2.2.0.0 Insulin Pumps
Recommendations
7.3 Individuals with diabetes who have been successfully using continuous subcutaneous insulin infusion should have continued access across third-party payers. E
7.4 Most adults, children, and adolescents with type 1 diabetes should be treated with intensive insulin therapy with either multiple daily injections or an insulin pump. A
7.5 Insulin pump therapy may be considered as an option for all children and adolescents, especially in children under 7 years of age. C
Continuous subcutaneous insulin injection (CSII) or insulin pumps have been available in the U.S. for 40 years. These devices deliver rapid-acting insulin throughout the day to help manage blood glucose levels. Most insulin pumps use tubing to deliver insulin through a cannula, while a few attach directly to the skin, without tubing.
Most studies comparing multiple daily injections (MDI) with CSII have been relatively small and of short duration. However, a recent systematic review and meta-analysis concluded that pump therapy has modest advantages for lowering A1C (–0.30% 95% CI -0.58 to -0.02]) and for reducing severe hypoglycemia rates in children and adults (8). There is no consensus to guide choosing which form of insulin administration is best for a given patient, and research to guide this decision making is needed (9). Thus, the choice of MDI or an insulin pump is often based upon the individual characteristics of the patient and which is most likely to benefit him or her. Newer systems, such as sensor-augmented pumps and automatic insulin delivery systems, are discussed elsewhere in this section.
Adoption of pump therapy in the U.S. shows geographical variations, which may be related to provider preference or center characteristics (10,11) and socioeconomic status, as pump therapy is more common in individuals of higher socioeconomic status as reflected by race/ethnicity, private health insurance, family income, and education (11,12). Given the additional barriers to optimal diabetes care observed in disadvantaged groups (13), addressing the differences in access to insulin pumps and other diabetes technology may contribute to fewer health disparities.
Pump therapy can be successfully started at the time of diagnosis (14,15). Practical aspects of pump therapy initiation include: assessment of patient and family readiness, (although there is no consensus on which factors to consider in adults (16) or pediatrics), selection of pump type and initial pump settings, patient/ family education of potential pump complications (e.g., diabetic ketoacidosis [DKA] with infusion set failure), transition from MDI, and introduction of advanced pump settings (e.g., temporary basal rates, extended/square/dual wave bolus).
Complications of the pump can be caused by issues with infusion sets (dislodgement, occlusion), which place patients at risk for ketosis and DKA and thus must be recognized and managed early (17); lipohypertrophy or, less frequently, lipoatrophy (18,19); and pump site infection (20). Discontinuation of pump therapy is relatively uncommon today; the frequency has decreased over the past decades and its causes have changed (20,21). Current reasons for attrition are problems with cost, wearability, disliking the pump, suboptimal glycemic control, or mood disorders (e.g., anxiety or depression) (22).
Insulin Pumps in Pediatrics
The safety of insulin pumps in youth has been established for over 15 years (23). Studying the effectiveness of CSII in lowering A1C has been challenging because of the potential selection bias of observational studies. Participants on CSII may have a higher socioeconomic status that may facilitate better glycemic control (24) versus MDI. In addition, the fast pace of development of new insulins and technologies quickly renders comparisons obsolete. However, randomized controlled trials (RCTs) comparing CSII and MDI with insulin analogs demonstrate a modest improvement in A1C in participants on CSII (25,26). Observational studies, registry data, and meta-analysis have also suggested an improvement of glycemic control in participants on CSII (27–29). Although hypoglycemia was a major adverse effect of intensified insulin regimen in the Diabetes Control and Complications Trial (DCCT) (30), data suggests that CSII may reduce the rates of severe hypoglycemia compared with MDI (29,31–33). There is also evidence that CSII may reduce DKA risk (29,34) and diabetes complications, in particular, retinopathy and peripheral neuropathy in youth, compared with MDI (35). Finally, treatment satisfaction and quality-of-life measures improved on CSII compared with MDI (36,37). Therefore, CSII can be used safely and effectively in youth with type 1 diabetes to assist with achieving targeted glycemic control while reducing the risk of hypoglycemia and DKA, improving quality of life and preventing long-term complications. Based on patient-provider shared decision making, insulin pumps may be considered in all pediatric patients. In particular, pump therapy may be the preferred mode of insulin delivery for children under 7 years of age (38). Because of a paucity of data in adolescents and youths with Type 2 diabetes, there is insufficient evidence to make recommendations.
Common barriers to pump therapy adoption in children and adolescents are concerns regarding the physical interference of the device, discomfort with idea of having a device on the body therapeutic effectiveness, and financial burden (27,39).