FormalPara Key Summary Points

Why carry out this study?

Type 1 diabetes mellitus is on the rise in Saudi Arabia.

Studies on insulin pump use and associated issues among T1DM Arab adults are scarce in the region.

What was learned from the study?

Insulin pump therapy among Arab adults with T1DM sub-optimally improves glycaemic control.

Device malfunctions is the most common issue and this may negatively influence adherence.

Digital Features

This article is published with digital features, including a summary slide, to facilitate understanding of the article. To view digital features for this article go to https://doi.org/10.6084/m9.figshare.13049705.

Introduction

Type 1 diabetes mellitus (T1DM) is an autoimmune disease previously known as insulin-dependent or juvenile-onset type diabetes [1], characterized by absolute insulin deficiency secondary to lack or total destruction of pancreatic β-cells. It is the most common type of diabetes among children. According to the International Diabetes Federation (IDF) Diabetes Atlas (9th edition), more than a million children worldwide have T1DM as of 2019 [2]. Glycaemic targets in patients with T1DM can be achieved through continuous subcutaneous insulin infusion (CSII) or insulin pump therapy [3]. This management was introduced > 40 years ago and is still widely used globally for T1DM patients with well-defined clinical problems who must be interested, keen and able to undergo this therapy [3]. A crucial advantage of CSII compared to MDIs (multiple daily injection), especially in children, is its superior ease and flexibility [4]. Programmable basal rates are delivered routinely and with unparalleled precision, while bolus doses can be used effortlessly to regulate insulin exposure around meals and activities and to correct hyperglycaemia [4]. Among its major disadvantages are risk for ketoacidosis, infection at the infusion site and relatively higher cost compared to other insulin treatments [5].

The Kingdom of Saudi Arabia (KSA) ranks ninth out of the top ten countries with the highest incidence of T1DM per year as per the Diabetes Atlas (9th edition) [2]. However, in contrast to that in the developed countries, the number of research studies on the prevalence, incidence and sociodemographic aspects of T1DM is distressingly low [6]. Studies on Saudi T1DM adults is even fewer compared to the paediatric counterparts. Most of these studies focus on glycaemic control during Ramadan, the fasting month of Muslims where people with diabetes are at higher risk for complications [7, 8]. A recent study by Almogbel compared the impact of pump therapy among T1DM Saudi users and observed that those under insulin pump had better glycaemic control over multiple-dose insulin injections (MDI), but had modestly more hypoglycaemic episodes per week [9]. Despite meaningful findings for the Saudi T1DM population, the previous study was non-randomized case-control and acknowledged that it failed to address several significant confounders such as patients’ satisfaction, including issues encountered in adopting such technologies. Other studies on the use of CSII in the region were mostly qualitative in design focusing on children [10] or T2DM patients [11]. In this retrospective study, we determine the common issues encountered by Saudi T1DM adult patients on CSII therapy, their experiences and level of glycaemic control after CSII commencement. The present study is arguably the first in the region to address insulin pump issues among Arab T1DM adult patients.

Methods

This is a retrospective chart review conducted at the Adult Diabetes and Endocrinology Center, King Abdullah Specialized Children Hospital, King Abdulaziz Medical City (KAMC) in Riyadh, Saudi Arabia. Saudi adults with known T1DM aged 15–45 years old and who are on CSII therapy were included in the chart review. Exclusion criteria included T1DM patients who are < years old, have severe diabetes complications, have learning disabilities and are not CSII therapy. Other types of DM as well as non-Saudis were also excluded. The study was performed in accordance with the Helsinki Declaration of 1964 and its later amendment. Ethical approval was obtained from the Institutional Review Board of KAMC, Riyadh, KSA (approval no. RC18/100/R). The Institutional Review Board of KAMC, Riyadh, also waived the need for informed consent.

At KAMC, CSII therapy is implemented following a training programme for patients and their parents/relatives. This training programme is led by the endocrinologist consultant and assisted by a multidisciplinary team for different settings. Throughout its use and after a period of maintenance on CSII, patients are followed up routinely, and for each visit, HbA1c is measured, which serves as guidance prior to needed insulin adjustments.

Data Collection

Demographic and clinical information was retrieved in charts of patients included. These included personal data (age and sex), age at diagnosis, duration of CSII, reasons for choosing CSII therapy, benefits of CSII therapy, problems encountered, hospital admissions, reasons for stopping CSII therapy, frequency of hypoglycaemic or hyperglycaemic episodes and glycated haemoglobin (HbA1c) levels at baseline and last follow-up. The type and model of insulin pump were also noted.

Data Analysis

Data were analysed using SPSS version 16.5 (SPSS Inc., Chicago, IL, USA). Continuous data were presented as mean ± standard deviation for normally distributed variables and median (inter-quartile range) for non-normally distributed variables. Categorical data were presented as frequencies (%). Independent t test was done to compare parameters according to sex and paired t test was done to compare baseline and follow-up HbA1c levels. Figures were plotted in MS Excel. Significance was set at p < 0.05.

Results

In the present retrospective, single-centre study, a total of 118 subjects [34 males aged 22.8 ± 8.3 years (28.8%) and 84 females aged 27.0 ± 7.7 years (71.2%); p = 0.01] fulfilled the criteria for inclusion. Of the 118 patients included, 37 claimed to be admitted specifically for DM management while on pump (31.4%). Of these 37, 19 (51.4%) were confirmed in the system (not shown table). Table 1 shows the general characteristics of subjects. The mean age of subjects was 25.6 ± 8.0 years, with a median age of diagnosis at 11 years. The median average of CSII use was 5 years. Overall, while there was a significant improvement in HbA1c in all subjects, these changes were still clinically suboptimal. When stratified according to sex, females were significantly older than males (p < 0.01) and were slightly older at time of T1DM diagnosis (p = 0.09). There was no significant difference in age at first break, years using CSII as well as baseline and follow-up levels of HbA1c. Both males and females had significantly lower HbA1c levels at follow-up compared to baseline (p = 0.008 and < 0.001, respectively) (Table 1). Between-group analysis adjusted for age showed no significant difference in HbA1c change.

Table 1 General characteristics of T1DM subjects
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CSII

At the time period of study, 13% (N = 15) of subjects were not using insulin pump. Among the 103 users, 99% were using Medtronic® (Medtronic Plc, Dublin, Ireland) while 2 (1%) were on Omnipod® (Insulet Corp, Acton, MA, USA). Among Medtronic® users, most (61%) were using MMT 722 followed by MMT 772 (34.7%), MMT 640 (2.5%) and MMT 754 (0.8%) (not mentioned in tables).

Common Problems, Reasons and Benefits Related to Using CSII

Less than half of the patients (N = 53, 44.9%) reported no significant problems in their CSII experience. The most common problem encountered by the patients on CSII was breaking down of the pump (30.0%), relocation of the cannula or tubing (22%) and air bubbles affecting delivery (16.1%). Around 15% of the subjects do not like wearing the pump (Table 2). Subjects had varying reasons for using the pump but most are aware that it is for diabetes control (59.3%). More than half of all the participants are also using it because it was recommended by their physicians (58.5%) and is compatible with their lifestyle (52.5%). Less common reasons were to improve diabetes control (27.1%) and to prevent long-term complications (22.9%) (Table 2). Top benefits for using CSII according to subjects include better control of diabetes and fits with lifestyle (both at 74.6%) and that relocation of tubing is more convenient than several injections per day (73.7%). Most also thought it just feels better (67.8) and more convenient (55.9%). Other listed benefits are included in Table 2.

Table 2 Common problems, reasons and benefits related to using CSII (all subjects)
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Hospitalizations, Breaks and Complications

Eighty-one subjects (68.6%) claimed to have been admitted for DM management while on CSII. Sixty-four subjects (54.2%) had their last contact with their specialist within 3 months while 34.7% within 3–6 months. Most subjects (70.3%) never had a break in CSII therapy and only 25.4% claimed to have one break while 4.2% had two breaks. Among the few subjects who stopped CSII, the most common reason was they do not like wearing pump (5.1%) and found the pump was faulty (2.5%) (not shown in tables). Severity of reported hypoglycaemia was mild in more than half of the subjects (59.3%) while 37.3% reported moderate and 2.5% had severe hypoglycaemia. Frequency of hypoglycaemic attacks after starting on CSII and while on CSII is shown in Figs. 1 and 2. More than one third (65.6%) of the subjects reported having fewer hypoglycaemic attacks after CSII therapy while 13.6% reported more episodes (Fig. 1). More than half of the subjects reported having at least one episode in a week (24.6%) or twice in a week (28.8%) (Fig. 2).

Fig. 1
figure 1

Frequency of hypoglycaemic attacks after starting on CSII

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Fig. 2
figure 2

Frequency of hypoglycaemic attacks while on CSII

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Discussion

The prevalence of DM in Saudi Arabia is continuously increasing and has been considered one of the most common chronic diseases contributing in the economic health burden in the Kingdom [12]. Achieving glycaemic control among Saudis with diabetes, regardless of type, is therefore a constant challenge not only for the patient but also for the entire medical community [13]. This retrospective study is arguably the first to address insulin pump issues among T1DM adult patients in the region.

The present study identified that the prevalence of device malfunction is high (30%), followed by relocation of the cannula or tubing (22%) and air bubbles affecting delivery (16.1%). The prevalence of device malfunction is lower compared to other studies done elsewhere such as in New Zealand (38%) [14] and France (68%) [15]. Issues related to insulin pump malfunctions in general and Medtronic® in particular have been the most reported problems in the Food and Drug Authority (FDA) in the US [16]. Unfortunately, many companies will not reveal adverse events reported related to devices, but this type of information is useful for quality assurance and safety. As such, the need to address the safety concerns related to these devices and push the manufacturers to improve their designs aside from the usual warranty should be addressed. Furthermore, eligibility of users should be screened properly to prevent human errors and proper education, training and continuous technical provided to reduce the incidence of adverse events related to device malfunction [17].

As with CSII therapy, it is worth noting that only 53 (44.9%) of the subjects reported no significant problems with CSII use. Furthermore, 40 of the 118 subjects (33.8%) reported having either no significant change in frequency of hypoglyacaemic attacks or more hypoglycaemic attacks after CSII therapy. CSII has been highlighted in several health economic studies as being more cost effective than MDI, at least in adults [18, 19], but not in children [20]. In the present study, the common issues encountered by the subjects regarding their medical devices should be reported to the Saudi Food and Drug Administration (SFDA) where approval of such devices takes place.

One of the major findings in the present study is that while most subjects are using CSII because of the convenience and compatibility with their lifestyle, the glycaemic control achieved by using CSII therapy remains suboptimal. This is true for both males and females. The poor glycaemic control is also reflected by the high prevalence of hospital admissions in the cohort. A recent study by Alshareef and colleagues demonstrated a high correlation between hospital visits and glycaemic control among 530 adult Saudis with diabetes [21]. In their study, each unit of increase in HbA1c was attributed to a 43% increase in emergency department visits. They also highlighted that most participants were not followed up for emergence of complications 12 months prior to ER visits, a clear indication that diabetes care in KSA also has its own shortcomings [21].

Lastly, females outnumber males by almost 2:1, and this is consistent with the most recent epidemiological study conducted in KSA on T1DM [12] as well as the previous prospective study on T1DM and CSII use [22]. The sexual dimorphism in T1DM maybe more attributable to pathophysiological differences than the care provided, as significant variances have also been observed in other ethnic groups, with women having higher prevalence and being more likely to suffer from T1DM complications than men [23,24,25]. These gender differences in T1DM outcomes can also be attributed to differences in immune response and other external factors that underlie bias towards females especially with respect to autoimmune diseases [26]. Worth mentioning is that females were significantly older than males, confirming previous observations that autoimmune diseases in males are of young onset as opposed to acute onset in females [27].

The present study has several limitations. The design is retrospective and convenience sampling was used. Selection bias therefore cannot be avoided. The convenience sampling used however is homogeneous, as opposed to conventional convenience sampling, and the findings are more generalizable [28], albeit for a narrower population (Saudi T1DM adults). The findings are also limited to issues involving CSII therapy, since comparisons with other insulin delivery systems such as MDI have already been studied [9]. The present study nevertheless has merits, since it fills the gaps of previous observations that did not address insulin pump device issues in the assessment of its efficacy in achieving glycaemic control. Furthermore, the study adds value not only because of its comparatively larger sample size compared to previous local studies, but it is also the first to shed light on the issues and experiences of Saudi T1DM adult patients related to the use of CSII. Further investigations on an even larger scale (e.g. multi-centre) should be done on whether different insulin pumps show variances in efficacy among Saudi T1DM patients.

Conclusions

In summary, the prevalence of device malfunction is high among Arab adult T1DM users of CSII and this can partly explain the suboptimal improvement in their glycaemic control. Education and training need to be reemphasized among users for better outcome of insulin pumps. Issues on adherence and device malfunctions should be investigated further.