Clinical trial NCT01351922: A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in India
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-05-11
Enrollment: 12000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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 inclusion and exclusion criteria.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Mean age of onset of type 1 diabetes mellitus
timeFrame: Evaluation visit
measure: Mean age of onset of type 2 diabetes mellitus
timeFrame: Evaluation visit
measure: Mean duration of treatment of type 2 diabetes mellitus
timeFrame: Evaluation visit
measure: Percentage of patients on Insulin therapy
timeFrame: Evaluation visit
measure: Percentage of patients on Oral Anti-Diabetics Drug (OADs) therapy
timeFrame: Evaluation visit
measure: Mean duration of diabetes in type 1 patients
timeFrame: Evaluation visit
measure: Mean duration of diabetes in type 2 patients
timeFrame: Evaluation visit
measure: Mean FPG (fasting plasma glucose)
timeFrame: Evaluation visit
measure: PPG (post prandial glucose)
timeFrame: Evaluation visit
measure: HbA1c (Glycosylated Haemoglobin)
timeFrame: Evaluation visit
measure: Percentage of patients archiving HbA1c target below or equal 6.5%
timeFrame: Evaluation visit
measure: Percentage of patients archiving HbA1c target below or equal 7.0%
timeFrame: Evaluation visit
measure: Percentage of patients having complications (dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications)
timeFrame: Evaluation visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.