4.2.0.0 Real-‍time Con­tin­u­ous Glu­cose Mon­i­tor Use in Youth

Rec­om­men­da­tion

Recommendation

7.13 Real-‍time con­tin­u­ous glu­cose mon­i­tor­ing should be con­sid­ered in chil­dren and ado­les­cents with type 1 di­a­betes, whether using mul­ti­ple daily in­jec­tions or con­tin­u­ous sub­cu­ta­neous in­sulin in­fu­sion, as an ad­di­tion­al tool to help im­prove glu­cose con­trol and re­duce the risk of hy­po­glycemia. Benefits of con­tin­u­ous glu­cose mon­i­tor­ing cor­re­late with ad­her­ence to on­go­ing use of the de­vice. B

Data re­gard­ing use of real-‍time CGM in youth con­sist of find­ings from RCTs and small ob­ser­va­tion­al stud­ies, as well as anal­y­sis of data col­lected by reg­istries. Some of the RCTs have in­cluded both adult and pe­di­atric par­tic­i­pants (41,64–66), while oth­ers have only in­cluded pe­di­atric par­tic­i­pants (67) or lim­it­ed the anal­y­sis of larg­er stud­ies to just the pe­di­atric par­tic­i­pants (41). Given the fea­si­bil­i­ty prob­lems of per­form­ing RCTs in very young chil­dren, small ob­ser­va­tion­al stud­ies have also pro­vided data on real-‍time CGM use in the youngest age groups (68–70). Fi­nal­ly, while lim­it­ed by the ob­ser­va­tion­al na­ture, reg­istry data pro­vide some ev­i­dence of real-‍world use of the tech­nolo­gies (71,72).

Im­pact on Glycemic Con­trol

When data from adult and pe­di­atric par­tic­i­pants is an­a­lyzed to­geth­er, CGM use in RCTs has been as­so­ci­at­ed with re­duc­tion in A1C lev­els (64–66). Yet, in the JDRF CGM trial, when youth were an­a­lyzed by age-‍group (8- to 14-‍year-‍olds and 15- to 24-‍year-‍olds), no change in A1C was seen, like­ly due to poor CGM ad­her­ence (41). In­deed, in a sec­ondary anal­y­sis of that RCT’s data in both pe­di­atric co­horts, those who uti­lized the sen­sor ≥6 days/‍week had an im­provement in their glycemic con­trol (73). One crit­i­cal com­po­nent to suc­cess with CGM is near-‍daily wear­ing of the de­vice (64,74–76).

Though data from small ob­ser­va­tion­al stud­ies demon­strate that CGM can be worn by pa­tients <8 years old and the use of CGM pro­vides in­sight to glycemic pat­terns (68,69), an RCT in chil­dren aged 4 to 9 years did not demon­strate im­provements in glycemic con­trol fol­low­ing 6 months of CGM use (67). How­ev­er, ob­ser­va­tion­al fea­si­bil­i­ty stud­ies of tod­dlers demon­strated a high de­gree of parental sat­is­fac­tion and sus­tained use of the de­vices de­spite the inabil­i­ty to change the de­gree of glycemic con­trol at­tained (70).

Reg­istry data has also shown an as­so­ci­a­tion be­tween CGM use and lower A1C lev­els (71,72), even when lim­it­ing as­sess­ment of CGM use to par­tic­i­pants on in­jec­tion ther­a­py (72).

Im­pact on Hy­po­glycemia

Apart from the Sens­ing With In­sulin pump Ther­a­py to Con­trol HbA1c (SWITCH) study, which showed a sig­nif­i­cant ef­fect of adding CGM to in­sulin pump ther­a­py on time spent in hy­po­glycemia (64), most stud­ies fo­cus­ing on glycemic man­agement over­all failed to demon­strate a significant or rel­e­vant re­duc­tion in level 1 hy­po­glycemia (41,65– 67,77). No­tably, RCTs pri­mar­i­ly aimed at hy­po­glycemia pre­vention did demon­strate a significant re­duc­tion in mild hy­po­glycemia in terms of re­duc­ing the time spent in hy­po­glycemia by ap­prox­i­mate­ly 40% and re­duc­ing the num­ber of level 1 hy­po­glycemia events per day (78,79).