Arun Shankar

Cost-Effective Use of Telemedicine and Self-Monitoring of Blood Glucose via Diabetes Tele Management System (DTMS) to Achieve Target Glycosylated Hemoglobin Values Without Serious Symptomatic Hypoglycemia in 1,000 Subjects with Type 2 Diabetes Mellitus—A Retrospective Study

OBJECTIVE This study assessed the effectiveness, safety, and costs of the Diabetes Tele Management System (DTMS(®); Dr. Jothydev Kesavadev, Jothydevs Diabetes and Research Center, Kerala, India)-based health care in type 2 diabetes (T2D) patients in South India. RESEARCH DESIGN AND METHODS We conducted a retrospective cohort study using electronic health records in our Center. The study sample comprised T2D patients enrolled in DTMS-based management, 30-75 years old, eligible for a glycosylated hemoglobin (HbA1c) target <6.5% and actively participating in various components of DTMS such as regular reporting of self-monitoring of blood glucose (SMBG) values and dose adjustments via telemedicine. We analyzed HbA1c, lipid profile, and other parameters measured at the first visit and on subsequent physical visits at months 3 and 6 and estimated the incidence of hypoglycemia. RESULTS We analyzed records of 1,000 subjects with 6-month follow-up data (mean age, 53.2 ± 9.8 years; 64% male). Patients had an average of 17 ± 2 telemedicine follow-ups and reported 66,745 SMBG values over 6 months. The mean ± SD HbA1c value was 8.5 ± 1.4% at the initial visit and was reduced to 6.3 ± 0.6% at 6 months (P<0.0001). The rate of SMBG values <70 mg/dL was approximately 0.04/patient/month, with 84% patients reporting no hypoglycemia. The recurring extra cost to patient for DTMS, not considering cost of oral drugs and insulin, was equivalent to 9.66 U.S. dollars/month. CONCLUSIONS DTMS, based on telemedicine follow-up and multidisciplinary care with SMBG-based monitoring, appears to be safe and cost-effective in the intensive treatment of T2D without serious co-morbidities. This system also avoids limitations of a traditional health care such as the need for very frequent physical visits for each and every drug dose adjustment, diet, and exercise advice.

Liraglutide therapy beyond glycemic control: an observational study in Indian patients with type 2 diabetes in real world setting

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Suggested use of vaccines in diabetes

Diabetes has emerged as a disease of major public health importance in India affecting the rich and the poor alike. Conventionally, comprehensive diabetes management is aimed at preventing micro and macro vascular complications. However, morbidity and mortality due to infections are also significant. In developing countries like India, the concept of adult immunization is far from reality. Recently the H1N1 pandemic has triggered the necessity for considering immunization in all age groups for the prevention of vaccine-preventable fatal infectious diseases. Considering the economics of immunization in a developing country, providing free vaccines to all adults may not be a practical solution, although the free universal immunization program for children is in existence for several decades. There is no consensus on the use of vaccines in diabetes subjects in India. However, there are some clinics offering routine pneumococcal, influenza and other vaccinations. Patients with diabetes have a deranged immune system making them more prone for infections. Hospitalization and death due to pneumococcal disease and influenza are higher in diabetes patients. They, like other healthy individuals, have a normal humoral response to vaccination with clinically significant benefits. The American Diabetes Association, Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention, World Health Organization, United Kingdom Guidelines and a number of other scientific organizations have well defined guidelines for vaccination in diabetes. In this article we make some suggestions for clinicians in India, regarding use of vaccines in subjects with diabetes.

Unproven Therapies for Diabetes and Their Implications

Diabetes is a chronic disease and is one of the leading causes of morbidity and mortality worldwide. Being an ancient disease, many individuals follow complementary and alternative medicinal (CAM) therapies for either the cure or prevention of the disease. The popularity of these practices among the general public is in no way a testimony to their safety and efficacy. Due to the possibility of undesirable interactions with conventional medicines, it is imperative that patients are asked about CAM use during patient assessment. Patient- and physician-targeted awareness programs on various aspects of CAM use must be initiated to create a better understanding of evidence-based use of these practices. In addition, there should be guidelines in place based on clinical trial outcomes, and stricter regulations need to be enforced on CAM practices to ensure their safety and effectiveness.

Telemedicine for diabetes care: An Indian perspective - feasibility and efficacy

Diabetes is a chronic and costly disease. In India, the usual practice among patients is to visit the doctor once in every 2–3 months to get advice on changes in the dosages of medications. The Diabetes Tele Management System (DTMS®) is a telemedicine based follow-up program originally introduced at Jothydevs Diabetes Research Centre at Trivandrum South India in 1998. It is a chronic disease management system which enables patient to interact lively with a professionally trained multidisciplinary team comprising of diabetes educators, nurses, dieticians, pharmacists, psychologists, physicians, etc., in modifying the dosages of medications, diet, and physical activity either through telephone/email/secure website. The uniquely designed software and the trained multidisciplinary team overcomes the globally recognized major barriers to diabetes management namely fear of hypoglycemia, polypharmacy, discontinuation of stains, and antihypertensives or wrong injection techniques. DTMS is designed to provide individualized therapy advices on glycosylated hemoglobin, blood pressure, and low density lipoprotein customized to multiple patient characteristics which help attain goals of therapy. The system has been tested on various platforms over a decade and was shown to be a patient friendly approach with successful outcomes due to a live “round-the-clock” interactive communication in contrast to text or recorded messages. The major challenge to the widespread use of DTMS® is seeking a source of funding this unique telemedicine program.

Efficacy and safety of liraglutide therapy in 195 Indian patients with type 2 diabetes in real world setting

BACKGROUND GLP-1 analogues has established role in the management of type 2 diabetes mellitus (T2DM). Liraglutide, a human GLP-1 analogue is used as an adjunct to diet and exercise in adults with T2DM for improvement of glycemic control. OBJECTIVE To assess the efficacy and safety of liraglutide in Indian patients with T2DM in real-world setting. METHODS A prospective, open label, single arm, single centre, observational study of 24 weeks duration in a real-world setting. Subjects with T2DM with impaired glucose control despite of antidiabetic therapy and clinically suitable for liraglutide therapy were enrolled and managed. All subjects received liraglutide therapy in addition to their existing anti-diabetic therapy. Starting dose of liraglutide (Victoza) was 0.6 mg/day for 7 days followed by 1.2 mg/day for next 7 days and finally 1.8 mg/day for 22 weeks. Subjects were evaluated at baseline and at 24 weeks. Adverse events (AE) noted during course of therapy were recorded. Student t test (two tailed, dependent) was performed for assessment of statistical significance. RESULTS Total 195 subjects were studied over 24 weeks. Mean fasting plasma glucose (FPG) was decreased from 163.81 mg/dL to 111.6 (P<0.001); similarly HbA1c was reduced from 8.14% to 6.96% (P=0.006) at 24 weeks. At week 24, 49.23% and 41.03% subjects treated with liraglutide reached an HbA1c<7.0% and ≤6.5%, respectively. Mean weight was reduced from 86.41 kg to 82.37 kg (P<0.001). Additionally mean systolic and diastolic blood pressure was reduced from 129.31 and 76.18 mm of Hg to 119.59 (P=0.90) and 70.88 (P<0.001) mm of Hg, respectively. Serum cholesterol was reduced from 166.68 mg/dL to 124.86 mg/dL (P<0.001). Twenty-two (11.28%) subjects reported adverse events (AE), the most common AEs being vomiting, tiredness, loose motion and nausea. All AEs were mild to moderate in nature without any serious AE. CONCLUSION In 195 Indian patients with T2DM receiving anti-diabetic drugs, addition of liraglutide resulted in significant improvement in glycemic parameters and was well tolerated. Clinically significant reduction in weight, blood pressure and serum cholesterol were also noted.

Exploratory CSII Randomized Controlled Trial on Erectile Dysfunction in T2DM Patients (ECSIITED)

Type 2 diabetes (T2DM) individuals are at higher risk of developing erectile dysfunction (ED). A lower prevalence of neuropathy and ED is observed in subjects with better glycemic control. Apart from targeting HbA1c and mean glucose concentrations, reducing the glycemic variability (GV) is the key to successful management of diabetes and associated complications. A parallel arm, open-label, randomized, controlled study (ClinicalTrials.gov identifier NCT01468519) was conducted in T2DM men with ED (n = 20) to assess whether better glycemic control achievable with the continuous subcutaneous insulin infusion (CSII) relative to multiple daily injection therapy (MDI), would result in improved ED and diabetic peripheral neuropathy. Subjects were randomized (1:1) to CSII (intervention) or MDI (control) arms. All subjects were on insulin, oral hypoglycemic agents (OHAs), and a statin. Concomitant therapies were continued and antihypertensives were used as required. Modifications to medication, diet, and exercise were prescribed based on their structured self-monitoring of blood glucose (sSMBG) values, professional continuous glucose monitoring (P-CGM, at 0 and 3 months of study) reports, and other comorbidities. At six months, CSII arm showed increased International Index of Erectile Function scores (addresses the relevant domains of male sexual function, +7.87, P = .0037). More subjects in the CSII than the MDI arm achieved reductions in ED severity (Figure 1) and were listed under the “No ED” category (6 vs 1, P = .0108). Those in the CSII arm achieved lowered HbA1c levels (−0.87%, P = .0036), PHQ-9 scores (represents the severity of depression, −1.33, P = .0017), and hsCRP levels (a biomarker of inflammation and risk factor for ED, −0.53 mg/l, P = .0110), whereas those in the MDI arm had increased HbA1c levels (+0.76%, P = .0227). Total cholesterol, triglycerides, low-density, and high-density lipoproteins showed no significant changes in both the treatment arms. Vibration perception threshold analysis demonstrated that CSII arm achieved improvements in the severity of neuropathy. Subjects in the mild, moderate, and severe categories were 40%, 10%, and 50% at the start of study vs 50%, 20%, 794704 DSTXXX10.1177/1932296818794704Journal of Diabetes Science and TechnologyKesavadev et al letter2018

An Asian Indian woman with Wolfram syndrome on insulin pump: successful pregnancy and beyond.

Wolfram syndrome (WS), or DIDMOAD (diabetes insipidus, diabetes mellitus, optic atrophy, and deafness), is a rare autosomal recessive neurodegenerative disorder with a median life expectancy of 30 years and occurs in one in 770,000 live births. To date only five successful pregnancies have been reported among WS subjects worldwide. Here we describe the sixth report of successful pregnancy in a WS patient and the first from India. The subject is still on an insulin pump, now 31 years old and doing well. She developed diabetes at 5 years of age, optic atrophy at 14 years, and diabetes insipidus at 25 years and had a successful delivery in 2007 while on an insulin pump. Sequencing of exonic regions of the WFS1 gene showed five changes, two of which were pathogenic (exon 8). Magnetic resonance imaging of brain showed generalized neurodegenerative changes. The benefits of continuous subcutaneous insulin infusion and that of tight metabolic control in prevention of abortions and fetal malformations in diabetes associated with pregnancy are well documented. The impression of probable pleiotropic action of insulin pumps over and above that of glycemic reduction is gaining momentum. Recent evidence supports use of insulin pumps in alleviating neuropathic pain in diabetes, probably by virtue of its action in minimizing mean amplitude of glycemic excursions not possible with conventional insulin shots. WS is a progressive neurodegenerative disorder, which will probably help us in understanding the positive impact of continuous subcutaneous insulin infusion in prolonging the life span and retarding neuronal damage in WS.