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Keywords:

  • tuberculosis;
  • diabetes mellitus;
  • screening;
  • India

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgements and disclaimer
  9. References
  10. Appendix 1

Objective

To assess feasibility and results of screening patients with tuberculosis (TB) for diabetes mellitus (DM) within the routine healthcare setting across the country at: eight tertiary care hospitals and more than 60 peripheral health institutions in eight tuberculosis units.

Methods

Agreement on how to screen, monitor and record was reached in October 2011 at a stakeholders' meeting, and training was carried out for staff in the facilities in December 2011 and January 2012. Implementation started from January 2012, and we report on activities up to 30 September 2012.

Results

Of 8269 TB patients diagnosed and initiated on treatment in participating facilities, 8109 (98%) were assessed for DM and 1084 (13%) were found to have DM; of these, 682 (8%) had a previously known diagnosis of DM and 402 (5%) were newly diagnosed. There was a higher prevalence of DM in patients with TB diagnosed in tertiary care hospitals (16%) than in those diagnosed in tuberculosis units (9%) (P < 0.001) and amongst those from South India (20%) than from North India (10%) (P < 0.001). The screening and referral process worked well although significantly more patients with DM diagnosed in hospitals were referred to DM care (96%) than patients diagnosed in tuberculosis units (92%) (P < 0.05).

Conclusion

This pilot project shows that it is important and feasible to screen patients with TB for DM in the routine setting, resulting in earlier identification of DM in some patients and opportunities for better management of comorbidity. A policy decision has since been made by the National TB Control Programme of India to implement this intervention countrywide.

Objectif

Evaluer la faisabilité et les résultats du dépistage du diabète sucré (DS) chez les patients atteints de tuberculose (TB) dans le cadre des soins de santé de routine à travers le pays, dans 8 hôpitaux de soins tertiaires et plus de 60 établissements de santé périphériques et dans 8 unités de TB.

Méthode

L'accord sur la façon de dépister, de suivre et d'enregistrer le dépistage a été atteint en octobre 2011 lors d'une réunion des parties prenantes et la formation du personnel a été réalisée dans les établissements en décembre 2011 et janvier 2012. La mise en œuvre a commencé en janvier 2012 et nous rapportons sur les activités jusqu'au 30 septembre 2012.

Résultats

Sur 8269 patients TB diagnostiqués pour traitement de la TB dans les établissements participants, 8109 (98%) ont été examinés pour le DS et 1084 (13%) ont été trouvés avec le DS; de ceux-ci, 682 (8%) avaient un diagnostic de DS précédemment connu et 402 (5%) étaient nouvellement diagnostiqués. Il y avait une prévalence plus élevée de DS chez les patients TB diagnostiqués dans les hôpitaux de soins tertiaires (16%) que chez ceux diagnostiqués dans les unités TB (9%) [P < 0,001] et plus chez ceux du sud de l’Inde (20%) que chez ceux du nord de l’Inde (10%) [P < 0,001]. Le processus de dépistage et d'aiguillage a bien fonctionné, bien que beaucoup plus de patients atteints de DS diagnostiqués dans les hôpitaux aient été référés à des soins de DS (96%) que les patients diagnostiqués dans les unités TB (92%) [P < 0,05].

Conclusion

Ce projet pilote montre qu'il est important et possible de dépister le DS chez les patients atteints de TB dans le cadre des soins de routine, ce qui entraîne une identification plus précoce du DS chez certains patients et une meilleure prise en charge de la co-morbidité. Une décision de politique a depuis été prise par le Programme National de Lutte contre la Tuberculose de l’Inde pour implémenter cette intervention à l’échelle nationale.

Objetivo

Evaluar la viabilidad y los resultados de examinar a pacientes con TB en busca de DM dentro de los cuidados sanitarios rutinarios a lo largo del país: 8 hospitales de cuidados terciarios y más de 60 instituciones periféricas en 8 Unidades de Tuberculosis.

Método

Se llegó a un acuerdo sobre como realizar los exámenes, la monitorización y el registro en Octubre 2011 durante una reunión de las partes interesadas, y se llevó a cabo la formación del personal sanitario entre Diciembre del 2011 y Enero del 2012. La implementación comenzó en Enero del 2012, y aquí reportamos las actividades realizadas hasta el 30 de Septiembre del 2012.

Resultados

De 8269 pacientes diagnosticados con TB para tratamiento de TB en los centros participantes, 8109 (98%) se examinaron en busca diabetes y se encontró DM en 1084 (13%); de estos, 682 (8%) habían sido previamente diagnosticados con DM y en 402 (5%) era el primer diagnóstico. Había una mayor prevalencia de DM entre pacientes con TB diagnosticados en hospitales terciarios (16%) que en aquellos diagnosticados en Unidades de Tuberculosis (9%) [< 0.001], y entre aquellos del Sur de India (20%) que en los del Norte de la India (10%) [P < 0.001]. Los procesos de evaluación y remisión funcionaron bien, aunque el número de pacientes diagnosticados con DM y referidos a cuidados para DM fue significativamente mayor en los pacientes diagnosticados en hospitales (96%) que en los pacientes diagnosticados en las Unidades de Tuberculosis (92%) [P < 0.05].

Conclusión

Este proyecto piloto muestra que es importante y factible examinar a los pacientes con TB en busca de DM bajo condiciones de rutina, resultando en la identificación temprana de DM en algunos pacientes y en un mejor manejo de las comorbilidades. Desde entonces el Programa Nacional de Control de la TB ha tomado la decisión política de implementar esta intervención a nivel nacional.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgements and disclaimer
  9. References
  10. Appendix 1

India is a country with 1.2 billion people (17.5% of the world's population) and has the highest global number of tuberculosis (TB) cases (estimated at 2.2 million per annum, range 2.0–2.5 million) in the world (WHO 2012). The proportion of TB cases (all forms) detected out of all estimated incident cases was 59% in 2011, but in those patients detected and initiated on treatment, the success rate was 88%.

As a consequence of population growth, ageing, changed lifestyle and urbanisation, the country is also experiencing an escalating epidemic of diabetes mellitus (DM). Data suggest that an estimated 7.8% of people older than 20 years have DM, with about half of those in both rural and urban areas being unaware of the problem (Ramachandran et al. 2010; Danaei et al. 2011; International Diabetes Federation 2011). Estimates suggest that there are more than 61 million people with DM in the country; nearly a million deaths were attributable to DM in the year 2011 (International Diabetes Federation 2011).

A number of systematic reviews and meta-analyses show that people with DM have a 2–3 times higher risk of developing active TB than in those who do not have DM (Stevenson et al. 2007; Jeon & Murray 2008; Dooley & Chaisson 2009; Ruslami et al. 2010). DM patients with TB also experience more adverse TB treatment outcomes: with delayed sputum culture conversion, an increased risk of death during anti-TB treatment and an increased risk of recurrent disease after successful completion of treatment (Baker et al. 2011).

Despite a successful national TB programme, it is likely that in a country such as India, the diabetes epidemic is hampering TB control efforts. Three recently published clinical research studies in South India in about 1500 patients with TB found a high prevalence of DM: about 25% in Tamil Nadu and about 44% in Kerala (Gupta et al. 2011; Balakrishnan et al. 2012; Viswanathan et al. 2012). Although routine screening and care for DM take place in some sites, there is no standardised system in place and the screening activities are not part of the routine recording and reporting of patients with TB.

Given the burden of DM in India, it might be worthwhile screening patients with TB for DM on a routine and national basis. A recently launched WHO-Union Framework for Collaborative Activities to reduce the dual burden of DM and TB recommends bidirectional screening of the two diseases (WHO & IUATLD 2011). However, how this is best done and monitored in routine healthcare settings is not known (Jeon et al. 2010).

This article describes the screening procedures, implementation, monitoring, results and challenges of screening patients with TB for DM within routine healthcare settings in India. Standardised procedures for screening patients with TB for DM for use in hospitals and more peripheral clinics, a monitoring tool linked to the TB registration system and quarterly reporting, were developed for the pilot project and agreed upon in the last half of 2011 with implementation starting in 2012.

Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgements and disclaimer
  9. References
  10. Appendix 1

Design

This was a prospective observational implementation project in hospital and tuberculosis units within routine health services in India. The project design was similar to that used in China for a similar pilot project (Li et al. 2012).

Setting and sites

With the support of World Diabetes Foundation (WDF), a national stakeholders meeting was held in New Delhi, India, in October 2011, which included the national programme managers of the Revised National Tuberculosis Control Programme (RNTCP) and the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS), national experts on TB and Diabetes, The Union, WHO and the World Diabetes Foundation (WDF) to review and discuss linkages between DM and TB, the need for bidirectional screening and the WHO-The Union Collaborative Framework. Broad guidelines for how the screening should be performed were worked out and agreed upon, and sites for screening patients with TB for DM were selected. These included eight tertiary care hospitals and 67 peripheral health institutions in eight tuberculosis units (geographical areas defined under RNTCP as subdistrict level programme management units, each covering a population of 250 000–500 000 with TB diagnostic and treatment services being delivered through a network of primary, secondary and tertiary healthcare facilities). Figure 1 shows the geographical distribution of these sites, while details of the hospitals and tuberculosis units, the type of tests used for screening and diagnosing DM (capillary or venous blood) and start of project implementation are shown in Tables 1 and 2. The sites were selected to give broad representation of different types of health facilities (hospitals and primary healthcare centres) and wide geographical coverage. Four of eight tuberculosis units were also part of the initial 30 districts identified for piloting the roll-out of non-communicable disease (NCD) prevention and control activities in the country through the NPCDCS Programme.

Table 1. Details of the tertiary hospitals involved in the pilot study in India (including type of blood glucose test and project start date)
Name of health facilityCityStateNorth (N) or South (S) IndiaNumber of hospital bedsNumber of daily outpatient visitsApproximate number of patients with TB diagnosed in 2011Capillary blood or venous blood RBGCapillary blood or venous blood FBGProject start date in 2012
  1. LNH, Lok Nayak Hospital; RBIPMT, Rajan Babu Institute for Pulmonary Medicine and Tuberculosis; AIIMS, All India Institute of Medical Sciences; KLES, KLES Dr. Prabhakar Kore Hospital & Medical Research Center; BLCH, Bowring & Lady Curzon Hospital, Bangalore Medical College & Research Institute; SRMCRI, Sri Ramachandra Medical College and Research Institute; GMC, Government Medical College; CDH, Chest Diseases Hospital, Pulayanarkotta, Trivandrum; TB, tuberculosis; RBG, random blood glucose; FBG, fasting blood glucose.

LNHNew DelhiDelhiN250040002500CapillaryVenous15 February
RBIPMTNew DelhiDelhiN11552505000CapillaryCapillary1 March
AIIMSNew DelhiDelhiN240066002000CapillaryVenous6 March
KLESBelgaumKarnatakaS25003000600CapillaryVenous1 February
BLCHBangaloreKarnatakaS5709001000VenousVenous1 March
SRMCRIChennaiTamil NaduS12923750450VenousVenous1 April
GMCTrivandrumKeralaS19161800850VenousVenous19 March
CDHPulayanarkotta, TrivandrumKeralaS50860327VenousVenous15 March
Table 2. Details of the tuberculosis units involved in the pilot study in India (including type of blood glucose test and start of project)
Name of the TB unitDistrictStateNorth(N) or South(S) IndiaPopulation served (in millions)Number of health facilitiesNumber of patients with TB registered in 2011Capillary blood or venous blood RBGCapillary blood or venous blood FBGProject start date in 2012
  1. a

    Only one health facility located at tuberculosis unit headquarters implemented the protocol.

  2. TB, tuberculosis; RBG, random blood glucose; FBG, fasting blood glucose.

Lok Nayak Chest ClinicLok NayakDelhiN0.59a997CapillaryVenous15 February
Kingsway Chest ClinicCivil LinesDelhiN1.013a1800CapillaryCapillary1 July
RamnagarNainitalUttarakhandN0.37467CapillaryCapillary1 January
AnkalavAnandGujaratN0.616789CapillaryCapillary1 January
BunduRanchiJharkhandN0.53300CapillaryCapillary1 January
BangarpetKolarKarnatakaS0.517481CapillaryCapillary1 January
SaluruVizianagaramAndhra PradeshS0.210525CapillaryCapillary1 January
TrivandrumTrivandrumKeralaS0.512413VenousVenous1 April
image

Figure 1. Map of India showing the study sites. LNH, Lok Nayak Hospital; RBIPMT, Rajan Babu Institute for Pulmonary Medicine and Tuberculosis; AIIMS, All India Institute of Medical Sciences; KLES, KLES Dr. Prabhakar Kore Hospital & Medical Research Center; BLCH, Bowring & Lady Curzon Hospital, Bangalore Medical College & Research Institute; SRMCRI, Sri Ramachandra Medical College and Research Institute; CDH, Chest Diseases Hospital, Pulayanarkotta; GMC, Government Medical College.

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In December 2011 and January 2012, a training module was held with staff from the participating tertiary care hospitals and the tuberculosis units to agree on standardised guidelines for screening and referral of patients and monitoring and reporting of data. Patient treatment cards and quarterly cohort reporting forms were developed, printed and distributed to the study sites. Trained staff returned to their health facilities and provided in-service training for the other healthcare staff working in their health facilities. Implementation of activities started in the first quarter of 2012, with some sites starting in January and others in February or March. It was agreed that data would be reported in quarterly (Q) cohorts: Q1-2012 (January to March); Q2-2012 (April to June); and Q3-2012 (July to September) and that implementers would convene in October–November 2012 to discuss results, challenges and ways forward.

Patients

At tertiary care hospitals, patients were all persons aged 15 years and older who were consecutively diagnosed and registered for TB treatment between January and March up to 30 September 2012. At the tuberculosis units, patients from all ages who were consecutively diagnosed and registered for TB treatment during the period were included.

Screening, diagnosis and referral of TB patients with DM to diabetes care

Every patient with confirmed TB was started on TB treatment immediately. Treatment regimens and anti-TB drug formulations were in accordance with those recommended by WHO (2009) and in line with Revised National TB Control Programme guidelines (Central Tuberculosis Division, 2005). The screening for and diagnosis of DM followed national guidelines, which stipulate that a fasting blood glucose (FBG) is used with cut-off thresholds in line with those recommended by the WHO (WHO 2006). In brief, FBG ≥126 mg/dl (≥7 mm) indicates DM; FBG from 110 mg/dl (6.1 mm) to <126 mg/dl (6.9 mm) indicates impaired fasting glucose; FBG < 110 mg/dl (<6.1 mm) is normal.

In all sites, patients were first asked whether they had a known diagnosis of DM. In patients with a known diagnosis, referrals were made back to DM care so that blood glucose levels could be controlled. In those with no known diagnosis of DM, random blood glucose (RBG) was carried out followed by FBG at the next visit if the RBG was ≥110 mg/dl. If patients with TB were found to have FBG ≥126 mg/dl, the patients were diagnosed as having presumptive DM and referred to diabetes services for a definitive diagnosis and enrolment to care. Sites varied as to whether they used a capillary blood test (with a glucometer) or venous blood sample, and this is shown site by site in Tables 1 and 2. In the majority of cases, the tests for blood glucose were free, but in some sites, there was a nominal health service charge (usually <1 USD) for the use of laboratory investigations and this was usually ‘means tested’. In terms of referral for DM care, all the tertiary care hospitals had a DM clinic within the health facility to which the patients could be referred free of charge, whereas in peripheral health institutions of tuberculosis units, patients with TB–DM had to be referred to other public hospitals with facilities for DM care.

Monitoring, recording and reporting

An additional TB–DM register was developed and used to record data about whether the patient was already known to have DM and was under DM care or whether the patient needed screening for DM. Separate register formats were used at the tertiary care health facilities and the peripheral tuberculosis units as the amount of information that needed to be additionally captured was different (Figures 2a, b and 3). The cascade of screening with the tests and the test results was captured in the register. A record was made of all patients with DM (known and new) and those referred to and enrolled to DM care.

image

Figure 2. (a) Register of diabetes (DM) screening in patients with TB at tertiary health facilities – left hand page. Ten rows per page (therefore ten patients per page). Type of TB: new smear-positive PTB; new smear-negative PTB; new EPTB; new other; relapse TB; treatment after default; treatment after failure; retreatment other. (b) Register of diabetes (DM) screening in patients with TB at tertiary health facilities – right hand page. Ten rows per page (therefore ten patients per page). Current smoker, smoked cigarettes/bidis in last 3 months; DM, diabetes mellitus. RBG, random blood glucose; FBG, fasting blood glucose. If known DM is no, then screen for DM. If RBG ≥ 110 mg/dl, do second screen with FBG at next visit. If FBG ≥ 126 mg/dl, diagnosis, diabetes mellitus. Refer all new patients with diabetes and known patients with diabetes to diabetes care.

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image

Figure 3. Register of diabetes (DM) screening in patients with TB at tuberculosis units. Current smoker, smoked cigarettes/bidis in the last 1 month. DM, diabetes mellitus; RBG, random blood glucose; FBG, fasting blood glucose; Y, yes; N, no. If known DM (column 3) is ‘Y’, then write NA (not applicable) in columns 4–8. If known DM (column 3) is ‘N’, then screen for DM. If RBG ≥ 110 mg/dl, do second screen with FBG at next visit. If FBG ≥ 126 mg/dl, diagnosis, diabetes mellitus.

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Standardised quarterly report forms were developed and used for the recording of screening data. These were compiled by health facility staff within 30 days after the end of each quarter to allow for the collection of data from Diabetes Clinics. These reports were kept at the facilities and also sent to the office of the National Programme Manager, RNTCP and The Union's South-East Asia Regional Office at New Delhi for collation. Supervision and site visits were undertaken by staff from The Union's Office and the RNTCP during the study.

Data analysis and statistics

Aggregate patient data were received and cross-checked by staff of RNTCP and The Union's South-East Asia Regional Office at New Delhi and analysed. Health facilities were divided into those belonging to North India or South India based on their location relative to the Tropic of Cancer. To assess whether there were statistical differences between patients known and newly diagnosed with DM in health facilities from North and South India, chi-square tests and odds ratios (OR) with 95% confidence intervals were calculated using epi info software (CDC version 3.5.1). The level of significance was set at 5%.

Ethics approval

Because this was a pilot project aiming to test the feasibility of the DM screening amongst TB patients with a view to learning lessons for national scale up, formal ethics approval was deemed not to be necessary, although site approval and in some cases local ethics approval were obtained. Permission to use, report and publish the collected data was obtained from The Union's Ethics Advisory Group, Paris, France.

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgements and disclaimer
  9. References
  10. Appendix 1

Aggregate data for all the hospital sites, the tuberculosis units and for all sites together for the three-quarters are shown in Table 3. About 98% of patients with TB were screened, resulting in 13% having a diagnosis of DM based on fasting blood glucose. This included 8% of all registered patients with a diagnosis of DM already known and 5% having a new diagnosis of DM.

Table 3. Screening patients with TB for DM in tertiary hospitals and tuberculosis units: data combined for the three-quarters in India, 2012
IndicatorTertiary hospitalsTuberculosis unitsTotal
  1. TB, tuberculosis; DM, diabetes mellitus; RBG, random blood glucose; FBG, fasting blood glucose.

Number of patients with TB registered over the three-quarters521730528269
Number (%) with known diagnosis of DM526 (10)156 (5)682 (8)
Number needing to be screened with RBG469128967587
Number (%) actually screened with RBG4666 (99)2801 (97)7467 (98)
Number with RBG >110 mg/dl and needing to be screened with FBG19379012838
Number (%) screened with FBG1824 (94)879 (98)2703 (95)
Number (%) with FBG ≥ 126 mg/dl (newly diagnosed with DM)283 (6)119 (4)402 (5)
Number (%) with known and newly diagnosed DM809 (16)275 (9)1084 (13)
Number (%) with known and newly diagnosed DM referred to DM care779 (96)254 (92)1033 (95)
Number (%) with known or newly diagnosed DM who reached DM care7792411020

There were some differences between tertiary hospitals and TB units (Table 3). The proportion of patients diagnosed with DM was higher in hospitals (16%) compared with TB units (9%) (OR 1.9, 95% CI 1.6–2.1, P < 0.001); this was predominantly due to the fact that more patients had a known diagnosis of DM in hospitals (10%) than in TB units (5%) (OR 2.1, 95% CI 1.7–2.5, P < 0.001). Once diagnosed with DM, the proportion of patients referred to DM care was higher in hospitals (96%) than in TB units (92%) (OR 2.1, 95% CI 1.2–3.8, P < 0.01).

Differences in results of screening between health facilities in North and South India are shown in Table 4. A significantly higher proportion of patients with TB were diagnosed with DM in the South (20%) than in the North (10%), largely due to the higher proportion with already known DM in the South (15%) than the North (5%).

Table 4. Known and newly diagnosed DM in patients with TB according to North or South India, 2012
IndicatorSouth IndiaNorth IndiaOR (95% CI), P-value
  1. OR, odds ratio; CI, confidence Interval; TB, tuberculosis; DM, diabetes mellitus; FBG, fasting blood glucose.

Number of patients with TB registered over the three-quarters26445625 
Number (%) with known diagnosis of DM406 (15)276 (5)3.5 (2.9–4.1), P < 0.001
Number (%) with FBG ≥126 mg/dl (newly diagnosed with DM)141 (5)261 (5) 
Total number (%) with known and newly diagnosed DM547 (20)537 (10)2.3 (2.0–2.6), P < 0.001

There were various problems with the screening, which differed between tertiary care hospitals and tuberculosis units, and are summarised in Box 1. The most important one relates to the use of capillary blood glucose measurements (using glucometers) for the screening with fasting blood glucose at the peripheral level.

Box 1. Challenges with screening of patients with tuberculosis for diabetes

At tertiary care health facilities

  • Some patients have to make payment in some settings for venous fasting blood glucose tests.
  • If the blood tests for DM are required to be taken after the diagnosis of TB, then patients will have to make additional visits to the health facility.
  • After patients are referred for diabetes care, feedback from those clinics is poor.
  • Standardised TB treatment under the Revised National TB Control Programme (RNTCP) is available at all levels of healthcare facilities, whereas standardised diabetes treatment is not guaranteed if patients have to be referred to a health facility near to their place of residence.
  • Additional manpower is required if records and reports have to be maintained.

Peripheral health facilities in tuberculosis units

  • There is lack of an established collaborative mechanism between RNTCP and National Programme for prevention of Cancer, Diabetes and Stroke. (NPCDCS).
  • Venous blood glucose measurements are not available at primary health centres. Decisions will have to be made based on capillary blood glucose levels.
  • Additional visits may be required if fasting blood glucose measurements are needed.
  • Inadequate training on appropriate usage of glucometers.
  • Shortages/irregular supply/short expiry of glucometer strip.
  • Maintenance of additional records and reports adds to the burden of work.

Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgements and disclaimer
  9. References
  10. Appendix 1

This is the first nationwide study from India reporting on the feasibility and outcomes of routine screening of patients with TB for DM. In general, the screening procedures worked well, the monitoring and recording were excellent and the overall prevalence of DM in over 8000 patients with TB who were screened was 13%. There was a higher proportion of patients overall with a known history of DM than patients newly diagnosed with DM. Higher rates of DM, especially patients with a known history of DM, were found in hospitals and in the southern part of the country.

The proportion of patients with a previously known diagnosis of DM was higher in tertiary hospitals. This may be explained by the observation that sick patients attending the hospitals are routinely screened with a battery of investigations that include those for DM and for TB. Due to the ease and speed of diagnosing DM compared with TB, the former diagnosis is usually made before that of TB, and hence, the patient will already be known to have DM when the TB diagnosis is made. We do not have the dates and times of when these two diagnoses were made, so this explanation is speculative and requires further detailed study. Even in peripheral health facilities within tuberculosis units, more than 50% of the patients with DM were diagnosed before the screening. This could be due to the fact that in 4 of 8 TB units, NPCDCS was being implemented with community-based screening of all persons older than 30 years for DM (Directorate General of Health Services, India 2010). In other districts and country settings, where this is not implemented, probably more new cases would be identified. The population in southern India is known to have a higher prevalence of DM than that of other regions (Ramachandran et al. 2010; International Diabetes Federation 2011; Gupta 2012), and this could explain the findings of higher DM rates amongst the patients with TB in the South.

The findings of this pilot implementation study are important. Similar to the extrapolations made with the data from China (Li et al. 2012), the screening process used in India, if scaled up, could potentially identify 13% of 2.2 million patients with TB per annum with DM translating into a total of 286 000 cases of DM, if similar prevalence rates as obtained in this study were seen. The screening of those with no known diagnosis of DM could result in a yield of 5%, translating to 110 000 newly diagnosed patients with DM per year. It is accepted that half of all the patients with DM worldwide are undiagnosed (International Diabetes Federation 2011), and such screening amongst patients with TB would improve early diagnosis of this important non-communicable disease.

Most patients with DM were referred to DM care, with this process working marginally better at the tertiary hospitals than tuberculosis units, presumably because of much easier access to the clinics that were usually in the same hospital facility. Referral of patients to DM care should benefit not only their diabetes but might impact positively on the patients' TB treatment outcomes.

Regarding the challenges identified, the most important concern was the fact that blood glucose measurement was taken on a capillary blood sample rather than a venous blood sample in the peripheral health institutions. Although WHO states that venous and capillary blood thresholds for diagnosing DM are identical (WHO 2006), there were issues with quality control of the glucometers and difficulties in securing reliable supplies of test strips. These problems will need to be resolved if consistent and reliable testing is to occur.

Because TB may induce infection-related hyperglycaemia, there is concern about whether screening should be performed at the time of TB diagnosis or later during the course of treatment to avoid false-positive diagnosis of DM. Previous studies assessing blood glucose levels at multiple points during the course of anti-TB treatment (Kishore et al. 1973; Goyal et al. 1978; Singh et al. 1984; Oluboyo & Erasmus 1990) show that the prevalence of hyperglycaemia decreased over time. However, because we do not fully understand the effect of transient hyperglycaemia on the TB treatment outcomes, we feel it is better to err on the side of overdiagnosis of DM. Screening earlier on in the course of TB treatment may be better because this allows opportunities to intervene and better control DM and influence TB treatment outcomes.

The strengths of this study are that we implemented screening using the existing resources within the routine health system/patient care system, and minimal financial support (on an average approximately USD 300 per site) was provided through the project to support the implementation of this activity. The standardised cohort monitoring system allowed consistent data to be collated across different sites. Interim data were presented to the Central TB Division within the Ministry of Health and Family Welfare of the Government of India, and a policy decision was made in September 2012 to scale up screening of patients with TB nationwide. There should be substantial public health benefits from this approach, not least of which is the ease of access to services to patients with comorbidities.

Limitations include some of the problems discussed, including the difficulties in knowing whether a high FBG in the context of TB means true DM disease or infection-induced hyperglycaemia. Further research into this conundrum, possibly with tests such as glycosylated haemoglobin (HbA1C) or oral glucose tolerance tests, is needed. HbA1C provides a measure of blood glucose levels over a period of 2–3 months and is not subject to the rapid swings that can occur with random and fasting blood glucose measurements (International Expert Committee 2009; Kumar et al. 2010; WHO 2011). It is also accepted that FBG may miss true cases of DM, identified, for example, with an oral glucose tolerance test. In a large survey in China, nearly 50% of patients with a diagnosis of DM had a normal FBG (Yang et al. 2010), and similar findings have been reported from India (Ramachandran et al. 1998). Thus, the prevalence rates of DM in this study in India may underestimate quite considerably the true DM burden amongst patients with TB. Further prospective research is also needed to assess the effect of better DM control on TB treatment outcomes and whether this leads to a decrease in the reported risk of recurrent TB (Baker et al. 2011). Finally, we have presented the aggregate data by pooling information from all sites and this may have masked any variations at the individual sites.

Conclusion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgements and disclaimer
  9. References
  10. Appendix 1

After the launch of the WHO and The Union Collaborative Framework for the Care and Control of Diabetes and Tuberculosis in 2011, India has undertaken a pilot project of screening patients with TB for DM. In different types of health facilities across the country, the project has shown that DM screening using RBG and then FBG is feasible and identifies one in eight patients with the disease. This activity, and the subsequent scale up that should now take place, should lead to better and earlier detection of DM, earlier and better treatment of DM (which might have gone unrecognised) and improved clinical outcomes on anti-TB treatment.

Acknowledgements and disclaimer

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgements and disclaimer
  9. References
  10. Appendix 1

We thank all the staff at the hospitals and TB units for their support in managing and monitoring patients. KL and SAN are staff members of the World Health Organization. The authors alone are responsible for the views expressed in this publication, and they do not necessarily represent the decisions or policies of the World Health Organization. We thank the World Diabetes Foundation for supporting the training modules and the stakeholder meetings in India that facilitated the design and implementation of the screening project.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgements and disclaimer
  9. References
  10. Appendix 1
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Appendix 1

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Conclusion
  8. Acknowledgements and disclaimer
  9. References
  10. Appendix 1

Members of Tuberculosis-Diabetes Study Group

Ashok Kumar, DC Jain, Devesh Gupta, Directorate General of Health Services, Ministry of Health and Family Welfare, New Delhi; Srinath Satyanarayana, Ajay MV Kumar, Sarabjit Singh Chadha, Nevin Wilson, South-East Asia Office, International Union Against Tuberculosis and Lung Disease, New Delhi; Sharath Burugina Nagaraja, Amar N Shah, Balaji Naik, Rajabhau D Yoele, Imran Farooq Irshad Ali Syed, Shanta Achanta, Sreenivas Achutan Nair, World Health Organization Country Office for India, New Delhi; Surendra K Sharma, Manish Soneja, Darshan Krishnappa, All India Institute of Medical Sciences, New Delhi; Banahalli Chikkaiah Prakash, Koratagere Shivalingamurthy Ravish, Thimmanahalli Sobagiah Ranganath, Bowring & Lady Curzon Hospital, Bangalore Medical College & Research Institute, Bangalore; Minaxi C Chauhan, District TB Office, Anand, Gujarat; Paresh V Dave, Directorate of Health Services, Gujarat; M. V. Narayanaswamy, District TB Office, Kolar, Karnataka; M. D. Suryakanth, Directorate of Health Services, Karnataka; Ajay Bhist, District TB Office, Nanital, Uttarakhand; Umesh Chandra Sinha, District TB Office, Ranchi, Jharkhand; Rakesh Dayal, Directorate of Health Services, Jharkhand; Rama Rao Tekumalla, District TB Office, Vizianagaram, Andhra Pradesh; Sanjeev Nair, Anitha K Kumari, Government Medical College, Trivandrum; Jayashankar Subramonianpillai, Directorate of Health Services, Kerala; Mallikarjun V Jali, Vinay K Mahishale, Murigendra Basayya Hiremath, KLES Diabetes Centre, KLES Dr. Prabhakar Kore Hospital & MRC, Belgaum, Karnataka; Ashwani Khanna, Sheelu Lohiya, Lok Nayak Hospital, New Delhi; Anil Chaudhry, Nikhil Shaw, Rajan Babu Institute for Pulmonary Medicine and Tuberculosis (RBIPMT), New Delhi; Suresh Varadarajan, Preetam Arthur, BWC Sathiyasekaran, Sri Ramachandra Medical College and Research Institute, Chennai; Anil Kapur, World Diabetes Foundation, Gentofte, Denmark; Knut Lönnroth, Stop-TB Department, World Health Organization, Geneva, Switzerland; Rony Zachariah, Medecins Sans Frontiers, Operational Center Brussels, MSF Luxembourg; Anthony D. Harries, International Union Against Tuberculosis and Lung Diseases, Paris, France and London School of Hygiene and Tropical Medicine, UK.