Hypoglycaemia a validated questionnaire, which was quantified. The

Hypoglycaemia is a significant
complication of intensive diabetes therapy a true medical emergency, which
requires prompt recognition and treatment to prevent organ and brain damage .Several
studies that documented patient’s knowledge status about the disease have
revealed that most of the diabetic patients are unaware about hypoglycaemia.
Therefore, knowledge about diabetes can play an important role in maintaining glycaemic
control and prevent hypoglycaemic complications. This study was aimed to
develop and assess the impact of patient information leaflets to prevent hypoglycaemia
in outpatients with type 2 diabetes mellitus. The open labelled,
observational study was conducted in endocrinology Out Patient Department (OPD)
in a tertiary care hospital over a period of 9 months . The
information was provided to patients through a developed patient information
leaflet and their awareness and glycaemic status were assessed by a validated
questionnaire, which was quantified. The study showed statistically significant
(P<0.05) improvement in knowledge and glycaemic control in male patients and in knowledge, compliance and glycaemic control for female patients. Literate patients showed more significant improvement in knowledge, compliance, life style and glycemic control than illiterate patients. Results of the study suggested pharmacist provided patient education & awareness helped diabetic patients to prevent hypoglycaemic risk effectively. KEYWORDS  Diabetes, Hypoglycaemia, Patient information leaflets, Glycaemic control,                           Education   INTRODUCTION Hypoglycaemia is a condition featuring lower than normal levels of blood glucose. It can be defined as "mild" if episode is self-treated; "moderate" if assisted and "severe" if hospitalised and assisted by physician (Diabetes Control and Complications Trial, 1993). Hypoglycaemia could be classified as a true medical emergency, which left untreated may lead to organ and brain damage 1. It is a significant complication of intensive diabetes therapy. Severe untreated hypoglycaemia can cause significant economic and personal burden.  Hence, identification and prevention of hypoglycaemia are very important factors for prevention of hypoglycaemia complications 2. Diabetic medications, including insulin and sulfonyl ureas, are among the most common causes of hypoglycaemia in diabetic subjects 3. Occasional episodes of hypoglycaemia with Metformin are reported when an imbalance between food intake and dose of Metformin  2. According to Diabetes Audit and Research in Tayside Scotland (DARTS) study, severe hypoglycaemia was 7.3% and 0.8% in patients with Type 2 Diabetes Mellitus (T2DM) treated with insulin and oral sulfonylurea respectively 4. The risk of hypoglycaemia is highest in those with type 2 diabetes who have received insulin for more than 10 years 5. T2DM patients lose on an average three productive days following a severe hypoglycaemic attack 4. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial has demonstrated increased mortality rates in patients who experienced episodes of hypoglycaemia. Repeated episodes of hypoglycaemia can result significant mortality which is reportedly associated with a six fold increase in death 4. The clinical approach to minimizing hypoglycaemia while improving glycaemic control includes addressing the issue, applying the principles of aggressive glycaemic therapy, including flexible and individualized drug regimens, and considering the risk factors for iatrogenic hypoglycaemia 6. Main measures to prevent hypoglycaemia includes drug counselling, meal plan, limiting the use of alcoholic beverages, and through appropriate diabetes management plan. The knowledge and education can also help patients to manage their glycaemic conditions effectively along with pharmacological management 7-13.  Many health professionals rely on a verbal explanation, but this has been shown to be ineffective; patients tend to forget approximately half of the given information 14. One method of providing information is to supply patient information leaflet. It have also been shown to increase knowledge of drug side effects in a series of studies undertaken in the community 15,16.  The present study is undertaken to develop and evaluate the impact of patient information leaflet education by pharmacist with respect to knowledge, compliance, life style and glycaemic control in type 2 diabetes mellitus patients with hypoglycaemia. MATERIALS AND METHOD Study design: The open labelled, observational study was conducted in endocrinology outpatient department in a tertiary care hospital for a period of 9 months. Institutional Ethics Committee (IEC) approval was taken before initiation of the study.  Sample size was calculated as 55 based on the outpatient statistics of endocrinology department. RAOSOFT sample size calculator with margin of error 5%, confidence level 95%, probability was used for calculation. A total of 385 diabetic patients were screened out of which 100 hypoglycaemic patients were identified.  Fifty five patients were included in the study based on the inclusion & exclusion criteria.                                Inclusion & exclusion criteria: Both male and female patients of age >18 years
diagnosed with Diabetes Mellitus (DM) & on Oral Hypoglycemic Agents (OHA’s)
& insulin were included in the study. Pregnancy, lactation, psychosis,
mental retardation, active substance abuse & significant depression were excluded
from the study

Information Leaflet Development

Before the primary study preliminary study was
carried out with 10 consecutive hypoglycaemic literate and illiterate patients (demographic
data not shown) who were attending the outpatient clinic. First step of the
study was patient interaction, which helped us identifying various barriers
such as poor knowledge
about the condition, lack of compliance towards treatment, lifestyle, and poor
medication adherence.

After assessing the barriers a
questionnaire was prepared based on diabetic patients perception about
hypoglycaemia and its management. The self-prepared questionnaire in vernacular
language was validated by two expert endocrinologists. The questionnaire was an
effective tool to identify patient problems in order to give an effective
education. The questionnaire includes 20 questions out of which 5 questions are kept under 4 different categories like
knowledge,   compliance,
life style and glycaemic control which was tested in preliminary study 2
in 10 literate and illiterate patients (demographic data not shown)  .  None
experienced problems with its readability and the patients thought patient
information leaflet based on the questionnaire answered the queries they would
raise about hypoglycaemia and it’s management. Based on this, a comprehensive
patient information leaflet was prepared

A data collection form was also designed
to record laboratory values including blood glucose level and other patient
specific details. Informed consent from all patients was collected before
participation, briefing them about the study in colloquial language.

of Assessment:

Patient information leaflet was given to
the patient and the questionnaire was read out to the patients. Marks were
recorded based on the answering pattern after their enrolment in the start of
the study and during follow up (at sixty days interval). The assessment was
done based on the patient questionnaire marks and glycaemic status .



 The changes before and after the patient
information leaflet education  were
studied. The variables studied were knowledge, compliance & lifestyle and glycaemic
control. Data was analysed using student’t’ test (graph
pad prism version 5). Statistical
significance was taken at 95% CI (p<0.05) using SPSS. RESULTS AND DISCUSSION Out of 55 patients, 26 patients had a family history of diabetes mellitus.  Regarding the literacy of patients, 47(85.45%) patients were literate, 8(14.54%) patients were illiterate. Patients who did not complete high school education were categorised as illiterate persons.  Among the subjects, 17 (30.90%) were alcoholic, 20 (36.36%) were smokers. Hypertension and Dyslipidemia were the co morbidities in the study subjects and the other co morbidities are shown in (Fig. 1).Patients was on antihypertensive and dyslipedmic drugs in addition to drugs controlling diabetes. Hypoglycaemic episodes were more prevalent in the age group of 50-59 years in both male and female patients followed by the age group of 60-69 years (Table 1). These findings are similar to the observations by the Decoda study group stating that the prevalence was over 30% among those aged 50-69 years 17. The treatment aspects of the male patients are shown in Table 2.  Combinations of drugs were observed in the diabetic treatment schedule which may delay the need for insulin or in combination with insulin aid in achieving glycaemic goals. The advantage of differing mechanisms of action, in combination therapy as a mean of optimizing glycaemic control was also observed in the treatment pattern. Patients receiving Combination Oral Hypoglycaemic Agents (n=8), sulfonylureas (Gliclazide or Glimepride) along with  biguanides experienced more hypoglycaemic episodes than those on biguanides alone (n=4). The risk of hypoglycaemia was observed to be double when compared with biguanide therapy alone. In all the male age groups, sulfonylurea along with  biguanides did not show much increase in fasting blood sugar level after treatment, hence the hypoglycaemic chances are more. But, in the age group of 50 – 59 years and 60-69 years, biguanides and insulin showed statistically significant (p<0.05) improvement in fasting blood sugar level. Hence the hypoglycaemic chances are less. In the female age group of 40 – 49 years, those taking biguanides with insulin were found to have low fasting blood sugar level values, which may lead to hypoglycaemia. But those in the  age group of 50-59 and 60-69 years and taking biguanides with insulin showed statistically significant (p<0.05) improvement in fasting blood sugar levels. Hence the hypoglycaemic chances are less and the data are shown  in Table 3. This study reveals that the control of hypoglycaemic effect varies with the respect to age group. The study results also confirm that biguanides and insulin medication combinations showed good improvement in fasting blood sugar in higher age groups in both sexes. Post Prandial Blood Sugar (PPBS) level remains same with respect to the baseline and final values and it may prevent hypoglycaemic episodes. The effect of antidiabetic therapy on glycaemic status with respect to age group & duration of diabetes was not determined due to the small sample size among the groups. As expected on entry to the study both male and female patients little knew about hypoglycemia was noted through the baseline score. In this study, there was a considerable improvement in all parameters of hypoglycemic awareness status in male and female patients. The improvement in knowledge, compliance, and glycaemic control were statistically significant (p<0.05) in female patients. The baseline and final value of knowledge status were 10.86 ± 6.012 and 21 ± 4.397 respectively with a 'p' value of 0.001. The base line and final value of glycaemic control   were 9 ± 7.899 and 17.17 ± 6.795 with a 'p' value of 0.009 as in Table 4.   Literate study subjects showed significant improvement in knowledge, compliance, and glycaemic control after the conveying of relevant information through patient information leaflets. The baseline and final value of knowledge status were 32 ± 7.257 and 39.86 ± 5.815, respectively with a 'p' value of 0.012. The base line and final value of compliance were 36 ± 6.245and 41 ± 4.583 with a 'p' value of 0.038. The base line and final value of glycaemic control were 29.17 ± 9.62 and 39.33 ± 6.47 with a 'p' value of 0.029 as depicted in Table 5. Even though the illiterate showed improvement in knowledge, compliance, life style and glycaemic control, the level of significance is not perceptible in any of the parameters and this may be due to the small sample size of patients enrolled in the study. This also indirectly confirms the developed patient information leaflet was shorter at readable level, more easily understood format and increases patient knowledge about hypoglycemia. This information empowers patients to become more involved in the decision making and hypoglycemia management process   Paulose carried out disease awareness study in 400 literate diabetic patients in kerala. The study found that although 80% of patients knew the symptoms of hypoglycemia and 76% knew what to do when they develop these symptoms, only 17% carried glucose packets with them during travel and 29% patients told that their doctors did not inform them about hypoglycemic complications18. These studies suggest that it is essential to educate the patients regarding proper diet, exercise, glucose control and periodic consultations. Our study results also showed the impact of pharmacist education in the significant improvement on knowledge, compliance, and glycaemic control in hypoglycemic patients. In the light of these results, our study confirms various other studies in implying the importance of patient information leaflets, which are helpful tools in improving knowledge, compliance, & glycaemic control 1, 7, 12, 19.                         Patient involvement is essential for successful management of hypoglycaemia.  Educational efforts are also necessary to improve self-management of hypoglycaemia in diabetic patients. Along with other health care professionals, role of pharmacist as diabetic counsellor is much appreciated in many developed countries20. Although improving patients knowledge on hypoglycaemia through patient information leaflet is a  laudable aim it is acknowledged that knowing and understanding are different entities and consequently  it cannot be assumed from the results of this study. Further long duration studies covering large population are needed to validate the data.