Safety and user experience with off-label use of a flash glucose monitor (FreeStyle Libre® 1) among very young children with type 1 diabetes mellitus.

OBJECTIVES: FreeStyle Libre 1 (FGM) has been approved by the FDA for children older than 4 years. It enables noninvasive glucose monitoring without the need for finger pricking. Parents of very young children often use the device off-label. Thus, we aimed to evaluate the safety of and user experience with FreeStyle Libre® 1 and determine its impact on sleep and glycemic control. METHODS: This was an ambi-directional cohort study. We recruited parents of very young children with type 1 diabetes mellitus (T1DM) who were less than 5 years old when they started using FGM at the King Saud University Diabetes Center. The parents filled out a survey evaluating their experience with the system. In addition, the glucose metrics of the children were also obtained from the Libre View system. RESULTS: We included 31 children with mean age of the children when they started using FGM was 3.88 ± 1.10 years (range, 1.46-5.4 years), and the mean sensor use was 2.3 ± 1.3 years. During the use of the device, the parents had increased sleep duration of 0.71 h (p-value=0.04), had earlier bedtime by 2.8 h (p-value=0.04), and were able to sleep in a separate room from their children. In addition, the time in range improved by 9.9%, the time above range decreased by 8.8%, and the HbA1c level reduced by 1.56%. CONCLUSIONS: The safety profile of FGM used for very young children with T1DM is the same for older children, which leads to improved metabolic control and sleep quality of both the parent and the child.

The long-term growth, cost-effectiveness, and glycemic effects of growth hormone therapy on children born small for gestational age over 10 years: a retrospective cohort study.

OBJECTIVES: We aimed to report our 10-year experience of treating short children born small for gestational age (SGA) by comparing the long-term growth, metabolic safety, and cost-effectiveness of recombinant human growth hormone (rhGH) therapy in short children born SGA with those in rhGH-treated children with growth hormone deficiency (GHD) and Turner syndrome. METHODS: We performed a 10-year retrospective cohort study at King Saud University Medical City. We included children aged 3-16 years who received rhGH for GHD, SGA, or Turner syndrome for >1 year. RESULTS: A total of 166 children received rhGH therapy for GHD, 58 for SGA, and 16 for Turner syndrome. During the last study visit, the average height change was 21 cm for GHD children and 14 cm for children born SGA (p-value <0.001). The height SDS change was 0.84 for GHD children and 0.55 for SGA children (p-value=0.004). The average cost-effectiveness ratios for treating GHD and SGA children were USD 1,717.22 and USD 1,157.19 per centimeter gained, respectively. Moreover, the mean incremental cost-effectiveness ratio for GHD vs. SGA patients was USD 2,820.39 per centimeter gained. Dysglycemia developed in 70 patients: 43 (36.44%), 22 (40.74%), and 5 (13%) in the GHD, SGA, and Turner syndrome groups, respectively. CONCLUSIONS: rhGH is effective in height improvement of short children. However, pursuing rhGH treatment for children born SGA requires a shared decision-making approach to balance the modest benefit of final adult height gain with the long-term metabolic effects, considering the acceptable costs on the Saudi healthcare system.

Estimated Cost-effectiveness of Subcutaneous Insulin Aspart in the Management of Mild Diabetic Ketoacidosis Among Children.

Importance: Intravenous (IV) insulin infusion is the standard of care for treating diabetic ketoacidosis (DKA) worldwide. Subcutaneous (SC) insulin aspart could decrease the use of health care resources. Objective: To compare the cost-effectiveness of mild uncomplicated DKA management with SC insulin aspart vs IV insulin infusion among pediatric patients from the perspective of a public health care payer using clinical data. Design, Setting, and Participants: This economic evaluation included children aged 2 to 14 years presenting to the emergency department of a single academic medical center with mild DKA between January 1, 2015, and March 15, 2020. The medical records for DKA treatment course and its associated hospitalization costs were reviewed. Data were analyzed from January 1, 2015, to March 15, 2020. Exposures: Subcutaneous insulin aspart vs IV regular insulin infusion. Main Outcomes and Measures: The incremental cost-effectiveness ratio (US dollars per hour), duration of DKA treatment, and length of hospital stay. Results: A total of 129 children with mild DKA episodes (mean [SD] age, 9.9 [3.1] years; 72 girls [55.8%]) were enrolled in the study. Seventy children received SC insulin aspart and 59 received IV regular insulin. Overall, the length of hospital stay in the SC insulin group was reduced (mean, 16.9 [95% CI, -31.0 to -2.9] hours) compared with the IV insulin group (P = .005). The mean (SD) cost of hospitalization in the SC insulin group (US $1071.99 [US $523.89]) was less than that in the IV insulin group (US $1648.90 [US $788.03]; P = .001). The incremental cost-effectiveness ratio was -34.08 (95% CI, -25.97 to -129.82) USD/h. The use of SC insulin aspart was associated with a lower likelihood of prolonged hospital stay (ß = -17.22 [95% CI, -32.41 to -2.04]; P = .03) than IV regular insulin when controlling for age and sex. Conclusion and Relevance: Findings of this economic evaluation suggest that SC insulin aspart is dominant vs IV regular insulin in the management of mild uncomplicated DKA in children.

The Arabic Translation and Cross-Cultural Adaptation of the Bristol Activity of Daily Living Scale.

BACKGROUND: There are few Arabic language functional scales for patients with dementia. The Bristol Activity of Daily Living Scale (BADLS) was designed and validated for use in patients with dementia. OBJECTIVE: Our study aimed to translate, cross-culturally adapt, and validate the BADLS to the Arabic language for people with neurocognitive decline and dementia. METHODS: The original BADLS scale was translated to the Arabic language followed by face validity assessment through a pilot testing in five Arabic countries. The Arabic BADLS was assessed in a sample of 139 participants and their caregivers for concurrent and convergent validity. RESULTS: The Arabic BADLS had excellent internal consistency, Cronbach's alpha 0.95 (95% CI 0.93-0.96). Likewise, the Arabic BADLS had strong convergent validity with the Montreal Cognitive Assessment (r = -0.82, p < 0.001). CONCLUSION: The Arabic BADLS is a valid scale that can used to assess the functional performance of people living with dementia.