Type 2 diabetes mellitus (DM) is a chronic endocrine disorder of hyperglycemia either as a result of insulin resistance or relatively impaired insulin secretion. The prevalence of type 2 diabetes has markedly increased in the past few decades and is emerging as a serious public health concern. It currently affects 285 million people globally and is projected to affect over 439 million by the year 2030.
Patients with type 2 (DM) need a long restricted treatment regimen to achieve glycemic control. The United Kingdom Prospective Diabetes Trial (UKPDS) has suggested the benefits of tight glycemic control in individuals with type 1 and type 2 diabetes in reducing diabetes complications. For example, it showed that a 1% decrease in HbA1c was associated with a 37% reduction in the risk of micro vascular complications and a 14% reduction in the risk of macro vascular complications. Insulin therapy is known to be a highly effective choice of treatment in diabetes resulting in tight glycemic control and the reduction of diabetes-related complications. American Diabetic Association (ADA) recommends initiating insulin therapy (with or without additional agents) in patients with newly diagnosed type 2 diabetes who are symptomatic and/or have A1C more than 10% (86 mmol/mol) and/or blood glucose levels of more than 300 mg/dl (16.7 mmol/L).
Psychological insulin resistance is defined as psychological opposition toward the use of insulin by people with diabetes and health-care providers. It describes both doctor- and patient-barriers to initiating and maintaining insulin treatment. One of the principal factors which contributes to PIR is patients' lack of accurate knowledge about diabetes and insulin treatment. Some patients believe that insulin is appropriate for those with severe diabetes and so patients with PIR believe that a new prescription of insulin treatment is a negative sign of their diabetes. They consider its prescription as a sign of their worsening diabetes instead of it being an important next step in management. Apart from this, patients have varying fears of insulin and its use;. Some fear the pain of insulin injection, for some it is the fear of self-administration. Others have concerns regarding lifestyle changes and the time required. Studies suggest that some patients think that poor self-management in the past caused their need of insulin and some blame their health-care providers for not explaining the risks and benefits of insulin adequately. Psychological insulin resistance in type 2 diabetes patients is, therefore, considered a barrier to insulin therapy. A systematic review (1985–2007) found that psychological insulin-resistance played an important role in glycemic control and should not be ignored. Knowledge and awareness of its prevalence would enhance the role of health education for both the physician and the patient.
The situation in Saudi Arabia indicates that PIR is a public health problem. A study conducted in Riyadh found a PIR rate of almost 30%. Another study in Aseer region of Saudi Arabia also showed that the overall prevalence of therapeutic non-adherence was 38% and the most common barriers to patients' adherence to insulin therapy were: forgetfulness, fear of low blood glucose, increase in weight and difficulties with injection techniques. Thus, the aim of this study was to determine the factors associated with Psychological insulin resistance in type 2 diabetic patients and the barriers to initiating insulin therapy in them. We aimed to find out if there was any association between doctor–patient relationship and patient acceptance of starting insulin therapy.
Materials and Methods
This was a cross-sectional study conducted at the Ministry of Health primary healthcare (PHC) centers of the Al-Ahsa region in Saudi Arabia between February 2019 and January 2020. The study population consisted of all type 2 diabetic patients (estimated to be 30,000 patients) attending the chronic disease clinics at PHC centers. Epi info CDC software was used to calculate the sample size based on the result of the same type of study done in Riyadh, which showed PIR as 34.6% in type 2 diabetic patients. Therefore, for sample size calculation, we assumed a prevalence of PIR at 34%. The calculated sample size was 396 type 2 diabetics based on a 95% confidence level with an additional 20% to compensate for missing data.
A multistage sampling technique was used. Stratified cluster was done for stage I and systemic random sampling for stage II. The Al-Ahsa area has 72 PHC centers distributed in 3 sectors: Al-Omran, Al-Hufof and Al-Mubarraz. Cluster sampling was done for all these three sectors. Three PHC centers from each sector were randomly selected and Info epidemiologic software was used to calculate a representative sample. The inclusion criteria were: Both males and females aged between 18 and 65 years old who had been diagnosed with type 2 DM, whether on insulin therapy or not and were being followed at PHC centers. DM patients with psychiatric disorders and patients with medical conditions in which hypoglycemia increased mortality and morbidity such as malignancy and dementia were excluded from the study. Data were collected with a self-administered validated questionnaire. The questionnaire had been translated into Arabic and its validity and reliability assessed by means of a pilot study. In order to re-assess the reliability of the same questionnaire we also conducted a pilot study for 20 participants and found 83.2% Cronbach's alpha reliability co-efficient. The participants of the pilot study were excluded from the main study. The first section of the questionnaire consisted of sociodemographic data such as age, gender, level of education, location of residence and diabetes duration. The second section contained 19 questions on thoughts, knowledge, attitude and concerns that the patients might have with regard to insulin injection on the Likert scale of 1–5 where, 1 indicates strongly agree and 5 strongly disagree. Section 3 consisted of a 9-item patient-doctor relationship questionnaire (PDRQ-9). The PDRQ-9 was developed and established by Helping Alliance Questionnaire of Lubrosky and validity was assessed after the application of the questionnaire. It was used to assess the patient's understanding and feeling toward his primary care physician (PCP). For each item there were 5 lickert scale response options (1 = “not at all appropriate,” 2 = “somewhat appropriate,” 3 = “appropriate,” 4 = “mostly appropriate,” 5 = “totally appropriate.” The total score was interpreted as: Score 18 = 40%, score 27 = 60%, and score 36 = 80%. Not appropriate = ≤40%, somewhat appropriate = 40%–60%, mostly appropriate = 60%–80%, and very appropriate = ≥80%.
Ethical approval was obtained from the Institutional Review Board vide letter No. 1420798/4/26/41 dated 13/03/2019 and informed written consent was taken from all participants in the study.
Data entry, analytic and descriptive analysis were done using the IBM SPSS Statistics version 23 (New York, USA). Each variable was coded for purposes of analysis in the questionnaire. Inference analysis was done using Chi-square. P = 0.05 was considered as statistically significant. Demographic data were reported as percentages. The degrees of agreement to insulin therapy were agree and strongly agree, and unwillingness in patients who disagreed or strongly disagreed. Natural option was considered as undecided.
Out of 396 participants who received the questionnaires, 366 returned them giving a response rate of 92%. The mean age of the participants was 47.71 years ± 11.33 (standard deviation). Fifty-one percent of them were male. Fifty percent of them were preuniversity, 31.1% university educated and 18.6% uneducated. Most of the participants (80.9%) had been diagnosed with diabetes for <15 years. The details of the sociodemographic data are shown in Table 1.
About one third (32.5%) of the participants stated that they were unwilling to use insulin, but 8.7% were undecided. There was a significant relationship between age and willingness (P = 0.013) in favor of (50–65 years). In addition, there was a significant relationship between the length of diabetes diagnosis and willingness (P = 0.0001). However, there was no significant relationship between gender and educational level and willingness. The details of the participants' characteristics by willingness to use insulin are shown in Table 2.
There were significant differences between agreement categories in all attitude items. The participants significantly agreed that insulin would help to improve diabetes and can reliably prevent long term complications resulting from diabetes, but also agreed that diabetes would be worse with the use of insulin and they were fearful of insulin-related side effects such as hypoglycemia and weight gain. They believed that their need to use insulin meant they had failed to properly care for their diabetes but they would rather delay the use of insulin until there was no alternative. On the other hand, the participants significantly disagreed thinking that insulin might cause more diabetic complications in the long term, injection-related issues and diet-related issues. The details of the participants' attitude toward insulin are shown in Tables 3 and 4.
There were no significant differences in the willingness of participants according to their opinion on the “fear of hypoglycemia” and on “weight gain.” The most notable negative attitudes toward insulin therapy in unwilling participants compared to willing and undecided participants were: “heard that some people had a bad experience with insulin” (59.34%, P < 0.05), “dependence owing to regular injection” (54.20%, P < 0.05), “not enough time for regular doses of insulin” (51.78%, P < 0.05), and “inability to pay close attention to their diet as insulin treatment requires” (50.46%, P < 0.05). Additional comparisons of participants' attitudes on insulin therapy between willing, undecided, and unwilling participants are presented in Table 4.
Almost 89% of the participants responded “appropriate to most appropriate” to the statement that “my PCP helped me” and so did 79% with the statement that “my PCP had enough time for me.” “Eighty-eight percent of the participants responded that they trusted their PCP.” Similarly, 84% of the participants affirmed the statement that treating PCP understood them as “appropriate” and that the treating PCP was dedicated to helping them. The same was true with the statements that “my doctor and I fully understood the nature of my medical symptoms” and that they were content with their PCP treatment. Here 87% and 86% of the participants answered with “appropriate” to “most appropriate” respectively. Only 21% of the participants did not respond with “appropriate” to the question whether the PCP was easily accessible. The details of the response of the participants on patient–doctor relationship questionnaires are shown in Table 5.
Those participants whose responses were “mostly appropriate and very appropriate” for the questionnaires in patient–doctor relationship were significantly willing to take insulin (64.9% vs. 24.5% and 70.3% vs. 22.9% P = 0.0001) than those who were unwilling to take insulin. However, those whose response were “somewhat appropriate” were significantly unwilling to accept insulin treatment than those who were willing (49.5% vs. 40%, P = 0.0001). However, those whose response was” not appropriate” were significantly unwilling to take insulin than those who were willing (80% vs. 20%, P = 0.0001). The details of the relationship between the willingness of the participants and PDRQ-9 are shown in Tables 5 and 6.
The present study was conducted to determine the psychological insulin resistance in the type 2 diabetes patients attending the PHC centers of Al-Ahsa region in Saudi Arabia. One-third of the participants in our study expressed their unwillingness to use insulin. Globally, in similar studies done in the USA, Netherland Kenya and Korea the prevalence of PIR have been found to be from 30% to 83%. However, a study done on the Bangladeshi population in East London found a comparatively lower level of refusal for insulin injection among the type 2 diabetic patients. Almost the same result was found in a Saudi study where one-fourth of the studied type 2 diabetic population refused insulin. A moderately low level of insulin therapy refusal (15%) was found in a Malaysian study, but a very high level of unwillingness for insulin was reported in a Libyan study in which 94.6% of the participants expressed unwillingness to accept insulin therapy.
The prevalence of PIR in males was higher than in females in our study, but the difference was not statistically significant. Moreover, another Korean study found significantly higher prevalence of insulin refusal in males compared to females, results which are similar to our study results. However, the reverse is true in the American study in which females were more unwilling for insulin than males. In addition, the Congo study showed significantly higher PIR in females than males. Similar results were found in Malaysian and South Iranian studies. The disparities in the results may be due to socio-cultural differences of the countries as well as demographic dissimilarities in the samples recruited in the different studies (e.g., male-to-female ratio of the included population and duration of diabetes).
There was a significant relationship between the duration of diabetes diagnosis and insulin willingness (P = 0.0001) in our study. Higher duration of diabetes was associated with lower insulin refusal in a Malaysian study also where odds ratio was 0.89, 95% confidence interval = 0.87, 0.93 when the relation of duration of diabetes and refusal rate was compared. In the same study, patients diagnosed with diabetes <10 years previously had an increased chance of insulin refusal by more than two-fold. In a Korean study, the researchers found that insulin refusal was more among diabetic patients of less duration than those of more duration. However, one Saudi as well as one Libyan study found that there were no significant associations between unwillingness to start insulin with the duration of diabetes. The most pronounced negative attitudes of the participants in our study which led to the PIR were: hearing that some people had had a bad experience with insulin, fear of dependence due to regular injections, lack of time for regular doses of insulin, and inability to pay close attention to diet as insulin treatment requires. As observed in a study done in a university hospital in Germany, patients who were already on insulin treatment had a less negative attitude toward the use of insulin compared to patients who were not on insulin treatment.
The perception of the type 2 diabetic participants that insulin therapy was painful and that insulin was addictive was also noted in the Libyan study in which almost 50% of the participants with PIR agreed. The same result was found in the Congo where the participants who refused insulin were significantly apprehensive of the pain and the possibility of being addicted as compared to those who accepted insulin. In a qualitative study in Kuala Lumpur, Malaysia, injection pain, needle phobia and the belief that insulin was for life and for more severe disease were the negative perceptions of the diabetic patients who were unwilling to take insulin. Unlike other studies, there were no significant differences in the willingness of participants who were fearful of hypoglycemia and weight gain in our study. In Kenyan study, nearly 40% of the participants who showed unwillingness cited weight gain and the risk of hypoglycemia with insulin use as the main reason for PIR respectively. In the USA study the issue of hypoglycemia was also one of the important reasons for the negative attitude of diabetic patients toward insulin therapy. Fear of dependency and pain as the main factors contributing to the unwillingness of participants were in accord with the results of other studies.
A positive doctor–patient relationship plays a pivotal role in patient care and patients' compliance with the treatment and is highly dependent on patients' perceptions, physician empathy, and communication style. Commencing insulin treatment for diabetic patients poses a challenge for treating physicians because the acceptance of this treatment depends on how the treating physician manages to convince the patients by removing their doubt and alleviating their fear of insulin treatment. In our study, the good doctor–patient relationship played an important role in the willingness to undergo insulin treatment. Those patients who were satisfied with their doctors' management were more willing to take insulin treatment. A similar result was wrevealed in a Hong Kong study where proper counseling by the treating physician was one of the factors in lower prevalence of PIR.
A study in the USA showed that the participants' perceived starting insulin as a negative experience that would be painful and would lead down the “slippery slope” to complications. The healthcare providers engaged in four primary behaviors that involved a display of the insulin pen/needle and a demonstration of the injection process, an explanation of how insulin could help in diabetes control and reduce the risk of complications, the use of a collaborative communication style and a show of support and a willingness to answer questions so that participants are not be “on their own.” After initiation, most participants noted that insulin was not as bad as they thought and recommended insulin to other adults with type 2 diabetes. Another study done in Argentina demonstrated that patients with type 2 diabetes who were dissatisfied with aspects of their interactions with physicians, exhibited poor insulin adherence. In this study, perceived physician inattention and lack of engagement (and diabetes-related distress) directly affected insulin adherence and glycemic control.
Limitation of the study
PIR in our study was measured by self-reported items that reflected expectation and not the actual behavior and practices. Therefore, further study is needed to truly translate into true PIR once recommendations are made. The attitudinal items in the questionnaires were necessarily limited and there may be other important contributions to PIR that were not assessed. The study could be extended to determine other social factors and to remove any confounding effect of these factors.
The study showed that one-third of the patients with type 2 diabetes had PIR. The main negative attitude toward insulin were: Hearing of bad experience with insulin, feeling of dependence on insulin, lack of time for regular doses of insulin and the fear of not being able to pay as close attention to diet as is required by insulin treatment. The participants who were satisfied with the treating doctors were more willing to start the insulin treatment. However, there is a need for further improvement in doctor–patient communication and the establishment of a suitable therapeutic education program to reduce the prevalence of PIR and its harmful consequences on the control of DM and quality of life of diabetic patients.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
1. Bao H, Liu J, Ye J. Influencing factors of the diabetes distress among Chinese patients with type 2 diabetes
mellitus Psychiatr Danub. 2018;30:459–65
2. Harris MI. Impaired glucose tolerance in the US population Diabetes Care. 1989;12:464–74
3. Sullivan PW, Morrato EH, Ghushchyan V, Wyatt HR, Hill JO. Obesity, inactivity, and the prevalence of diabetes and diabetes-related cardiovascular comorbidities in the US, 2000-2002 Diabetes Care. 2005;28:1599–603
4. Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030 Diabetes Res Clin Pract. 2010;87:4–14
5. Marín-Peñalver J, Martín-Timón I, Sevillano-Collantes C, Cañizo-Gómez F. Update on the treatment of type 2 diabetes
mellitus World J Diab. 2016;7:354
6. U.K. Prospective Diabetes Study Group. Diabetes. 1995;44:1249–58
7. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes
(UKPDS 33). . UK Prospective Diabetes Study (UKPDS) Group Lancet. 1998;352:837–53
8. . Summary of Revisions: Standards of Medical Care in Diabetes-2020, ADA Diabetic Care. 2020Last accessed on 2020 Jul 20;43(Suppl 1):S4–6 Available from: https://care.diabetesjournals.org/content/43/Supplement_1/S4
9. Leslie CA. Psychological insulin resistance: A missed diagnosis? Diabetes Spect. 1994;7:52–7
10. Allen NA, Zagarins SE, Feinberg RG, Welch G. Treating psychological insulin resistance in type 2 diabetes
J Clin Transl Endocrinol. 2017;7:1–6
11. Polonsky W, Hajos T, Dain M, Snoek F. Are patients with type 2 diabetes
reluctant to start insulin therapy? An examination of the scope and underpinnings of psychological insulin resistance in a large, international population Curr Med Res Opinion. 2011;27:1169–74
12. Tong WT, Vethakkan SR, Ng CJ. Why do some people with type 2 diabetes
who are using insulin have poor glycaemic control? A qualitative study BMJ Open. 2015;5:e006407
13. Holmes-Truscott E, Pouwer F, Speight J. Assessing Psychological Insulin Resistance in Type 2 Diabetes
: A Critical Comparison of Measures Curr Diab Rep. 2017;17:46
14. Brod M, Kongsø JH, Lessard S, Christensen TL. Psychological insulin resistance: Patient beliefs and implications for diabetes management Qual Life Res. 2009;18:23–32
15. Bahrmann A, Abel A, Zeyfang A, Petrak F, Kubiak T, Hummel J, et al Psychological insulin resistance in geriatric patients with diabetes mellitus Patient Educ Couns. 2014;94:417–22
16. Batais MA, Schantter P. Prevalence of unwillingness to use insulin therapy and its associated attitudes amongst patients with Type 2 diabetes
in Saudi Arabia Prim Care Diabetes. 2016;10:415–24
17. Almaghaslah D, Abdelrhman AK, Masdaf SK, Majrashi LM, Matary BM, Asiri WM, et al Factors contributing to non adherence to insulin therapy among type 1 and type 2 diabetes
mellitus patients in Asser region, Saudi Arabia Biomed Res. 2018;29:2090–95
18. Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013;35:121–6
19. Van der Feltz-Cornelis CM, Van Oppen P, Van Marwijk HW, De Beurs E, Van Dyck R. A patient-doctor relationship questionnaire (PDRQ-9) in primary care: Development and psychometric evaluation Gen Hosp Psychiatry. 2004;26:115–20
20. Polonsky WH, Fisher L, Guzman S, Villa-Caballero L, Edelman SV. Psychological insulin resistance in patients with type 2 diabetes
, the scope of the problem Diabetes Care. 2005;28:2543–5
21. Moura CS, Rosenberg ZB, Abrahamowicz M, Bernatsky S, Behlouli H, Pilote L. Treatment discontinuation and clinical events in type 2 diabetes
patients treated with dipeptidyl peptidase 4 inhibitors or NPH insulin as third line therapy J Diabetes Res. 2018;2018:4817178
22. Gulam AH, Otieno FC, Omondi-Oyoo G. Prevalence of psychological insulin resistance among patients with type 2 diabetes
at Kenyatta National Hospital, Kenya Health Sci J. 2017;11:1
23. Song Y, Ku BJ, Cho J, Jun Y, Kim B, Nam S. The prevalence of insulin refusal and psychological insulin resistance among Korean patients with type 2 diabetes
mellitus Ann Transl Med. 2019;7:760
24. Khan H, Lasker SS, Chowdhury TA. Prevalence and reasons for insulin refusal in Bangladeshi patients with poorly controlled Type 2 diabetes
in East London Diabet Med. 2008;25:1108–11
25. Ishak NA, Awang H, Abd Aziz R, Abdullah AJ, Bahari N. Prevalence and determinants for Insulin therapy refusal among type 2 diabetes
mellitus patients in primary health care facilities in east Coast Region of peninsular Malaysia Int J Public Health Clin Sci. 2019;6:160–71
26. Sabei LT, Sammud M. Attitude towards insulin therapy among patients with type 2 diabetes
in Tripoli, Libya Ibnosina J Med Biomed Sci. 2015;7:127–35
27. Rita SL, Lubaki FJ, Bompeka LF, Ogunbanjo GA, Ngwala LP. Prevalence and determinants of psychological insulin resistance among type 2 diabetic patients in Kinshasa, Democratic Republic of Congo Afr J Prim Health Care Fam Med. 2019;11:e1–e5
28. Jalilolghadr S, Javadi A, Mahram M, Farshidgohar M, Javadi M. Prevalence of metabolic syndrome and insulin resistance in children and adolescent of Qazvin, Iran Malays J Med Sci. 2015;22:32–9
29. Tan WL, Asahar SF, Harun NL. Insulin therapy refusal among type II diabetes mellitus patients in Kubang Pasu district, the state of Kedah, Malaysia Singapore Med J. 2015;56:224–7
30. Lee KP. Psycholosocial factors associated with psychological insulin resistance in primary care patients in Hong Kong J Clin Sranslat Endocrinol. 2015;2:157–62
31. Stuckey HL, Polonsky W, Fisher L, Hessler DM, Snoek FJ, Tang TS, et al Key factors for overcoming psychological insulin resistance an examination of a large international sample through content analysis Diabetes. 2018;67(Supplement 1)
32. Pichon-Riviere A, Irazola V, Beratarrechea A, Alcaraz A, Carrara C. Satisfaction with treatment in type 2 diabetes
patients requiring insulin treatment in Buenos Aires, Argentina Health Outcomes Res Med. 2012;3:e231–7