Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00805922

Purpose

This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, complications in diabetic subjects in Asia.

Condition	Intervention
Diabetes Mellitus	Other: No treatment given

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Observational
Study Design:	Ecologic or Community, Cross-Sectional
Official Title:	DiabCare Asia 2008. A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Asia & To Evaluate Perceptions and Practices of Physicians & Patients About Diabetes Management in Asia.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Mean blood glucose parameters of diabetic patients [ Time Frame: Study start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patients' perception will be analysed through patient questionnaire measuring psychological well-being, quality of life and patients' compliant to treatment [ Time Frame: Study start ] [ Designated as safety issue: No ]
Physician perception of diabetes and its management will be analysed through physician questionnaire measuring awareness about HbA1c test and its goal, anti-diabetic treatment and barriers towards optimum diabetes control [ Time Frame: Study start ] [ Designated as safety issue: No ]
Duration of diabetes associated with highest number of diabetic complications [ Time Frame: Study start ] [ Designated as safety issue: No ]
Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, Nephropathy and retinopathy) [ Time Frame: Study start ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Capillary or venous blood will be drawn for analysing HbA1c.

Estimated Enrollment:	2329
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Other: No treatment given Capillary or venous blood will be drawn for analysing HbA1c.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with diabetes mellitus being treated at general hospitals, diabetes clinics and referral clinics will be selected according to the inclusion and exclusion criteria.

Criteria

Inclusion Criteria:

Diabetic patients registered in the particular centre for more than 12 months.
Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit.
Patients willing to sign informed consent form.

Exclusion Criteria:

Repetition of any patient as patients should not be included twice for any reason.
Unwilling to participate or unable to comply with protocol requirements.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805922

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Locations

Thailand
	Recruiting
Bangkok, Thailand, 10500

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Warattaya Faengyong, B.Sc., M.Sc.

Novo Nordisk Pharma Ltd.

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	INS-3707
Study First Received:	December 9, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00805922
Health Authority:	Thailand: Ministry of Public Health

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009