Effectiveness of sensor-augmented pump therapy in children and adolescents with type 1 diabetes in the STAR 3 study
ABSTRACT Maintenance of appropriate A1C values and minimization of hyperglycemic excursions are difficult for many pediatric patients with type 1 diabetes. Continuous glucose monitoring (CGM) sensor-augmented pump (SAP) therapy is an alternative to multiple daily injection (MDI) therapy in this population.
Sensor-augmented pump therapy for A1C reduction (STAR 3) was a 1-yr trial that included 82 children (aged 7-12) and 74 adolescents (aged 13-18) with A1C values ranging from 7.4 to 9.5% who were randomized to either SAP or MDI therapy. Quarterly A1C values were obtained from all subjects. CGM studies were carried out at baseline, 6 months, and 12 months to quantify glycemic excursions [calculated as area under the glucose concentration-time curve (AUC)] and variability. In the SAP group, sensor compliance was recorded.
Baseline A1C values were similar in subjects randomized to the SAP (8.26 ± 0.55%) and MDI groups (8.30 ± 0.53%). All subsequent A1C values showed significant (p < 0.05) treatment group differences favoring SAP therapy. Compared with the MDI group, subjects in the SAP group were more likely to meet age-specific A1C targets and had lower AUC values for hyperglycemia with no increased risk of hypoglycemia. Glucose variability improved in the SAP group compared to the MDI group. Children wore CGM sensors more often and were more likely to reach age-specific A1C targets than adolescents.
SAP therapy allows both children and adolescents with marginally or inadequately controlled type 1 diabetes to reduce A1C values, hyperglycemic excursions, and glycemic variability in a rapid, sustainable, and safe manner.
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Article: Self-Monitoring of Blood GlucoseInternational journal of clinical practice. Supplement 02/2012; 17(175):2-7. DOI:10.1111/j.1742-1241.2011.02847.x
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ABSTRACT: Background: This study aimed to describe the development and psychometric evaluation of novel youth and parent measures of self-efficacy related to continuous glucose monitoring (CGM) in pediatric patients with type 1 diabetes. This evaluation also assessed the predictive validity of the CGM Self-Efficacy (CGM-SE) surveys on CGM use and hemoglobin A1c (HbA1c) levels. Subjects and Methods: Study participants included 120 youth with type 1 diabetes for ≥1 year enrolled in a 2-year randomized clinical trial comparing CGM use with and without the addition of a family-focused CGM behavioral intervention. Youth and parents completed the CGM-SE surveys at randomization after a 1-week run-in to assess CGM tolerability. Analyses of predictive validity excluded the intervention group and included 61 youth in the control group in order to assess CGM use and HbA1c outcomes 3 and 6 months after randomization. Results: At study entry, youth were 12.7±2.7 years old with a diabetes duration of 6.1±3.6 years and an HbA1c level of 8.0±0.8% (64±9 mmol/mol); blood glucose monitoring frequency was 6.8±2.4 times/day, and 84% received pump therapy. CGM-SE surveys had acceptable internal consistency (Cronbach's α=0.80 for youth and 0.82 for parents). Youth reporting higher baseline CGM self-efficacy (CGM-SE score of >80) had significantly greater CGM use and lower HbA1c level after 3 and 6 months compared with youth reporting lower baseline CGM self-efficacy (CGM-SE score of ≤80). Conclusions: The CGM-SE surveys appear to have strong psychometric properties. CGM self-efficacy may offer an opportunity to assess the likelihood of CGM adherence and glycemic improvement in youth with type 1 diabetes in clinical and research settings.Diabetes Technology & Therapeutics 02/2015; DOI:10.1089/dia.2014.0366 · 2.29 Impact Factor
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ABSTRACT: Continuous glucose monitoring (CGM), while a relatively new technology, has the potential to transform care for children with type 1 diabetes. Some, but not all studies, have shown that CGM can significantly improve hemoglobin A1c levels and reduce time spent in the hypoglycemic range in children, particularly when used as part of sensor-augmented pump (SAP) therapy. Despite the publication of recent clinical practice guidelines suggesting CGM be offered to all children 8 years of age or older who are likely to benefit, and studies showing that younger children can also benefit, this technology is not yet commonly used by children with type 1 diabetes. Effects of CGM are enhanced when used on a near-daily basis (a use-dependent effect) and with insulin pump therapy. Therefore, coordinated strategies are needed to help children and their families initiate and continue to use this resource for diabetes care. This review introduces CGM to pediatric endocrinologists who are not yet familiar with the finer details of this technology, summarizes current data showing the benefits and limitations of CGM use in children, reviews specific case examples demonstrating when CGM can be helpful, and shows the value of both retrospective and real-time CGM. It is hoped that this information leads to discussion of this technology in pediatric endocrinology clinics as an important next step in improving the care of children with type 1 diabetes.International Journal of Pediatric Endocrinology 03/2013; 2013(1):8. DOI:10.1186/1687-9856-2013-8