A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM (INSIGHT)
5 de septiembre de 2014 actualizado por: AstraZeneca
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
Tipo de estudio
De observación
Inscripción (Actual)
4911
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Delhi, India
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New Delhi, India
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Andhara Pradesh
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Vijayawada, Andhara Pradesh, India
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India
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Khammam, Andhra Pradesh, India
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Kurnool, Andhra Pradesh, India
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Nellore, Andhra Pradesh, India
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Vijayawada, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
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Andhra Pradesh,
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Hanamkoda, Andhra Pradesh,, India
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Kammam, Andhra Pradesh,, India
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Khammam, Andhra Pradesh,, India
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Vijayawada, Andhra Pradesh,, India
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Assam
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Guwahati, Assam, India
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Bangalore
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Mysore, Bangalore, India
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Chhattisgarh
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Bilaspur, Chhattisgarh, India
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Raipur, Chhattisgarh, India
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Goa
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Mapusa, Goa, India
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Gujarat
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Ahemdabad, Gujarat, India
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Ahmadabad, Gujarat, India
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Anand, Gujarat, India
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Chennai, Gujarat, India
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Nadiad, Gujarat, India
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Vadodara, Gujarat, India
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Haryana
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Karnal, Haryana, India
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Haryana-
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Panchkula, Haryana-, India
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Jharkhand
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Dhanbad, Jharkhand, India
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Ranchi, Jharkhand, India
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Karnataka
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Bangalore, Karnataka, India
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Kanpur, Karnataka, India
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Mangalore, Karnataka, India
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Mysore, Karnataka, India
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Trichy, Karnataka, India
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Karnatka
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Hubli, Karnatka, India
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Mangalore, Karnatka, India
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Mysore, Karnatka, India
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Kerala
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Kannur, Kerala, India
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MP
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Indore, MP, India
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Madhya Pradesh
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Bhopal, Madhya Pradesh, India
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Gwalior, Madhya Pradesh, India
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Indore(MP), Madhya Pradesh, India
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Ujain, Madhya Pradesh, India
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Maharastra
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Mumbai, Maharastra, India
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Pune, Maharastra, India
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Mahrastra
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Pune, Mahrastra, India
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New Delhi
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Delhi, New Delhi, India
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New Delh, New Delhi, India
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Orissa
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Bhubaneswar, Orissa, India
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Pondicherry
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Puducherry, Pondicherry, India
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Punjab
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Ludhiana, Punjab, India
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Rajasthan
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Jaipur, Rajasthan, India
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Jodhpur, Rajasthan, India
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Kota, Rajasthan, India
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Pushkar, Rajasthan, India
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Tamil Nadu
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Chennai, Tamil Nadu, India
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Chennai., Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Tamilnadu
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Chennai, Tamilnadu, India
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Coimbatore, Tamilnadu, India
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Cuddlore, Tamilnadu, India
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Kanchipuram, Tamilnadu, India
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Karaikal, Tamilnadu, India
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Thuckalay, Tamilnadu, India
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Trichy, Tamilnadu, India
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Vellore, Tamilnadu, India
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UP
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Bhilai, UP, India
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Fatepur, UP, India
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Ghaziabad, UP, India
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Kanpur, UP, India
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Noida, UP, India
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Uttar Pradesh
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Gorakhpur, Uttar Pradesh, India
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Lucknow, Uttar Pradesh, India
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Noida, Uttar Pradesh, India
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West Bangal
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Kolkata, West Bangal, India
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West Bengal
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Kolkata, West Bengal, India
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
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1
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire
Periodo de tiempo: 2nd February 2012 - 2nd August 2012
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2nd February 2012 - 2nd August 2012
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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HbA1c and its correlation with frequency of hypoglycemia
Periodo de tiempo: 2nd February 2012 - 2nd August 2012
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2nd February 2012 - 2nd August 2012
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Frequency and impact of hypoglycemia using HFS-II (worry subscale)
Periodo de tiempo: 2nd February 2012 - 2nd August 2012
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2nd February 2012 - 2nd August 2012
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Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)
Periodo de tiempo: 2nd February 2012 - 2nd August 2012
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2nd February 2012 - 2nd August 2012
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Abhay Raut, MD, Prashanti Clinic,
- Investigador principal: Sashi Kumar, MBBS, Dianova Diabetes Centre
- Investigador principal: Subodh Chandra, MD, Chandra Medicals Pvt. Ltd
- Investigador principal: Debashish Maji, MD, DM, Calcutta Diabetes and endocrine Foundation,
- Investigador principal: Mayur Patel, MD, Swasthya (All India Institute of Diabetes and Research)
- Investigador principal: Nallaperumal Sivagnam, MBBS, Swamy Diabetes Centre,
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2012
Finalización primaria (Actual)
1 de febrero de 2013
Finalización del estudio (Actual)
1 de febrero de 2013
Fechas de registro del estudio
Enviado por primera vez
30 de enero de 2012
Primero enviado que cumplió con los criterios de control de calidad
30 de enero de 2012
Publicado por primera vez (Estimar)
1 de febrero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de septiembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
5 de septiembre de 2014
Última verificación
1 de septiembre de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NIS-CIN-XXX-2011/3
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .