Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Sekhmet Technologies Pvt. Ltd