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
|
|
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. |