NCT00788853

Brief Summary

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. Further perceptions and practices of physicians and subjects about diabetes management in Asia will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,832

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

3 months

First QC Date

November 10, 2008

Last Update Submit

June 23, 2014

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Keywords

DiabCare Asia 2008, Cross-sectional survey, Glycemic control, Psychosocial well-being, Diabetic complications, Quality of life.

Outcome Measures

Primary Outcomes (12)

  • Mean age of onset of either type 1 or type 2 diabetes mellitus

    study visit

  • Mean duration of treatment of type 2 diabetes mellitus.

    study visit

  • Percentage of patients on either insulin therapy or OAD (oral anti-diabetic drug) therapy.

    study visit

  • Mean duration of diabetes in type 1 and type 2 diabetes patients respectively.

    study visit

  • Mean FPG (fasting plasma glucose),PPG (post prandial glucose) and HbA1c of diabetic patients.

    study visit

  • Percentage of diabetic patients with HbA1c target below or equal to 7.0%.

    study visit

  • Percentage of diabetic patients with HbA1c target below or equal to 6.5%.

    study visit

  • Percentage of diabetic patients having dyslipidemia and hypertension

    study visit

  • Percentage of diabetic patients having cardiovascular complications

    study visit

  • Percentage of diabetic patients having peripheral vascular disease

    study visit

  • Percentage of diabetic patients having diabetic nephropathy

    study visit

  • Percentage of diabetic patients having diabetic eye complications

    study visit

Secondary Outcomes (4)

  • Patients' perception will be analysed through Patient questionnaire measuring:Psychological well-being, Quality of life and Patients' compliant to treatment

    study visit

  • Physician questionnaire measuring awareness about:HbA1c test and its goal, Anti-diabetic treatment and Barriers towards optimum diabetes control

    study visit

  • Duration of diabetes associated with highest number of diabetic complications

    study visit

  • Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy)

    study visit

Study Arms (1)

A

Other: No treatment given

Interventions

No treatment givenOTHER

No treatment is given

A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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 inclusion and exclusion criteria. Patients will be selected randomly from clinic record/list to avoid any bias.

You may qualify if:

  • 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 before the initial study visit.
  • Patients willing to sign informed consent form.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Jakarta, 12520, Indonesia

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2008

First Posted

November 11, 2008

Study Start

November 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

ID(1)