DiabetesDiabCare AsiaNCT00788853
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Indonesia
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- How many people
- 1,832 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2008to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Repetition of any patient as patients should not be included twice for any reason.
- Unwilling to participate or unable to comply with protocol requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DiabCare Asia 2008. A Cross-sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Asia and to Evaluate Perceptions and Practices of Physicians and Patients About Diabetes Management in Asia. DiabCare Asia 2008 - Indonesia
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.
- Being tested
- No treatment given
- Keywords
- DiabCare Asia 2008, Cross-sectional survey, Glycemic control, Psychosocial well-being, Diabetic complications, Quality of life.
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment is given
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean age of onset of either type 1 or type 2 diabetes mellitus
Measured: study visit
Mean duration of treatment of type 2 diabetes mellitus.
Measured: study visit
Percentage of patients on either insulin therapy or OAD (oral anti-diabetic drug) therapy.
Measured: study visit
Mean duration of diabetes in type 1 and type 2 diabetes patients respectively.
Measured: study visit
Mean FPG (fasting plasma glucose),PPG (post prandial glucose) and HbA1c of diabetic patients.
Measured: study visit
Percentage of diabetic patients with HbA1c target below or equal to 7.0%.
Measured: study visit
Percentage of diabetic patients with HbA1c target below or equal to 6.5%.
Measured: study visit
Percentage of diabetic patients having dyslipidemia and hypertension
Measured: study visit
Percentage of diabetic patients having cardiovascular complications
Measured: study visit
Percentage of diabetic patients having peripheral vascular disease
Measured: study visit
Percentage of diabetic patients having diabetic nephropathy
Measured: study visit
Percentage of diabetic patients having diabetic eye complications
Measured: 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
Measured: study visit
Physician questionnaire measuring awareness about:HbA1c test and its goal, Anti-diabetic treatment and Barriers towards optimum diabetes control
Measured: study visit
Duration of diabetes associated with highest number of diabetic complications
Measured: study visit
Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy)
Measured: study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,832 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788853
- Sponsor's protocol ID
- INS-3677
- Acronym
- DiabCare Asia
- Status last verified
- Jun 2014
- First submitted
- 10 Nov 2008
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiabCare Asia 2008. A Cross-sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in Asia and to Evaluate Perceptions and Practices of Physicians and Patients About Diabetes Management in Asia. DiabCare Asia 2008 - Indonesia
- ClinicalTrials.gov ID
- NCT00788853
- Acronym / sponsor ID
- DiabCare Asia / INS-3677
- Keywords
- DiabCare Asia 2008, Cross-sectional survey, Glycemic control, Psychosocial well-being, Diabetic complications, Quality of life.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,832 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: No treatment given |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Repetition of any patient as patients should not be included twice for any reason.
- Unwilling to participate or unable to comply with protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenNo treatment is given | Other | A |
Primary outcome
Mean age of onset of either type 1 or type 2 diabetes mellitus
Time frame: study visit
Mean duration of treatment of type 2 diabetes mellitus.
Time frame: study visit
Percentage of patients on either insulin therapy or OAD (oral anti-diabetic drug) therapy.
Time frame: study visit
Mean duration of diabetes in type 1 and type 2 diabetes patients respectively.
Time frame: study visit
Mean FPG (fasting plasma glucose),PPG (post prandial glucose) and HbA1c of diabetic patients.
Time frame: study visit
Percentage of diabetic patients with HbA1c target below or equal to 7.0%.
Time frame: study visit
Percentage of diabetic patients with HbA1c target below or equal to 6.5%.
Time frame: study visit
Percentage of diabetic patients having dyslipidemia and hypertension
Time frame: study visit
Percentage of diabetic patients having cardiovascular complications
Time frame: study visit
Percentage of diabetic patients having peripheral vascular disease
Time frame: study visit
Percentage of diabetic patients having diabetic nephropathy
Time frame: study visit
Percentage of diabetic patients having diabetic eye complications
Time frame: study visit
4 secondary outcomes
Patients' perception will be analysed through Patient questionnaire measuring:Psychological well-being, Quality of life and Patients' compliant to treatment
Time frame: study visit
Physician questionnaire measuring awareness about:HbA1c test and its goal, Anti-diabetic treatment and Barriers towards optimum diabetes control
Time frame: study visit
Duration of diabetes associated with highest number of diabetic complications
Time frame: study visit
Minimum duration of diabetes associated with 10% incidence of diabetic complications (CVD, nephropathy and retinopathy)
Time frame: study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean age of onset of either type 1 or type 2 diabetes mellitus (time frame: study visit). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.