A Survey to Evaluate Diabetes Management, Control, Complications and Psychosocial Aspects of Diabetic Patients in Philippines

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2
• Interventions: Other: No treatment given

• Registration Number: NCT00874159
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of this observational study is to describe the diabetes management, control status and complication profile in a diabetic population of Philippines.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-03-31
• Study Start: 2009-04
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 770

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Mean age of onset of type 1 diabetes mellitus	at baseline visit/study start
Mean age of onset of type 2 diabetes mellitus	at baseline visit/study start
Percentage of patients on Insulin therapy	at baseline visit/study start
Mean duration of treatment of type 2 DM	at baseline visit/study start
Percentage of patients on OAD therapy	at baseline visit/study start
Mean duration of diabetes in type 1 and type 2 patients respectively	at baseline visit/study start
Mean FPG of diabetic patients	at baseline visit/study start
Mean PPG of diabetic patients	at baseline visit/study start
Mean HbA1c of diabetic patients	at baseline visit/study start
Percentage of diabetic patients with HbA1c target below 7.0%	at baseline visit/study start
Percentage of diabetic patients with HbA1c target below 6.5%	at baseline visit/study start
Percentage of diabetic patients having dyslipidemia and hypertension	at baseline visit/study start
Percentage of diabetic patients having cardiovascular complications	at baseline visit/study start
Percentage of diabetic patients having peripheral vascular disease	at baseline visit/study start
Percentage of diabetic patients having diabetic nephropathy	at baseline visit/study start
Percentage of diabetic patients having diabetic eye complications	at baseline visit/study start

Secondary Outcome Measures

Name	Time	Method
Patients' perception will be analysed through Patient questionnaire measuring: Psychological well-being, Quality of life, Patients' compliant to treatment	at baseline visit/study start
Physician perception of diabetes and its management will be analysed through Physician questionnaire measuring awareness about:o HbA1c test and its goal,Anti-diabetic treatment,Barriers towards optimum diabetes control	at baseline visit/study start
Duration of diabetes associated with highest number of diabetic complications	at baseline visit/study start
Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy)	at baseline visit/study start