Diabetes Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Trialists will identify 3 separate clusters of urban, rural and a special population per 20 regions in India. They will visit 2000 consecutive homes in each cluster to invite the adult family members
Sponsors
Vision Research Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Vulnerable adults in whom it may not be possible to carry out all tests 2. Anyone in the opinion of the health worker deemed not appropriate to be screened
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy and sensitivity of non-laboratory versus laboratory tests to diagnose pre-diabetes and diabetes, assessed at the study visit by the proportion of people who test positive for diabetes (true positive rate) and the proportion of test negatives who are true negatives (negative predictive value). The accuracy of non-laboratory tests will be defined by the results of standard diabetes diagnostic tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following are assessed at the study visit: 1. Specificity (true negative rate): 1.1. The proportion of people who do not have diabetes who test negative in blood tests 1.2. The proportion of people who do not have microalbuminuria who test negative in urine tests 1.3. The proportion of people who do not have diabetic retinopathy who test negative in retinal imaging 1.4. The proportion of people who do not have increased blood pressure and/or blood lipids who test negative in blood tests 1.5. The proportion of people who do not have more than one complication of diabetes who test negative in blood tests 2. Sensitivity (true positive rate): 2.1. Microalbuminuria: 2.1.1. The proportion of people who test positive for microalbuminuria 2.1.2. Accuracy of the non-laboratory test (index test) will be defined by the results of the standard panel of diagnostic tests for microalbuminuria 2.2. Diabetic retinopathy: 2.2.1. The proportion of people who test positive for diabetic retinopathy 2.2.2. Accuracy of the non-laboratory test (index test) will be defined by the results of the standard panel of diagnostic tests for diabetic retinopathy and complications of diabetes 2.3. Blood pressure and/or blood lipids: 2.3.1. The proportion of people who test positive for increased blood pressure and/or blood lipids 2.3.2. Accuracy of the non-laboratory test (index test) will be defined by the results of the standard panel of diagnostic tests for macrovascular complications of diabetes 3. Cost-effectiveness of non-laboratory tests or alternate tests compare to standard blood tests for diabetes diagnosis 4. Test acceptability, assessed using a short questionnaire comparing the acceptability of non-lab | — |
Countries
India
Outcome results
None listed