An Observational Study on the Mortality Pattern of Type 1 Diabetic Patients in West Bengal, India: A 22 Years' Follow Up Report of 212 Patients.

BACKGROUND: Limited information is available on the total profile of type 1 diabetes mellitus (T1DM) patients in India as type 1 diabetes is not common in India. The present study has been undertaken therefore, in search of mortality pattern of the type 1 diabetics attending the diabetic clinic run by the Calcutta Diabetes and Endocrine Foundation at Kolkata which has a special diabetes care program for the type 1 diabetics. OBJECTIVES: • To obtain the mortality rate of type 1 diabetes in India and to compare it with overall Indian mortality. • To identify the role of different complications of diabetes responsible for the death and thereby, getting a mortality pattern in type 1 diabetes. • To take necessary action for prevention of the complication(s), mainly responsible for the death Study Design and settings: Longitudinal Observational Study: A number of 264 type 1 diabetics attending our clinic were considered for the study. The patients registered in the clinic since April 1996 and had at least one or more follow up visits per year have been included in the study. Follow-up up to 31st March, 2019 have been determined as selection criteria. Out of 264, 212 patients satisfied the criteria and therefore have been included in the study. METHODS OF STUDY: Age, sex, height, weight, educational qualifications, profession, annual family income and number of family members of each patient was recorded in the first visit. Age and year of detection of diabetes was also recorded. Fasting and Post Prandial plasma glucose level, insulin type and dose, daily dietary habit, presence of diabetic complications, i.e. Retinopathy Neuropathy, Nephropathy, Coronary Artery Disease. Life Style and diabetic education status were assessed during first visit and also in successive visits. An average value for each of the above parameters was calculated for every patient and recorded to explain their individual status. Mortality data was collected from the patients expired during this period. RESULTS: 22 (10.38%) out of 212 patients were expired during the study period. 8 (36.36%) of them were males and 14 (63.64%) were females. The age of the expired patients at death varied from 5 to 73 years. 3 ( 13,64% ) patients died within 20 years of age,14 (63.64%) between 21-40 years, 2 ( 9.09% ) between 41 - 60 years and 3 ( 13.63% ) were above 60 years. Chronic Kidney Disease (CKD) was the cause of death for maximum number of patients (45.45%) followed by Diabetic Ketoacidosis (DKA, 18.18%),!3.63% died of Coronary Artery Disease, 9.09% of infections (pneumonia, encephalitis). Accidental and psycho-social reasons were present in 13.63%. CONCLUSION: In this observational study, the total number of death observed was 22 out of 212 type 1 diabetic patients in this 22 years' period.CKD is the leading cause of death in this cohort, followed by DKA, Infection, and Coronary Artery Disease. Infection and DKA was found in the poor socio economic group. Some patients died of accident and other psycho social problem in the family. A regular communication with the patients made a lot of positive influence in our patients.

Consensus on "Basal insulin in the management of Type 2 Diabetes: Which, When and How?"

INTRODUCTION: Type 2 diabetes mellitus (T2DM) has attained epidemic proportions and continues to increase despite the availability of a number of oral antidiabetic medications and major advances made in insulin delivery since its discovery nearly a hundred years ago. One, amongst many other reasons responsible for the inability to achieve adequate glycaemic control in a substantial proportion of T2DM patients is the delayed initiation and inappropriate intensification of insulin treatment. Appropriate initiation and intensification of insulin is critical for the successful achievement of tight glycaemic control. OBJECTIVE: To provide simple and easily implementable guidelines to primary care physicians on basal insulin initiation and intensification, along with use of basal insulin in special situations (hepatic failure, renal failure and gestational diabetes mellitus). METHODS: Each consensus statement on basal insulin initiation, intensification and use of basal insulin in special situations was evaluated for dosing and titration based on established guidelines, data from approved pack inserts, prescribing information or summary of product characteristics for each insulin type, and published scientific literature. These evaluations were then factored into the national context based not only on the clinical experience of the expert committee representatives' but also based on the common therapeutic practices followed in India to successfully achieve optimal glucose control. RESULTS: Recommendations on initiation and intensification of basal insulin, and its use in special situations, have been developed. The key recommendations are to initiate basal insulin when 2 or 3 oral antidiabetic medications fail to achieve target glycaemic control, or in symptomatic patients with glycated haemoglobin value greater than 9%. Depending upon patient characteristics, any of the four available basal insulins [Neutral protamine Hagedorn (NPH), Glargine (IGlar), Detemir (IDet), Degludec (IDeg)] can be used. However, IDeg has a longer duration of action, comparatively lesser hypoglycaemia (both overall and nocturnal) and more flexibility in administration timing compared to IGlar) and IDet. Inability to maintain glycaemic control should lead to prompt intensification of basal insulin treatment by adding mealtime insulin, consisting of one to three injections of either rapid-acting insulin analog or regular insulin; depending upon patient characteristics, intensification can also be achieved by transition from basal insulin to twice daily premixed insulin analogs/premixed human insulin/insulin co-formulations. IDeg/IDet can be used in all grades of renal and hepatic impairment; and IDet has been approved for use in gestational diabetes mellitus. CONCLUSIONS: We hope that these consensus based recommendations shall be a useful reference tool for health care practitioners and help them in initiating and intensifying insulin therapy in T2DM patients in order to achieve optimal glycaemic control.

Barriers and solutions to diabetes management: An Indian perspective.

India, with one of the largest and most diverse populations of people living with diabetes, experiences significant barriers in successful diabetes care. Limitations in appropriate and timely use of insulin impede the achievement of good glycemic control. The current article aims to identify solutions to barriers in the effective use of insulin therapy viz. its efficacy and safety, impact on convenience and life-style and lack of awareness and education. Therapeutic modalities, which avoid placing an undue burden on patients' life-style, must be built. These should incorporate patient-centric paradigms of diabetes care, team-based approach for life-style modification and monitoring of patients' adherence to therapy. To address the issues in efficacy and safety, long-acting, flat profile basal insulin, which mimics physiological insulin and show fewer hypoglycemic events is needed. In addition, therapy must be linked to monitoring of blood glucose to enable effective use of insulin therapy. In conjunction, wide-ranging efforts must be made to remove negative perception of insulin therapy in the community. Patient- and physician - targeted programs to enhance awareness in various aspects of diabetes care must be initiated across all levels of health-care ensuring uniformity of information. To successfully address the challenges in facing diabetes care, partnerships between various stakeholders in the care process must be explored.

Safety of statins.

Statins are an established class of drugs with proven efficacy in cardiovascular risk reduction. The concern over statin safety was first raised with the revelation of myopathy and rhabdomyolysis with the use of now withdrawn cerivastatin. Enhanced understanding of the mechanisms behind adverse effects of statins including an insight into the pharmacokinetic properties have minimised fear of statin use among clinicians. Studies reveal that occurrence of myopathy and rhabdomyolysis are rare 1/100000 patient-years. The risk of myopathy/rhabdomyolysis varies between statins due to varying pharmacokinetic profiles. This explains the differing abilities of statins to adverse effects and drug interaction potentials that precipitate adverse effects. Higher dose of rosuvastatin (80 mg/day) was associated with proteinuria and hematuria while lower doses were devoid of such effects. Awareness of drugs interacting with statins and knowledge of certain combinations such as statin and fibrates together with monitoring of altered creatine kinase activity may greatly minimise associated adverse effects. Statins also asymptomatically raise levels of hepatic transaminases but are not correlated with hepatotoxicity. Statins are safe and well tolerated including more recent potent statins such as, rosuvastatin. The benefits of intensive statin use in cardiovascular risk reduction greatly outweigh risks. The present review discusses underlying causes of statin-associated adverse effects including management in high risk groups.

Protocol of an observational study to evaluate diabetic nephropathy through detection of microalbuminuria in Indian patients.

AIM: To assess the prevalence of persistent microalbuminuria (MAU), its clinical correlates by dip stick method, its predictive value for potential kidney disease and the utility of this test as objective cue for health care seeking behavior in adult Indian patients with type 2 diabetes mellitus. MATERIALS AND METHODS: Approximately 400,000 patients shall be enrolled in this multicentric, cross sectional study. Patients meeting eligibility criteria shall be screened for MAU through urine dipstick test using random daytime single spot urine specimen. Result shall be expressed either positive or negative based on the presence or absence of albumin in the urine and will be correlated with the corresponding random blood glucose. Height, weight, waist circumference and blood pressure shall be assessed. There will be three visits with a minimum interval of 28 days between two visits, to be completed within 180 days, and at least two of three urine tests measured in this period must show elevated albumin levels to diagnose MAU. CONCLUSION: Detection of MAU through the dipstick method is postulated to be a rapid, reliable test for early detection of diabetic nephropathy, which, in turn will help the physician to plan treatment strategy. Further, it will help to identify the disease burden on the individual and society, and may serve as an objective cue for improved health care seeking behavior, as well as a catalyst for health policy change.

Addition of insulin aspart with basal insulin is associated with improved glycemic control in Indian patients with uncontrolled type 2 diabetes mellitus: the A1chieve observational study.

Insulin aspart (IAsp) has been used in patients for more than a decade. A plethora of data is available, from clinical trials, to document its efficacy and safety and suggest that IAsp is a favorable choice to be used in a basal-bolus regimen. The A1chieve@ was a non-interventional study that explored the safety and effectiveness of initiating or switching to insulin analogues in routine clinical practice in more than 60,000 patients from 28 different countries. In this manuscript, we discuss the findings from the subgroup of the Indian cohort who were treated with insulin aspart (IAsp), in addition to a basal insulin analogue (insulin detemir, IDet). In a cohort of 343, who were on IAsp + IDet, 175 (51%) were insulin naive and 168 (49%) had been on insulin therapy earlier. Glycaemic parameters were high at baseline. Mean HbA1c was 9.3% in them and was comparable in both insulin naive and insulin experienced groups. After 24 weeks of therapy with IAsp + basal insulin, there were reductions in HbA1c in both the insulin naive group, (-1.6) and insulin experienced group (-1.5). Fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) levels were also reduced significantly from baseline (-77 and - 110 mg/dL, respectively, p < 0.001). Overall, hypoglycaemia decreased from 0.97 (baseline) to 0.18 events/patient years (24 weeks). There was also an increase in quality of life score as evaluated by EQ-5D questionnaire. Addition of IAsp with a basal insulin in patients with poor glycaemic control leads to an improvement in glycaemic profile with no major hypoglycaemia or clinically significant weight gain along with an improvement in the quality of life in patients with type 2 diabetes.

Vitamin D toxicity.

A 67-year-old female was admitted to the hospital with a history of lethargy, memory impairment, confusion, anorexia and gait imbalance for 2 weeks duration. She did not have any history of fall or head injury. She had total hip replacement 1 year back and was on orthopedic follow-up. Magnetic resonance imaging (MRI) on admission revealed no focal abnormalities. Routine biochemistry detected hypercalcemia, and she was treated with I/V fluid, diuretics and glucocorticoids. She was screened thoroughly to exclude occult malignancy. After 7 days of admission, a follow-up orthopedic prescription revealed that she was getting inj. Arachitol 6 lac units every week for last 3 months. On the 9(th) day of admission, she was detected to have very high serum 25(OH) vitamin D level (254.70 ng/ml). Patient was discharged after 2 weeks after her serum calcium came down to normal range with the advice of no dietary calcium and vitamin D intake. Her 25(OH) vitamin D level remained high for the next 6 months. Now she is completely asymptomatic and her serum 25(OH) D is normal.