Role of automated insulin delivery in managing insulin-treated outpatients with type 2 diabetes: A systematic review and meta-analysis

Abstract

BACKGROUND

Automated insulin delivery (AID) systems have demonstrated benefits in managing patients with type 2 diabetes (T2D), but data are still limited. Moreover, the efficacy and safety of the AID systems in these patients have been inadequately explored by systematic reviews and meta-analyses.

AIM

To provide a comprehensive understanding of the optimal use of AID in managing insulin-treated outpatients with T2D.

METHODS

A systematic search of multiple databases and registries, including MEDLINE, Scopus, Web of Science, Cochrane Library, and ClinicalTrials.gov, was conducted from inception to May 15, 2025, to identify studies on AID use for outpatients with T2D. The co-primary outcomes were the change in glycated hemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics. Statistical analyses were conducted using Review Manager Web software with random-effects models and the inverse variance statistical method. The results were presented as mean differences (MDs) or risk ratios (RRs) with 95%CI.

RESULTS

A total of 15 studies with 28985 participants were identified, including 6 randomized trials (n = 748; 3 crossover and 3 parallel-group trials) and 9 single-arm studies. All included randomized trials raised some concerns, and the single-arm studies had serious risks of overall bias. Meta-analysis of randomized trials showed that AID is more effective than the control group in lowering HbA1c (MD: -0.89%, 95%CI: -1.32 to -0.46, P < 0.0001, I² = 82%). Compared to control interventions, AID use was linked to a higher percentage of time in range (MD: 19.25%, 95%CI: 11.43-27.06, P < 0.00001, I² = 74%) and a lower percentage of time above range > 10 mmol/L (MD: -19.48%, 95%CI: -27.14 to -11.82, P < 0.00001, I² = 73%); however, time below range remained similar between the two groups. The mean sensor glucose level was lower in the AID group; however, the coefficient of variation of glucose was the same in both groups. AID use also led to a reduction in insulin dose, but this is not a consistent finding across all study designs. The risks of serious adverse events (AEs) and severe hypoglycemia were similar in both groups; however, AID use raised the risk of device deficiency. Single-arm studies with participants using AID systems also demonstrated reductions in HbA1c (ranging from 0.7% to 2.07%) and improvements in CGM metrics, along with acceptable safety data.

CONCLUSION

Based on short-term study data, the use of AID systems in outpatients with T2D appears to improve glycemic outcomes and CGM metrics, with no significant AEs. Larger and longer-term randomized controlled trials involving diverse populations, along with a cost-benefit analysis, are needed to guide more informed clinical practice decisions.

Keywords: Automated insulin delivery; Type 2 diabetes; Time in range; Glycated hemoglobin; Meta-analysis

Core Tip: This is the first systematic review and meta-analysis specifically targeting the efficacy and safety of automated insulin delivery (AID) systems in patients with type 2 diabetes in the outpatient setting. Analyzing six randomized controlled trials and nine single-arm studies involving 28985 participants, we observed that AID systems enhance glycemic control, evidenced by larger decreases in glycated hemoglobin and improved continuous glucose monitoring metrics compared to standard treatment. AID use increases time in range, reduces time above target glucose, and maintains similar rates of hypoglycemia and serious adverse events. While AID slightly increases the risk of device deficiency, safety is still within acceptable limits. The results indicate short-term effectiveness, but larger and longer-term studies are necessary to confirm the benefits and assess cost-effectiveness.