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CTRI Number  CTRI/2023/08/057086 [Registered on: 30/08/2023] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Study 
Study Design  Other 
Public Title of Study   To check the effectiveness and safety of blood sugar care programs in the management of high blood glucose patients.  
Scientific Title of Study   To evaluate the effectiveness and safety of COMPrehensive diAbetes Care PROgram (CDCP) for the management of type 2 diabetes mellitus in India – A prospective observational study 
Trial Acronym  COMPAC Pro Study 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
Protocol No.DRL-CMD-001 Ver 2.0 Date 14 Aug 2023   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sukhpreet Singh 
Designation  Clinical Innovation Lead 
Affiliation  Dr. Reddys Laboratories Ltd. 
Address  Dr. Reddys Laboratories Ltd. Door No 8-2-337, Road No 3, Banjara Hills-500034, Hyderabad, Telangana, India

Hyderabad
TELANGANA
500034
India 
Phone  9953486799  
Fax  040-49002999  
Email  sukhpreetsingh@drreddys.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Venugopal Madhusudhana 
Designation  VP Research 
Affiliation  Sekhmet Technologies Pvt. Ltd 
Address  A Plot No. 7(2 bays), Urban Estate, Opposite Jet Airways Training Center, Sector 32 Gurgaon HARYANA India

Gurgaon
HARYANA
122001
India 
Phone  7738371973  
Fax    
Email  venugopal@thb.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Venugopal Madhusudhana 
Designation  VP Research 
Affiliation  Sekhmet Technologies Pvt. Ltd 
Address  A Plot No. 7(2 bays), Urban Estate, Opposite Jet Airways Training Center, Sector 32 Gurgaon HARYANA India

Gurgaon
HARYANA
122001
India 
Phone  7738371973  
Fax    
Email  venugopal@thb.co.in  
 
Source of Monetary or Material Support  
Dr. Reddys Laboratories Ltd Door No 8-2-337, Road No 3, Banjara Hills Hyderabad, Telangana, India 
 
Primary Sponsor  
Name  Dr. Reddys Laboratories Ltd 
Address  Door No 8-2-337, Road No 3, Banjara Hills Hyderabad, Telangana, India Hyderabad TELANGANA 500034 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vitrag Shah  Achintya Diabetes Care Clinic   Dept of Diabetes, ground floor UL-14 Aagam Krupa Complex, Near White lotus school, Surat - 395007
Surat
GUJARAT 
7016409530

care.drvitrag@gmail.com 
Dr Debmalya Sanyal  Ananda Clinic  Dept of Diabetes, ground floor, Ananda Clinic : 568, Diamond Harbour Road, Auddy Bagan Basti, Kolkata
Kolkata
WEST BENGAL 
9830118388

drdebmalyasanyal@gmail.com 
Dr Amit Gupta  Centre for Diabetes Care  Dept of Diabetes, ground floor, G8/G9, Greater Noida, Alpha 1, 201308
Gautam Buddha Nagar
UTTAR PRADESH 
9891718374

dramitaol@gmail.com 
Dr Banshi Saboo  Dia Care - Diabetes Care & Hormone Clinic  Dept of Diabetes, ground floor,#1 & 2 - Gandhi Park, 120 Feet Ring Road, Landmark: Near Nehrunagar Circle., Ahmedabad-380015
Ahmadabad
GUJARAT 
9824047676

banshisaboo98@gmail.com 
Dr Mahesh Padsalge  Diabecare Diabetes and Endocrine Clinic  Office No.:3, Plot No.-46 & 47 Ramkrishna CHS Opp. Nexus Mall Sec-40, Seawoods (W), Navi Mumbai- 400706
Mumbai
MAHARASHTRA 
9322509497

drmaheshpadsalge@gmail.com 
Dr S S Dariya  Diabetes Education and Research Foundation  Dept of Diabetes, ground floor, B-64, Shyam Mitra Mandalnagar,Opposite road no. 5, V.K.I.A, Jaipur, Rajasthan-302039
Jaipur
RAJASTHAN 
9414270277

drssdariya@gmail.com 
Dr K D Modi  Dr. Modis Clinic  Dept of Diabetes, ground floor,10-2-509, Royal Castle Building, Mehdipatnam, Landmark: Beside Siddiqua Function Hall, Hyderabad
Hyderabad
TELANGANA 
9848115322

drkdmodi@yahoo.co.in 
Dr Nimmi Mulwani  Dr.Nimmis Diabetes Care  Dept of Diabetes, 4th Floor, Aura Space, Above Tanishq, Visat Gandhinagar Highway
Gandhinagar
GUJARAT 
9428421863

drnimmisdiabetescare@gmail.com 
Dr Sambit Das  Dr.Sambits Centre of Diabetes and Endocrinology  Dept of Diabetes, ground floor, N4/18 IRC Village, Swapneshwar Lane, Landmark: Near Swapneswar Temple, Bhubaneswar
Khordha
ORISSA 
8093060177

sambitd2001@yahoo.co.in 
Dr Rajeev Chawla  North Delhi Diabetic Centre  Dept of Diabetes, ground floor,180, Jai Appartment, Rohini Sector 9, Delhi - 110085, Near Metro Pillar Number-417,Opposite Geeta Ratan Public School
North
DELHI 
9811799666

rajeevaastikchawla@yahoo.com 
Dr Abhyudaya Verma  Superspeciality Endocrinology & Women Care Centre  109, Onam Plaza, AB Road, Landmark: Near Industry House, Indore
Indore
MADHYA PRADESH 
7869270767

abhyuday9@gmail.com 
Dr Rajesh Kesari  Total Care Control Diabetes Care Centre  Dept of Diabetes, ground floor, B294, New Ashok nagar opposite main gate eastend appartment and metro pillar number 159, Mayur Vihar, Landmark: New Ashok nagar near metro station, Delhi
East
DELHI 
9899155255

rajesh.kesari@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
1. Tagore Hospital Ethics Committee  Approved 
10. VMH Institutional Ethics Committee  Approved 
11. Indira IVF Hospital Ethics Committee-Kolkata  Approved 
12. Adroit Ethics Committee  Approved 
2. Royal Pune Independent Ethics Committee  Approved 
3. ACEAS-Independent Ethics Committee   Approved 
4. ACEAS-Independent Ethics Committee   Approved 
5. Good Society for Ethical Research  Approved 
6. S2J Independent Ethics Committee  Approved 
7. Good Society for Ethical Research  Approved 
8. Good Society for Ethical Research  Approved 
9. Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Not Applicable  Not Applicable 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult patients (≥18 years) diagnosed with T2DM.
2. Patients with glycated hemoglobin (HbA1c) levels ≥ 9%
3. Patients possessing a personal Android (Google)/iOS smartphone with an active internet connection.
4. Patients who have fluency in the English language.
5. Patients who have signed the informed consent form and are willing to comply with the study protocol. 
 
ExclusionCriteria 
Details  1. Patients with type 1 diabetes (T1D), gestational diabetes mellitus (GDM), latent autoimmune diabetes in adults (LADA), and maturity-onset diabetes of the young (MODY)
2. Patients with visual impairment
3. Pregnant, breastfeeding women or planning for a pregnancy in the next year
4. Patients currently enrolled in other clinical studies or participated in any clinical study in the last 6 months  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of comprehensive diabetes care program in the management of type 2 diabetes mellitus (T2DM)  3, 6, 9, & 12 months from baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. To investigate the impact of comprehensive diabetes care program on health outcomes in the patients with T2DM
2. To assess the effectiveness of continuous glucose monitoring (CGM)-guided care program in the management of T2DM
3. To evaluate the safety of comprehensive diabetes care program in the management of T2DM
 
3, 6, 9, & 12 months from baseline 
Tertiary Objectives
1. To assess the healthcare resource utilization & associated costs during the comprehensive diabetes care program
2. To evaluate the patient-reported outcomes (PROs) to assess the diabetes treatment and management satisfaction
3. To assess the acceptance of comprehensive diabetes care program 
at baseline, 3, 6, 9, & 12 months 
 
Target Sample Size   Total Sample Size="683"
Sample Size from India="683" 
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   N/A 
Date of First Enrollment (India)
Modification(s)  
17/10/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
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
Modification(s)  
Diabetes is a global health concern that requires urgent attention due to its increasing incidence and potential for serious health problems if not managed properly. In India, the number of individuals with diabetes is alarmingly high and expected to rise significantly in the coming years.2 The World Health Organization reports that a large proportion of Indians are unaware of their diabetes status, indicating a need for improved detection and management strategies.3
Maintaining optimal blood glucose control is crucial for managing type 2 diabetes mellitus (T2DM) and preventing complications. However, achieving glycemic control can be challenging due to various factors that affect blood glucose levels throughout the day. Therefore, regular monitoring is recommended, especially for individuals under the age of 45 and those with risk factors for T2DM and prediabetes. Lifestyle interventions and self-management education are also endorsed as effective strategies to prevent or delay the onset of T2DM.4,5
Digital health technologies have emerged as valuable tools for self-management of chronic diseases, including diabetes. These technologies gather data that can contribute to improving the quality of healthcare and addressing the increasing burden of diabetes. The Indian government has recognized the potential of digitization in healthcare and has launched initiatives, such as the National Digital Health Mission, to integrate technology into healthcare delivery. 7
Two digital monitoring methods, self-monitoring blood glucose (SMBG) and continuous glucose monitoring (CGM), have shown promise in helping individuals with T2DM achieve adequate glycemic control. SMBG, although a traditional method, has been proven effective for patients on insulin therapy. However, its impact on T2DM patients not on insulin therapy remains uncertain. CGM, on the other hand, offers real-time blood glucose monitoring and provides valuable insights into treatment and lifestyle impacts on daily glucose levels. It also helps monitor glycemic variability and motivates patients to manage their diabetes effectively.
Despite the potential benefits of digital technology in providing timely and connected care through real-time transmission, there is a dearth of Indian studies evaluating the role of digital technology in the effective management of T2DM. However, some studies1,20 have demonstrated the effectiveness of smartphone-connected glucometers and digital therapeutic interventions in improving glycemic control and reducing hypoglycemia episodes in Indian T2DM patients. To address this research gap and further enhance blood glucose monitoring and control, this study aims to evaluate the effectiveness and safety of a comprehensive diabetes care program (CDCP) in individuals with T2DM.
 
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