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Effectiveness of Fenugreek for Lowering Hemoglobin (HbA1c) in Patients with Self-Management of Type 2 Diabetes: A Randomized Controlled TrialRashid Ansari1 and Saiqaa Ansari2[1] School of Public Health, University of New England, Australia[2] School of Population Health, University of Queensland, Australia1. In this video we discuss diabetic foot conditions and why accurate diagnosis and proper treatment is so critical. Our nationally recognized foot and ankle specialists understand the special circumstances involved with treating the feet of diabetics. We have decades of combined experience treating diabetic foot conditions including Charcot foot, diabetic neuropathy, ulcers and infections. In 2010, the HSE through the ONMSD launched national ‘Guidelines for the Management of Pre-gestational and Gestational Diabetes Mellitus form Pre-conception to the Postnatal period’. The programme has been peer reviewed by relevant stakeholders throughout the country and has been endorsed by Ms Sheila Sugrue, National Lead Midwife, Dr Brendan Kinsley, Consultant Endocrinologist, Mater Hospital and Mr Michael Shannon, Office of the Nursing and Midwifery Services Director. This publication highlights the various contraception methods available to women with diabetes and provides information on early pregnancy planning.
For questions about health services, your entitlements, or how to access HSE health or social services in your area? Pain in the joints from this type of arthritis is usually worse late in the day and sometimes the joint can develop redness feel warm and become swollen. I was in hurry so all I had for b Metformin isn’t likely to cause low blood sugar I called my doctor and she said to stop taking Metformin until my next set of blood and urine test results come in.
Gestational diabetes is a condition characterized by high blood sugar (glucose) levels that is first recognized during signs of diabetes affecting feet co denver pregnancy. Stephen Castorino diagnoses, treats, and manages endocrine disorders, or those affecting the body's secretion of hormones such as thyroid problems or diabetes. Castorino believes if you can regulate and control the hormones that have influence on the rest of the entire body and be able to artistically manipulate the external self we may be able to master the art and science of regeneration. It could very well be the hidden culprit behind your flagging energy, your moodiness, perhaps even that 'flat tire' feeling that makes it difficult for you to just get out of bed some mornings. One procedure which has a proven track record is injections of Platelet Rich Plasma (PRP) which we introduce into the Scalp, Face, Joints, or Muscle. PRP has also been erroneously referred to as Stem Cell therapy, which it technically does not contain. Both of which will support, guide, and inspire you toward the best possible health outcomes for you and your family. IntroductionThe incidence of type 2 diabetes is increasing worldwide, resulting in large measure from the increasing prevalence of obesity (Yale, 2000). Following the launch of these guidelines the requirement for a standardised accredited Diabetes programme for midwives nationally was identified.
Programme content is delivered through lectures and workshops and subjects range from the epidemiology of diabetes to the role of the midwife in providing midwifery care to women with pre-gestational and gestational diabetes mellitus and their babies. The publication was developed to target women with diabetes in order to promote the concept of either actively planning to conceive or actively avoiding pregnancy. Time for large randomised trials of vitamin D for women with gestational diabetes mellitus to improve perinatal health Prepare for low glucose levels as well by keeping snacks on hand for when your blood sugar Gestational Diabetes Glucose Tolerance Test False Positive Wisconsin Green Bay dips. From Mayo Clinic a leading authority in health and nutrition comes The Mayo Clinic Diabetes Diet the reliable plan you need to lose weight and help you control your diabetes. Glycosuria-excess glucose in urine; may define type ii diabetes diabetes infants toddlers symptoms virginia richmond mellitus ann arbor michigan indicate diabetes. While people who do not have any metabolic problems can complain of symptoms suggestive of low blood sugar, true hypoglycemia usually occurs in people being treated for diabetes (type 1 and type 2). Diabetes mellitus is a pandemic disease and is one of the main threats to human health (Narayan, 2005).
A programme has now been developed by the ONMSD to provide a national standardised education update for midwives in relation to diabetes in pregnancy. The programme will be disseminated through the ONMSD and is intended for national roll out through all relevant midwifery stakeholders; the CNME’s and midwifery units.
By providing information on contraception and early pregnancy care to women with diabetes, it is hoped that more women with diabetes will plan their pregnancies and discuss their treatment options with their GP and diabetes team prior to conception. It was developed and endorsed by experts in the field of diabetes and pregnancy and has also been endorsed by Professor Michael Turner, Lead for the HSE Obstetrics and Gynaecology Clinical Programme and Dr.
Gestational Diabetes Glucose Tolerance Test False Positive Wisconsin Green Bay for example gastric MALT lymphomas may present as an upset stomach Hormonal hyperthyroidism pregnancy perimenopause or early menopause hypoglycemic episodes in those with or without diabetes others. It is often diabetes related to glaucoma mt helena symptomless producing a mild glucose intolerance that does not require insulin treatment. Figure 2 A 3-year-old child with type 1 diabetes mellitus seen photographed in 1922 before insulin treatment was available. Traditional Wound Management Market to 2019 looks at the market nephropahty and wound healing disorders Diabetes mellitus wound healing process Topical Wound Healing Body Image Psychosocial Aspects of Wounds Wound Dressing The treatment of war wounds is an ancient art – Prediabetes is a condition that raises the risk of developing type 2 diabetes heart disease and stroke.
Identifies and provides basic information on common symptoms and illnesses associated with living with HIV. The relative contributions of insulin resistance and beta-cell dysfunction to the pathophysiology of type 2 diabetes. The risk of diabetes is high if someone is having family history of diabetes low physical activity obese and also bad food habits.
People who will eventually develop this disease are insulin resistant several yea Facts o But in Type 2 diabetes the bod ends up producing abnormally high levels of insulin over the years eventually begins to have a negative effect.
BACKGROUND: Diabetes mellitus is a chronic disease associated with a significant burden on individuals and society. It is projected that this number will be increased by 72% to 333 million by 2025, and nearly 80% of these cases will be in the poorer industrialized countries (IDF, 2003).
Weight gain and physical inactivity Wilkin proposes This topic discusses how to manage diet in people with type 1 diabetes. Type 2 diabetes usually appears after age 40, but people of all ages, even children, can develop it. According to a 2005 US Government estimate, approximately 21 million people in the United States have diabetes (Gerich, 2005). Type II diabetes mellitus or NIDDM is an endocrine abnormality caused by insulin resistance or insufficient levels of insulin. The new treatment is a direct result of research to understand the genetics of the disease. It is frequently diagnosed in asymptomatic patients during a routine medical examination or when patients It is one of the earliest symptoms of diabetes, which when left untreated may lead to foot ulcers or even amputation. In 2002, diabetes was the sixth leading cause of death and had an estimated total cost of $132 billion (Hogan et al. Permanent neonatal diabetes (PND) is defined by chronic hyperglycemia due to severe nonautoimmune insulin deficiency diagnosed in the first months of life. Type 2 diabetes is a disease characterized by a dual defect: 1) by insulin resistance which prevents cells from using insulin properly, and 2) degrees of reduced pancreatic insulin secretion.
They are kind, thorough and caring!Anita D.I have had a hard time finding a doctor that is not rushing and truly listens. Additionally, 30 (73.17%) patients had family history of type 2 diabetes mellitus (Table 2) and most of the patients (70%) had duration of 510 years (Table 3). A quarter of the population of Pakistan would be classified as overweight or obese with the use of Indo-Asian-specific BMI cutoff values. Jafar et al (2006) have reported that prevalence of overweight was 25% and obesity was 10% in a large population-based sample of people over the age of 15 years in Pakistan. On the age-specific prevalence of overweight and obesity, they found that more than 40% of women and 30% of men aged 35–54 years were classified as overweight or obese. It has been suggested in a variety of observational and epidemiological studies that physical activity may play a significant role in the prevention of type 2 diabetes mellitus. The relationships between physical activity and overweight are only beginning to be understood for the adult population, sedentary behaviours, particularly watching television (TV) and videos, surfing the internet have been found to be related to higher body mass index (BMI) for adult’s population (Struber, 2004).


The literature linking physical activity levels with risk of overweight in adults is not consistent but physical activity is an important component of effective obesity treatments (Saelens, 2003). The main health promotion intervention here is the public health education which highlights the importance of physical activity for the prevention of type 2 diabetes in the middle-aged population of sub-continent and particularly Pakistan, which is experiencing a rapid and substantial decline of physical activity levels as a result of poor eating habits, unhealthy food supply, expansion of television, computerization, and mechanization, more prevalent car ownership and sedentary behaviour. In parallel with decreasing levels of physical activity, the prevalence of overweight and obesity has increased significantly in Pakistan and as a consequence, diabetes mellitus has become a major public health issue. Therefore, promoting an active lifestyle or regular exercise has become the highest public health priority in that country to overcome the onslaught of type 2 diabetes. Also, the search for dietary adjuncts along with usual medical care to treat this life altering disease has become more important and dietary supplements that can modulate glucose homeostasis and potentially improve lipid parameters would be desirable.
Fenugreek (Trigonella foenum-graecum Linn) is a dietary supplement that may hold promise in this regard and is one of the oldest medicinal plants, originating in India and Northern Africa and dating back to ancient Egyptian times (Jensen, 1992).In Pakistan and India, fenugreek is commonly consumed as a condiment (Yoshikawa et al.
Fenugreek seeds also lower serum triglycerides, total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) (Al-Habori and Raman, 1998).
The lipid-lowering effect of fenugreek might also be attributed to its estrogenic constituent, indirectly increasing thyroid hormones (Basch, 2003). The plant protein in fenugreek is 26%, so it might exert a lipid lowering effect (Sharma, 1986). Since a high proportion of diabetic patients in sub-continent suffer from malnutrition, the use of fenugreek which is rich in protein and fiber (48%), has a distinct advantage in these patients (Sharma, 1986). This chapter addresses the effectiveness of fenugreek for lowering hemoglobin (HbA1c) in this randomized controlled trial and determines whether the intervention of taking fenugreek in combination of usual medical care lowers HbA1c in patients with type 2 diabetes.
Effectiveness trials such as this are critical in determining if the interventions are effective in the practical world in which patients live. This randomized control trial addresses the research question “Is Fenugreek treatment with medical care for patients with type 2 diabetes more effective than usual medical care and can it help to lower the haemoglobin in patients with poorly controlled type 2 diabetes”? Characteristics of type 2 diabetesType 2 diabetes is associated with certain ethnic groups, obesity, family history of diabetes, and physical inactivity, among other factors.
Chronic, untreated hyperglycemia can lead to serious complications that include cardiovascular diseases, blindness, kidney failure, and stroke. Furthermore, very low values of blood glucose (hypoglycemia) for even a short duration can result in loss of consciousness and coma.
The figure 1 shows the complications of type 2 diabetes which is a syndrome characterized by insulin deficiency, insulin resistance, and increased hepatic glucose production. These metabolic abnormalities are treated by use of various medications which are designed to correct one or more of these metabolic abnormalities (Saltiel & Olefsky, 2001). Type 2 diabetes is most common in adults, although younger people are also developing this type of disease. It starts with a slow onset with thirst, frequent urination, weight loss developing over weeks to months.
It is also considered to run in families but it may happen with a person without a family history of diabetes as well. In its early stages, many people with type 2 diabetes can control their blood glucose levels by losing weight, eating properly and exercising. Many may subsequently need oral medication, and some people with type 2 diabetes may eventually need insulin shots to control their diabetes and avoid the disease's serious complications (Saltiel & Olefsky, 2001). Even though there is no cure for diabetes, proper treatment and glucose control enable people with type 2 diabetes to live normal, productive lives.
A major advance for people at risk of developing type 2 diabetes - such as family members of those with the condition - occurred recently when it was shown that diet and exercise can prevent or delay type 2 diabetes. 2004), however, population-based data on the prevalence of diabetic retinopathy in Pakistan and on the visual impairment due to diabetic retinopathy is lacking and only the hospital-based data is available (Kayani et al.
Diabetic nephropathy is present in 18% of people diagnosed with diabetes (DSG, 1993) and is a leading cause of end-stage renal disease (Molitch et al.
2003)Stroke: diabetes is associated with a 2- to 4-fold increase in cardiovascular mortality and stroke (Kannel et al. Therefore, early detection and treatment of diabetes is essential in order to reduce the impact of its serious complications. Development of type 2 diabetesDevelopment of type 2 diabetes is the result of multifactorial influences that include lifestyle, environment and genetics.
The disease arises when insulin resistance-induced compensatory insulin secretion is exhausted. A high-caloric diet coupled with a sedentary lifestyle is one of the major contributing factors in the development of the insulin resistance and pancreatic ?-cell dysfunction as shown in Figure 2.
However, a predisposing genetic background has long been suspected in playing a contributing role in the development of type 2 diabetes.
The metabolic syndrome is defined as a clustering of atherosclerotic cardiovascular disease risk factors that include visceral adiposity (obesity), insulin resistance, low levels of HDLs and a systemic proinflammatory state. There are key components to the metabolic syndrome which include in addition to insulin resistance (the hallmark feature of the syndrome), hypertension, dyslipidemia, chronic inflammation, impaired fibrinolysis, procoagulation and most telling central obesity.3.
Randomized controlled trials with fenugreekThe multiple trials in the past have shown conflicting results of the effect of fenugreek on the patients of type 2 diabetes. These studies showed some positive results on fasting serum glucose but did not examine hemoglobin (HbA1c) levels. Gupta et al (2001) reported the results of a small randomized, controlled, double-blind trial to evaluate the effects of fenugreek seeds on glycemic control. The authors reported that there were no significant differences between groups in mean glucose tolerance test values at the study's end. However, the trial may have been too small or brief to detect significant mean differences between groups. Raghuram et al (1994) reported the results of a randomized, controlled, crossover trial of fenugreek seeds in 10 patients with type 2 diabetes.
In the fenugreek-treated patients, statistically significant mean improvements were reported for glucose-tolerance test scores and serum-clearance rates of glucose.
Sharma and Raghuram (1990) conducted two randomized, controlled, crossover studies in patients with type 2 diabetes. Significant mean improvements in fasting blood-glucose levels and glucose-tolerance test results were described in the fenugreek-treated patients. Moosa et al (2006) conducted study to evaluate the effect of fenugreek on serum lipid profile in hypercholesteremic type 2 diabetic patients and concluded that fenugreek seeds powder significantly reduced serum total cholesterol, triglyceride and LDL-cholesterol but serum HDL-cholesterol level elevation was not significant. Neeraja and Rajyalakshmi (1996) presented a case series including six men with type 2 diabetes and six without diabetes. The cases suggested fenugreek reduced postprandial hyperglycemia primarily in subjects with diabetes, but less so in subjects without diabetes.
The studies conducted to date have been methodologically weak, lacking adequate descriptions of blinding, randomization, baseline patient characteristics, statistical analysis, and standardization data for the therapy used. Demonstrating the efficacy of fenugreek has also been confounded by inconsistencies in the preparations, dosing regimens, and outcome measures used in the trials.
Moreover, none of the investigations have been conducted over the longer period (Basch, 2003). Method of patient selectionThe patients were recruited from the diabetic medical centre in rural area of Peshawar conducting the study of management of type 2 diabetes among the population aged 30-65 years.
Patients having coexisting liver, kidney or thyroid disorder were not included in the study.
Diabetes Criteria for patientsThe well known standard screening test for diabetes, the fasting plasma glucose (FPG), is also a component of diagnostic testing.
The FPG test and the 75-g oral glucose tolerance test (OGTT) are both suitable tests for diabetes; however, the FPG test is preferred in clinical settings because it is easier and faster to perform, more convenient and acceptable to patients, and less expensive.
When it was found necessary, plasma glucose testing was also performed on individuals who have taken food or drink shortly before testing.
Such tests are referred to as casual plasma glucose measurements and are given without regard to time of last meal. A confirmatory FPG test or OGTT was also completed on such patients on a different day if the clinical condition of the patient permits. Laboratory measurement of plasma glucose concentration is performed on venous samples with enzymatic assay techniques, and the above-mentioned values are based on the use of such methods. The A1C test values remain a valuable tool for monitoring glycemia, but it is not currently recommended for the screening or diagnosis of diabetes. Pencil and paper tests, such as the American Diabetes Association’s risk test, may be useful for educational purposes but do not perform well as stand-alone tests. Capillary blood glucose testing using a reflectance blood glucose meter has also been used but because of the imprecision of this method, it is better used for self-monitoring rather than as a screening tool. Determination of study sample size The study sample size was determined based on the assumption of the estimation of Standard Deviation (SD). Therefore, the study design was selected to detect an effect size of 0.5 SD lowering of HbA1c. It was assumed that 15% patients might be lost to follow-up in control group over the period of three months and only 5 % patients will be lost to follow-up in intervention group. This assumption was based on the popularity of fenugreek seeds used by diabetic patients in sub-continent to manage their glycemic control.


Study population and randomizationInitially 325 patients with type 2 diabetes were invited to pre-randomized interview, out of which only 210 patients were included in the actual trial. Out of the 325 patients, 93 patients did not meet the inclusion criteria and 22 patients refused to participate in the trial.
Finally, two hundred and ten (210) patients agreed to participate and signed informed consent documents at the clinic where they used to visit for their usual medical care for diabetes. Therefore, 102 patients were randomized to intervention group (fenugreek supplements) and 108 to the control group (usual medical care). The randomization code was developed using a computer random number generator in a block size of eight patients.
That helped to allocate patients to the intervention and control groups equally in each block – that is each patient would have an equal chance of allocation to either group. Once the randomization phase was completed, all patients were instructed to follow-up the usual medical care for their diabetes for the duration of the 90 days trial. The patients were allowed to adjust their usual medications as recommended by their doctors. In addition, each patient was asked to go for blood test for HbA1c on day 1 and then return to give blood sample after 90 days.
In addition, participants were advised not to take any other new treatments for the management of type 2 diabetes during the trial periods.
The control group in randomized controlled trial received medical care from a physician-coordinated team.
This team included physicians, nurses, dietitians, and mental health professionals with expertise and a special interest in diabetes.
It is essential in this collaborative and integrated team approach that individuals with diabetes assume an active role in their care. The management plan in that group was based on individualized therapeutic alliance among the patient and family, the physician, and other members of the health care team. This plan has recognized diabetes self-management education as an integral component of care and in developing the plan, consideration was given to the patient’s age, work schedule and conditions, physical activity, eating patterns, social situation and personality, cultural factors, and presence of complications of diabetes or other medical conditions. Patient self-management was emphasized, and the plan emphasized the involvement of the patient in problem-solving as much as possible.
A variety of strategies and techniques were employed to provide adequate education and development of problem-solving skills in the various aspects of diabetes management. During the implementation of the management plan it was assured that each aspect of diabetes management was understood and agreed on by the patient and the care providers and that the goals and treatment plan were reasonable. Those patients randomized to take fenugreek (intervention group) received 100 gms fenugreek seeds powder from the pharmacy in the clinic. They were instructed to take 50 gms doses twice a day at lunch and dinner time in addition to their normal medications for diabetes.
Those patients randomized to usual medical care (control group) were instructed to take their normal medicines and follow-up with their doctor as per their normal schedule. All participants were contacted again after 90 days (3-months) to give their blood sample for HbA1c testing. At that time, a questionnaire was sent via e-mail to participants in both intervention and control groups to assess the progress of the fenugreek treatment and clinical care without fenugreek. The clinical and demographic characteristics of the patients in the two groups were well balanced at randomization. A demographic measure included age, gender, weight, ethnicity, religion, marital status, previous episodes of glycemic control, previous and current treatments of type 2 diabetes. The table 3 gives baseline characteristics of intervention and control groups in RCT trial.
Diabetes treatment with medicationsThe treatment options of type 2 diabetes is shown in figure 4 suggesting the specific areas of actions using medications which influence the various organs of the body to correct the metabolic abnormalities such as reducing the liver glucose production, slowing down absorption of sugars from the gut and reducing the insulin resistance.
There are currently six distinct classes of hypoglycemic agents available to treat type 2 diabetes. The patients in both the groups in RCT trials received medications recommended by their physicians. The most common combinations among both the groups were Meglitinide (repaglinide) with Thiazolidendiones and Sulfonylurea with Biguanides. Details of hypoglycaemic medications used in RCT trialThe diabetes medications mentioned in table 4 work in different ways but the main function of all these medications include lowering blood sugar levels; help improve the body’s use of glucose, decrease the symptoms of high blood sugar, help keeping patients with diabetes functioning normally and may prevent the complications, organ-damaging effects and premature deaths diabetes can cause.
Since the drugs work in different ways, these are sometimes used in combination to enhance the effectiveness of treatment. In this RCT trial Sulfonylurea was used in combination with Biguanide (metformin) and Meglitinide was used in combination with Thiazolidinedione. The main function of Sulfonylurea is to bind and inhibit the pancreatic ATP-dependent potassium channel that is normally involved in glucose-mediated insulin secretion.
Like the sulfonylurea, meglitinide therapy results in significant reduction in fasting glucose as well as HbA1c.
The mechanism of action of the meglitinide is initiated by binding to a receptor on the pancreatic ?-cell that is distinct from the receptors for the sulfonylurea.
Metformin is a member of this class and is currently the most widely prescribed insulin-sensitizing drug in current clinical use. Metformin administration does not lead to increased insulin release from the pancreas and as such the risk of hypoglycemia is minimal. Because the major site of action for metformin is the liver its use can be contraindicated in patients with liver dysfunction. Thiazolidinedione: The thiazolidinedione (pioglitazone) has proven useful in treating the hyperglycemia associated with insulin-resistance in both type 2 diabetes and non-diabetic conditions. The net effect of the thiazolidinedione is a potentiation of the actions of insulin in liver, adipose tissue and skeletal muscle, increased peripheral glucose disposal and a decrease in glucose output by the liver.
Diabetes treatment with diet and exerciseThe normal diabetes treatment addresses the issues related to unhealthy lifestyles, such as lack of physical activity and excessive eating, which are the main causes to initiate and propagate the majority of type 2 diabetes (Michael, 2007). Studies have demonstrated strong relationship between excess weight and the risk of developing type 2 diabetes, hypertension, and hyperlipidemia. Therefore, the objective of physicians is to motivate patients to lose weight and exercise to improve the control of diabetes and slow down or even reverse the natural course of the disease (Michael, 2007).However, it is difficult to overstate the importance of the relationship between lifestyle and the risk of developing type 2 diabetes. There are prospective studies which have demonstrated that lifestyle modification in the form of diet and regular moderate exercise sharply decrease the likelihood of developing type 2 diabetes in high-risk individuals who have impaired glucose tolerance or impaired fasting glucose. The effectiveness of this intervention superseded that of metformin therapy (Knowler et al. In this RCT trial, physicians compiled the flow scheme shown in Figure 5 which represents the method of treatment of type 2 diabetes by the combination of diet, exercise and medication for diabetes monitoring and control. It has been divided into two segments: for obese and normal weight patients and the combination of medication for both the groups of patients. Dietary consideration for patients (intervention and control group)It has been recommended that carbohydrate and monosaturated fat consumption for the patients with type 2 diabetes should comprise 60-70% of total calories. However, there is some concern that increased unsaturated fat consumption may promote weight gain in obese patients with type 2 diabetes and therefore may cause in reduction of insulin sensitivity (Bantle et al. The “glycemic index” is an attempt to compare the glycemic effects of various foods to a standard, such as white bread. Although several authors have proposed its clinical usefulness in controlling postprandial hyperglycemia, prospective studies have not demonstrated a clear improvement in hemoglobin (HbA1c) in patients using low-glycemic index diets (Michael, 2007). The physicians in this trial have recommended the best mix of carbohydrate, protein, and fat that was adjusted to meet the metabolic goals and individual preference of the patients with diabetes in both the intervention and control groups. It has been recommended for individuals with diabetes, that the use of the glycemic index and glycemic load may provide a modest additional benefit for glycemic control over that observed when total carbohydrate is considered alone (ADA, 2011). Monitoring carbohydrate, whether by carbohydrate counting, choices, or experience-based estimation, remain a key strategy in achieving glycemic control. Physical activity consideration for patients (intervention and control group)Physical activity is a key component of lifestyle modification that can help individuals prevent or control type 2 diabetes.
It is considered that diet is probably more important in the initial phases of weight loss, incorporating exercise as part of a weight loss regimen helps maintain weight and prevent weight regain (Klein et al. In this trial, the message was given to both the groups that as little as 30 minutes of moderate physical activity daily may offer greater benefits to these patients in managing their diabetes. It has also been reported that in patients with type 2 diabetes, structured regimens of physical activity for 8 weeks or longer improved HbA1c independent of changes in body mass (Sigal et al.
The evidence supports the contention that controlling blood glucose through modification of diet and lifestyle should be mainstay of diabetes therapy. It was found in this RCT that despite being one of the most time-consuming discussions with the patients in both the groups, this is probably the most important patient-physician discussion in regard to diabetes control and prevention of disease progression and complications.
Statistical analysisWe analysed the primary outcome by an un-paired sample t-test (mean difference between baseline and final HbA1c).
The statistical analysis was carried out on an intention to treat basis and that was subject to the availability of data at follow up as well as at entry level for individual patients.



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