Assessment of self-monitoring of blood glucose in type 1 diabetic children and adolescents and its influence on quality of life: practice and perspective

Self-monitoring blood glucose (SMBG) includes an assessment of the capillary glucose concentration as well as the interpretation of and responding to the readings. The purpose of this study was to assess patients’ compliance to self-monitoring blood glucose (SMBG), identify factors and barriers that affect it, and to correlate performance of SMBG to blood glucose monitoring and patients’ quality of life. Three hundred and thirty children and adolescents with type 1 diabetes were subjected to the following: (1) an interview pre-structured questionnaire which included personal, medical history, and details about SMBG; (2) Questionnaire about Quality of Life Index (Diabetes Version-III) by Ferrans and Powers for patients aging 10–16 years; and (3) glycated hemoglobin (HA1C) measurement. About 67% of the patients assessed their blood glucose 3 times per day, while 0.57% assessed blood glucose 7 times. The most influential factors affecting compliance of SMBG were the cost of strips and glucometers, the fear of pain and injection, psychological frustration, lack of availability of information to deal with high reading, and the absence of motivation for doing regular SMBG. The more the frequency of SMBG daily, the better the HA1C of the patients (p < 0.01). Adolescent patients aged 10–16 years who have more frequent SMBG and those with less HA1C have significant better quality of life (p < 0.05). More frequent SMBG practice was associated with better glycemic control and better quality of life. Patients’ compliance is influenced by several factors which affect their frequency of SMBG.


Background
Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia resulting from defects in insulin secretion, insulin action, or both [1]. Frequent and accurate blood glucose monitoring and concomitant optimal adjustment of insulin to carbohydrate intake and exercise are the basis of diabetes treatment in type 1 diabetes mellitus (T1DM) [2]. Selfmonitoring blood glucose (SMBG) includes an assessment of the capillary glucose concentration (self-measurement) as well as the interpretation of and responding to the readings (self-regulation) [3]. The frequency of (SMBG) is associated with improved HbA1c levels in patients with T1DM [4]. This is thought to be due to both better insulin adjustment for food consumed, an improved ability to quickly correct out-of-target glucose values, and early detection of lower glucose values prior to symptomatic hypoglycemia, especially during and post exercise [5]. The number and regularity of SMBG should be individualized depending on availability of the equipment, type of insulin regimen, and ability of the patient to identify hypoglycemia. Fasting, preprandial targets, and postprandial targets for SMBG have been outlined in several guidelines [6]. Blood glucose self-monitoring is not frequently used in developing countries due to priority problems with governments, unavailability of glucose meters and/or test strips, lack of education, or cultural issues. It is not always used as prescribed, even in settings where it is available [7].
T1DM and its complications may affect adolescents' living conditions over the years and may also influence their quality of life (QOL) [8]. People with T1DM have to cope with many factors that affect everyday disease management. The study of quality of life (QOL) in these patients is somewhat different from other populations, since T1DM requires making frequent glucose monitoring, insulin injection and dose adjustment, carbohydrate estimation, planning of therapeutic adjustments to physical activity, etc. [9].
The current study aimed to assess patients' compliance to SMBG, identify factors and barriers that affect it, and to correlate performance of SMBG to blood glucose monitoring and patients' quality of life.

Methods
This cross-sectional study was carried out on 330 children and adolescents with type 1 diabetes. Patients were recruited from the outpatient diabetes specialized clinic, pediatric hospital during the period from December 2015 till December 2016. Random sample was drawn from children and adolescents attending the outpatient diabetes specialized clinic twice weekly.

Sample size
Estimation with margin of error 5%, confidence level 95%, and the response distribution 50% of 900 population size. Calculated number is 270, plus 20% for response rate of 80%; it was 324 rounded to 330.

Methods
Included both questionnaires and mean glycated hemoglobin (HA1C) measurement during the study period

Questionnaires
i. An interview pre-structured questionnaire which included the following: personal and demographic data as age, sex, parents educational degree and career, number of siblings and order of birth, assessment of anthropometric measures including weight in kilograms (Kg) and height in centimeters (cm), and plotting them according to standard deviation scores-medical history for patient and family, health services, assessment of self-monitoring blood glucose including frequency and timing, and health education during the last year ii. Ferrans and Powers Quality of Life Index (Diabetes Version-III) Arabic version, excluding questions that are not applicable or not socially accepted among Egyptians as questions regarding the sexual practice (https://qli.org.uic.edu/questionaires/pdf/ diabetesversionIII/ArabicQOL%20Diabetes.ver-sion%203.pdf). iii. Adolescents aged 10-16 years who had been diagnosed with type 1 diabetes mellitus were subjected to quality of life interview questionnaire. Patients with verbal communication difficulties or any disease affecting their intellectual functions were excluded from answering this questionnaire [10].

Validity
Content validity of the QLI was supported by the fact that items were based both on an extensive literature review of issues related to quality of life and on the reports of patients regarding the quality of their lives [11]. Mean glycated hemoglobin (HA1C) measurement during the study period estimated from the whole blood by column chromatography technique.

Statistical analysis
Data were collected, revised, coded, and entered to the Statistical Package for Social Science (IBM SPSS) version 20. The quantitative data were presented as mean, standard deviations, and ranges when their distribution found parametric and median, (IQR) when distribution found non-parametric, while qualitative data were presented as number and percentages. The comparison between two independent groups with qualitative data was done by using chi-square test. The comparison between two independent groups with quantitative data and parametric distribution was done by using independent t test and one-way analysis of variance (F) (ANOVA) technique to compare means of numerical data. Data with nonparametric distribution was done by Mann-Whitney test. Spearman correlation coefficients were used to assess the correlation between two quantitative parameters in the same group. The confidence interval was set to 95% and the margin of error accepted was set to 5%. So, the p value was considered significant as the following: p > 0.05, non-significant; p < 0.05, significant.

Results
The study sample included 47% males and 53% females; their mean age was 10.56 ± 4.055 years, 64.8% of them live in urban areas and 35.2% in rural areas ( Table 1).
The mean duration of diabetes was 3.65 ± 2.59 years. Regarding the type of insulin used, it was found that 255 patients (77.3%) were using basal-bolus analogs, while 75 patients (22.7%) were using regular insulin and NPH.
The mean HA1C in the current study was 8.8 ± 0.11%, and 25.2% (83 patients) of the studied patients were well controlled with HA1C < 7.5%, while 33.3% (110 patients) were moderately controlled with HA1C 7.5-9%, and 41.5% (137 patients) were poorly controlled with HA1C > 9%. Classification of the patients using HA1C as a predictor of glycemic control was done according to ISPAD guidelines 2014 which was the most recent guidelines at the time of the study.
It was found that 245 patients (74.2%) received health education during their visits to the clinic and 86.7% of them know how to do carbohydrate counting.
HA1C was significantly lower in patients who practice regular SMBG than those who practice irregular (less than 3 times per day) SMBG (p < 0.01). The more the frequency of SMBG daily, the better the HA1C of the patients (p < 0.01). Twenty eight percent of the patients who assess 3 times daily have HA1C < 7.5, while all patients who assess 6 and 7 times daily have HA1C < 7.5 ( Table 2).
Assessment of SMBG of T1DM children attending diabetic clinic in the current study showed that 53.0% of them were on regular SMBG practice more than 3 times per day and 47.0% were irregularly practicing SMBG method.
During assessment of frequency of SMBG in patients with regular SMBG practice, it was observed that, most of the patients assess their blood glucose 3 times per day, while minority of them assess their blood glucose 6 and 7 times per day. None of the patients was on continuous glucose monitoring method (Table 3).
Regarding the timing of SMBG done by the studied patients, it was found that all patients measure their blood glucose before breakfast and before sleeping, while 84.5% measure their blood glucose preprandial and 29% measure it postprandial. Only 4.5% measure their blood glucose at down.
When comparing patients on regular SMBG practice and those who are not on regular SMBG as regards their personal data, it was found that, patients with younger age [mean ± SD (9.97 ± 3.98) years] and their parents have high educational level, and patients who live at urban areas, patients who have fewer siblings and patients who were diagnosed from a short period of time [mean ± SD (3.18 ± 2.26) years] were significantly more compliant on SMBG practice (p < 0.05).  During comparison of both groups regarding the factors affecting compliance of SMBG practice in our study, it was observed that all studied type 1 diabetes mellitus children attending diabetic clinic faces common barriers and factors that can affect their practice of SMBG with no significant difference between them (p > 0.05). However, it was found that patients with regular SMBG practice significantly disagree with the idea that using the device in public can be a stigma and that the presence of inadequate place to do SMBG could be barriers for regular SMBG practice (p < 0.05) ( Table 4).
Regarding patients' quality of life scoring (QOL) and its relation to the frequency of SMBG and glycemic control, a total of 199 adolescents aged 10-16 years were assessed using quality of life interview questionnaire. It was found that health and functioning subscale had 48.7% of the score, while family subscale had only 6.7% of the score. Adolescent patients aged from 10 to 16 years who have less HA1C and less complications have significant better quality of life (p < 0.05). Adolescents who practice SMBG about 4 or 5 times have better quality of life than others who infrequently do SMBG and those who do SMBG more than 5 times per day (p < 0.05). No significant relation was found between QOL and frequency of admission to the hospital (t = 0.171, p = 0.865), health education regarding diabetes education and knowledge about carb counting (t = 0.981, p = 0.328), and type of insulin (t = 0.59, p = 0.551) (p > 0.05) (Tables 5, 6, and 7).
Multiple regression analysis revealed that HA1C level and the presence of complications are the predicting factors on the outcome of QOL total score p < 0.001, OR = 0.093 and p < 0.001, OR = 0.593 respectively.

Discussion
The mean HA1C in the current study was 8.8 ± 0.11%. These results agree with a group of studies evaluating HA1C in their patients. A cross-sectional study that included children and adolescents with T1DM visiting the pediatric diabetes clinic at the King Abdulaziz University Hospital (KAUH), Saudi Arabia, reported that glycated hemoglobin (HA1C) level was 8.8% [12]. Also, a Turkish study found that mean hemoglobin A1C level was 8.5 ± 1.6% [13]. Found in multicentered study conducted in Europe, Japan, and the USA that HA1C was 8.6 ± 1.7% (10). A French cross-sectional study which was conducted on children and adolescents with type 1 diabetes found that the mean HA1C was 8.97% [14,15].
On the other hand, there were some studies which found higher HA1C. Aljabri and Bokhari described HA1C values in a study done in kingdom of Saudi Arabia to be 9.9 ± 2.3% in patients less than 20 years old [16], while Mortensen et al. [17] found that HA1C was 9.1% in Denmark, while another population-based study which was done in Scotland found a value of HA1C to be 9.1% [18].
The current study reported that about quarter of the studied patients were well controlled with HA1C < 7.5, while third of them were moderately controlled with HA1C 7.5-9, and 41.5% were poor controlled with HA1C > 9. Meanwhile Sayed et al. reported that only 31.2% of children and adolescents with T1DM were well controlled in retrospective study that was performed at Jeddah, western Saudi Arabia [19].
During assessment of frequency of SMBG in patients who were compliant on SMBG, it was found that 67.4% of the patients assess blood glucose 3 times per day, while 0.57% assess blood glucose 7 times. None of the patient could afford the financial expense of use of continuous glucose monitoring devices.
Regarding the opinion of the children and their parents about reasons for not achieving good glycemic control and the most influential factors affecting compliance of SMBG, the patients conceded that the cost of strips and glucometers, the fear of pain and injection, psychological frustration, lack of availability of information to deal with high reading, no motivation, and in adequate place to assess SMBG were the main reasons for not practicing regular SMBG. These results agree with a number of other studies found that lack of awareness and cost of glucometers were reported to be the main reasons for not practicing SMBG [20]. Another study reported that specific SMBG information deficits, motivation obstacles, and behavioral skill limitations were identified in a substantial proportion of participants [21]. Non compliance practice of SMBG can be attributed to some causes as the cost of monitoring supplies, lack of diabetes self-management skills, or concerns about the reliability of blood glucose readings [22]. In the same context, Mansour assessed patient opinion for not achieving good glycemic control among a group of patients with HbA1C ≥ 7.30. Some of the patients said that they were unaware of diabetics' complications. Others reported that strips were not available or could not be used [23]. The factors that influenced SMBG were mainly related to cost, participants' emotion, and the SMBG process. The barriers identified included are as follows:  frustration related to high blood glucose reading, perception that SMBG was only for insulin titration, stigma, fear of needles and pain, cost of test strips and needles, inconvenience, unconducive workplace, and lack of motivation, knowledge, and self-efficacy [24].
In the current study, it was observed that the more the frequency of SMBG daily, the better the HA1C of the patients (p < 0.01). Twenty-eight percent of the patients who assess 3 times daily have HA1C < 7.5, and all patients who assess 6 and 7 times daily have HA1C < 7.5. Our results consistently with a number of studies which found that, more frequent SMBG was significantly associated with better metabolic control. On average, a drop of HA1C of 0.20% for one additional SMBG per day (p < 0.001) could be observed. However, increasing the SMBG frequency above five per day did not result in further improvement of metabolic control (decrease in HA1C). Restricted to the range of 0-5 measurements per day, HA1c decreased by 0.46% per one additional measurement [25].
In another study, a multicenter randomized trial involving subjects on basal-bolus insulin, HA1C ≥ 8.0%, and poorly compliant with SMBG. HA1C levels decreased by about 0.6% in patients who became compliant with SMBG, irrespective of the glucose meter used, while no or only minor changes in HA1C levels were documented in patients who remained not compliant with SMBG during the study [26].
In this study, it was found that adolescent patients aged from 10 to 16 years who have more frequent SMBG and those with less HA1C and less complications have significant better quality of life (p < 0.05). Similarly, Lalić et al. reported that the use of structured SMBG combined with intensive education was associated with clinically significant reductions in HA1C, increased SMBG frequency, and improved quality of life [27]. Also, Vyas et al. reported that the appropriate education and counseling diminish impact of diabetes, improve QOL, and help to achieve desired glycemic (HA1C) level in poorly control T1D patients [28].