DiabetesDiabCare IndiaNCT01351922
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in India
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in India.
Trial summary
This study is conducted in Asia. The aim of this observational study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in India. Perceptions and practices of physicians and subjects about diabetes management will also 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
- 12,000 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2011to Sep 2011
- 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.
Who may be able to join
- Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit
- First twenty patients of diabetes visiting the centre during the data collection period
- Patients willing to sign the 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: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in India and to Evaluate Perceptions and Practices of Physicians and Patients About Diabetes Management in India (DiabCare India 2011)
This study is conducted in Asia. The aim of this observational study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in India. Perceptions and practices of physicians and subjects about diabetes management will also be evaluated.
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
Patients will fill out a questionaire by interview.
| 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 type 1 diabetes mellitus
Measured: Evaluation visit
Mean age of onset of type 2 diabetes mellitus
Measured: Evaluation visit
Mean duration of treatment of type 2 diabetes mellitus
Measured: Evaluation visit
Percentage of patients on Insulin therapy
Measured: Evaluation visit
Percentage of patients on Oral Anti-Diabetics Drug (OADs) therapy
Measured: Evaluation visit
Mean duration of diabetes in type 1 patients
Measured: Evaluation visit
Mean duration of diabetes in type 2 patients
Measured: Evaluation visit
Mean FPG (fasting plasma glucose)
Measured: Evaluation visit
PPG (post prandial glucose)
Measured: Evaluation visit
HbA1c (Glycosylated Haemoglobin)
Measured: Evaluation visit
Percentage of patients archiving HbA1c target below or equal 6.5%
Measured: Evaluation visit
Percentage of patients archiving HbA1c target below or equal 7.0%
Measured: Evaluation visit
Percentage of patients having complications (dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications)
Measured: Evaluation visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 12,000 participants (estimated)
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
- NCT01351922
- Sponsor's protocol ID
- INS-3933
- Other IDs
- U1111-1120-5710
- Acronym
- DiabCare India
- Status last verified
- Jan 2017
- First submitted
- 10 May 2011
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mohan V, Shah SN, Joshi SR, Seshiah V, Sahay BK, Banerjee S, Wangnoo SK, Kumar A, Kalra S, Unnikrishnan AG, Sharma SK, Rao PV, Akhtar S, Shetty RV, Das AK; DiabCare India 2011 Study Group. Current status of management, control, complications and psychosocial aspects of patients with diabetes in India: Results from the DiabCare India 2011 Study. Indian J Endocrinol Metab. 2014 May;18(3):370-8. doi: 10.4103/2230-8210.129715.
PubMed 24944934
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in India and to Evaluate Perceptions and Practices of Physicians and Patients About Diabetes Management in India (DiabCare India 2011)
- ClinicalTrials.gov ID
- NCT01351922
- Acronym / sponsor ID
- DiabCare India / INS-3933
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 May 2011 (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 the current status of diabetes management, control, and complications in diabetic subjects in India. Perceptions and practices of physicians and subjects about diabetes management will also 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.
Key inclusion criteria (3 listed)
- Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit
- First twenty patients of diabetes visiting the centre during the data collection period
- Patients willing to sign the 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 givenPatients will fill out a questionaire by interview. | Other | A |
Primary outcome
Mean age of onset of type 1 diabetes mellitus
Time frame: Evaluation visit
Mean age of onset of type 2 diabetes mellitus
Time frame: Evaluation visit
Mean duration of treatment of type 2 diabetes mellitus
Time frame: Evaluation visit
Percentage of patients on Insulin therapy
Time frame: Evaluation visit
Percentage of patients on Oral Anti-Diabetics Drug (OADs) therapy
Time frame: Evaluation visit
Mean duration of diabetes in type 1 patients
Time frame: Evaluation visit
Mean duration of diabetes in type 2 patients
Time frame: Evaluation visit
Mean FPG (fasting plasma glucose)
Time frame: Evaluation visit
PPG (post prandial glucose)
Time frame: Evaluation visit
HbA1c (Glycosylated Haemoglobin)
Time frame: Evaluation visit
Percentage of patients archiving HbA1c target below or equal 6.5%
Time frame: Evaluation visit
Percentage of patients archiving HbA1c target below or equal 7.0%
Time frame: Evaluation visit
Percentage of patients having complications (dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications)
Time frame: Evaluation 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 19 Jan 2017.
- Results publication: PubMed 24944934Mohan V, Shah SN, Joshi SR, Seshiah V, Sahay BK, Banerjee S, Wangnoo SK, Kumar A, Kalra S, Unnikrishnan AG, Sharma SK, Rao PV, Akhtar S, Shetty RV, Das AK; DiabCare India 2011 Study Group. Current status of management, control, complications and psychosocial aspects of patients with diabetes in India: Results from the DiabCare India 2011 Study. Indian J Endocrinol Metab. 2014 May;18(3):370-8. doi: 10.4103/2230-8210.129715.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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 India.
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 19 Jan 2017. 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 India. 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 type 1 diabetes mellitus (time frame: Evaluation visit). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351922, which also lists 1 linked publication.
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 19 Jan 2017.