Assessment of Barriers toward Initiating Insulin among Gestational Diabetes Pregnant Women, Diabetes Center, Hera’a General Hospital, Makkah ()
1. Introduction
Gestational diabetes (GD) is one of the most common pathologies in pregnancy. Gestational diabetes has been defined as any degree of glucose intolerance with onset or first recognition during pregnancy [1] . Many factors like age, diet, obesity, ethnicity, family history, history of GDM in a previous pregnancy, macrosomia, hypertension or pregnancy-related hypertension, history of spontaneous abortions, and unexplained stillbirths cause an increased risk of glucose intolerance in pregnant women [2] . The prevalence of GDM ranges from 1% - 14% based on the population under investigation; the prevalence is increasing worldwide [3] [4] [5] . The global prevalence of hyperglycemia in pregnant women of 20 - 49 years was supposed to be 16.9% and affected 21.4 million live births in 2013 [6] .
Maternal hyperglycemia correlated with GDM has a serious complication that can lead to short and long-term health risks for the mother and her baby [7] . Optimal blood glucose regulation within suggested glycemic targets using lifestyle variations and/or pharmacological therapies aims to reduce or prevent the adverse outcomes connected with GDM [8] . A woman’s thoughts of GDM may influence whether she adopts any lifestyle changes, complies with the advised therapy, and achieves optimal blood glucose control [9] .
The successful control of diabetes depends on keeping blood glucose levels within a recommended target range, as well as suitably modifying other cardiovascular risk factors like dyslipidemia and hypertension. For example, early blood glucose control has been shown to decrease the risks of morbidity and mortality from the coronary artery disease [10] .
Unfortunately, both clinicians and patients are often reluctant to begin insulin therapy, a phenomenon that has been known as psychological insulin resistance (PIR) [11] . Clinicians may choose to delay initiation only after alternative therapies have been attempted and have failed to achieve or maintain glycemic control [12] . However, this procedure runs the risk of initiating insulin only when the disease has significantly advanced, and the patient has experienced more advanced complications [13] . Additional clinician barriers to insulin initiation that can be recognized as clinical realities of initiating insulin therapy include 1) concern that patients would resist insulin treatment, 2) the effect on the practice’s resources, such as the time required to properly educate patients and their families on the role of insulin replacement treatment, 3) the intensive monitoring required when the initial phase of insulin initiation and titration, 4) the learning required for the control of any crises, and 5) the risk of hypoglycemia from insulin therapy [14] . Finally, clinicians may be apprehensive about weight gain with insulin [15] .
For the insulin-naïve patient, PIR may be rooted in logistical obstacles to initiating insulin, such as difficulties in self-injecting the insulin and the ability to appropriately estimate and time doses with meals [16] . Other common barriers to insulin initiation among insulin-naïve patients include 1) misconceptions regarding insulin risk, 2) beliefs that needing insulin reflects a personal failure, 3) concerns that insulin is ineffective and that insulin injections are painful, and 4) anxiety about long-term complications and side effects of therapy, loss of independence, and cost [16] .
Pervious international studies reported some common barriers to insulin initiation among GDM patients, however to our knowledge; there are no similar studies in Saudi Arabia. Therefore this study was conducted to identify the barriers of initiating insulin among GDM pregnant women in Makkah, Saudi Arabia.
2. Patients and Methods
An observational cross-sectional study through collection of data using a questionnaire was conducted in the GDM clinic, Diabetes Center in Hera’a General Hospital, Makkah, Saudi Arabia in a period of 4 months during their routine antenatal visits in GDM clinic. Inclusion criteria were age above 18 years old, pregnant women with Gestational diabetes, and with pre-existing type 2 diabetes not on insulin prior to pregnancy. Pregnant women on Insulin pump therapy were excluded from the study. No other exclusion criteria were specified.
Sample size was calculated using online Raosoft sample size calculator for population survey (https://www.raosoft.com/samplesize.html) assuming that the margin of error as 5%, estimated target population of 723 (based on total number of attendees during 2020), at confidence level of 90%, estimated prevalence of 50%, the minimum sample size was 198 patients. Data were collected over a period of 4 months (approximately 16 weeks). It has been estimated that about 12 patients with the inclusion criteria attended the weekly gestational diabetic clinic at Hera’a General Hospital, based on previous experience. Thus, all patients who attended the clinic throughout the period of data collection were included.
The main tool in this study was a self-administered questionnaire structured by the researcher, from review of similar literature and validated by three consultants. The questionnaire is divided into three parts:
• First, socio-demographic data (age, nationality, number of parity, number of children, the trimester of pregnancy, history of gestationaldiabetes mellitus, history of insulin treatment during pregnancy).
• Second, perceived (personal, social, pharmacological, occupational and misconception) barriers towards insulin therapy.
• Third, Solutions to overcome the above-mentioned barriers.
The barriers/perceptions part was designed with five points Likert scale answers ranging from strongly agree, agree to strongly disagree to measure the patients’ perceptions about the insulin therapy barriers. Questionnaires were distributed by triage nurses to the randomly selected participants (hand to hand) and were collected by the same triage nurse on the same day.
2.1. Data Entry and Analysis
The data were entered and analyzed using SPSS 26.0 version. Descriptive statistics in the form of frequency and percentage were used for categorical variables. Chi-square or Fisher’s exact test (in case of small frequencies) were used in statistical analysis. A p-value of <0.05 was used to report the statistical significance of results.
2.2. Ethical Considerations
Prior permission was obtained from the concerned authorities after explaining the objectives of this study. All information of hospitals was kept confidential and data were used for the proposed research. Data were collected after obtaining the ethical approval from the Institutional Review Board (IRB) of Diabetes Centre in Hera Hospital.
3. Results
3.1. Sociodemographic Characteristics
A total of 164 pregnant women with gestational diabetes were included in the study with a response rate of 82.8%. Their sociodemographic characteristics are presented in Table 1. The age of 36.4% of them exceeded 35 years. Majority of them (82.3%) were unemployed and the monthly income of 41.7% of them ranged between 3000 and 5000 Saudi Riyals. Most of them (59.8%) were university educated or postgraduates. Half of them had between 2 and 4 children.
3.2. Obstetric History
Primigravidae represented 13.7% of the participants whereas more than 4 gravity women represented 36.6% of them. More than half of them (55.8%) were in the third trimester of pregnancy (Table 2).
Past history of gestational diabetes mellitus was reported by 50.6% of the women as displayed in Figure 1 while past history of treatment with insulin during pregnancy was reported by 31.4% of them as seen in Figure 2.
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Table 1. Sociodemographic characteristics of the participants (n = 165).
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Table 2. Obstetric history of the participants (n = 165).
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Figure 1. Past history of gestational diabetes mellitus among the participants (n = 162).
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Figure 2. Past history of treatment with insulin during pregnancy among the participants (n = 159).
3.3. Barriers to Initiate Insulin Therapy
3.3.1. Personal Barriers
Among studied personal barriers, more than half (56.4%) of the participants preferred other treatment methods over insulin and 45.4% were unaware of insulin dose control method while 41.2% fear of needles and pain at the injection site and 40.6% were unawareness of the injection method. More than one-third of patients (35.2%) reported forgetfulness as a personal barrier.
3.3.2. Family (Social) Barriers
Abound a quarter of women (23.6%) reported past family experience of insulin-related complications while 15.8% reported lack of family support for taking insulin injections.
3.3.3. Side Effects Barriers
More than half of the women reported that fear of hypoglycemia (59.4%) and fear of weight gain (50.9%) are barriers against use of insulin in the management of gestational diabetes whereas 41.2% reported Fear of allergic reactions at the injection site as a barrier.
3.3.4. Misconceptions about Insulin Injections
More than one-quarter of women (26%) agreed that insulin is addictive; the injection will continue for life whereas 15.2% and 12.2% agreed that insulin may lead to stillbirth and negatively affects sexual desire, respectively.
3.3.5. Work-Related Barriers
Among employed women, 55.2% agreed that irregular eating times during working hours and long working hours are barriers for insulin use in the management of gestational diabetes while lack of privacy during injection was agreed upon by 48.3% of patients.
3.4. Factors Associated with Barriers to Initiate Insulin Therapy
3.4.1. Patients’ Age
Younger patients (18 - 25 years) were more likely than older patients (>35 years) to agree that unawareness of insulin dose control method (69.2% vs. 35.6%), p = 0.021 and religious beliefs (15.4% vs. 5.1%), p = 0.047 are barriers to initiate insulin therapy while those aged 26 - 30 years were more likely than those in the age group 31 - 35 years to agree that feeling stigmatized is a barrier to initiate insulin therapy (20% vs. 1.8%), p = 0.009 (Table 3).
3.4.2. Patients’ Employment Status
Unemployed women were more likely than employed women to agree that lack of family support for taking insulin injections is a barrier to initiate insulin therapy (18.5% vs. 3.4%), p = 0.031 while employed women were more likely than unemployed women to agree that insulin negatively affects sexual desire (24.1% vs. 9.6%), p = 0.030 (Table 4).
3.4.3. Patients’ Income
Patient with moderate income (5001 - 10,000 SR/month) were more likely than those of low income (3000 - 5000 SR/month) to agree that long working hours (39.3% vs. 7.9%), p = 0.009, irregular eating times during working hours (39.3% vs. 5.3%), p = 0.002 and lack of privacy during injection (25% vs. 5.3%), p = 0.050 are a barrier to initiate insulin therapy (Table 5).
3.4.4. Patients’ Educational Level
More than half (56.1%) of university graduated patients compared to only 20% of primary school educated patients agreed that unawareness of insulin dose control method is a barrier to initiate insulin therapy in the management of gestational diabetes, p = 0.006. Similarly, university graduated patients were more likely than primary school educated patients to agree that long working hours (22.4% vs. zero), p = 0.007 and irregular eating times during working hours (23.5% vs. zero) are barrier to initiate insulin therapy in the management of gestational diabetes (Table 6).
3.4.5. Patients’ Number of Children
Women with one child were more likely than those with ≥5 children to agree that unawareness of insulin dose control method is a barrier to initiate insulin therapy in the management of gestational diabetes (70% vs. 10.3%), p < 0.001. Also women with 2 - 4 child were more likely than those with no children to
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Table 3. Association between gestational diabetes patients’ age and barriers to initiate insulin therapy.
*Percentage of agreement, ˚Chi-square test.
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Table 4. Association between gestational diabetes patients’ employment status and barriers to initiate insulin therapy.
*Percentage of agreement, ˚Chi-square test. #Fischer Exact test.
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Table 5. Association between gestational diabetes patients’ income and barriers to initiate insulin therapy.
*Percentage of agreement, ˚Chi-square test.
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Table 6. Association between gestational diabetes patients’ educational level and barriers to initiate insulin therapy.
*Percentage of agreement, ˚Chi-square test.
agree that fear of (needles, pain at the injection site). Is a barrier to initiate insulin therapy in the management of gestational diabetes (51.9% vs. 20%), p = 0.029. Majority of women with no children (90%) compared to 41.4% of those with five children and more agreed that fear of hypoglycaemiais a barrier to initiate insulin therapy in the management of gestational diabetes, p = 0.018. Women with 2 - 4 child were more likely than those with no children to agree that insulin is addictive; the injection will continue for life is a barrier to initiate insulin therapy in the management of gestational diabetes (39.2% vs. zero), p = 0.004 (Table 7).
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Table 7. Association between gestational diabetes patients’ number of children and barriers to initiate insulin therapy (n = 158).
*Percentage of agreement, ˚Chi-square test.
3.4.6. Patients’ Gravidity
Second gravidity women were more likely than more than fourth gravidity women to agree that unawareness of insulin dose control method is a barrier to initiate insulin therapy in the management of gestational diabetes (76.2% vs. 27.1%), p = 0.001. However, women with more than fourth gravidity were more likely than primigravidae and those with second gravidity to agree that past personal experience of insulin-related complications is a barrier to initiate insulin therapy in the management of gestational diabetes (23.7% vs. zero), p = 0.014 (Table 8).
3.4.7. Patients’ Trimester of the Current Pregnancy
As shown in Table 9, there was no statistically significant difference between women’s trimester of the current pregnancy and their agreement regarding barriers to initiate insulin therapy in the management of gestational diabetes (p > 0.05).
3.4.8. Past History of Gestational Diabetes Mellitus
It is realized from Table 10 that there was no statistically significant association between women’s past history of gestational diabetes and their agreement regarding barriers to initiate insulin therapy in the management of gestational diabetes.
3.4.9. Past history of Treatment with Insulin during Pregnancy
Women with no past history of insulin therapy were more likely than those with such history to agree that unawareness of the injection method (47.7% vs. 26%), p = 0.010 and insulin is addictive; the injection will continue for life (31.2% vs. 16%), p = 0.044 are barriers to initiate insulin therapy in the management of gestational diabetes. On the other hand, women with post history of insulin therapy were more likely than those without such history to agree that barriers to initiate insulin therapy in the management of gestational diabetes include long working hours (24% vs. 11%), p = 0.034 and lack of privacy during injection (24% vs. 7.3%), p = 0.003 (Table 11).
3.5. Possible Solutions to Initiate and Commit to Insulin Therapy
From Table 12, it is realized that majority of the participants either strongly agreed or agreed that facilitate access to healthcare services (94%), engage the patient in decision-making and development of the treatment plan (91.6%), activate virtual clinics and social media for remote follow-up (86.6%) and organize social support groups for pregnant women who use insulin to share their experiences are the possible solutions to initiate and commit to insulin therapy. Also, 78.8% and 77.8% of them either strongly agreed or agreed that promote family, peer, and community support and conducting training courses to teach insulin injection and improve awareness, respectively are possible solutions to initiate and commit to insulin therapy.
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Table 8. Association between gestational diabetes patients’ gravidity and barriers to initiate insulin therapy (n = 158).
*Percentage of agreement, ˚Chi-square test.
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Table 9. Association between gestational diabetes patients’ trimester of the current pregnancy and barriers to initiate insulin therapy (n = 158).
*Percentage of agreement, ˚Chi-square test.
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Table 10. Association between gestational diabetes patients’ past history of gestational diabetes and barriers to initiate insulin therapy.
*Percentage of agreement, ˚Chi-square test.
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Table 11. Association between gestational diabetes patients’ past history of treatment with insulin and barriers to initiate insulin therapy.
*Percentage of agreement, ˚Chi-square test.
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Table 12. Possible solutions to initiate and commit to insulin therapy according to the participants’ opinions.
4. Discussion
Achieving glycemic control is challenging among pregnant women with GDM and initiation of insulin therapy is one of these challenges to achieve the glycemic control [17] . American Diabetes Association [18] and Diabetes Canada Clinical Practice Guidelines Expert Committee [19] have recommended insulin as the first-line of antihyperglycemic therapy for treating GDM. Additionally, use of insulin decreases both fetal and maternal morbidity [20] [21] . Up to our knowledge, this study is unique in its nature to assess the attitude of GDM pregnant women toward different patients’ related barriers to initiate insulin therapy as well as to identify possible solutions to overcome those barriers.
In the current study, the most commonly reported personal barriers to initiate insulin therapy for management of GDM were preferring other treatment methods over insulin, unawareness of insulin dose control method, fear of needles and pain at the injection site, unawareness of the injection method and forgetfulness. Younger patients in this study were more likely than older patients to consider unawareness of insulin dose control method and religious beliefs as barriers to initiate insulin therapy. Higher educated women were more likely to consider unawareness of insulin dose control method as a barrier to initiate insulin therapy in the management of GDM. Women with one child were more likely than those with ≥5 children to consider unawareness of insulin dose control method while those with 2 - 4 child were more likely than those with no children to agree that fear of (needles, pain at the injection site)is a barrier to initiate insulin therapy in the management of GDM. Women with low gravidity were more likely than those with high gravidity to consider unawareness of insulin dose control method. However, women with high gravidity were more likely than those with low gravidity to consider past personal experience of insulin-related complications as a barrier to initiate insulin therapy in the management of GDM. Women with no past history of insulin therapy were more likely than those with such history to be unaware of the injection method. Kalra S, et al. reported that barriers could be classified as patient/community, drug/device, and physician/provider barriers. The patient barriers included high cost and inadequacy. The patient’s barriers were affected by the education of the patient, counseling, and support [22] .
As regards Family (social) barriers, past family experience of insulin-related complications and lack of family support for taking insulin injections were the most frequently reported barriers. Unemployed women were more likely than employed women to consider lack of family support for taking insulin injections as a barrier to initiate insulin therapy. Feeling stigmatized was more considered as a barrier to initiate insulin among relatively younger women. Stigmatization and lack of family support were reported as barriers to initiate insulin therapy by others [22] [23] [24] [25] .
In the present study, fear of hypoglycemia, weight gain and allergic reactions at the injection site were considered by most of women as barriers against use of insulin in the management of GDM. Women with no children were more likely than those with high number of children to consider fear of hypoglycemiaas a barrier to initiate insulin therapy in the management of GDM. This is might be due to lack of family support in this group of women. Injection phobia and fear of hypoglycemia were also mentioned by others as barriers to initiate insulin therapy [26] [27] [28] .
In this study, 26% of patients believed that insulin is addictive whereas a considerable proportion of them believed that insulin may lead to stillbirth and negatively affects sexual desire. Women with no past history of insulin therapy were more likely than those with such history to believe that insulin is addictive; the injection will continue for life. This is expected as those with no history of insulin therapy depended on misconceptions taken from others while those with previous history of insulin therapy depend on their own experience. Additionally, those with children were more likely than those with no children to believe that insulin is addictive; the injection will continue for life. Employed women were more likely than unemployed women to believe that insulin negatively affects sexual desire. In agreement with that, Karter et al. reported that subjects failing to initiate prescribed insulin commonly reported misconceptions regarding insulin risk [26] .
Among employed women in the current study, 55.2% considered irregular eating times during working hours and long working hours as main barriers for insulin use in the management of gestational diabetes while lack of privacy during injection was considered a barrier by 48.3% of patients. Women with past history of insulin therapy were more likely than those without such history to consider long working hours and lack of privacy during injection as barriers to have insulin. This is again is expected due to their previous experience. Higher educated women were more likely to consider long working hours and irregular eating times during working hours as barrier to initiate insulin therapy in the management of GDM. Women with moderate income were more likely than those of low income to consider long working hours, irregular eating times during working hours and lack of privacy during injection as barriers to initiate insulin therapy. Hui et al. reported that quick adaptation to dietary management in a short time period created challenges for women with GDM [29] .
The current study revealed that facilitating access to healthcare services, engaging the patient in decision-making and development of the treatment plan, activate virtual clinics and social media for remote follow-up and organize social support groups for pregnant women who use insulin to share their experiences are the most frequently reported possible solutions to initiate and commit to insulin therapy. These strategies may assist women as well as their health professionals concerning how best to meet the needs of women with gestational diabetes as well as their families to achieve optimal glycemic control and consequently reduce adverse outcomes for those women and their babies [17] [30] [31] .
Few but important limitations of this study should be addressed. First of all, being a single center study is an important limitation that could affect negatively the ability to generalize the findings over other settings. Utilizing a self-administered tool to collect data is another limitation, which is subjected to bias. Despite of those limitations, the study could have both clinical as well as public health importance in detecting important barriers to initiate insulin in women with GDM and set possible solutions to overcome these barriers.
In conclusion, various barriers were identified against initiation of insulin therapy in the management of gestational diabetes; mostly due to personal factors, misconception and work-related factors. Facilitating access to healthcare services, engaging the patient in decision-making and development of the treatment plan, activate virtual clinics and social media for remote follow-up and organize social support groups for pregnant women who use insulin to share their experiences were the most frequently reported possible solutions recommended by women to initiate and commit to insulin therapy. Further multi-center study is needed to have a much better overview of the situation in Makkah.