Assessment of quality of life and its determinants in type-2 diabetes patients using the WHOQOL-BREF instrument in Bangladesh.

BACKGROUND: Diabetes mellitus (DM) is rising at a rapid rate worldwide. As a chronic, incurable metabolic disease, diabetes affects a person's life in all ways. Studies thus far have focused on the impact of diabetes on the physical and mental health of persons affected by the quality of life (QoL). This study aimed to explore the whole range of QoL deficits using the World Health Organization Quality of Life brief version (WHOQOL-BREF) in type-2 diabetic patients. METHODS: This cross-sectional study was carried out among individuals aged at or above 15 years with type 2 diabetes (T2DM). Patients with prior mental health illness and unwillingness to give consent were excluded. A pretested structured questionnaire including the 26-item WHOQOL-BREF questionnaire was used for face-to-face interviews. Appropriate ethical measures were ensured. All statistical analyses were carried out using the statistical software STATA (Version 16.1). Graphs were created using R (Version 4.0.0). RESULTS: A total of 500 T2 DM patients with a mean age of 55.8 ± 13.2 years (± SD) and a female proportion of 50.8% were included. Overall, 22.2% of participants rated their QoL as poor, and 25% were dissatisfied with their health (as assessed by questions 1 and 2 of the WHOQOL-BREF questionnaire). More than half (54% and 51.2%, respectively) had an average evaluation of their QoL and health. The QoL scores were below average, with mean scores (± SD) for the physical health, psychological, social relationship, and environmental domains of 37.2 ± 20.5, 44.2 ± 21.0, 39.6 ± 23.2, and 41.6 ± 19.5, respectively. Multiple regression analysis revealed that the patient's level of education and monthly family income were significant positive modifiers and that complications (nephropathy, retinopathy, and peripheral artery disease) were significant negative determinants of the QoL score in different domains. CONCLUSION: This study found the overall quality of life among T2DM patients below average. Health authorities and clinicians should take these findings into account and incorporate necessary measures to ameliorate negative modifiers of the quality of life of sufferers.

Intestinal alkaline phosphatase deficiency increases the risk of diabetes.

INTRODUCTION: Our previous case-control study demonstrated that a high level of intestinal alkaline phosphatase (IAP), an endotoxin-detoxifying anti-inflammatory enzyme secreted by villus-associated enterocytes and excreted with stool, plays a protective role against type 2 diabetes mellitus (T2DM) irrespective of obesity. In the current study, we investigated the long-term effect of IAP deficiency (IAPD) on the pathogenesis of T2DM. RESEARCH DESIGN AND METHODS: A healthy cohort of participants without diabetes (30-60 years old), comprising 188 without IAPD (IAP level: ≥65 U/g stool) and 386 with IAPD (IAP level: <65 U/g stool), were followed up for 5 years. We measured stool IAP (STAP) and fasting plasma glucose, and calculated the risk ratio (RR) using log-binomial regression model. RESULTS: T2DM incidence rates were 8.0%, 11.7%, 25.6%, and 33.3% in participants with 'persistent no IAPD' (IAP level: always ≥65 U/g stool), 'remittent IAPD' (IAP level: increased from <65 U/g stool to ≥65 U/g stool), 'persistent IAPD' (IAP level: always <65 U/g stool), and 'incident IAPD' (IAP level: decreased from ≥65 U/g stool to <65 U/g stool), respectively. Compared with 'persistent no IAPD' the risk of developing T2DM with 'incident IAPD' was 270% higher (RR: 3.69 (95% CI 1.76 to 7.71), χ2 p<0.001). With 'persistent IAPD' the risk was 230% higher (RR: 3.27 (95% CI 1.64 to 6.50), p<0.001). 'Remittent IAPD' showed insignificant risk (RR: 2.24 (95% CI 0.99 to 5.11), p=0.0541). Sensitivity analyses of persistent IAP levels revealed that, compared with participants of the highest persistent IAP pentile (always >115 U/g stool), the rate of increase of fasting glycemia was double and the risk of developing T2DM was 1280% higher (RR: 13.80 (95% CI 1.87 to 101.3), p=0.0099) in participants of the lowest persistent IAP pentile (always <15 U/g stool). A diabetes pathogenesis model is presented. CONCLUSIONS: IAPD increases the risk of developing T2DM, and regular STAP tests would predict individual vulnerability to T2DM. Oral IAP supplementation might prevent T2DM.

The Incidence of Hypoglycemia among Insulin-Treated Patients with Type 1 or Type 2 Diabetes: Bangladeshi Cohort of International Operations-Hypoglycemia Assessment Tool Study.

OBJECTIVES: The objective of this study was to assess the incidence of hypoglycemia in patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) in Bangladeshi cohort of the International Operations-Hypoglycemia Assessment Tool study. MATERIALS AND METHODS: Patients diagnosed with either T1DM or T2DM, aged ≥18 years, treated with insulin (any regimen) for >12 months, and completed self-assessment questionnaires (SAQs) to record demography, treatment information, and hypoglycemia during the 6-month retrospective and 4-week prospective periods (a total of 7 months) were enrolled in the study. RESULTS: A total of 1179 patients were enrolled and completed the SAQ1 (T1DM, n = 25; T2DM, n = 1154). Almost all patients (T1DM: 100.0% [95% confidence interval (CI): 86.3%, 100.0%] and T2DM: 97.0% [95% CI: 95.9%, 97.9%]) experienced at least 1 hypoglycemic event prospectively. The estimated rates of any and severe hypoglycemia were 26.6 (95% CI: 19.8, 35.0) and 14.1 (95% CI: 9.3, 20.4) events per patient-per year (PPY), respectively, for patients with T1DM and 18.3 (95% CI: 17.4, 19.2) and 12.1 (95% CI: 11.4, 12.9) events PPY, respectively, for patients with T2DM during the prospective period. At baseline, mean glycated hemoglobin (HbA1c) (±standard deviation) was 8.1 (±1.8%) for T1DM and 8.8 (±1.8%) for T2DM. Hypoglycemic rate was independent of HbA1c levels and types of insulin. CONCLUSIONS: This is the first patient dataset of self-reported hypoglycemia in Bangladesh; results confirm that hypoglycemia is underreported.

Risk stratification of persons on premixed insulin in Ramadan.

The International Diabetes Federation (IDF), in collaboration with the Diabetes and Ramadan (DAR) International Alliance, has recently published practical guidelines on the management of diabetes and Ramadan .The risk stratification categorizes all persons wishing to fast into three groups, based upon potential risk. In spite of evidence to the contrary, all persons using premixed insulin are categorized as having high risk. In this article, we present data from randomized controlled trials, and discuss the placement of premixed insulin in the risk stratification framework.

Diabetes and Anemia: International Diabetes Federation (IDF) - Southeast Asian Region (SEAR) position statement.

Anemia is often associated with diabetes mellitus and is known to intensify the risk of developing diabetes-related microvascular and macrovascular complications. There is paucity in understanding of co-existence of these conditions, especially in Southeast Asian countries. Iron and/or erythropoietin deficiencies are the major causes of anemia in diabetes, and diabetic kidney disease plays a key role. Patients with diabetes need to be screened for anemia along with other risk factors and anemia should be corrected appropriately to improve overall clinical outcomes. This position statement aims to provide a comprehensive overview and an algorithm for appropriate management of anemia in patients with diabetes.

Safe and pragmatic use of sodium-glucose co-transporter 2 inhibitors in type 2 diabetes mellitus: South Asian Federation of Endocrine Societies consensus statement.

Diabetes prevalence shows a continuous increasing trend in South Asia. Although well-established treatment modalities exist for type 2 diabetes mellitus (T2DM) management, they are limited by their side effect profile. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) with their novel insulin-independent renal action provide improved glycemic control, supplemented by reduction in weight and blood pressure, and cardiovascular safety. Based on the clinical outcomes with SGLT2i in patients with T2DM, treatment strategies that make a "good clinical sense" are desirable. Considering the peculiar lifestyle, body types, dietary patterns (long duration religious fasts), and the hot climate of the South Asian population, a unanimous decision was taken to design specific, customized guidelines for T2DM treatment strategies in these regions. The panel met for a discussion three times so as to get a consensus for the guidelines, and only unanimous consensus was included. After careful consideration of the quality and strength of the available evidence, the executive summary of this consensus statement was developed based on the American Association of Clinical Endocrinologists/American College of Endocrinology protocol.

Effects of vildagliptin relative to sulfonylureas in Muslim patients with type 2 diabetes fasting during Ramadan: influence of age and treatment with/without metformin in the VIRTUE study.

BACKGROUND: VIRTUE was a prospective, observational study assessing the effectiveness and safety of vildagliptin vs sulfonylureas (SUs) (both as monotherapy and in combination with metformin) in patients with type 2 diabetes mellitus who fasted during Ramadan. A post hoc analysis was carried out to assess the effect of treatment with/without metformin and age (<65 years or ≥65 years). PATIENTS AND METHODS: Patients were recruited from the Middle East and Asia. The primary end point was proportion of patients with one or more hypoglycemic event (HE) during Ramadan. Secondary end points included change from baseline in glycated hemoglobin (HbA1c), body weight, and safety. RESULTS: Overall, 684 patients received vildagliptin and 631 received SUs. Most patients received dual therapy with metformin (n=1,148) and were aged <65 years (n=1,189). A few patients experienced one or more HE with vildagliptin vs SU monotherapy (6.5% vs 14.5%) and with vildagliptin + metformin vs SUs + metformin (5.3% vs 20.6%); the latter achieved statistical significance (P<0.001) in both age subgroups (<65 years: 5.5% vs 18.4%, P<0.001; ≥65 years: 2.8% vs 30.9%, P<0.001). Vildagliptin was associated with numerically greater HbA1c and body weight reductions vs SUs, regardless of the therapy type or age. A higher proportion of SU- vs vildagliptin-treated patients experienced adverse events across all subgroups. CONCLUSION: A few patients experienced HEs with vildagliptin vs SUs regardless of age, and in patients on dual therapy. Vildagliptin ± metformin was also associated with good glycemic and weight control and was well tolerated. Vildagliptin might be a useful treatment option for patients with type 2 diabetes mellitus, particularly high-risk populations such as the elderly fasting during Ramadan.

Pragmatic use of insulin degludec/insulin aspart co-formulation: A multinational consensus statement.

Insulin degludec/insulin aspart (IDegAsp) is a modern coformulation of ultra-long-acting basal insulin degludec, with rapid-acting insulin aspart. IDegAsp provides effective, safe, well-tolerated glycemic control, with a low risk of hypoglycemia while allowing flexibility in meal patterns and timing of administration. This consensus statement describes a pragmatic framework to identify patients who may benefit from IDegAsp therapy. It highlights the utility of IDegAsp in type 2 diabetic patients who are insulin-naive, suboptimally controlled on basal or premixed insulin, or dissatisfied with basal-bolus regimens. It also describes potential IDegAsp usage in type 1 diabetic patients.

Place of sulfonylureas in the management of type 2 diabetes mellitus in South Asia: A consensus statement.

Since their introduction in clinical practice in the 1950's, Sulfonylureas (SUs) have remained the main-stay of pharmacotherapy in the management of type 2 diabetes. Despite their well-established benefits, their place in therapy is inappropriately being overshadowed by newer therapies. Many of the clinical issues associated with the use of SUs are agent-specific, and do not pertain to the class as such. Modern SUs (glimepiride, gliclazide MR) are backed by a large body of evidence, experience, and most importantly, outcome data, which supports their role in managing patients with diabetes. Person-centred care, i.e., careful choice of SU, appropriate dosage, timing of administration, and adequate patient counseling, will ensure that deserving patients are not deprived of the advantages of this well-established class of anti-diabetic agents. Considering their efficacy, safety, pleiotropic benefits, and low cost of therapy, SUs should be considered as recommended therapy for the treatment of diabetes in South Asia. This initiative by SAFES aims to encourage rational, safe and smart prescription of SUs, and includes appropriate medication counseling.

Safety and effectiveness of biphasic insulin aspart 30 in a Bangladeshi subgroup of type 2 diabetic patients switched from biphasic human insulin 30: a sub-analysis of the A1chieve study.

AIM: To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) therapy in Bangladeshi type 2 diabetes (T2D) patients switched from biphasic human insulin (BHI) as a sub-analysis of the A1chieve study. METHODS: Bangladeshi patients switched from BHI to BIAsp 30 at the discretion of their physicians were included. The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia. Secondary outcomes comprised changes from baseline to Week 24 in the number of hypoglycaemic events, glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), systolic blood pressure and body weight. Quality of life (QoL) was evaluated at baseline and Week 24 using the EQ-5D questionnaire. RESULTS: A total of 82 patients (mean age ± SD: 52.3 ± 12.2 years; body mass index: 25.6 ± 3.3 kg/m(2)) with a mean diabetes duration of 9.5 ± 5.5 years and mean duration on insulin of 2.5 ± 2.4 years were included. The mean BIAsp 30 dose was 0.49 ± 0.20 U/kg at baseline and 0.47 ± 0.17 U/kg at Week 24. No SADRs were reported. No events of hypoglycaemia (overall, major, minor or nocturnal) were reported at Week 24. Mean HbA1c, FPG and PPPG levels improved by -2.5 ± 1.3%, -65.0 ± 31.8 mg/dL and -119.3 ± 48.7 mg/dL, respectively, over 24 weeks. QoL also improved (mean change from baseline: +28.5 ± 12.9 points). CONCLUSION: Switching from BHI to BIAsp 30 therapy improved blood glucose control and was well-tolerated in this Bangladeshi subgroup.

South Asian Consensus Guideline: Use of insulin in diabetes during Ramadan.

A person with diabetes mellitus (DM) has every right to perform the ritual of fasting during Ramadan. In daily practice we come across both type 1 and type 2 DM who wish to fast. This Consensus Statement describes the pre-Ramadan assessment, planning, prescription, management, and monitoring of patients on insulin, who wish to fast.

Role of oral hypoglycemic agents in the management of type 2 diabetes mellitus during Ramadan.

It is obligatory for all adult Muslims to observe fast during the holy month of Ramadan, but sick individuals including those with diabetes mellitus are exempted from the duty of fasting. Specific medical advice must be provided to individual patients concerning the potential risks they must accept if they decide to fast. Any alteration in medications deemed necessary to provide an effective and safe antidiabetic regimen should be instituted well before the start of Ramadan. Diet-controlled patients and those well controlled on insulin sensitizers have low risk of hypoglycemia and may safely fast with some modification in the timing of the doses. Newer generation sulfonylureas (gliclazide MR and glimepiride) have reasonable safety profile during Ramadan fasting and are economical options for a large number of diabetics worldwide, especially in the developing countries; older, long acting sulfonylureas like glibenclamide and chlorpropamide should be avoided during fasting. Oral DPP-IV inhibitors are important substitutes to sulfonylureas for patients with diabetes mellitus during fasting owing to their glucose-dependent mechanism of action, efficacy, and tolerability. This group of drugs causes a moderate A1c reduction, are weight neutral, and have a very low risk of hypoglycemia. Short-acting insulin secretagogues are an option in the subset of fasting diabetic patients who have predominantly post-prandial hyperglycemia.

Diabetic emergencies including hypoglycemia during Ramadan.

Majority of physicians are of the opinion that Ramadan fasting is acceptable for well-balanced type 2 patients conscious of their disease and compliant with their diet and drug intake. Fasting during Ramadan for patients with diabetes carries a risk of an assortment of complications. Islamic rules allow patients not to fast. However, if patient with diabetes wish to fast, it is necessary to advice them to undertake regular monitoring of blood glucose levels several times a day, to reduce the risk of hypoglycemia during day time fasting or hyperglycemia during the night. Patient with type 1 diabetes who fast during Ramadan may be better managed with fast-acting insulin. They should have basic knowledge of carbohydrate metabolism, the standard principles of diabetes care, and pharmacology of various antidiabetic drugs. This Consensus Statement describes the management of the various diabetic emergencies that may occur during Ramadan.

Guidelines regarding management of adrenal insufficiency in the Holy month of Ramadan.

Adrenal insufficiency is a life-threatening event, so it is recommended for patients with known adrenal insufficiency to be properly educated regarding sick-day management. In the month of Ramadan, people refrain from eating and drinking during daylight hours. It is very important for patients with adrenal insufficiency, who wish to keep a fast, to be well aware of the disease, the suitable drug to be used for that particular period, warning signs, sick-day management, physical activity, and dietary limits. This article describes guidelines for the sick-day management of patients with adrenal insufficiency, in the month of Ramadan.

Thyroid diseases and Ramadan.

In the month of Ramadan, patients with thyroid diseases, most of the time, do not need treatment adjustments and can fast safely without any health hazards. Patients with hypothyroidism taking thyroxine can take their tablets on an empty stomach at bedtime instead of half an hour before Sehr. Patients with hyperthyroidism, on methimazole/carbimazole can continue their dose in once or twice daily regimes, while those on propylthiouracil need to be switched. Hyperthyroid patients with severe symptoms should start treatment immediately and can avoid fast for few days after a consultation with their religious scholar.

South Asian Consensus Guideline: Use of GLP-1 analogue therapy in diabetes during Ramadan.

Ramadan is a lunar based month, during which Muslims across the world observe the ritual fast. This provides a challenge not only to the diabetic patient who wishes to observe the fast but also to the health care professional managing his diabetes. The challenge is to use therapies which are effective in maintaining good glycemic control and at the same time have a low propensity to cause hypoglycemia during the several hours of no calorie intake. The GLP-1 analogues are unique agents which are effective in providing glycemic reduction with a very low risk of hypoglycemia and hence find an important place in the management of diabetes during Ramadan. This Consensus Statement describes the pre-Ramadan assessment, planning, prescription and management and monitoring of patients who are on GLP-1 analogues, with or without other antidiabetic therapies.