Ak Das

Baseline characteristics of the Indian cohort from the IMPROVE™ study: a multinational, observational study of biphasic insulin aspart 30 treatment for type 2 diabetes

IntroductionThe IMPROVE™ study is an openlabel, nonrandomized, observational study aimed at determining the safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) treatment in subjects with type 2 diabetes from 11 countries. Here, we report the baseline data of the Indian cohort.MethodsAll subjects with type 2 diabetes requiring insulin and considered suitable for BIAsp 30 therapy based on their physician’s clinical judgment were eligible to enter the study. The data recorded at baseline included demographic characteristics, detailed medical histories, physician-cited reasons for starting BIAsp 30 treatment, and the chosen dosage regimens.ResultsThe Indian cohort included 17,995 subjects with diabetes. Poor glycemic control (glycated hemoglobin [HbA1c], 8.7%–9.6%) was observed at baseline in all four geographical zones (North, South, East, and West) and prestudy treatment groups (no therapy, only oral antidiabetic drug [OAD], OAD ± insulin, and OAD ± insulin ± BIAsp 30). Prevalence of both micro- and macrovascular complications was high, also reflecting poor glycemic control. Improving HbA1c and fasting and postprandial blood glucose levels were the most common reasons for starting BIAsp 30 therapy. The subjects were prescribed a mean BIAsp 30 dose of approximately 24 IU, and a twice-daily regimen was employed in almost 80% of subjects.ConclusionThe baseline results of the IMPROVE study Indian cohort confirm the poor glycemic control and the delayed initiation and/or inadequacy of treatment in subjects with type 2 diabetes. These results also highlight the need for timely and appropriately intensive insulin-based therapy.

Patient-centered management of hypothyroidism

This communication from the National Indian Patient-centered Thyroid management group (InPACT) deals with a novel, yet essential, aspect of hypothyroidism management. The authors describe the role and scope of patient-centered care in this condition. They focus on the relevance of a patient-centered clinical approach, which will help decide appropriate targets, as well as techniques to achieve those targets. Means of helping persons with hypothyroidism live a healthy life, such as education about precaution in concomitant food and medications intake, as well as sick day management, are discussed.

Clinical experience of switching from biphasic human insulin to biphasic insulin aspart 30 in Indian patients with type 2 diabetes in the A1chieve study.

Aim: The aim of the following study is to evaluate the safety and effectiveness of switching from biphasic human insulin (BHI) to biphasic insulin aspart 30 (BIAsp 30) in Indian patients with type 2 diabetes as a sub-analysis of the 24-week, non-interventional A1chieve study. Materials and Methods: Indian patients switching from BHI to BIAsp 30 based on the physicians’ decisions were included. The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycemic events; secondary outcomes included changes in hypoglycemia in the 4 weeks preceding baseline and week 24 and changes from baseline to week 24 in glycated hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), body weight and quality of life (QoL). Results: Overall, 1976 patients (mean ± standard deviation age, 55.1 ± 10.6 years and diabetes duration, 10.1 ± 5.3 years) on a mean pre-study BHI dose of 0.44 ± 0.18 U/kg were included. The mean BIAsp 30 dose was 0.43 ± 0.17 U/kg at baseline and 0.44 ± 0.17 U/kg at week 24. No SADRs were reported. The proportion of patients reporting overall hypoglycemic events reduced significantly from baseline to week 24 (15.0% vs. 2.9%, P < 0.0001). The mean HbA1c level improved significantly from 9.1 ± 1.4% at baseline to 7.5 ± 1.0% at week 24, along with improvements in FPG, post-breakfast PPPG and QoL (P < 0.001). The mean body weight decreased from 69.3 ± 10.8 kg at baseline to 69.1 ± 10.4 kg at week 24 (P = 0.003). Conclusion: Switching from BHI to BIAsp 30 therapy was well-tolerated and was associated with improved glycemic control.

Baseline results indicate poor glycemic control and delay in initiation and optimization of insulin therapy: results from the improving management practices and clinical outcomes in type 2 diabetes study.

Introduction: Improving management practices and clinical outcomes in type 2 diabetes (IMPACT), was a prospective, open-label, 26- week, comparative, multi-center study to compare efficacy and safety of the Indian insulin guideline (IIG) group versus routine clinical practice (RCP) group in patients with type 2 diabetes. Materials and Methods: A total of 20,653 patients from 885 centers across India were enrolled and treated with premixed insulin therapy as per IIG or routine care. Results: Most of the participating centers (81.7%) reported following a diabetes guideline in their practice routinely but only 20.4% targeted HbA1c <7%. Very few of the physicians (2.7%) reported that most of their patients (>75%) achieved an HbA1c <7%. Most of the physicians (39.8%) also agreed that only 10-25% of the patients agree to start insulin therapy at the first counseling. Mean duration of diabetes before initiating insulin in patients using oral anti-diabetic drugs (OADs) was 7 years, indicating a delay in initiating insulin therapy. The difference in mean daily dose of insulin at initiation vs. at 26 weeks was only 0.8 U (25.8 ± 11.3 at initiation compared to 26.6 ± 9.5, respectively, p = ns) suggesting lack of treatment optimization. Weekly titration till achieving HbA1c <7% was done in 51.1% of the patients and only 8.9% performed self-titration. Conclusion: Baseline glycemic control in these patients was poor and reflects a delay in initiating insulin therapy. Data also reflect a lack of optimization of insulin doses.

Improving adherence to insulin: Hope with degludec

Scientific literature on diabetes supports the contention that research in diabetes is increasing, which we understand more about its pathophysiology, and that we have better drugs to manage it. These improvements, however, do not seems to be able to keep pace with the needs imposed by the diabetes pandemic. For every new therapeutic target unearthed and for every new drug discovered, diabetes poses a fresh challenge . For example, the discovery of insulin brought succor to many sufferers, yet insulin-related challenges like compliance, hypoglycemia, and weight gain continue to vex clinicians and their patients.

Consensus statement on diabetes in children

While T1DM has been traditionally seen as a minor concern in the larger picture of pediatric ailments, new data reveals that the incidence of T1DM has assumed alarming proportions. It has long been clear that while the disease may be diagnosed at an early age, its impact is not isolated to afflicted children. The direct impact of the disease on the patient is debilitating due to the nature of the disease and lack of proper access to treatment in India. But this impact is further compounded by the utter apathy and often times antipathy, which patients withT1DM have to face. Lack of awareness of the issue in all stakeholders, low access to quality healthcare, patient, physician, and system level barriers to the delivery of optimal diabetes care are some of the factors which hinder successful management of T1DM. The first international consensus meet on diabetes in children was convened with the aim of providing a common platform to all the stakeholders in the management of T1DM, to discuss the academic, administrative and healthcare system related issues. The ultimate aim was to articulate the problems faced by children with diabetes in a way that centralized their position and focused on creating modalities of management sensitive to their needs and aspirations. It was conceptualized to raise a strong voice of advocacy for improving the management of T1DM and ensuring that “No child should die of diabetes”. The unique clinical presentations of T1DM coupled with ignorance on the part of the medical community and society in general results in outcomes that are far worse than that seen with T2DM. So there is a need to substantially improve training of HCPs at all levels on this neglected aspect of healthcare.

Indian Public Health Standards 2012 and the diabetes pharmacopoeia.

As India grapples with an unprecedented epidemic of non-communicable diseases, the healthcare system faces more demands and newer challenges. Earlier geared towards infectious diseases, maternal and child health problems, public health issues and now includes in its ambit ‘modern’ or non-communicable disease diabetes mellitus. The growing concern of disease burden as per global and national statistics is well-known and needs no repetition in this journal. The Indian Public Health Standards (IPHS), revised in 2012,[1,2,3,4,5] are an attempt to set operating standards for government health institutions, ranging from sub-centers and primary health centers to sub-district/sub-divisional and district hospitals. The IPHS provide exhaustive coverage of the physical and human resources necessary to run health institutions, duties and responsibilities of staff, and the processes and procedures by which these are to be achieved. Included in the IPHS are lists of drug to be made available at health facilities of various levels. To some extent, but not completely, the drug lists of the IPHS demonstrate concordance with the National List of Essential Medicines (NLEM).[6] The NLEM, last revised in 2011, is a governmental list of drugs, which are essential at primary, secondary, and tertiary levels of healthcare system. The strong presence of endocrine pharmacopoeia in the Indian NLEM has already been discussed.[7] This underscores the heightened importance given to endocrine and metabolic disease at the policy-maker level. Equally important, it also demonstrates the responsibility felt by the endocrine community towards fulfilling its mandate of better patient care at not only the individual, but also the public health level. This editorial discusses the diabetes drugs listed in the IPHS, and suggests simple changes which maybe implemented to improve care for people with diabetes, irrespective of which healthcare facility they choose to visit. The Indian public health system comprises of sub-centers, primary healthcare centers, community health centers, sub-district and sub-divisional hospitals (31 to 100 beds), and district hospitals (101 to 500 beds). Each level of healthcare performs different duties and fulfils unique responsibilities. This is achieved with a pre-specified set of physical equipments and drug lists.

Baseline characteristics of the IMPROVE control study population: A study to evaluate the effectiveness of a standardized healthcare professionals training program

Introduction: The IMPROVE Control Training program was designed by Indian Academy of Diabetes (IAD), and a non-intervention study was conducted to evaluate the effectiveness of this standardized healthcare professionals (HCPs) training program on achieving treatment goals in patients with diabetes mellitus and its impact on standard of care. Materials and Methods: This multi-center, parallel group, open-label, non-randomized, non-intervention study included patients with type 2 diabetes who had an HbA1c >9 at time of diagnosis or an HbA1c >7% even after 6 months of initiation of therapy with anti-diabetic agents (Oral anti diabetic agents (OADs) and/or insulin). The data recorded at baseline included demographic characteristics, medical history, and the treatment regimens. Results: The study included 20,493 patients with diabetes, of which 13,295 (64.9%) were men. The mean [standard deviation (SD)] duration of diabetes was 6.4 (4.2) years and 6608 (32.2%) reported complications of diabetes. Poor glycemic control [HbA1c = 9.4 (1.3), FPG (mg/dl) = 181.2 (45.7); mean (SD)] was observed. The postprandial glucose was also high [post-breakfast, lunch, and dinner values in mg/dl were 263.6 (68.5), 278.1 (69.6), and 250.2 (63.7), respectively] in these patients. Failure of OADs was the most common reason cited for initiation of insulin. Premixed insulin was rated the regimen of choice for initiating therapy by the physicians (62.2% vs. 34.5% who preferred basal insulin). Conclusion: The baseline results confirm the poor glycemic control and the delayed initiation and/or inadequacy of treatment in subjects with type 2 diabetes. These results also highlight the need for early and optimal insulin-based therapy.

Physicians' perceptions of a national consensus guideline on insulin therapy: Data from the IMPACT study.

Introduction: The effectiveness and impact of the Indian insulin guideline in clinical practice was evaluated by the Improving Management Practices and Clinical Outcomes in Type 2 Diabetes (IMPACT) Study. The study also evaluated the participating physicians’ perceptions on the use of IIG versus RCP for management of diabetes. Materials and Method: This 26 week multicenter, open label, randomized, prospective study aimed to evaluate effectiveness of Indian insulin guideline (IIG) versus routine clinical practice (RCP) in patients with type 2 diabetes (T2D). Results: Out of 426 physicians who completed the physicians’ perception questionnaire, 189 (44.4%) felt that it was “easy” to initiate insulin in their patients using IIG. Cost of therapy (52.3%), followed by poor adherence (40.3%), and lack of motivation among physicians (40.4%) were the most important reasons cited for delay in initiation of insulin therapy. Two hundred and thirty three (54.7%) physicians felt that insulin titration was made “easy” in their patients using IIG, while 104 (24.4%) had a neutral approach. A total of 222 physicians (52.1%) felt it was “convenient” applying IIG in their practice, and 239 (67.8%) physicians felt “satisfied” with using IIG for achieving the targeted HbA1c <7%. One hundred and seventy seven (41.5%) physicians felt that there was scope for improving the IIG further by simplifying and revising the titration charts [117 (27.5%)]. Conclusion: Primary care physicians in India have perceived the IIG to be easy algorithm to initiate and titrate insulin therapy. These results will encourage the use and facilitate future revision of the guideline.