Technology for the Management of Type 1 Diabetes Mellitus in Saudi Arabia and MENA Region: A Systematic Review.

BACKGROUND: Diabetes technology in the form of digital health or medical devices holds a promise for improving the quality of life and glycemic outcomes. A comprehensive insight into diabetes technology and its impact in Saudi Arabia and the MENA region may improve type 1 diabetes mellitus (T1DM) management. OBJECTIVE: This study aimed to assess the impact of different DM-specific technologies: insulin pump therapy, continuous glucose monitoring (CGM), and automated insulin delivery system in terms of glycemic control and QoL among T1DM patients in Saudi Arabia and the MENA region. METHOD: A systematic literature search was performed in PubMed and Scopus from 2005 until August 2023. The search was based on the PICO strategy, focusing on T1DM patients, diabetes technology, and QoL. The inclusion criteria were studies illustrating the effect of diabetes technologies on glycemic control or quality of life or both among T1DM patients. Systematic reviews, books, letters, or studies, including type 2 diabetes mellitus, were excluded. RESULTS: From 101 articles, eighteen studies were duplicated, and thirty-three studies were excluded after reading the title and abstract. Of the 50 articles analyzed, twenty-five articles did not meet the inclusion criteria. Therefore, 25 articles involving a total of 3088 participants were enrolled in the study. It was shown that a continuous glucose monitoring system and continuous subcutaneous insulin infusion improved the glycemic control and the QoL of T1DM patients. CONCLUSION: There was a positive impact of insulin pumps, continuous glucose monitoring (CGM) systems, and telemedicine in achieving optimal glucose control and better QoL. Further studies are recommended to clarify the significant role of advanced diabetes technologies.

Glycemic Control in Patients with Type 1 Diabetes: Comparison of Holidays versus Schooldays.

BACKGROUND AND AIMS: To examine the influence of school life in children and adolescents with type 1 diabetes (T1D) by comparing the glycemic control and Ambulatory Glucose Profile (AGP) between the holidays and schooldays. METHODS: This is a retrospective study conducted on 147 patients with T1D (14-19 years) who used an intermittently scanned Continuous Glucose Monitoring (isCGM) system to self-test their glucose levels during the periods of school time and holiday time. A record was maintained of the Continuous Glucose Monitoring (CGM) metrics i.e., Glucose Variability (GV) (%), mean Time in Range (TIR), Time above Range (TAR), Time below Range (TBR), and average time period of the hypoglycemic events during schooldays and the holidays. RESULTS: The study revealed differences between the recorded values during the holidays and schooldays, in % in target 70-180 mg/dL (38.2 vs 49.5; p = 0.039), mean glucose (194 vs 185; p = 0.048), frequency of low glucose events (9.2 vs 5.1; p = 0.036), mean duration of low glucose levels (117 vs 65; p = 0.021), % TBR below 70 mg/dL (2.9 vs 1.45; p = 0.023), % TBR below 54 mg/dL (1.1 vs 0.51; p = 0.031), TAR 181-250 mg/dL (21.1 vs 16.5; p = 0.037) and TAR >250 mg/dL (8.9 vs 6.5; p=0.043). On comparing the HbA1c levels of the study population recorded during the holidays (8.34%) with those recorded during the schooldays (8.13%), the HbA1c values during the school days were observed to be lower; however, no significant changes were noted in the HbA1c level between the holidays and schooldays. Concerning the FreeStyle Libre (FSL) scanning, the frequency during the holidays (n=6.2) was significantly lower than during the schooldays (n=9.5) (p=0.042). CONCLUSION: From the findings, it appears that children with T1D have good diabetes control during schooldays rather than during the holidays. To improve their glucose control during the holidays, these patients may also benefit from receiving greater attention and guidance.

Metabolic control, adherence to the gluten-free diet and quality of life among patients with type 1 diabetes and celiac disease.

AIMS: In this cross-sectional study, we aimed to evaluate metabolic control, adherence to a gluten-free diet (GFD), and quality of life (QoL) in individuals with type 1 diabetes (T1D) and celiac disease (CD). METHODS: We targeted individuals with T1D and CD at a major tertiary hospital in Saudi Arabia. We gathered retrospective data from medical records and prospectively assessed glycemic control using HbA1c and ambulatory glucose metrics, adherence to a GFD using the Celiac Dietary Adherence Test (CDAT), and QoL using the Celiac Disease Quality of Life survey (CD-QoL). RESULTS: Forty-eight out of 1095 patients screened (4.38%) were included. Mean age and HbA1c were 21.3 (± 6.6) and 8.3% (± 0.8%). The average time in range% and above range% were 38.5 (range 24-68) and 29.6 (± 7.4). The median hypoglycemic events/month was 8, with a median duration of 80 min. The median overall CDAT and CD-QoL scores were 20.5 and 54. No significant correlations were observed between glucose management indicator (GMI), % in target, and CDAT/CD-QoL scores (all p > 0.05). CONCLUSIONS: No significant effect of GFD on QoL or glycemic control was observed. Further prospective studies are warranted to establish solid evidence of the impact of GFD on individuals with T1D and CD.

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.

Use of Flash Glucose Monitoring and Glycemic Control in Patients with Type 2 Diabetes Mellitus Not Treated with an Intensive Insulin Regimen: 1-Year Real-Life Retrospective Cohort Study.

INTRODUCTION: Estimation of laboratory-derived glycated hemoglobin (HbA1c) cannot be individually used to monitor clinically significant trends in glucose variability. Hence, clinicians advise use of continuous glucose monitoring (CGM) devices such as the Freestyle Libre™ flash glucose monitoring system (FLASH) to optimize glycemic control by estimating glucose monitoring index (GMI) values, which convert mean glucose into an estimate of simultaneously measured laboratory HbA1c. This study aimed to investigate the sustainability of intermittently scanned continuous glucose monitoring (isCGM) in patients with type 2 diabetes mellitus (T2DM) not on intensive insulin regimen, and correlations between GMI values obtained from isCGM and laboratory-derived HbA1c values. METHODS: A retrospective review of 93 patients with T2DM not on intensive insulin regimen, using FLASH device, was conducted at a major tertiary hospital in Saudi Arabia, over 1 year of continuous device use. To determine the sustainability of isCGM, various glycemic markers such as average glucose and time in range were evaluated. Paired t test or Wilcoxon signed-rank test was used to assess differences in markers of glycemic control, and Pearson's correlation was used to determine correlations between HbA1c and GMI values. RESULTS: Descriptive analysis shows the mean HbA1c value significantly decreased following continued use of isCGM. Pre-isCGM mean HbA1c value of 8.3% improved to 8.1% (p < 0.001) and 7.9% (p < 0.001) in the first 90 and last 90 days of device use, respectively. For both 90-day time periods, correlation analysis revealed a statistically significant positive correlation and linear regression between laboratory-derived HbA1c and GMI values (first 90 days r = 0.7999, p < 0.001; last 90 days r = 0.6651, p < 0.001). CONCLUSION: Continuous use of isCGM demonstrated reductions in HbA1c levels for patients with T2DM not on an intensive insulin regimen. The GMI values showed high levels of agreement with measured HbA1c, indicating their accuracy in glucose management.

Comparison of Point-of-Care and Laboratory Glycated Hemoglobin A1c and Its Relationship to Time-in-Range and Glucose Variability: A Real-World Study.

Introduction The main objective of the current study was to perform a comparison of point-of-care testing for hemoglobin A1c (POCT-HbA1c) versus the standard laboratory method (Lab HbA1c) and their relationship to time-in-range (TIR) and glucose variability (GV) among patients with diabetes mellitus (DM) presented to the outpatient diabetes clinics. Methods This single-center cross-sectional study was carried out on diabetic patients (aged ≥14 years of both genders) who undergo routine follow-up at our institution and whose physicians ordered HbA1c analysis for routine care. The included patients were those using the intermittently scanned continuous glucose monitoring (isCGM) Abbott's FreeStyle Libre system for at least three months and regular CGM users with at least 70% use. Results We included 97 diabetic patients (41 female and 56 male), with a median age of 25 years (Interquartile range= 18) and a mean DM duration of 10.33±5.48 years. The mean values of Lab-HbA1c and POCT HbA1c were 8.82%±0.85% and 8.53%±0.89%, respectively. The TIR, time below range, and time above range were 33.47±14.38 minutes (47.78%±14.32%), 5.44±2.58 minutes (8.41%±4.42%), and 28.8±8.27 minutes (43.81%±13.22%), respectively. According to the Bland-Altman plot analysis, the POCT-HbA1c values are consistent with the standard Lab-HbA1c values (SD of bias= 0.55, and 95% CI= -0.78 to 1.4). The univariate linear regression analysis showed a statistically significant relationship between laboratory HbA1c and POCT HbA1c (R2= 0.637, p <0.001), TIR (R2= 0.406, p <0.001), and GV (R2= 0.048, p= 0.032). After adjusting for age, gender, disease duration, diabetes type, and percentage of sensor data in a multivariable linear regression model, the linear associations remained significant (all p < 0.05). Conclusion The current findings show that TIR and GV can be used as endpoints and valuable parameters for the therapy of DM.

Flash Glucose Monitoring System facilitates sustainable improvements in glycemic control in patients with type 1 diabetes: A 12-month follow-up study in real life.

BACKGROUND AND AIMS: Examine the glycemic control on Type 1 Diabetes (T1D) wearing the Flash Glucose Monitoring (FGM) system for a one-year period of time. METHODS: This prospective study done using 187 patients with T1D (14-40yrs) who self-tested their glucose levels by FGM. 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 at the 3, 6, and 12 month time periods. RESULTS: At 6th, 9th and 12th months, for values of GV, % in target, TAR and %>250 mg/dL, no significant changes (p > 0.05) were noted compared to 3 months. However, significant changes from the baseline were evident for the values of the mean glucose level at the 3rd (p = 0.028), 9th (p = 0.048) and 12th months (p = 0.022). When the mean glucose value at 3 months was compared to the same at 6, 9, and 12 month period, no significant changes (p > 0.05) were seen. When compared with baseline values, low glucose events at 3 months (p = 0.028), 6 months (p = 0.048), 9 months (p = 0.022) and 12 months (p = 0.038) showed significant changes. However, the percentage below 70 mg/dL (barring the value at 12 months, p = 0.046), no significant changes were observed. The HbA1c revealed significant drop in 3, 6, 9 and 12 months compared to baseline values. CONCLUSION: Significant improvement was noted in CGM metrics when patients switched from conventional finger pricking method over to FGM system, and the effect was observed during the entire study period.

Evaluation of Patient Reported Satisfaction and Clinical Efficacy of Insulin Glargine 300 U/mL Versus 100 U/mL in Patients With Type 1 Diabetes Using Flash Glucose Monitoring System.

Background and Aims: To analyze patient-reported satisfaction and clinical effectiveness of concentrated insulin glargine 300 U/mL (Gla-300) among patients with type 1 diabetes (T1D) using a flash glucose monitoring (FGM) system. Methods: This comparative study was conducted among 86 patients with T1D (aged 14-40 years), who were treated with Glargine 100 U/mL (Gla-100) and switched to Gla-300 at day 1 (baseline). The following data were collected from each patient: demographic information, clinical parameters, and glycemic control markers. All patients completed the Diabetes Treatment Satisfaction Questionnaire (Arabic version), first at baseline and then after 12 weeks. A comparison was done for all the data recorded at baseline (on Gla-100) and after 12 weeks (on Gla-300) and subjected to analysis. Results: Compared to patients treated with Gla-100, significant improvements were observed in the Gla-300 group, in terms of the ambulatory glucose profile (AGP) markers, such as percentage of time spent within the target range of the glucose levels (70-180 mg/dL) (P = .037), percentage which fell below the target (<70 mg/dL) (P = .027), and percentage of time spent (<54 mg/dL) (P = .043). Compared to Gla-100, patients treated with Gla-300 experienced significant improvements in the current treatment satisfactions (P = .047), convenient finding treatment recently (P = .034), and flexible finding treatment recently (P = .041), recommend the current treatment (P = .042) and satisfied to continue the current treatment (P = .035). Conclusion: Compared to the patients on Gla-100, patients treated with Gla-300 exhibited significant improvements in the AGP markers and degree of treatment satisfaction.

Evaluating the impact of Ramadan fasting on ambulatory glucose profile among patients with type 1 diabetes using Flash Glucose Monitoring System: A comparative study.

BACKGROUND AND AIMS: Evaluating the impact of Ramadan fasting on Ambulatory Glucose Profile (AGP) among Patients with Type 1 Diabetes (T1D) using Flash Glucose Monitoring (FGM) System. METHODS: The present study is a comparative study, performed using 87 patients with T1D, whose health status permitted them to fast, based on the risk stratification adopted by Diabetes and Ramadan (DAR Guidelines). Besides the demographic data, other data connected with the glycemic profile such as the mean Time in Range (TIR), mean Time Above Range (TAR), mean Time Below Range (TBR), mean glucose level, hemoglobin A1c (HbA1c), Glucose Variability (GV), and Glucose Monitoring Indicator (GMI %), were recorded at three specific periods, namely, pre- (prior to), during and post Ramadan. RESULTS: The mean age of the study population was 21.3 ± 8.2 years, and 52.9% of this population was female. Compared to the pre-Ramadan data, no significant alterations (p > 0.05) were noted in terms of the low glucose events, percentage of glucose level below 70 mg/dL, the average duration of hypoglycemic events, and percentage of glucose level below 54 mg/dL, from the values observed during and post-Ramadan. In comparison with the pre-Ramadan data, no significant changes appeared (p > 0.05) concerning the GV, average glucose, GMI, percentage within target, TAR (181-250 mg/dL), and percentage >250 mg/dL), for the periods during and post-Ramadan, except scanning of FreeStyle Libre (p = 0.042) during Ramadan month compared to pre-Ramadan. CONCLUSION: Fasting during Ramadan was achievable in patients with T1D who received adequate counseling and support.

Evaluation of Patient Satisfaction and Clinical Efficacy of Using Blood Glucose Meters Featuring Color-Coded Indicators in Patients With Type 1 Diabetes: An Observational Hospital-Based Study.

Introduction Because of the difficulties in interpreting the level of blood glucose using the traditional numeric glucometers, the blood glucose meters featuring color-coded range indicators (CRI) offered a simple way to understand and interpret blood glucose readings. Therefore, this study aimed to assess glucose monitoring satisfaction (GMS) and clinical efficacy of blood glucose meters featuring color-coded in patients with Type 1 Diabetes (T1DM) in Saudi Arabia. Methods T1DM patients who switched to color-coded Medisafe Fit Smile glucometer were included in this study. Demographic data, clinical characteristics, glycemic parameters were collected. A trained interviewer collected the GMS survey at baseline and 12 weeks. At the end of the study, patient-reported satisfaction with the Medisafe Fit Smile color-coded features (MSCF) survey was collected.  Results This study included 62 T1DM patients with a mean age of 17.8 (±3.1), and the majority had three or more confirmed hypoglycemic episodes per month. Compared to baseline data, we showed a significant improvement in the mean hemoglobin A1C level (8.43 [±1.2] versus 8.36 [±1.1], p<0.001), with a significantly lower frequency of hypoglycemic episodes (2.74 [±1.1] versus 2.0 [±0.78], p<0.001) after 12 weeks of using glucometer featuring CRI. Most importantly, significant improvements in the GMS survey subdomains of openness (p<0.001), emotional burden (p<0.001), behavioral burden (p<0.001), but not trust (p=0.71) were detected at the end of the study with a significantly higher total GMS survey of 4.33 (±0.13) after using blood glucose meters featuring CRI compared to the lower score of 2.84 (±0.22) at baseline (p<0.001). Furthermore, patient satisfaction with the MSCF survey revealed evidence of satisfaction among the TIDM patients at the end of the study. Conclusion The current study confirmed that individuals with T1DM may benefit from blood glucose meters featuring CRI device exposure. Also, using a glucometer featuring CRI was associated with a high level of satisfaction with blood glucose measures and significant improvement in the glycemic parameters. However, definitely, further studies are needed to confirm whether the long-term use of the CRI-based blood glucose meters will produce improved results in the GMS survey.

Level of Agreement and Correlation Between the Estimated Hemoglobin A1c Results Derived by Continuous or Conventional Glucose Monitoring Systems Compared with the Point-of-Care or Laboratory-Based Measurements: An Observational Study.

INTRODUCTION: Hemoglobin A1C (HbA1c) is an important marker for diabetes care management. With the increasing use of new technologies such as continuous glucose monitoring (CGM) and point-of-care testing (POCT), patients and their physicians have been able to monitor and continuously check their blood glucose levels in an efficient and timely manner. This study aimed to investigate the level of agreement between the standard laboratory test for HbA1c (Lab-HbA1c) with point-of-care testing (POCT-HbA1c) and glucose monitoring index (GMI) derived by intermittently scanned CGM (isCGM) or estimated average glucose (eAG) derived by conventional self-monitored blood glucose (SMBG) devices. METHODS: A cross-sectional study was conducted at the Diabetes Treatment Center, Prince Sultan Military Medical City, Saudi Arabia, between May and December 2020 with 81 patients with diabetes who used the isCGM system (n = 30) or conventional finger-pricking SMBG system (n = 51). At the same visit, venous and capillary blood samples were taken for routine HbA1c analysis by the standard laboratory and POCT methods, respectively. Also, for isCGM users, the GMI data for 28 days (GMI-28) and 90 days (GMI-90) were obtained, while for SMBG users, eAG data for 30 days (eAG-30) and 90 days (eAG-90) were calculated. The limits of agreement in different HbA1c measurements were evaluated using a Bland-Altman analysis. Pearson correlation and multivariate linear regression analyses were also performed. RESULTS: Based on the Bland-Altman analysis, HbA1c levels for 96.7% and 96.1% of the patients analyzed by the POCT and the standard laboratory methods were within the range of the 95% limit of agreement in both isCGM and conventional SMBG users, respectively. About 93.3% of the GMI measurements were within the 95% limit of agreement. Also, about 94.12% of the eAG-30 and 90.2% of the eAG-90 measurements were within the 95% limit of agreement. Moreover, the correlation analysis revealed a statistically significant positive correlation and linear regression among Lab-HbA1c, POCT-HbA1c, GMI, and eAG in both conventional SMBG and isCGM users (all p < 0.001). These positive results persisted significantly after adjusting for different factors (all p < 0.001). CONCLUSION: GMI derived by isCGM or eAG derived by conventional SMBG systems, as well as the POCT-HbA1c measurements, showed a high level of agreement; therefore, we recommend them as potential methods for diabetes monitoring, especially when a rapid result is needed or with patients with uncontrolled diabetes or on intensive insulin therapy.

Evaluation of Patient-Reported Satisfaction and Clinical Efficacy of Once-Weekly Semaglutide in Patients with Type 2 Diabetes: An Ambispective Study.

INTRODUCTION: The method of therapy administration and injection device characteristics have been documented to influence perceptions and preference of treatment among patients with type 2 diabetes (T2D). We aimed to assess the metabolic effectiveness and patient-reported satisfaction of once-weekly semaglutide compared to liraglutide in suboptimally controlled patients with T2D. METHODS: We conducted this single-center cohort study at diabetes center clinics at a tertiary care hospital between February 2021 and August 2021. We included suboptimally controlled patients with T2D who had been treated with liraglutide for at least 3 months at baseline, then shifted to once-weekly semaglutide and followed up for the same period. Ambulatory glucose profile (AGP) metrics [i.e., mean glucose level, glycemic variability (GV), time above range (TAR), and time in range (TIR)] for baseline and follow-up were compared. To assess the satisfaction with shifting, we used the valid Arabic version of the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change (DTSQc) while the injection device preference was assessed using the Diabetes Injection Device Preference Questionnaire (DID-PQ). RESULTS: We included 52 patients (25 male and 27 female), with a mean age of 48 (± 6) years and a mean diabetes mellitus duration of 7.27 (± 3.79) years. We observed a significantly decreased mean HbA1c level following semaglutide treatment (7.79% at study end vs. 8.07% at baseline, p < 0.001) and body weight (84.64 ± 7.68 vs. 87.15 ± 8.011, p < 0.001). Compared to the glucometrics data at baseline, we observed a significantly improved mean average glucose, GV, TAR, and TIR (p < 0.001). Data from the DTSQs and DTSQc questionnaires showed a high level of patient-reported satisfaction after shifting to semaglutide treatment. All patients preferred/strongly preferred once-weekly semaglutide over liraglutide in most DID-PQ questionnaire domains. CONCLUSIONS: Switching from once-daily liraglutide to once-weekly semaglutide led to improvements in both clinical measures of glycemic control and patient-reported satisfaction.

Effectiveness of the freestyle libre 2 flash glucose monitoring system on diabetes-self-management practices and glycemic parameters among patients with type 1 diabetes using insulin pump.

AIMS: To determine the effectiveness of Freestyle Libre 2 (FSL2) on diabetes-self-management (DSM) practices and glycemic parameters among patients with type 1 diabetes (T1D) using insulin pump. METHODS: This prospective study was performed among 47 patients with T1D (13-21yrs) who self-tested their glucose levels by the conventional finger-prick method using blood glucose meters (BGM). Data related to glycemic profile i.e., mean time in range (TIR), mean time above range (TAR) mean time below range (TBR), mean glucose level, hemoglobin A1c (HbA1c), total daily dose of insulin (TDDI), frequency of glucose monitoring and DSM responses were collected at baseline and 12 weeks. RESULTS: The mean TIR was 59.8 ± 12.6%, TAR 32.7 ± 11.6%, TBR 7.5 ± 4.3%, mean glycemic variability, standard deviation 63.2 ± 12.5 mg/dL, and the coefficient of variation 41.3 ± 11.4% at 12 weeks. At baseline, the HbA1c level was 8.3%, and at 12 weeks, it dropped to 7.9% (p = 0.064). Baseline glucose monitoring frequency through BGM was 2.4/day; however, after the patients employed the FSL2, a higher degree of frequency of glucose monitoring was evident at 12 weeks as 8.2/day (p < 0.001). Significant improvements were observed in all the DSM subscales at 12 weeks. CONCLUSION: Using FSL2 was found to raise the patients' DSM levels and improved metabolic control.

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.

The Impact of Flash Glucose Monitoring on Markers of Glycaemic Control and Patient Satisfaction in Type 2 Diabetes.

INTRODUCTION: The effect of flash glucose monitoring on glycaemic control and patient satisfaction in insulin-treated type 2 diabetes (T2D) from Saudi Arabia is uncertain. The aim of this prospective observational study was to evaluate the change in HbA1c (Hemoglobin A1c) and satisfaction with treatment following the initiation of flash glucose monitoring. METHODS: This single-arm, single-centre prospective observational study included flash glucose monitoring-naive adult patients with T2D managed with multiple daily injections of insulin therapy (MDI) and HbA1c ≥7%. HbA1c was measured, and the Diabetes Treatment Satisfaction Questionnaire (DTSQ, Arabic version) and Glucose Monitoring Satisfaction Survey (GMSS) were completed at baseline and 12 weeks. RESULTS: For participants (n=54) from one diabetes centre, HbA1c significantly improved by 0.44% from 8.22%±0.69 (mean±SD) at baseline to 7.78%±0.71 at 12 weeks, p<0.001. Confirmed hypoglycaemic episodes reduced from 4.43±1.51 episodes/month to 1.24±1.15 (-3.19, p<0.001). Glucose monitoring frequency improved, indicated by the number of scans per day, with a mean increase of 5.13 (p <0.001) tests/day. GMSS scores improved across all four categories, as did overall treatment satisfaction (p<0.001 for all categories). Patients perceived clear improvements across all questions relating to satisfaction and frequency of hypo- or hyperglycaemic episodes. CONCLUSION: Following initiation of flash glucose monitoring in patients with T2D and MDI insulin therapy, HbA1c improved with reduced hypoglycaemic events and increased patient-reported satisfaction. This study contributes valuable data on the use of flash glucose monitoring in this population, and a larger multicentre study is warranted to inform future health policy for T2D in Saudi Arabia.

Frequency of Diabetic Ketoacidosis in Patients with Type 1 Diabetes Using FreeStyle Libre: A Retrospective Chart Review.

INTRODUCTION: Diabetic ketoacidosis (DKA) is an acute complication associated with poorly managed or undiagnosed diabetes. DKA is associated with significant morbidity, mortality, and healthcare costs, but can be prevented with appropriate management of diabetes. The FreeStyle Libre is flash glucose monitoring device that measures glucose levels in the interstitial subcutaneous tissue and has been shown to reduce HbA1c, time in hypoglycemia and hyperglycemia, as well as improve health-related quality of life. METHODS: A retrospective chart review of patients with type 1 diabetes mellitus (T1DM) and recurrent DKA and who initiated FreeStyle Libre (Abbott Diabetes Care, Alameda, CA, USA) was conducted. DKA frequency and severity, glycated hemoglobin (HbA1c), and frequency of blood glucose monitoring were compared between the 2-year period before FreeStyle Libre initiation and the 2-year period after FreeStyle Libre initiation. RESULTS: A total of 47 patients with T1DM with recurrent DKA were included. FreeStyle Libre was associated with a reduction in the frequency of DKA events, with a mean of 0.2 (standard deviation [SD] 0.4) events per person during the 2 years after FreeStyle Libre initiation versus 2.9 (SD 0.9) during the 2 years before FreeStyle Libre initiation. Severity of DKA events was also reduced, with fewer severe (before mean 0.3 [SD 0.5] versus after 0.0 [SD 0.0]; p < 0.001) DKA events. A reduction in HbA1c (mean 7.4% [SD 0.5] after versus 9.9% [SD 1.2] before [p < 0.001]) and an increase in frequency of blood glucose testing (mean 8.1 scans/day [SD 1.7] after versus 2.2 finger-pricks/day [SD 0.7] at before [p < 0.001]) were also observed. CONCLUSION: FreeStyle Libre is associated with a reduction in the frequency and severity of DKA events, reduction in HbA1c, and increase in frequency of blood glucose testing in patients with T1DM and recurrent DKA. The use of such a glucose monitoring tool can help to reduce the burden of morbidity, mortality, and healthcare costs associated with complications of diabetes.

Efficacy of i-Port Advance system on patients satisfaction and glycemic control among patients with type 1 diabetes in Saudi Arabia.

BACKGROUND AND AIMS: To determine the efficacy of i-Port Advance system on patients satisfaction and glycemic control among patients with type 1 diabetes (T1D). METHODS: This prospective study was performed among 73 patients with T1D (13-29 years) at Prince Sultan Military Medical City, Riyadh, Saudi Arabia. Demographic data were collected at baseline and clinical characteristics were collected at baseline and 12 weeks. Patients' responses to Morisky Medication Adherence Scale (MMAS-8) and Insulin Delivery Satisfaction Survey (IDSS) were recorded at baseline and 12 weeks after initiating the i-Port Advance system. RESULTS: At 12 weeks, significant improvement was evident in the IDSS subscales, which comprises the IDSS effective (p = 0.048), burdensome (p = 0.032), and IDSS inconvenient (p = 0.001), with the total baseline IDSS score being 2.6 ± 0.42, and at 12 weeks being 3.7 ± 0.72 (p = 0.037). The MMAS total score at baseline was 4.6 ± 1.2, and at 12 weeks, it increased to 6.4 (p = 0.028). HbA1c level was 8.4% at baseline and decreased to 7.9% (p = 0.001) at 12 weeks. The total daily dose of insulin at baseline registered 0.9 ± 0.13, which declined to 0.8 ± 0.12 (p = 0.048) at 12 weeks. Fasting blood sugar value was 197 ± 23.4 at baseline, which dropped to 182 ± 24.5 at 12 weeks (p = 0.01); and the postprandial glucose at baseline was 195 ± 21.4 and declined to 177 ± 19.2 at 12 weeks (p = 0.01). The hypoglycemic episodes revealed a noteworthy reduction after the i-Port Advance system usage. CONCLUSION: Use of i-Port Advance system was found to raise the patients' satisfaction levels and lower both the hypoglycemic episodes as well as the HbA1c levels.

Patient-Reported Preference and Clinical Efficacy of Insulin Pen Devices With Safety Needles in Adolescents and Young Adults With Type 1 Diabetes: A Prospective Study.

Purpose Current evidence indicates that diabetic patients' preference and medication adherence can be affected by the type of insulin pen needles. We aimed to assess the impact of insulin pen devices with safety needles (SPN) on the usability, behavioral, lifestyle, and emotional aspects of type 1 diabetes mellitus (T1DM) in adolescents and young adults. Patients and methods We conducted a prospective single-center study on adolescent T1DM patients treated with multiple insulin doses using basal-bolus therapy for at least one year. Patients were followed for 12 weeks to compare the changes in the baseline usability and insulin fear of self-injection scales between SPN and conventional needles. Results In this 12-week study, we included 72 participants with a mean age of 15.5 ± 1.3 years. The mean disease duration was 5.1 ± 2.2 years. At 12 weeks, substantial improvement was evident in the SPN group, compared to the conventional group, in terms of the overall satisfaction score with a mean difference (MD) of 4.1 ± 1.9 (p < 0.01). Participants in the SPN group reported significant reduction in all aspect of fear from self-injection, such as being restless (MD = -1.4 ± 0.9), tense (MD = -1.8 ± 0.9), afraid (MD = -1.9 ± 0.9), worried (MD = -1.9 ± 0.9), nervous (MD = -1.7 ± 0.9), and brood using the SPN needles (MD = -1.6 ± 0.9), as compared to the conventional needles group. The glycemic control parameters, as determined by HbA1c and fasting blood glucose, exhibited significant improvements in the SPN group compared to the conventional group (p < 0.05). Conclusion SPN significantly improved usability, glycemic parameters, and reduced the fear of insulin self-injections amongst T1DM patients compared to conventional pen therapy.

Impact of the FreeStyle Libre flash glucose monitoring system on diabetes- self-management practices and glycemic control among patients with type 2 diabetes in Saudi Arabia: A prospective study.

BACKGROUND AND AIMS: To examine the efficacy of FreeStyle Libre Flash Glucose Monitoring System (FGMS) on Diabetes Self-Management Practices (DSMP) and glycemic control among patients with type 2 diabetes (T2D). METHODS: This prospective study was conducted among 105 patients with T2D (aged 30-70 years), who self-tested their glucose levels by conventional finger-prick method using blood glucose meters (BGM). At baseline visit, FGMS sensors were fixed by a diabetes educator to all patients. At the baseline and at 12 weeks of the study, an interviewer collected the responses of Diabetes Self-Management (DSM) from all the study population using a questionnaire. RESULTS: At 12 weeks, significant improvements in the DSM subscales were observed, which includes glucose management (P = 0.042), dietary control (P = 0.048), physical activity (P = 0.043), health care use (P = 0.001) and self-care (P = 0.001), compared to the values at baseline. At baseline, when the HbA1c level was 8.2%, at 12 weeks, it dropped to 7.9%. Also, at baseline, when the hypoglycemia frequency was 3.1, it declined to 1.2 episodes/month at 12 weeks. While comparing the blood glucose monitoring through BGM at the baseline (1.92/day), a higher degree of frequency of blood glucose monitoring was evident at 12 weeks (6.84/day), after the patients employed the FreeStyle Libre. CONCLUSION: After 12 weeks of using the FreeStyle Libre, the frequency of hypoglycemic episodes and the HbA1c levels were dropped, while the practice of DSM and frequency of blood glucose monitoring were improved.