging  12 and 24 months 
 
Target Sample Size   Total Sample Size="242"
Sample Size from India="242" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/12/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This study is a multicentre, randomized, open label, pilot study on the effectiveness of using automated mobile phone text messaging in improving glycaemic control among newly detected type 2 diabetic patients. Control arm will be receiving Standard care (Advice on physical  activity, healthy diet habits, medication adherence and diabetes awareness plus physicians prescribed drugs during every visit) and Intervention arm will be receiving standard care plus automated text messages weekly thrice on lifestyle modification (Increased physical  activity and  healthy diet habits), medication adherence and diabetes awareness for 24 months.121 patients with newly diagnosed type 2 diabetes will be enrolled in each arm. The study will be conducted in five centres across India. The primary outcome measures the improvement of glycaemia (HbA1c less than or equal to 7.0% (53mmol/mol)) in the intervention group in comparison with standard care. The secondary outcomes are reduction of BMI, changes in blood pressure, fasting, postprandial plasma glucose and lipid profile, improvement of quality of life and acceptance of text messages.

 
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