A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM (INSIGHT)
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This is a non-interventional, cross sectional, multicentric study in T2DM patients which will involve a single visit for study related procedures. This study will be conducted in approximately 5,000 patients at around 300 hospitals/primary care clinics across India. Approximately 18-20 patients per site will be enrolled. This study has been designed to evaluate diabetes related quality of life (DQoL), frequency and impact of hypoglycaemia in relation to HbA1c control and to assess disease modifying variables-BMI and BP in T2DM patients on oral / injectable anti-diabetic drugs with/without insulin therapy.
Condition or disease
Type II Diabetes Mellitus
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Approximately 5,000 adult patients (≥ 18 years) diagnosed with T2DM will be randomly selected from around 300 hospitals/primary care clinics across India to participate in this study.
Patients with diagnosis of T2DM for > 1 year prior to entry in the study willing and able to complete the questionnaire and on pharmacotherapy
Patients who are currently treated with a single or combination of injectable/oral antidiabetic drugs with or without insulin therapy
Treatment type must be unchanged in the previous 3 months. However, dose modifications are allowed
Patients who agree to participate in the study and give their written informed consent
Patients with type 1 diabetes
Patients with diabetic ketoacidosis and/or hyperosmolar hyperglycaemic state
Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies)
Patients with concurrent treatment involving systemic glucocorticoids. However, inhaled, locally injected and topical use of glucocorticoids is allowed
Patients suffering from severe cardiac, hepatic, renal diseases as judged by the investigator
Any condition of the patient which may have an impact on objective and outcome of the trial example: patients currently undergoing major/ minor surgical