5.0.0.0 AU­TO­MAT­ED IN­SULIN DE­LIV­ERY

Rec­om­men­da­tion

7.20 Au­to­mat­ed in­sulin de­liv­ery sys­tems may be con­sid­ered in chil­dren (>7 years) and adults with type 1 di­a­betes to im­prove glycemic con­trol. B

To pro­vide phys­i­o­log­ic in­sulin de­liv­ery, in­sulin doses need to be ad­justed based on glu­cose val­ues, which is now fea­si­ble with au­to­mat­ed in­sulin de­liv­ery sys­tems con­sisting of three com­po­nents: an in­sulin pump, a con­tin­u­ous glu­cose sen­sor, and an al­go­rithm that de­ter­mines in­sulin de­liv­ery. With these sys­tems, in­sulin de­liv­ery can­not only be sus­pended but also in­creased or de­creased based on sen­sor glu­cose val­ues. Emerg­ing ev­i­dence sug­gests such sys­tems may lower the risk of ex­er­cise-‍re­lat­ed hy­po­glycemia (117) and may have psy­choso­cial benefits (118–121).

While even­tu­al­ly in­sulin de­liv­ery in closed-‍loop sys­tems may be truly au­to­mat­ed, meals must cur­rently be an­nounced. A so-‍called hy­brid ap­proach, hy­brid closed-‍loop (HCL), has been adopt­ed in first-‍gen­er­a­tion closed-‍loop sys­tems and re­quires users to bolus for meals and snacks. The FDA has ap­proved the first HCL sys­tem for use in those as young as 7 years of age. A 3-‍month noncon­trolled trial using this de­vice (n = 124) demon­strated safe­ty (122) and im­proved A1C in adults (re­duc­tion from 7.3 ± 0.9% to 6.8 ± 0.6%) andado­les­cents (7.7 ± 0.8% to 7.1 ± 0.6%) (123).

To date, the longest outpa­tient RCTs last­ed 12 weeks and com­pared HCL treat­ment (a sys­tem that is not cur­rently FDA ap­proved) to sen­sor-‍aug­ment­ed pumps in adults and chil­dren as young as 6 years of age (n = 86) with A1C lev­els above tar­get at base­line. Com­pared with sen­sor-‍aug­ment­ed pump ther­a­py, the HCL sys­tem re­duced the risk for hy­po­glycemia and im­proved glu­cose con­trol in A1C lev­els (124).

Fu­ture Sys­tems

A mul­ti­tude of other au­to­mat­ed in­sulin de­liv­ery sys­tems are cur­rently being in­ves­ti­gat­ed, in­clud­ing those with dual hor­mones (in­sulin and glucagon or in­sulin and pram­lin­tide). Fur­ther­more, some pa­tients have cre­at­ed do-‍it-‍yourself sys­tems through guid­ance from on­line com­mu­ni­ties, al­though these are not FDA ap­proved or rec­om­mended.