JAMA Pediatr. 2025 Sep 8. doi: 10.1001/jamapediatrics.2025.2740. Online ahead of print.
ABSTRACT
IMPORTANCE: Youth living with type 1 diabetes (T1D) are increasingly choosing automated insulin delivery (AID) systems to manage their blood glucose. Few systematic reviews meta-analyzing results from randomized clinical trials (RCTs) are available to guide decision-making.
OBJECTIVE: To study the association of prolonged AID system use in an outpatient setting with measures of glucose management and quality of life in youth with T1D.
DATA SOURCES: MEDLINE, Embase, CINAHL, and Cochrane Central were searched from January 2017 to March 2025 to identify eligible RCTs.
STUDY SELECTION: Two reviewers independently performed literature screening, data extraction, and quality assessment. Included in the analysis were RCTs of youth aged 6 to 18 years with T1D that assessed the efficacy of AID systems in outpatient settings longer than 48 hours compared with any other insulin regimen.
DATA EXTRACTION AND SYNTHESIS: Two reviewers performed data extraction and quality assessment independently and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and PRISMA literature search extension guidelines. Random-effects meta-analysis models were used to estimate the pooled measures of efficacy as a mean difference (MD) with 95% CIs for outcomes measures.
MAIN OUTCOMES AND MEASURES: The 2 primary outcome measures were time in range (TIR) and glycated hemoglobin (HbA1c).
RESULTS: Of 2363 citations retrieved, 11 RCTs (n = 901 participants) with measures of HbA1c and 10 RCTs (n = 786 participants) with measures of TIR were included. RCTs tested interventions lasting a mean (SD) of 31 (26) weeks on youth with a median age of 12 years (range, 10.8-15.9 years); 51% were female, mean (SD) HbA1c level was 8.4% (1.1%), and mean (SD) TIR was 51% (9%). Random-effects models revealed that, compared with any insulin regimen, HbA1c level was reduced -0.41% (95% CI, -0.58% to -0.25%; I2 = 39%), whereas TIR increased 11.5% (95% CI, 9.3%-13.7%; I2 = 23%) with nighttime TIR increasing 19.7% (95% CI, 17.0%-22.4%; I2 = 36%). Random-effects models also revealed that AID use was associated with reduced time spent in hypoglycemia (<3.9 mml/L; MD = -0.32%; 95% CI, -0.60% to -0.03%; I2 = 18%) and hyperglycemia (>10 mmol/L; MD = -10.8%; 95% CI, -14.4% to -7.2%; I2 = 55%), particularly during the night (MD = -14.4%; 95% CI, -19.9% to -8.9%; I2 = 79%) compared with any insulin regimen. There were no differences in adverse events between study arms. Only 2 studies reported changes in QOL.
CONCLUSIONS AND RELEVANCE: This systematic review and meta-analysis found that compared with any other insulin regimen, use of AID systems by youth with T1D was associated with clinically meaningful improvements in multiple measures of glucose management, including the risk of both hyperglycemia and hypoglycemia, without increasing the risk of adverse events. More data are needed on the efficacy of AID systems on patient report outcomes.
PMID:40920375 | DOI:10.1001/jamapediatrics.2025.2740
