NCT01351922

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

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

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

May 10, 2011

Last Update Submit

January 18, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (13)

  • Mean age of onset of type 1 diabetes mellitus

    Evaluation visit

  • Mean age of onset of type 2 diabetes mellitus

    Evaluation visit

  • Mean duration of treatment of type 2 diabetes mellitus

    Evaluation visit

  • Percentage of patients on Insulin therapy

    Evaluation visit

  • Percentage of patients on Oral Anti-Diabetics Drug (OADs) therapy

    Evaluation visit

  • Mean duration of diabetes in type 1 patients

    Evaluation visit

  • Mean duration of diabetes in type 2 patients

    Evaluation visit

  • Mean FPG (fasting plasma glucose)

    Evaluation visit

  • PPG (post prandial glucose)

    Evaluation visit

  • HbA1c (Glycosylated Haemoglobin)

    Evaluation visit

  • Percentage of patients archiving HbA1c target below or equal 6.5%

    Evaluation visit

  • Percentage of patients archiving HbA1c target below or equal 7.0%

    Evaluation visit

  • Percentage of patients having complications (dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications)

    Evaluation visit

Study Arms (1)

A

Other: No treatment given

Interventions

No treatment givenOTHER

Patients will fill out a questionaire by interview.

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.

You may qualify if:

  • 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

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)

Novo Nordisk Investigational Site

Bangalore, 560001, India

Location

Related Publications (1)

  • 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.

    PMID: 24944934RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

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

May 10, 2011

First Posted

May 11, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 19, 2017

Record last verified: 2017-01

Locations

IN(1)