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CTRI Number  CTRI/2023/03/051077 [Registered on: 27/03/2023] Trial Registered Prospectively
Last Modified On: 31/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Developing a hospital based electronic diabetes diary for diabetes management 
Scientific Title of Study   Development and testing of an electronic diabetes diary integrated with hospital information system for individuals with Type 2 Diabetes Mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Geena Mary Skaria 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Department of Health Information Management Manipal College of Health Professions MAHE, Manipal
Flat No- D 1703, D wing Royal Embassy Apartments, Vidyaratna Nagar
Udupi
KARNATAKA
576104
India 
Phone  9207379805  
Fax    
Email  geena.skaria@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Geena Mary Skaria 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Department of Health Information Management Manipal College of Health Professions MAHE, Manipal
Flat No- D 1703, D wing Royal Embassy Apartments, Vidyaratna Nagar
Udupi
KARNATAKA
576104
India 
Phone  9207379805  
Fax    
Email  geena.skaria@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Geena Mary Skaria 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Department of Health Information Management Manipal College of Health Professions MAHE, Manipal
Flat No- D 1703, D wing Royal Embassy Apartments, Vidyaratna Nagar
Udupi
KARNATAKA
576104
India 
Phone  9207379805  
Fax    
Email  geena.skaria@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Self 
Address  Assistant Professor Dept. of Health Information Management, MAHE, Manipal 576104, Udupi, Karnataka 
Type of Sponsor  Other [] 
 
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 Sahana Shetty  Kasturba Hospital  Dept. of Endocrinology (3rd Floor) Kasturba Hospital Manipal
Udupi
KARNATAKA 		 9944745014

sahana.shetty@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Kasturba Medical College and Kasturba Hospitale,   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 
Intervention  mobile Health application(electronic diabetes diary)  The study intends to develop a self-managed glucose monitoring system named Electronic Diabetes Diary abbreviated as EDDy, specifically for diabetes patients with the intention of giving them more control over their health information management practices. The study focuses on developing a digital diary that will be managed by the patient, at the same time will be connected to the doctor’s computer thus ensuring a two-way communication between the doctor and the patient module, thus ensuring prevention of data loss, better tracking of the patient’s diabetes history and better treatment plan. It is expected to improve the experience of their diabetes management, communication with healthcare providers and easy health information management. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  To analyze the health information management practices followed by Diabetes patients in management of their diabetes before and after the interventional mechanism
 Patients with in the age group of 40 to 65 who is diagnosed with Type 2 DM for a period of ≥ 2 years who are using glucometer
 HbA1c values between 7 to 10 %.
 Active patient at KH endocrinology OPD.
 Literate
 Patients using android smart phones.
 
 
ExclusionCriteria 
Details   Gestational Diabetes.
 Patient’s with other terminal illness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
identify the reasons for non-adherence, expectations from electroniv diabetes diary and mandatory requirements to develop the intervention mechanism.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Customized mHealth application can provide sufficient information for persons diagnosed with T2DM. This can lead to an effective intervention which will reduce the risk of person diagnosed with T2DM developing further disease complication like CKD, diabetic foot, retinopathies and peripheral neuropathies and thereby reduce cost of healthcare expenditure.  3 months 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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 3 
Date of First Enrollment (India)   23/09/2025 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [geena.skaria@manipal.edu].

  6. For how long will this data be available start date provided 01-06-2023 and end date provided 31-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Considering India’s ever-growing rate of Non-Communicable Diseases (NCDs), thinking beyond medical management of diseases is the idea behind this study. Type 2 Diabetes Mellitus (T2DM)is one of the leading NCD of our country that requires constant care and medication. The medical management and diabetes self-management practices (DSM) are essential to keep T2DM under check. To add value to the existing practices and with an intention of popularize mHealth application among general population, this study is focusing on developing a customized mHealth model that will be integrated with Hospital Information System (HIS) to enable real time transfer of information between patient’s module and doctor’s module. The information saved on EHR will facilitate clinician to have a clear picture of the patient’s diabetic history and accordingly treatment modification can be done. This self-documentation practice is an integral part of diabetes treatment and the study expects positive outcomes like better adherence to DSM practices and better treatment outcome. The outcome of the study will be beneficial in developing similar mHealth models for management of such diseases which will require intense care.

 
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