Bipin Sethi

Effectiveness of a Multicomponent Quality Improvement Strategy to Improve Achievement of Diabetes Care Goals: A Randomized, Controlled Trial

BACKGROUND Achievement of diabetes care goals is suboptimal globally. Diabetes-focused quality improvement (QI) is effective but remains untested in South Asia. OBJECTIVE To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes. DESIGN Parallel, open-label, pragmatic randomized, controlled trial. (ClinicalTrials.gov: NCT01212328). SETTING Diabetes clinics in India and Pakistan. PATIENTS 1146 patients (575 in the intervention group and 571 in the usual care group) with type 2 diabetes and poor cardiometabolic profiles (glycated hemoglobin [HbA1c] level ≥8% plus systolic blood pressure [BP] ≥140 mm Hg and/or low-density lipoprotein cholesterol [LDLc] level ≥130 mg/dL). INTERVENTION Multicomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records. MEASUREMENTS Proportions achieving HbA1c level less than 7% plus BP less than 130/80 mm Hg and/or LDLc level less than 100 mg/dL (primary outcome); mean risk factor reductions, health-related quality of life (HRQL), and treatment satisfaction (secondary outcomes). RESULTS Baseline characteristics were similar between groups. Median diabetes duration was 7.0 years; 6.8% and 39.4% of participants had preexisting cardiovascular and microvascular disease, respectively; mean HbA1c level was 9.9%; mean BP was 143.3/81.7 mm Hg; and mean LDLc level was 122.4 mg/dL. Over a median of 28 months, a greater percentage of intervention participants achieved the primary outcome (18.2% vs. 8.1%; relative risk, 2.24 [95% CI, 1.71 to 2.92]). Compared with usual care, intervention participants achieved larger reductions in HbA1c level (-0.50% [CI, -0.69% to -0.32%]), systolic BP (-4.04 mm Hg [CI, -5.85 to -2.22 mm Hg]), diastolic BP (-2.03 mm Hg [CI, -3.00 to -1.05 mm Hg]), and LDLc level (-7.86 mg/dL [CI, -10.90 to -4.81 mg/dL]) and reported higher HRQL and treatment satisfaction. LIMITATION Findings were confined to urban specialist diabetes clinics. CONCLUSION Multicomponent QI improves achievement of diabetes care goals, even in resource-challenged clinics. PRIMARY FUNDING SOURCE National Heart, Lung, and Blood Institute and UnitedHealth Group.

Improving diabetes care: Multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia—The CARRS Multi-center Translation Trial

AIMS Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in people with diabetes in South Asia. The CARRS Translation Trial tests the effectiveness, cost-effectiveness, and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan. METHODS We randomly assigned 1146 adults with diabetes recruited from 10 urban clinic sites, to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention. The intervention involves electronic health record management, decision-support prompts to the healthcare team, and the support of a care coordinator to actively facilitate patient and provider adherence to evidence-based guidelines. The primary outcome is a composite of multiple CVD risk factor control (blood glucose and either blood pressure or cholesterol, or all three). Other outcomes include control of the individual CVD risk factors, process and patient-centered measures, cost-effectiveness, and acceptability/feasibility. CONCLUSION The CARRS Translation Trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients (clinicaltrials.gov number: NCT01212328).

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.

Treat-to-target trials in diabetes.

Treat-to-target is a therapeutic concept that considers well defined and specific physiologic targets as aims in controlling the pathophysiology of the disease. It has been widely used in diseases that pathophysiology includes, chronic metabolic and physiological disturbances, namely rheumatic conditions, vascular medicine and diabetes. In diabetes, the availability of “gold-standard” quantitative measures like fasting plasma glucose and glycated hemoglobin make the application of treat-to-target trials especially pertinent. Treatment modalities which have used single therapeutic agents or combinations or in combination with a variety of titration algorithms and implementation protocols have broadened our understanding of diabetes management with specific reference to insulin initiation and maintenance. Treat-to-target trials have been used to investigate a wide variety of questions including efficacy, safety, effect of treatment on comorbidities and patient satisfaction, ideal mechanisms to implement insulin initiation etc. A more generalized acceptance and implementation of treat-to-target trials may finally revolutionize diabetes management by combining aspects of individual care with standard treatment protocols.

Type 1 diabetes: Awareness, management and challenges: Current scenario in India

Type 1 diabetes mellitus (T1DM) has a wide presence in children and has a high mortality rates. The disease, if left unmanaged, poses various challenges to the patient and healthcare providers, including development of diabetic complications and thus decreasing the life expectancy of the affected child. The challenges of T1DM include awareness of the disease that is very poor among the general public and also in parents of T1DM children along with the health care professionals. The challenge of lack of awareness of T1DM can be met by increasing public awareness programs, conducting workshops for diabetes educators regarding T1DM in children, newsletters, CMEs, online courses, and by structured teaching modules for diabetes educators. Diagnosis of T1DM was a challenge a few decades ago but the situation has improved today with diagnostic tests and facilities, made available even in villages. Investigation facilities and infrastructure, however, are very poor at the primary care level, especially in rural areas. Insulin availability, acceptability, and affordability are also major problems, compounded by the various types of insulin that are available in the market with a varied price range. But effective use of insulin remains a matter of utmost importance.

How many oral antidiabetic drugs before insulin

Worsening of glycemic control in type 2 Diabetes mellitus occur on account of declining beta cell function. This calls for up titration of the chosen drug, addition of another agent with complementary action and eventually insulin usually after 2 or three OADs. Introduction of insulin has many issues which include parenteral route of administration, cost and enhancement of hypoglycemic tendency. We propose the addition of another OAD in lieu of insulin in whom glycemic control can be achieved equally well without insulin

The thyroid registry: Clinical and hormonal characteristics of adult indian patients with hypothyroidism

Objectives: Appropriate treatment of hypothyroidism requires accurate diagnosis. This registry aimed to study the disease profile and treatment paradigm in hypothyroid patients in India. Materials and Methods: We registered 1500 newly diagnosed, treatment-naïve, adult hypothyroid males and nonpregnant females across 33 centers and collected relevant data from medical records. The first analysis report on baseline data is presented here. Results: The mean age of the study population was 41.1 ± 14.01 years with a female to male ratio of 7:3. The most frequently reported symptoms and signs were fatigue (60.17%) and weight gain with poor appetite (36.22%). Menstrual abnormalities were reported in all women (n = 730) who had not attained menopause. Grades 1 and 2 goiter (as per the WHO) were observed in 15.41% and 3.27% patients, respectively. Comorbidities were reported in 545 patients (36.36%), type 2 diabetes mellitus being the most prevalent (13.54%) followed by hypertension (11.34%). Total serum thyroxine (T4) and thyroid-stimulating hormone (TSH) levels were assessed in 291 (19.47%) patients only. In majority of patients (81%), treatment was based on serum TSH levels alone. The dose of levothyroxine ranged from 12.5 to 375 mcg. Conclusions: Guidelines suggest a diagnosis of hypothyroidism based on TSH and T4 levels. However, most of the patients as observed in this registry received treatment with levothyroxine based on TSH levels alone, thus highlighting the need for awareness and scientific education among clinicians in India. The use of standard doses (100, 75, and 25 mcg) of levothyroxine may point toward empirical management practices.

Trials and tribulations of managing type 1 diabetes.

Effective type 1 diabetes mellitus (T1DM) management tools are education, empowerment, insulin, and diet control. Exercise should be of moderate intensity so as to avoid hypoglycaemia. It is prudent to ensure that the required insulin levels are achieved in all children in order to manage the disorder well. The total daily dose of insulin may be 0.6–1.0 u/kg body weight, and it may be 2/3, 1/3 for split mixed insulin, and 50/50 for multiple subcutaneous injections. The dosages for the pump also vary from child to child. Basal bolus regimen is important and necessary in all T1DM children. It is not necessary to use all types of insulin analogs in all T1DM children, and the decision should depend on cost and delivery limiting factors. The advantages of using analogues are that some of these exhibit low hypoglycemic events (especially nocturnal events with basal insulin) and a few offer flexibility of administration to patients (most prandial analogs and some basal analogs).