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

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 - COMPAC Pro Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/08/057086
Enrollment
683
Registered
2023-08-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Not Applicable: Not Applicable Control Intervention1: Not Applicable: Not Applicable

Sponsors

Dr. Reddys Laboratories Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To assess the effectiveness of comprehensive diabetes care program in the management of type 2 diabetes mellitus (T2DM)Timepoint: 3, 6, 9, & 12 months from baseline

Secondary

MeasureTime frame
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 Timepoint: 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 programTimepoint: at baseline, 3, 6, 9, & 12 months

Countries

India

Contacts

Public ContactDr Venugopal Madhusudhana

Sekhmet Technologies Pvt. Ltd

venugopal@thb.co.in7738371973

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026