Glycemic Control and Social Challenges Among Saudi Children with Type 1 Diabetes Mellitus: The Impact of Virtual Clinics

1. Introduction

Type 1 diabetes mellitus (T1DM) is one of the most common endocrine metabolic disorders affecting children and adolescents across the globe with a 3-4% increasing yearly incidence creating a huge burden on patients and on health systems [1,2]. T1DM, a multifactorial disease, is caused by autoimmune destruction of pancreatic beta cells resulting in no insulin production which leads to hyperglycemia and morbidity [3]. Glycated hemoglobin (HbA1c) measurements, used to manage T1DM, can be challenging to control in pediatric patients. Children with T1DM should visit a diabetes outpatient clinic at least once every 3 months or more often if difficulties arise which poses demands in terms of time and expenditures. This can lead to missed appointments, especially for families from rural areas [4].

Children and adolescents with T1DM are twice as likely to have other comorbid psychological disorders such as mood disorders, eating disorders, and anxiety disorders. It is estimated that for every five children with T1DM, at least one child is diagnosed with more than one psychiatric disorder. The psychosocial aspects of T1DM can be overlooked and can create more challenges for the patient and the caregivers [1]. Studies have shown that 30-50% of female and 10-20% of male diabetic management is affected by disordered eating behaviors. Caregivers have a high prevalence of anxiety, depression, and posttraumatic stress disorder. Out of every five parents whose child is diagnosed with T1DM, at least one parent reports significant levels of distress within four years of diagnosis. [5]

Healthcare services are provided by the Ministry of Health (MOH) and other governmental and private facilities in Saudi Arabia [6].The country has dealt with the burden of high healthcare costs and with concerns regarding quality of care. More recently, increased healthcare spending and improved infrastructure have led to better quality of care [7]. Healthcare technology, including telemedicine, has been part of this investment [7]. Telemedicine could address many of the issues that type 1 diabetes patients face. There has been an increase in the use of continuous glucose monitoring (CGM) systems and also in the use of insulin pumps and of smart insulin pens. Results can be shared online with doctors and dieticians for review without the need for the patient to be physically present [8].

As of 2022, 98.6% of Saudi Arabia’s population had access to the internet [9]. Telemedicine aligns with “Saudi Vision 2030” which addresses diversifying the economy and improving the healthcare sector. Using telemedicine can enhance healthcare accessibility which should improve patient outcomes and increase system efficiency [10,11]. A recent study showed improvement in parents’ satisfaction with treatment and ability to maintain metabolic control during the COVID-19 pandemic in children with T1DM [12]. To ensure optimal management of this difficult chronic condition and to promote good quality of life, it is imperative to determine the most efficient way healthcare providers can assist children with T1DM to manage their condition and continue to thrive. We aimed to explore the impact of monthly virtual clinics on glycemic control in pediatric patients at King Faisal Specialist Hospital and Research Center (KFSH&RC)- Jeddah Branch by looking at changes to HbA1c. Additionally, we aimed to assess parents’ satisfaction with the virtual visits.

2. Materials and Methods

Data for this cohort study came from pediatric patients aged 14 years or younger diagnosed with type 1 diabetes mellitus (T1DM) seen at the pediatric endocrinology and diabetic clinic at KFSH&RC-Jeddah. Ethical approval was granted from the Institutional Review Board at King Faisal Specialist Hospital and Research Center in Jeddah and informed consent to participate was obtained from all of the participants in the study. Data collection occurred during the period from August 2022 to January 2023. Parents and patients engaged in monthly virtual consultations, complementing their regular clinic follow-ups for a span of six months. The average consultation duration of the virtual clinics was 10-15 minutes and these clinics were conducted by fellows, specialist consultants, residents, and diabetes educators. A checklist was used to ensure that specific topics were covered during the virtual clinic including: patient demographics, current insulin regimen, glycemic control, diet, physical activity, diabetes complications and lab trends, quality of life, intervention and follow-up, and counseling.

The patients’ parents completed a survey that was designed and pilot tested (Cronbach’s alpha = 0.95) for use specifically in this study before the first virtual clinic and at the end of the study period. The survey consisted of 30 multiple-choice questions divided into three sections assessing satisfaction with clinical services, treatment barriers, and competence in diabetes management (included as supplemental material). Data collected at baseline included information on patient and family demographics and patient comorbidities. The primary outcomes of interest in this study included: HbA1C measurements, frequency of glucagon injection, frequency of diabetic ketoacidosis (DKA), number of hypoglycemia episodes per week, and number of hospitalizations patients experienced in the six months before the monthly virtual consultation began compared to the six months after this intervention had been initiated.

Demographic and clinical variables were analyzed using the mean and standard deviation (SD) or the median and interquartile range (IQR) according to distribution of the data. Frequencies were generated for categorical variables. Bivariable analyses were carried out to look at the association between survey results and the outcomes associated with diabetes management before and after the initiation of the monthly virtual consultation. The paired t-test was used to compare pre and post survey results and HbA1C values for the participants. The exact McNemar’s test and the Bowker’s test of symmetry were used to compare categorical health-related outcomes measured before and after the intervention began for outcomes with two response categories and outcomes with more than two response categories respectively. Analyses were performed using SAS software, version 9.4, and statistical significance was determined at an α = 0.05 level.

3. Results

The median (IQR) for age of the n=25 participants in this study was 11.0 (9.0-13.0) and 56.0% of the study population was male (Table 1). The median (IQR) for participant weight increased from 30.0 (23.9-45.0) before the monthly virtual clinic was initiated to 37.0 (26.0-49.0) six months after the intervention had begun. The mean and standard deviation (SD) for participant height also increased during this time period and the mean ± SD for age at which participants in this study were diagnosed with type I diabetes was 5.3 ± 2.9 years.

Almost half of the participants (n=12, 48.0%) had a frequency of follow-up of 4 months and the mean and SD for total insulin was 1.02 ± 0.2 units/kg/day with almost all participants (88.0%) having an insulin regimen consisting of basal-bolus. Sixty percent of the participants (n=15) monitor their glucose 6 times per day. Comorbid conditions were present for 36% of the participants with one participant having both hypothyroidism and TOF post-repair. (Table 1)

The mother was the family member supervising the insulin regimen for the majority (84.0%) of the patients and 92.0% of the patients had married parents (Table 1). The patients’ mothers median (IQR) for age was 39.0 (37.0-42.5) compared to 43.0 (40.0-50.0) for the patients’ fathers (Table 2). The majority of the mothers were housewives (68.0%) while over two-thirds of the father’s worked either in government or the private sector. Just under one-third (32.0%) of the mothers and 44.0% of the father’s had a university education. (Table 2) The majority of the families live in apartments (88.0%) with just under one-half (44.0%) owning their home (Table 1). All of the families owned vehicles and 72.0% (n=18) live in a city (Table 1). The median and IQR for time it takes for the study participants to reach a hospital was 10.0 (7.0-20.0) minutes (Table 1).

There were no significant differences in the mean scores for parents’ satisfaction and competence responses to each survey section including clinical visit experience, difficulties and barriers for treatment, and competence in managing the diabetes pre and post the monthly virtual consultation intervention (Table 3). Anecdotally, however, some parents expressed discontent with the virtual clinics in stating they felt their competence was being questioned with regards to being able to care appropriately for their child with T1DM.

Comparing health related categorical outcomes pre and post the introduction of the monthly virtual clinic revealed a significant association between number and type of hypoglycemia episodes per week with a greater number of participants experiencing these episodes pre-intervention compared to experiencing them post-intervention (Symmetry Chi-sq = 12.0, df = 3, p = 0.0074, Table 4). The intervention made a difference with regards to number and type of hypoglycemia episodes. Participants had a significantly higher mean ± SD for HbA1C pre-intervention (9.3 ± 1.7) compared to post-intervention (8.8 ± 1.6) of the monthly virtual consultation (t-value = 3.06, df = 24, p-value = 0.0054) (Table 4).

4. Discussion

One of the primary objectives of our study was to assess the impact of monthly virtual clinics on glycemic control, measured by changes in HbA1c levels. The statistically significant reduction in HbA1c levels following the implementation of the monthly virtual clinics is a promising finding, suggesting that telemedicine may play a crucial role in improving glycemic control among pediatric T1DM patients. Our study revealed a significant drop in hypoglycemia episodes by type per week in participants. This finding is particularly encouraging, as reducing hypoglycemia episodes is a crucial aspect of diabetes management and can significantly improve the quality of life for patients and their families. Results from the satisfaction survey were unchanged before and after introduction of the monthly virtual clinics which could be due to the short duration of the study period or to parents being hesitant to share their feelings.

Wood et al. found that telemedicine helped to maintain pediatric patient HbA1C levels. In addition, there was improvement in patient satisfaction, a decrease in financial burden, and a lower absence from daily obligations for patients and family members [13]. Another multicenter controlled clinical trial in Germany showed that monthly video consultations over 6 months in addition to regular care did not significantly improve HbA1c in T1DM patients [4]. Over an extended period in this study, however, HbA1c did show significant improvement and the burden from diabetes decreased and parental treatment satisfaction increased. A cross sectional observational survey in Australia found that diabetic patients found videoconference clinics to be fairly satisfactory though 21% of respondents had concerns that physical contact may be necessary for diabetes management [14]. A recently conducted systematic review of pediatric patients with T1DM showed that virtual care is associated with stable or improved health-related quality of life and family satisfaction and suggested virtual access should be expanded in healthcare systems globally to ensure equitable access to care [15].

Telemedicine can be a convenient method for providing psychological care to patients and to caregivers. A study with the group-based telemedicine intervention Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP)was completed by involving 36 families of children with type 1 diabetes who expressed fear concerning hypoglycemia [16]. Cognitive behavioral principles were employed and structured qualitative interviews were conducted resulting in several positive influences for parents including increased knowledge, fear awareness, and confidence [16]. A study looking at how patients perceived their relationships with their physicians in virtual and in-person clinics during the COVID-19 pandemic revealed that satisfaction for parents with the care provided and patients’ perception of physician empathy did not differ for virtual vs. in-person visits [17].

A study conducted at the University of Florida focused on adolescents ages nine to eighteen years who had been diagnosed with T1DM and who were regularly hospitalized because of diabetic ketoacidosis or had high HbA1c. These participants were referred to the psychology services unit to receive telemedicine counseling sessions of 15-20 minutes in length for approximately 5.7 months. Results showed that HbA1c was reduced by an average of 0.7% from the baseline readings and there were no diabetes related hospitalizations during the intervention period [18].

Adequate data regarding the impact of telemedicine in Saudi Arabia, in particular for pediatric T1DM patients, is lacking. A cross-sectional study conducted in Jeddah revealed that primary caregivers were largely accepting of virtual clinics for pediatric patients with T1DM and telemedicine was recommended as part of routine care in addition to in-person clinic appointments to improve the quality of care [19]. Another study conducted in Jeddah during the COVID-19 pandemic revealed that many Saudi adult patients with T1DM had adapted to having virtual consultations but also suggested that patient experience should be enhanced moving forward [20].

In our study, some families displayed initial hesitancy in sharing information and raised concerns about their abilities being doubted during virtual clinic visits. This hesitancy may stem from the novelty of the virtual clinic application and differing cultural norms. As patients and caregivers become more used to telemedicine, these concerns may dissipate, allowing for more productive virtual interactions. Addressing these cultural considerations is essential in building trust and providing patient-centered care that respects the values and preferences of all patients and their families. A study conducted during the pandemic assessing telemedicine programs throughout Saudi Arabia found patients had acceptable satisfaction and attitudes towards the programs, however, it was suggested that patient knowledge should be increased regarding telemedicine overall [21].

The small sample size and short study duration may limit the generalizability of findings in our study. Additionally, further research is needed to fully comprehend the impact of telemedicine on patient and caregiver satisfaction. Future research should include larger samples of patients and an extended study duration to provide more comprehensive insights into the long-term effects of telemedicine on pediatric T1DM management in Saudi Arabia and to provide a more holistic understanding of the impact of telemedicine.

5. Conclusions

Our study suggests that the implementation of monthly virtual clinics in addition to standard care may lead to improvement in the management of pediatric T1DM in Saudi Arabia. The reduction in both HbA1c levels and hypoglycemia episodes six months post-intervention are indicative of the potential benefits of telemedicine for this patient population. As Saudi Arabia continues to strive toward its “Saudi Vision 2030” for improving healthcare accessibility and outcomes, further studies should be conducted with larger sample sizes and increased study time periods to determine if these clinical improvements persist and to assess parent tolerance and satisfaction with this approach. If incorporating virtual clinics as part of the routine treatment is shown to enhance the quality of life and accessibility to care for pediatric patients with T1DM, outcomes would likely improve for these patients and it would be important to expand these services for a comprehensive approach to healthcare for this patient population in Saudi Arabia.