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
(P18 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

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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


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