Primary prevention of diabetes is a major strategy to combat the rising global burden of diabetes and is of utmost importance in developing countries such as ours. However, these strategies have to be formulated considering the cultural, socio-economic aspects and structure of the health care system.

Today science has progressed to the extent that not only can diabetes be identified early but we can detect subjects even with pre-diabetes (those with the risk of developing diabetes). The main components of identifying high-risk individuals are positive family history, obesity, especially central adiposity (big tummy), sedentary life habits, and stress. Studies including ours have shown that diabetes can be prevented by lifestyle modification in people with prediabetes. This has changed the strategy in tackling diabetes in public health.

Indian Diabetes Prevention Programmes IDPP 1 and IDPP 2 have been the pioneer studies from South Asia which have shown that moderate, but consistent lifestyle modification is effective in preventing diabetes in high-risk subjects. These studies have also highlighted several peculiarities in the Indians with respect to the risk factors and the response to therapeutic interventions. Among Indians, a new translation research project is now in progress to identify a cheaper and widespread communication strategy such as SMS by cell phones, to motivate persons with high risk for diabetes to adhere to the LSM strategies.

Research Programmes

The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1)
Aims/hypothesis: Lifestyle modification helps
in the primary prevention of diabetes in multiethnic
American, Finnish and Chinese populations. In a prospective
the community-based study, we tested whether the
progression to diabetes could be influenced by interventions
in native Asian Indians with IGT who were younger,
leaner and more insulin resistant than the above populations.
Methods: We randomized 531 (421 men 110
women) subjects with IGT (mean age 45.9±5.7 years, BMI
25.8±3.5 kg/m2) into four groups. Group 1 was the
control, Group 2 was given advice on lifestyle modification
(LSM), Group 3 was treated with metformin (MET)
and Group 4 was given LSM plus MET. The primary
outcome measure was type 2 diabetes as diagnosed using
World Health Organization criteria. Results: The median
follow-up period was 30 months, and the 3-year cumulative
incidences of diabetes were 55.0%, 39.3%, 40.5%
and 39.5% in Groups 1–4, respectively. The relative risk
reduction was 28.5% with LSM (95% CI 20.5–37.3,
p=0.018), 26.4% with MET (95% CI 19.1–35.1, p=0.029)
and 28.2% with LSM + MET (95% CI 20.3–37.0,
p=0.022), as compared with the control group. The
number needed to treat to prevent one incident case of
diabetes was 6.4 for LSM, 6.9 for MET, and 6.5 for LSM +
MET. Conclusions/interpretation: Progression of IGT to
diabetes is high in native Asian Indians. Both LSM and
MET significantly reduced the incidence of diabetes in
Asian Indians with IGT; there was no added benefit from
combining them.
Beneficial effects of strategies for primary prevention of diabetes on cardiovascular risk factors: results of the Indian Diabetes Prevention Programme.

Scope: In subjects with impaired glucose tolerance (IGT) who participated in the Indian Diabetes Prevention Programme (IDPP), abnormalities related to body mass index (BMI), waist circumference (WC), blood pressure (BP), lipid profile and electrocardiography were analysed. The result was Asian Indian IGT subjects were observed to have a high prevalence of cardiovascular risk factors. LSM and MET had beneficial effects on the atherogenic phenotype of lipids but had no influence on blood pressure.

Changes in Insulin Secretion and Insulin Sensitivity in Relation to the Glycemic Outcomes in Subjects With Impaired Glucose Tolerance in the Indian Diabetes Prevention Programme-1.

Scope: The Indian Diabetes Prevention Programme-1 (IDPP-1) showed that lifestyle modification (LSM) and metformin were effective for primary prevention of diabetes in subjects with impaired glucose tolerance (IGT). A 3 year follow-up showed, risk reduction relative to control group was more in LSM and LSM plus MET groups. In this analysis, changes in insulin secretion and action in improving the outcome were studied. In the IDPP-1 subjects, beneficial outcomes occurred because of improved insulin action and sensitivity caused by the intervention strategies.

Pioglitazone does not enhance the effectiveness of lifestyle modification in preventing conversion of impaired glucose tolerance to diabetes in Asian Indians: results of the Indian Diabetes Prevention Programme-2 (IDPP-2).

Scope: This was a 3 year, prospective, randomized placebo-controlled study in 407 IGT subjects. The objective was to study whether combining pioglitazone with lifestyle modification would enhance the efficacy of lifestyle modification in preventing type 2 diabetes in Asian Indians with impaired glucose tolerance. The results showed that lifestyle modification (improved physical activity and healthy diet practices) reduced the conversion to diabetes, but addition of pioglitazone (30mg/day) to lifestyle modification did not improve the efficacy.

Immediate impact of a diabetes training programme for primary care physicians—An endeavour for national capacity building for diabetes management in India.

Scope: National capacity for management of diabetes has to be strengthened by improving knowledge of physicians treating diabetes, especially in semi urban and rural areas. A training programme was formulated and conducted at national level, as a step towards this goal. The training significantly improved knowledge on treatment, complications, pathophysiology and diagnosis of diabetes. Patient education and team-training were considered important in diabetes management. Well-planned short training programmes are useful in improving knowledge and in creating enthusiasm to improve diabetes care and awareness.

Efficacy of Primary Prevention Interventions When Fasting and Postglucose Dysglycemia Coexist-Analysis of the Indian Diabetes Prevention Programmes (IDPP-1 and IDPP-2).

Scope: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have different pathophysiological abnormalities, and their combination may influence the effectiveness of the primary prevention tools. The hypothesis was tested in this analysis, which was done in a pooled sample of two Indian Diabetes Prevention Programmes (IDPP-1 and IDPP-2). Subjects with IGT_IFG had a higher proportion developing diabetes in 3 years and a lower rate of reversal to normoglycaemia. The effectiveness of primary prevention strategies appears to be similar in subjects with IIGT or with combined IGT_IFG. However, the possibility remains that a larger study might show that the effectiveness is lower in those with the combined abnormality.

Predictive value of HbA1c for incident diabetes among subjects with impaired glucose tolerance—analysis of the Indian Diabetes Prevention Programmes.

Scope: The objectives of this study were to assess the predictive value of baseline HbA1c for incident diabetes among the participants with impaired glucose tolerance in the Indian Diabetes Prevention Programmes 1 and 2. Baseline HbA1c values had heterogenous distribution. The distribution was similar in isolated impaired glucose tolerance or in impaired glucose tolerance in combination with impaired fasting glucose. A progressive increase in diabetes occurred with increasing HbA1c. HbA1c showed the strongest association with incident diabetes in the multiple logistic regression analysis (odds ratio 3.548, P < 0.0001).

Reinforcement of Adherence to Prescription Recommendations in Asian Indian Diabetes Patients Using Short Message Service (SMS)-A Pilot Study.

Scope: This study was done to investigate the acceptability and feasibility of using short message services (SMS) via cell phones to ensure adherence to management prescriptions by diabetic patients. Type 2 diabetic patients with 5 or more years of diabetes and having HbA1c between 7.0% to 10% were randomized to the control arm (n=105) to receive standard care and to the intervention arm (SMS, n=110). Messages in English on principles of diabetes management were sent once in 3 days. The study duration was 1 year. A comparative assessment of the clinical, biochemical and anthropometric outcomes was made among the groups at the annual visit. SMS was acceptable to the patients and the median number requested was 2 per week. HbA1c and plasma lipids improved significantly in the SMS group. The pilot study showed that frequent communication via SMS was acceptable to diabetic patients and it helped to improve the health outcomes.

Eff ectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modifi cation in men in India: a prospective, parallel-group, randomised controlled trial

Background: Type 2 diabetes can often be prevented by lifestyle modification; however, successful lifestyle intervention
programs are labor-intensive. Mobile phone messaging is an inexpensive alternative way to deliver educational and motivational advice about lifestyle modification. We aimed to assess whether mobile phone messaging that encouraged lifestyle change could reduce incident type 2 diabetes in Indian Asian men with impaired glucose tolerance.
Methods: We did a prospective, parallel-group, randomized controlled trial between Aug 10, 2009, and Nov 30, 2012, at ten sites in southeast India. Working Indian men (aged 35–55 years) with impaired glucose tolerance were randomly assigned (1:1) with a computer-generated randomization sequence to a mobile phone messaging intervention or standard care (control group). Participants in the intervention group received frequent mobile phone messages
compared with controls who received standard lifestyle modification advice at baseline only. Field staff and participants were, by necessity, not masked to study group assignment, but allocation was concealed from laboratory personnel as well as principal and co-investigators. The primary outcome was the incidence of type 2 diabetes, analyzed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00819455.
Results: We assessed 8741 participants for eligibility. 537 patients were randomly assigned to either the mobile phone messaging intervention (n=271) or standard care (n=266). The cumulative incidence of type 2 diabetes was lower in those who received mobile phone messages than in controls: 50 (18%) participants in the intervention group developed type 2 diabetes compared with 73 (27%) in the control group (hazard ratio 0·64, 95% CI 0·45–0·92;
p=0·015). The number needed to treat to prevent one case of type 2 diabetes was 11 (95% CI 6–55). One patient in the
control group died suddenly at the end of the first year. We recorded no other serious adverse events.
Interpretation: Mobile phone messaging is an effective and acceptable method to deliver advice and support towards lifestyle modification to prevent type 2 diabetes in men at high risk.

Ez Scan Study

A cross-sectional study on evaluating the corrections between eZScan technology and Insulin secretion, sensitivity, and Inflammatory Markers in a population not known to have Impaired Glucose Tolerance or Type 2 Diabetes mellitus

A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK: a randomised controlled trial
Aims/hypothesis: This randomized controlled trial was performed in India and the UK in people with prediabetes to study whether
mobile phone short message service (SMS) text messages can be used to motivate and educate people to follow lifestyle modifications,
to prevent type 2 diabetes.
Methods: The study was performed in people with prediabetes (n = 2062; control: n = 1031; intervention: n = 1031) defined by HbA1c
≥42 and ≤47 mmol/mol (≥6.0% and ≤6.4%). Participants were recruited from public and private sector organizations in India (men and women aged 35–55 years) and by the National Health Service (NHS) Health Checks programme in the UK (aged 40–74 years without pre-existing diabetes, cardiovascular disease, or kidney disease). Allocation to the study groups was performed using a computer-generated sequence (1:1) in India and by stratified randomization in permuted blocks in the UK. Investigators in both countries remained blinded throughout the study period. All participants received advice on a healthy lifestyle at baseline. The intervention group in addition received supportive text messages using mobile phone SMS messages 2–3 times per week. Participants were assessed at baseline and at 6, 12, and 24 months. The primary outcome was conversion to type 2 diabetes and secondary outcomes included anthropometry, biochemistry, dietary and physical activity changes, blood pressure, and quality of life.
Results: At the 2 year follow-up (n = 2062; control: n = 1031; intervention: n = 1031), in the intention-to-treat population the HR
for development of type 2 diabetes calculated using a discrete-time proportional hazards model was 0.89 (95%CI 0.74, 1.07; p =
0.22). There were no significant differences in the secondary outcomes.
Conclusions/interpretation: This trial in two countries with varied ethnic and cultural backgrounds showed no significant reduction
in the progression to diabetes in 2 years by lifestyle modification using SMS messaging.
Trial registration The primary study was registered on www.ClinicalTrials.gov (India, NCT01570946; UK, NCT01795833).
Funding: The study was funded jointly by the Indian Council for Medical Research and the UK Medical Research Council.
DIABSMART Study

Development of a new generation of DIABetic footwear using an integrated approach and SMART materials.

This project was recently awarded funding by the European Union under the Maire Curie Seventh Framework Programme. The main objectives include: (1) the design and development of an integrated system of diabetic foot assessment, (2) to validate the newly developed system using experimental methods, (3) to develop a suitable material to meet the mechanical and clinical requirements, and (4) to evaluate the mechanical and clinical effectiveness of material choice in reducing the potential risk of foot complications.

This project is essentially a cross-sector collaboration that combines the industrial expertise of Salts Healthcare Ltd, and Technofootbed SL, Spain scientific and technical expertise of Hochschule Magdeburg, Germany and Staffordshire University along with the clinical expertise from Dr. A. Ramachandran’s Diabetes Hospitals through India Diabetes Research Foundation in an effort to customize the footwear products for diabetes considering the individual patient’s needs and requirements from a clinical perspective.

Biomarker Study

Role of specific inflammatory markers and adipokines in relation to insulin resistance and β-cell function

Effectiveness of mobile phone text messaging in improving glycaemic control among persons with newly detected type 2 diabetes

Aims: The aim of the study was to evaluate the effect of text messaging as a tool to improve glycaemic control among newly diagnosed T2D patients in a 2 year period.
Methods: This is a multicentric, randomized controlled trial conducted in 2 states of India. The primary outcome was an improvement in glycemia measured by an HbA1c value of 7%
(53 mmol/mol) with intervention. The secondary outcomes were changes in biochemical, dietary parameters, and physical activity. Acceptability of text messages was assessed. Persons having an HbA1c value of 6.5% (48 mmol/mol) at diagnosis were enrolled. A total of 248 participants with a mean age of 43.3 ± 8.7 years were recruited. Participants in the control group (n = 122) received standard care, the intervention group (n = 126) received customized text messages thrice a week. Both groups received  personal advice at the beginning of the study.
Results: Baseline characteristics were similar in both groups. At 24 months, both groups showed significant reduction in blood pressure and glycaemic variables in comparison to the baseline values. The intervention group showed a significant lowering of LDLc also. Multivariate analysis showed that a reduction in HbA1c was associated with intervention.
Conclusion: Text messaging can lead to an improvement in glycaemic control through personal empowerment and sustained behavioral changes.

Incidence of Type 2 Diabetes is Higher among Men with Persistent Impaired Glucose Tolerance than in Transient Impaired Glucose Tolerance – A 5 year Follow up Study

Objective: This was a 5-year comparative analysis of the incidence of type 2 diabetes in men who had persistent impaired glucose tolerance (P-IGT) versus transient impaired glucose tolerance (T-IGT). P-IGT (positive IGT on two oral glucose tolerance tests (OGTT), T-IGT (IGT in first OGTT, and normal glucose tolerance (NGT) in the 2nd OGTT).
Methods: The samples were collected from a randomized controlled diabetes prevention study. The prevention study was done using lifestyle modification (LSM) promoted by the use of mobile short message services (SMS) for 2 years. The control group of the randomized study who received advice on LSM at only the baseline formed the P-IGT group for the 3 years follow up study (n=236). T-IGT (n=569) were available from those who had NGT on the 2nd OGTT while screening for the prevention study. The total diabetes incidence at 5 years in the study groups was compared using standard OGTT (WHO criteria).
Results: The conversion rate to diabetes in 5 years was significantly lower among T-IGT than among P-IGT, OR=0.202 (95% CI, 0.145-0.296,p<0.0001). P-IGT had a higher rate of risk factors for diabetes than T-IGT. Conclusion: The risk of conversion to diabetes was 80 percent lower in T-IGT than in P-IGT. Identification of P-IGT will help in selecting persons who require early intervention for diabetes.

The post-trial analysis of the Indian SMS diabetes prevention study shows persistent beneficial effects of lifestyle intervention

Aims: We had shown that mobile-phone-based text messaging was an effective tool to deliver lifestyle changes among Asian Indian men with a 36% relative risk reduction in incident diabetes over two years. The present analysis investigated whether beneficial effects of
intervention on diabetes prevention persisted for an additional three years after the withdrawal of active intervention.
Methods: The primary two-year randomized controlled trial (2010–2012) compared lifestyle changes with the use of automated text messaging reminders in the intervention (n = 271) versus
standard care advice (n = 266) at baseline. At the end of the study, both groups received additional advice on lifestyle changes by a trained dietician. Participants free of diabetes (n= 394) were invited three years later to ascertain the sustained effect of the intervention. The primary outcome was the incidence of type 2 diabetes. This trial is registered with ClinicalTrials.gov, number NCT02848547.
Results: During the mean follow-up of 5 years, 346 out of 394 (87.8%) men were reviewed. The incidence of diabetes was reduced by 30% in the intervention group, with a declining gap between-group differences over time (Kaplan-Meier analysis). Significant improvement in dietary adherence occurred in the intervention group at 2nd and 5th year follow up (trend v2 = 21.35, p < 0.0001). Cox regression analysis showed that the 5th year incidence of diabetes was significantly reduced in the intervention group. Higher body mass index and 2h plasma glucose at 24 months increased the incidence of diabetes. Conclusions: Sustained reduction in incident diabetes was apparent after the cessation of active lifestyle intervention. This was possibly associated with the continuing practice of improved lifestyle.