To check the effectiveness and safety of blood sugar care programs in the management of high blood glucose patients.

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2023/08/057086

Lead Sponsor: Dr. Reddys Laboratories Ltd

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: All

Target Recruitment: 683

Inclusion Criteria

Adult patients (â‰¥18 years) diagnosed with T2DM.
Patients with glycated hemoglobin (HbA1c) levels â‰¥ 9% 3.
Patients possessing a personal Android (Google)/iOS smartphone with an active internet connection.
Patients who have fluency in the English language.
Patients who have signed the informed consent form and are willing to comply with the study protocol.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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
Tertiary Objectives	1. To assess the healthcare resource utilization & associated costs during the comprehensive diabetes care program

Trial Locations

Locations (12): Achintya Diabetes Care Clinic
🇮🇳
Surat, GUJARAT, India
Ananda Clinic
🇮🇳
Kolkata, WEST BENGAL, India
Centre for Diabetes Care
🇮🇳
Nagar, UTTAR PRADESH, India
Dia Care - Diabetes Care & Hormone Clinic
🇮🇳
Ahmadabad, GUJARAT, India
Diabecare Diabetes and Endocrine Clinic
🇮🇳
Mumbai, MAHARASHTRA, India
Diabetes Education and Research Foundation
🇮🇳
Jaipur, RAJASTHAN, India
Dr. Modis Clinic
🇮🇳
Hyderabad, TELANGANA, India
Dr.Nimmis Diabetes Care
🇮🇳
Gandhinagar, GUJARAT, India
Dr.Sambits Centre of Diabetes and Endocrinology
🇮🇳
Khordha, ORISSA, India
North Delhi Diabetic Centre
🇮🇳
North, DELHI, India
Scroll for more (2 remaining)
Achintya Diabetes Care Clinic
🇮🇳Surat, GUJARAT, India
Dr Vitrag Shah
Principal investigator
7016409530
care.drvitrag@gmail.com