Multi-centre risk-based screening for diabetes and its complications
| ISRCTN | ISRCTN57962668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57962668 |
| Secondary identifying numbers | V1.0 |
- Submission date
- 18/08/2018
- Registration date
- 24/09/2018
- Last edited
- 07/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
This study will test the accuracy of a number of non-laboratory tests to diagnose diabetes and pre-diabetes and their associated complications compared to the standard laboratory tests and retinal photographic images grading for diabetic retinopathy.
The tests will be done in 48,000 adult individuals at their homes across 20 regions in India and will include both rural and urban areas. In addition, special communities will also be included to ensure generalisability of the results and identify any high risks groups for diabetes and/or its complications.
The interventions are non-laboratory tests and these will be compared to the standard blood tests to test how accurately and cost-effectively these tests can identify people with diabetes, pre diabetes and those with complications of diabetes.
The standard tests are blood sugar tests, lipid profile and urine test for microalbuminuria. There are various blood tests available to test for diabetes and pre-diabetes and the ideal clinical and cost-effective point of care laboratory test will also be evaluated.
The most cost -effective tests may not be the most accurate tests. So the study will also evaluate the rate of false or over diagnosis of diabetes and its complications with non-laboratory tests compared to laboratory tests.
Participants whose retinal photographs are graded for treatable retinopathy will be treated at the research sites. The study will allow us to report the overall prevalence and regional prevalence of diabetic retinopathy and sight threatening retinopathy. As we are using a point of care retinal camera, the study will also evaluate the feasibility of this camera in terms of gradebale images, acceptability, the need for mydriatic eye examination. A diabetic care pathway will be established and a process evaluation of this pathway will be reported.
The anonymised data will be collected on a web-based database and will include the whole pathway from the point of identification of patient to treatment of diabetic retinopathy if required.
The study will also increase public awareness of diabetes and its complications and barriers and enhancers of the diabetes care pathway will be evaluated qualitatively.
Background and study aims
Current diagnoses of diabetes and its complications such as retinopathy (eye problems), diabetic kidney disease, stroke and ischaemic heart disease and diabetic foot are based on expensive tools and laboratory tests. Therefore, these are not accessible to many people around the world, meaning that we have a lack of data on the prevalence of diabetic retinopathy or a diabetic care pathway that is cost-effective in low and medium income countries. Non-laboratory tests may be more cost-effective than laboratory tests, and therefore may be more accessible in these countries.
This UK-India collaborative study will test whether non-laboratory tests could be accurately used to diagnose diabetes and each complication of diabetes. The aim is to find the most cost-effective test, or tests that include questionnaires and demographic data that could accurately be used, instead of the current standard tests that are not accessible to several people around the world because of the costs. The study will also allow us to report the overall prevalence and regional prevalence of diabetic retinopathy and sight-threatening retinopathy in India using a point of care retinal camera. By conducting a national study, we will also be able to evaluate the feasibility of a diabetic care pathway in India.
Who can participate?
The non-laboratory tests and standard tests will be done in 48,000 adult individuals by home visits by trained health workers across 20 regions in India and will include both rural and urban areas. In addition, special communities will also be included to ensure that the results may be used across all people with diabetes and/or its complications.
What does the study involve?
Health workers will conduct house to house visits in the study regions to ask participants to complete questionnaires and blood/urine tests, and capture retinal images using point of care kits. Anonymised data from the study will be sent to the UK for statistical and health economics analysis and for joint reporting of study findings.
What are the possible benefits and risks of participating?
The public awareness of diabetes and its complications will increase and people with newly identified conditions as a result of this study can be promptly treated. There are no known risks to participants taking part in this study.
Where is the study run from?
Vision Research Foundation, Chennai, India
When is the study starting and how long is it expected to run for?
October 2017 to September 2021
Who is funding the study?
The Global Challenge Research Fund, Medical Research Council (UK)
Who is the main contact?
Professor Sobha Sivaprasad, Moorfields Eye Hospital, London, UK
senswathi@aol.com
Contact information
Scientific
NIHR Moorfields Biomedical Research Centre
162, City Road
London
London
EC1V 2PD
United Kingdom
 ORCID ID |
0000-0001-8952-0659 |
|---|
Scientific
Institute of Ophthalmology
11-43 Bath Street
London
EC1V 9EL
United Kingdom
| Phone | 020 7608 6800 |
|---|---|
| d.conroy@ucl.ac.uk |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Home |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Translating research into clinical and community practice: a multi-centre statistical and economical modelling of risk-based stratified and personalised screening for complications of diabetes in India (SMART India). |
| Study acronym | SMART India |
| Study objectives | We hypothesise that non-laboratory tests may be sufficient to identify pre-diabetic and diabetic patients. We also hypothesise that patients with complications of diabetes can be discriminated from persons with no complications by one or a combination of tests that may be more cost-effective than current standard tests. |
| Ethics approval(s) | Vision Research Foundation, Institutional Review Board 09/05/2018, reference: 674A-2018-P |
| Health condition(s) or problem(s) studied | Diabetes |
| Intervention | 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 to participate in this study. After written informed consent, the trialists will obtain demographic data, and ask participants to complete questionnaires. They will also obtain blood pressure and blood sugar measurements from participants. Patients with diabetes or with a blood test positive for diabetes based on standard tests will complete further questionnaires (EuroQol-5D (EQ-5D) andVision and Quality of Life Index (VisQOL)) and expenses data, and have blood lipid tests and urine test for microalbuminuria. Retinal photography will also be completed. The retinal images will be sent for grading by primary and secondary graders, and an arbitration grader if required. The accuracy of non-laboratory tests will be measured against standard diagnostic tests for diabetes. Furthermore, accuracy of non-laboratory tests will be measured against standard tests for complications of diabetes. |
| Intervention type | Not Specified |
| Primary outcome measure | 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 outcome measures | 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-laboratory tests with standard diagnostic tests 5. Overall and regional prevalence of diabetic retinopathy and sight-threatening retinopathy, assessed by examining adjusted prevalence of diabetic retinopathy at national, regional and community worries 6. Qualitative evaluation of enhancers of the diabetes care pathway, assessed using Medical Research Council (MRC) guidance on process evaluations (including intervention, context, implementation, mechanisms of impact and outcomes). These components will be studied using quantitative and qualitative methods including questionnaires, on-site visits and interviews. |
| Overall study start date | 01/10/2017 |
| Completion date | 12/09/2021 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 48,000 across 20 regions to include urban and rural population and people within special communities to test for generalisability |
| Total final enrolment | 42416 |
| Key inclusion criteria | 1. Aged 18 years or older 2. Able to give informed consent |
| Key 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 |
| Date of first enrolment | 25/08/2018 |
| Date of final enrolment | 31/03/2020 |
Locations
Countries of recruitment
- India
Study participating centres
No. 41 (old 18), College Road
Chennai
600 006
India
Near Satyam Cinemas, Gopalapuram
Chennai
600086.
India
Madurai
625020
India
Hyderabad
500034
India
Kolkata
700099
India
Bengaluru
560008
India
Coimbatore
641002
India
Kochi
682020
India
Mumbai
400031
India
Aluva
683101
India
New Delhi
110002
India
Bhubaneswar
751024
India
Guwahati
781028
India
Bhopal
462016
India
Chitrakoot
485334
India
Raipur
492001
India
Haldia
721645
India
Little Flower Hospital and Research Centre
P.O. Box NO. 23
Angamaly
683572
India
Devalgaon Raja-Mantha road
Opposite Janta High school
Janla
431203
India
Survey No. 93, Taravade Vasti
Mohammedwadi Road, Hadapsar
Pune
411060
India
Sponsor information
Research organisation
41, College Road, Chennai
Chennai
600 006
India
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Current publication and dissemination plan as of 26/10/2022: A first publication has been accepted (Apr 2022) by Lancet Global Health entitled: Prevalence of diabetic retinopathy in India stratified by known and undiagnosed diabetes, urban-rural locations, and socio-economic indices: results from the SMART India population-based cross-sectional screening study. Another paper is being prepared for submission Previous publication and dissemination plan: We intend to publish in peer-reviewed journals and presentations by December 2021. The primary and secondary outcomes will be published separately. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 12/12/2020 | 10/08/2021 | Yes | No | |
| Results article | 31/10/2022 | 07/12/2022 | Yes | No |
Editorial Notes
07/12/2022: Publication reference added.
26/10/2022: The publication and dissemination plan was updated.
14/07/2022: The following changes were made to the trial record:
1. The overall end date was changed from 04/06/2021 to 12/09/2021.
2. The intention to publish date was changed from 01/07/2022 to 31/12/2022.
3. The plain English summary was updated to reflect these changes.
11/01/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2020 to 04/06/2021.
2. The intention to publish date was changed from 31/03/2022 to 01/07/2022.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was changed from 57808 to 42416.
10/01/2022: The intention to publish date was changed from 28/02/2022 to 31/03/2022.
13/12/2021: The intention to publish date was changed from 31/12/2021 to 28/02/2022.
13/08/2021: The IPD sharing statement has been added and the Participant level data has been changed from "To be made available at a later date" to "Other".
10/08/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 25/08/2021 to 31/03/2020.
2. The overall trial end date was changed from 31/12/2021 to 31/12/2020.
3. The intention to publish date was changed from 12/12/2021 to 31/12/2021.
4. Publication reference and total final enrolment number added.
