STUDY SETTING:
Data was collected from outpatient family medicine clinics (OPD’s) at Aga Khan University Hospital Pakistan (AKUH). AKUH is located in the Karachi city, which is the main economic and cultural hub of Pakistan. The hospital is ISO and JCIA certified.
DURATION OF STUDY:
One Year and one month from April 2018 to May 2019.
SAMPLE SIZE:
Sample size was calculated with WHO software for sample size determination. It was calculated on the basis of facilitators and barriers of SMBG and their percentage of SMBG usage. Based on these values, with 95% confidence interval and bound on error of 5% the sample size came out to be 227 at 21%. After addition of 10% of non-responders the final sample size was approximately 255 study participants.
Formula For Sample Size Calculation: (see Formula in the Supplementary Files)
SAMPLING TECHNIQUE:
A non-probability Consecutive sampling was used.
INCLUSION CRITERIA:
All diabetics’ patients from age 18 years to 60 years and were on any oral hypoglycemic and/or insulin were included.
EXCLUSION CRITERIA:
Those who do not give consent, or were terminally ill and those with psychiatric problems (for example dementia, mental retardation) were excluded.
Study Design
This study was cross sectional
DATA COLLECTION PROCEDURE:
Patients fulfilling the inclusion criteria were included in the study as mentioned above was questioned by well-developed questionnaire. Written informed consent was taken from the study participants. The consent described the purpose of this study, its risk, benefits, and right to refusal and withdrawal from study, without any prejudice.
ETHICAL CONSIDERATION:
The study was approved by an Institutional Ethical Review Committee of the Aga Khan University.
PLAN OF ANALYSIS:
Data was double entered and analyzed in SPSS version 19.0. Baseline information was analyzed using descriptive statistics. Frequencies and proportions were reported for categorical variables such as age, gender, educational status, and the perceived Facilitators to self-monitoring of blood glucose (desire to see the effect of dietary changes, desire to please the physician, family motivation, afraid of the complications of Diabetes, good patient information and education, doctor patient communication, setting glycemic targets with patients, financial support and experiencing hypoglycemic symptoms). Frequencies and proportions were also be reported for the Barriers to SMBG (test strip handling issues, pain, lack of motivation, not convinced it was necessary, did not think there was a need, did not have enough time for regular SMBG, cost issues, not having all the equipment needed for the test, finding it cumbersome to carry all the things needed to test, testing as frequently as they think they should because of lack of time). The outcome variables were Facilitators and Barriers to SMBG. Frequency and percentages of all questions related to Facilitators and Barriers to SMBG among type II diabetic patients were calculated. Chi-square test was applied to observe relation of various socio demographic variables (age, gender, monthly income, time since diagnosis of diabetes) with barriers and facilitators as mentioned above. Moreover, stratification was done on potential effect modifiers such as (age, gender, time since diagnosis of diabetes) to see their effect on SMBG. All the analysis were two tailed and P-value of 0.05 was considered statistically significant.