Automated Insulin Delivery Systems in Children and Adolescents With Type 1 Diabetes: A Systematic Review and Meta-analysis of Outpatient Randomized Controlled Trials
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Abstract
BACKGROUND: The glycemic control of automated insulin delivery (AID) systems in outpatient children and adolescents with type 1 diabetes (T1D) has not been systematically evaluated. PURPOSE: To evaluate the efficacy and safety of AID systems in children and adolescents in outpatient settings. DATA SOURCES: PubMed, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched until 4 May 2023. This study was registered with PROSPERO (2023, CRD42023395252). STUDY SELECTION: Randomized controlled trials that compared AID systems with conventional insulin therapy in outpatient children and adolescents with T1D and reported continuous glucose monitoring outcomes were selected. DATA EXTRACTION: Percent time in range (TIR) (3.9–10 mmol/L), time below range (TBR) (<3.9 mmol/L), and time above range (TAR) (>10 mmol/L) were extracted. Data were summarized as mean differences (MDs) with 95% CIs. DATA SYNTHESIS: Twenty-five trials (1,345 participants) were included in the meta-analysis. AID systems were associated with an increased percentage of TIR (MD, 11.38% [95% CI 9.01–13.76], P < 0.001; high certainty). The favorable effect was consistent whether AID was used over 3 months (10.46% [8.71–12.20]) or 6 months (10.87% [7.11–14.63]). AID systems had a favorable effect on the proportion of TBR (−0.59% [−1.02 to −0.15], P = 0.008; low certainty) or TAR (−12.19% [−14.65 to −9.73], P < 0.001; high certainty) compared with control treatment. LIMITATIONS: Substantial heterogeneity was observed in most analyses. CONCLUSIONS: AID systems are more effective than conventional insulin therapy for children and adolescents with T1D in outpatient settings. The favorable effect is consistent both in the short term and long term.
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Substantial heterogeneity, inadequate sample sizes, and publication bias were primary reasons for downgrading evidence.
“primarily due to: ? substantial heterogeneity [24, 38], potentially arising from differences in device brands and intervention durations (1–12 months); ? inadequate sample sizes, with most studies including fewer than 400 participants [15, 25, 30]; ? publication bias, as some systematic reviews were downgraded due to limited literature inclusion or asymmetric funnel plots [27, 30, 31].”
From Effectiveness of Wearable Devices for Diabetes Management: An Overview of Systematic Reviews and Meta‐Analyses (2026) · cites this paper as [38]
The Discussion (page unavailable) reports high heterogeneity in most analyses and small sample sizes in most trials, which reduced precision. It does not identify these as primary reasons for downgrading evidence or substantiate the stated sample-size threshold. The Results > Primary Outcome (page unavailable) report no evidence of publication bias on the Egger test or funnel plot, contrary to that part of the claim. (LLM, conf=0.87)
Experimental — accuracy not yet measuredData accessibility was inadequately reported, with only two studies specifying data retrieval pathways.
“Particularly, the protocol and registration information were reported in only three studies [37, 41, 42] and the data accessibility was inadequately reported, with only two studies specifying data retrieval pathways [25, 38].”
From Effectiveness of Wearable Devices for Diabetes Management: An Overview of Systematic Reviews and Meta‐Analyses (2026) · cites this paper as [38]
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- Authors
- Zeng, B., Gao, L., Yang, Q., Jia, H., & Sun, F.
- Affiliations
- Peking University (CN)
- University of Hong Kong (HK)
- Fifth Tianjin Central Hospital (CN)
- Corresponding author
- Zeng, Baoqi
- Sun, Feng
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2023-11-27
- Volume
- 46
- Issue
- 12
- Pages
- 2300-2307
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC10698220
- OpenAlex
- W4389042103
- Cited by
- 100
- References
- 37
- Citations by year
- 2026: 40 · 2025: 43 · 2024: 16 · 2023: 1
- FWCI
- 3.61
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Natural Science Foundation of China (72074011)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- artificial pancreas, type 1 diabetes, children and adolescents, glycemic control, continuous glucose monitoring, time in range, time below range, time above range, conventional insulin therapy, outpatient care, insulin pump therapy
- MeSH terms
- Adolescent, Blood Glucose, Child, Diabetes Mellitus, Type 1, Humans, Insulin, Outpatients, Blood Glucose Self-Monitoring, Randomized Controlled Trials as Topic
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