A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Malaysia (DiabCare Asia)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00877526
First received: April 6, 2009
Last updated: July 17, 2012
Last verified: July 2012
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Purpose
This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, and complications in diabetic subjects in Asia.
| Condition | Intervention |
|---|---|
|
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 |
Other: No treatment given |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Cross-Sectional |
| Official Title: | DiabCare Asia 2008 (Malaysia): 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
MedlinePlus related topics:
Diabetes
Diabetes Medicines
Diabetes Type 1
Diabetes Type 2
High Blood Pressure
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Mean age of onset of type 1 and type 2 diabetes mellitus, respectively [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
- Mean duration of treatment of type 2 Diabetes mellitus [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
- Percentage of patients on insulin and Oral Anti-Diabetics Drugs (OADs) theraphy, respectively [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
- Mean duration of diabetes in type 1 and type 2 diabetic patients respectively [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
- Mean FPG (Fasting plasma glucose), PPG (Post prandial glucose) and HbA1c of diabetic patients [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
- Percentage of diabetic patients with HbA1c target below 7.0% and below 6.5%, respectively [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
- Percentage of diabetic patients having dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications, respectively [ Time Frame: at baseline visit/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 treatmen [ Time Frame: at baseline visit/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, barriers towards optimum diabetes control [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
- Duration of diabetes associated with highest number of diabetic complications [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
- Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, Nephropathy and retinopathy) [ Time Frame: at baseline visit/study start ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Capillary or venous blood will be drawn for analysing HbA1c.
| Enrollment: | 1670 |
| Study Start Date: | May 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| A |
Other: No treatment given
Subject will only fill out a questionaire when entering the observational study.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with diabetes mellitus (both type 1 and type 2) 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 More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00877526 History of Changes |
| Other Study ID Numbers: | INS-3723 |
| Study First Received: | April 6, 2009 |
| Last Updated: | July 17, 2012 |
| Health Authority: | Malaysia: Drug Control Authority (DCA) |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013