Assessment of Patient-reported Satisfaction and Metabolic Outcomes Following Initiation of the Second Generation of Flash Glucose Monitoring in Patients with Type 1 Diabetes

BACKGROUND AND AIMS: This study aims to assess patient-reported satisfaction and metabolic outcomes following the initiation of the second generation of the Freestyle Libre 2 (FSL2) system in patients with type 1 diabetes (T1D). METHODS: This non-randomized single-arm observation study was conducted on 86 patients with T1D living in Saudi Arabia, who were asked to wear the FSL2 for 12 weeks. The demographic data were collected at baseline, while the continuous glucose monitoring (CGM) metrics were gathered, i.e., Glucose Variability (GV) (%), mean Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and average duration of hypoglycemic events were collected at baseline, 6th week and 12 weeks. Further, the Continuous Glucose Monitoring Satisfaction (CGM-SAT) was collected at the end of the follow-up RESULTS: Compared to the 6th week, significant differences were observed in the low glucose events (p = 0.037), % TIR (p = 0.045), and % below 70 mg/dL (p = 0.047) at 12 weeks. Improvement was seen in the other glucometric variables, but no significant changes were evident (p > 0.05). On completion of the study period, the ambulatory glucose profile (AGP) metrics showed a 74.3 ± 5.01 (mg/dL) FSL2 hypoglycemia alarm threshold and a 213 ± 38.1 (mg/dL) hyperglycemia alarm threshold. A majority of the patients stated that CGM-SAT had benefits (mean score > 3.58), although they felt FSL2 had 'additional benefits. With regard to the problems with the use of FSL2 majority of the patients stated that FSL2 has minimal discomfort. CONCLUSION: Using second-generation FSL2 in patients with T1D is positively associated with patient-reported satisfaction and metabolic outcomes.

Assessment of Patient Satisfaction with On-Site Point-of-Care Hemoglobin A1c Testing: An Observational Study.

INTRODUCTION: Poor glycemic control is a serious challenge in successful diabetes management. Given the low adherence and compliance with HbA1c testing frequency and the corresponding delay in the appropriate medication adjustment, point-of-care testing (POCT) for HbA1c provides an opportunity for better control of diabetes and higher patient satisfaction. The data with this regard are limited in Saudi Arabia. Therefore, we aimed to assess the level of patient satisfaction associated with the POCT service implementation for HbA1c and evaluate the differences between the number of requested and conducted HbA1c tests before and after POCT implementation and its effect on glycemic control in Saudi clinical practice. METHODS: We conducted a single-center ambispective descriptive cohort study in Riyadh, Saudi Arabia. This study had two phases: the retrospective phase (January 2017 to December 2017) and the prospective phase (January 2018 to December 2018). Patient satisfaction was assessed using the patient satisfaction questionnaire short form (PSQ-18) and on-site HbA1c point-of-care testing (HbA1c-POCT) satisfaction questionnaire. RESULTS: This study included 75 patients with diabetes (37% type 1, 63% type 2) with a mean age of 44.35 (± 17.97) years. The adherence to physician recommendations for HbA1c testing frequency increased from 24% to 85% (before and after POCT implementation, respectively). High levels of satisfaction across seven dimensions of PSQ-18 (77-88%) were reported towards the provided healthcare service after POCT implementation. Furthermore, a high level of agreement on the statements of the on-site HbA1c-POCT satisfaction questionnaire was also observed. Finally, the mean HbA1c level has significantly improved after POCT implementation compared to the traditional HbA1c laboratory testing before POCT implementation [8.34 ± 0.67 and 8.06 ± 0.62, respectively, p < 0.001). CONCLUSION: HbA1c testing at POCT improved adherence to recommendations for HbA1c testing frequency for better glycemic control and higher patient satisfaction. POCT reduces turnaround time, improves glycemic control, and facilitates the decision-making process. HbA1c measurement with POC devices is recommended to be implemented in diabetes treatment centers. All of the described benefits of POCT come together to make HbA1c testing the most common procedure for diabetes management at the point of care.

Assessment of risk factors for bone fractures in patients with type 2 diabetes mellitus: A study in Saudi Arabia.

BACKGROUND AND AIMS: This study aimed to estimate the prevalence of bone fractures and analyze their associated risk factors in people with and without type 2 diabetes (T2D) in Saudi Arabia. METHODS: This study was conducted among 1188 people (581 type 2 diabetes) in Prince Sultan Military Medical City, Riyadh, Saudi Arabia. In addition to the demographic variables, glycated hemoglobin (HbA1c), creatinine, estimated glomerular filtration rate (eGFR), use of teriparatide, presence of rheumatoid arthritis, presence of chronic obstructive pulmonary disease (COPD), Bone mineral density (BMD), Trabecular Bone Score (TBS) and Fracture Risk using the Fracture Risk Assessment Tool (FRAX) were also collected. RESULTS: There were 1188 people (mean age 66.5 ± 8.7yrs) included in this study, of which 1068 (89.9%) were female, and 120 (10.1%) were male. A total of 112 (9.4%) individuals had a fracture history. Female, use of teriparatide, TBS (partially degraded and degraded), FRAX with TBS (MOF), and FRAX with TBS (Hip fx) were identified as independent risk factors for fracture in the whole study population. Teriparatide use and FRAX with TBS (MOF) were observed as independent risk factors for fracture in the non-diabetic population, whereas age, creatinine, eGFR, teriparatide, osteopenia, osteoporosis, TBS (partially degraded, degraded), FRAX with TBS (MOF), FRAX with TBS (Hip fx) were determined as independent risk factors for fracture among patients with diabetes. CONCLUSION: Patients with T2D were observed to have a higher risk for fractures. The findings of the study highlight the requirement for fracture prevention strategies in patients with diabetes.

The Worrying Trend of Diabetes Mellitus in Saudi Arabia: An Urgent Call to Action.

From last few years, the pervasiveness of diabetes mellitus (DM), in Saudi Arabia, is growing at a frightening rate. Overall, one-fourth of the adult population is affected by DM, which is further predicted to rise to more than double by the year 2030. The most alarming is possibly the escalation propensity of diabetes, in recent years, where a nearly ten-fold increase has been witnessed over the past thirty years in Saudi Arabia. However, the number of research arbitrations on the prevalence and incidence of DM is woefully inadequate, as compared to developed countries. Apart from this, most of the existing research data carried out in Saudi Arabia is cross-sectional, with small sample sizes, which most often involve only certain parts of the country. Consequently, the present scenario demands more multidimensional and multisectoral research to strengthen the evidence base and to accumulate greater knowledge as a basis for measures and programmes to confront diabetes and its complications. Thus, the present report makes an attempt to depict the current trend of diabetes as well as intends to put forward essential measures for controlling diabetes in Saudi Arabia.

Evaluation of FreeStyle Libre Flash Glucose Monitoring System on Glycemic Control, Health-Related Quality of Life, and Fear of Hypoglycemia in Patients with Type 1 Diabetes.

BACKGROUND/OBJECTIVES: In the current era of modern technology and the development of smart devices such as the flash glucose monitoring (FGM) systems, patients can easily monitor their glucose levels more frequently without any inconvenience. In this study, we evaluate the effect of FreeStyle Libre FGM system on glycemic control, hypoglycemia, health-related quality of life (QoL), and the fear of hypoglycemia (FOH) among children and young people with type 1 diabetes (T1D). DESIGN AND METHODS: A prospective study was conducted at the Diabetes Treatment Center, Prince Sultan Military Medical City, Riyadh, Saudi Arabia, between January 2017 and May 2017 on 47 (aged 13-19 years) registered patients with T1D who used conventional finger-pricking method for self-testing the glucose. At baseline visit, the FGM sensors were placed on each participant by a trained diabetes educator. The data collected from the sensors were computed to generate the respective ambulatory glucose profiles so as to determine the total number of scans conducted during the study period. At the baseline and at 3 months of the experiment, a trained interviewer administered the questionnaire Hypoglycemia Fear Survey-Child Version (HFS-C) and PedsQL 3.0 (QoL questionnaire) to each patient. The age, sex, weight, height, adjusted body mass index, duration of diabetes, treatment modality, and glycosylated hemoglobin A1c (HbA1c) levels of each patient were recorded. RESULTS: As compared with the baseline, a significant improvement was noted in the behavior of FOH (P = .0001), worry (P = .0001), QoL (P = .002), HbA1c level (P = .008), and hypoglycemia (P = .023) at 3 months. Significant improvement was noted in the behavior (P = .0001), worry (P = .0001), QoL (P = .003), HbA1c level (P = .014), and hypoglycemia (P = .001) among the multiple-dose insulin injection-treated patients as compared with baseline. Significant improvement was noted in the behavior (P = .0001), worry (P = .0001), and hypoglycemia (P = .001) among the insulin pump-treated patients as compared with baseline. A positive correlation was recorded in the behavior (r = .47; P < .001), QoL (r = .70; P < .001), and the mean number of FGM scans. A negative correlation was recorded in the worry (r = -.43; P = .002), HbA1c level (r = -.58; P < .001), hypoglycemia (r = -.65; P < .001), and the mean number of FGM scans. CONCLUSIONS: The frequent use of FGM scanning reduced the frequency of hypoglycemia, HbA1c level, and worry and increased the behavior and QoL. As compared with self-testing by the conventional finger-pricking method, the use of FGM increased the frequency of self-testing and thus diabetes control.

Assessment of Hypogonadism in Men With Type 2 Diabetes: A Cross-Sectional Study From Saudi Arabia.

BACKGROUND/OBJECTIVES: A high incidence of hypogonadism in men with type 2 diabetes (T2D) has been globally reported. This study aimed to determining the frequency of hypogonadism and related risk factors among men with T2D in a single-site hospital in Saudi Arabia. DESIGN AND METHODS: A cross-sectional study was performed on 157 men with T2D (between 30 and 70 years of age). Using a prestructured questionnaire, the demographic features of these patients were gathered and their medical records were referred to gather information regarding the duration of the diabetes, smoking habits, and the presence of retinopathy, neuropathy, and nephropathy. Besides these, the biochemical parameters, total testosterone (TT), free testosterone, sex hormone-binding globulin, follicle-stimulating hormone, luteinizing hormone, prolactin, serum lipids, and glycosylated hemoglobin were also recorded. All the patients submitted the fully completed Androgen Deficiency in Aging Male (ADAM) questionnaire. The combination of symptoms (positive ADAM score) plus a TT level ⩽8 nmol/L constituted the condition of hypogonadism. RESULTS: The total frequency of hypogonadism was 22.9% (36/157). Of the 157 total patients, 123 (78.3%) were shown to be ADAM positive, and of these, 90 (73.2%) exhibited decreased libido, 116 (94.3%) had weak erections, and 99 (80.5%) reported more than 3 symptoms of ADAM. Of these hypogonadic patients, 22.2% (n = 8) revealed primary hypogonadism, whereas 77.8% (n = 28) showed secondary hypogonadism. From the univariate analysis conducted, significant relationship was observed between treatment type, body mass index (BMI), and hypogonadism. The regression analysis showed BMI acting an independent risk factor of hypogonadism. CONCLUSIONS: Saudi men with T2D revealed a high incidence of hypogonadism. Body mass index was identified as an independent risk factor for hypogonadism.

Type 2 Diabetes Mellitus in Saudi Arabia: Major Challenges and Possible Solutions.

The World Health Organization has ranked Saudi Arabia as having the second highest rate of diabetes in the Middle East (7th highest in the world) with an estimated population of 7 million living with diabetes and more than 3 million with pre-diabetes. This presents a pressing public health problem. Several challenges in diabetes management need to be tackled in Saudi Arabia, including the growing prevalence (chiefly among children and young adults), micro-and macrovascular complications, lifestyle changes, late diagnosis, poor awareness and high treatment costs. Over the last two decades, the Saudi population saw an increase in the expenses in healthcare and treatment of diabetes by more than 500%. In 2014, the health care budget was 180 billion (Saudi Riyal) of which 17 billion was spent on all Saudis, with an approximate 25 billion on the entire Saudi diabetic population. This implies that the direct expense of diabetes is costing Saudi Arabia around 13.9% of the total health expenditure. Therefore, unless a comprehensive epidemic control program/ multidisciplinary approach is stringently enforced, the diabetes mellitus burden on Saudi Arabia will probably increase to very serious levels. It is crucial to implement improved health and health-related quality of life of to those with diabetes, thus minimizing the social and personal expenses for diabetes care in Saudi Arabia. In this study we discuss the significant and major threats posed by diabetes mellitus to the Saudi population and recommend essential possible solutions to delay/ prevent this formidable issue.