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CGM-Based Real-World Data on the Transition from Glargine U100 to U300 in Children and Adolescents with Type 1
1Pediatric Endocrinology, Kocaeli University Medical Faculty, Kocaeli, Türkiye.
Insights
Switching from glargine U100 to glargine U300 in children with Type 1 diabetes (T1D) reduced hypoglycemia and glycemic variability. Continuous glucose monitoring (CGM) data showed glargine U300 improved safety without compromising glucose control.
Area of Science:
- Endocrinology
- Pediatric Diabetes Management
- Pharmacological Research
Background:
- Type 1 diabetes (T1D) management in pediatric populations requires careful insulin selection.
- Long-acting basal insulins like glargine U100 are commonly used but may have limitations in glycemic control and safety.
- Continuous glucose monitoring (CGM) provides valuable real-world data for assessing insulin efficacy and safety.
Purpose of the Study:
- To compare continuous glucose monitoring (CGM) parameters in children and adolescents with Type 1 diabetes (T1D) after transitioning from glargine U100 to glargine U300.
- To evaluate the efficacy and safety of glargine U300 compared to glargine U100 in a pediatric T1D cohort.
- To assess the impact of the insulin switch on glycemic variability, hypoglycemia, and time in range.
Main Methods:
- A cohort of 52 children and adolescents (6-18 years) with T1D using CGM were analyzed.
- CGM data were collected for two 2-week periods: one before and one after switching from glargine U100 to glargine U300 at the same dose.
- Dose adjustments for glargine U300 were made every three days based on CGM data. Nighttime glycemic variability was assessed using coefficient of variation (CV) and root mean squared error (RMSE).
Main Results:
- No significant differences were found in glucose management indicator (GMI) or time in range (TIR) between glargine U100 and glargine U300.
- Glargine U300 was associated with significantly reduced frequency and duration of hypoglycemia during both 24-hour and nighttime periods.
- Reduced nighttime glycemic variability was observed with glargine U300, indicated by lower CV and RMSE values. An average 10% increase in basal insulin dose was required post-transition.
Conclusions:
- Glargine U300 offers a safer profile for pediatric T1D management, primarily by reducing hypoglycemia.
- The transition to glargine U300 demonstrated improved glycemic stability, particularly during nocturnal hours.
- CGM-based real-world evidence supports glargine U300 as a beneficial option for enhancing safety and stability in pediatric diabetes care.
Abstract:
This study aimed to compare continuous glucose monitoring (CGM) parameters in children and adolescents with Type 1 diabetes (T1D) who transitioned from glargine U100 to glargine U300 to evaluate efficacy and safety. A total of 52 participants aged 6-18 years using CGM were analyzed before and after transitioning from glargine U100 to glargine U300. For each individual, a 2-week CGM data collection was conducted after optimizing the glargine U100 dose. Participants then switched to glargine U300 at the same dose, with doses adjusted based on CGM graphs every three days. One week after the final dose adjustment, a second 2-week CGM period was recorded. Additionally, nighttime (00:00-08:00 h) data were analyzed, with glucose fluctuations measured by coefficient of variation (CV) and root mean squared error (RMSE). All parameters were compared between glargine U100 and U300. No significant differences were observed in glucose management indicator (GMI) or time in range (TIR) between glargine U100 and U300. However, glargine U300 was associated with significantly reduced hypoglycemia frequency and duration across 24-hour and nocturnal periods. Lower CV and RMSE values during nighttime further indicated reduced glycemic variability with glargine U300. An average 10% increase in basal insulin dose was required following the transition. The study provides real-world, CGM-based evidence suggesting that glargine U300 offers a safer, more stable option for managing T1D in children, particularly in reducing hypoglycemia. These findings highlight glargine U300's potential advantages in glycemic stability, supporting its use in pediatric diabetes care.
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