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Efficacy and safety of closed-loop insulin delivery versus sensor-augmented pump in the treatment of adults with type 1 diabetes: a systematic review and meta-analysis of randomized-controlled trials

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Abstract

Background

Controversy remains regarding whether closed-loop (CL) insulin delivery or insulin sensor-augmented pump (SAP) delivery is more efficient for clinical treatment. Therefore, we aimed to compare the efficacy and safety of CL insulin delivery systems versus insulin SAP delivery for adults with type 1 diabetes (T1D).

Methods

Embase, Ovid MEDLINE, PubMed, ScienceDirect, Scopus, the Cochrane Library, and other databases were searched for related articles, and we analyzed the average blood glucose (BG), time in range (TIR), and adverse effects (AEs) as primary endpoints to evaluate efficacy and safety.

Results

Of 1616 articles, 12 randomized-controlled trials (RCTs) were included in the final analysis. Regarding BG control efficacy, CL insulin delivery resulted better outcomes than SAP therapy with regard to the average BG value, which was detected and recorded by continuous glucose monitoring (mean difference [MD][mmol/L]:  − 0.25 95% confidence interval [CI]  − 0.42 to − 0.08, p = 0.003); TIR 3.9–10 mmol/L (MD [%]: 7.91 95% CI 4.45–11.37, p < 0.00001). Similar results were observed for the secondary outcomes including low blood glucose index (LBGI) (MD:  − 0.41 95% CI − 0.55 to − 0.26, p < 0.00001), high blood glucose index (HBGI) (MD:  − 2.56 95% CI − 3.38 to − 1.74, p < 0.00001), and standard deviation (SD) of glucose variability (MD [mmol/L]: -0.25 95% CI − 0.44 to − 0.06, p = 0.01). Furthermore, SAP therapy was associated with more adverse effects (risk ratio: 0.20 95% CI 0.07–0.52, p = 0.001) than CL insulin delivery, and one of the most common adverse effects was hypoglycemia.

Conclusions

CL insulin delivery appears to be a better treatment method than SAP therapy for adults with T1D because of its increased BG control efficacy and decreased number of hypoglycemic events.

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Data availability

The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

AEs:

Adverse effects

AP:

Artificial pancreas

BG:

Blood glucose

BMI:

Body-mass index

CGM:

Continuous glucose monitoring

CI:

Confidence interval

CL:

Closed-loop

CSII:

Continuous subcutaneous insulin injection

GRADE:

Grading of recommendations assessment, development and evaluation system

HbA1c:

Hemoglobin A1c

HBGI:

High blood glucose index

IQR:

Interquartile range

LBGI:

Low blood glucose index

MeSH:

Medical subject heading

MD:

Mean difference

M/F:

Male/female

NA:

Not available

PRISMA:

Preferred reporting items for systematic review and meta-analysis

RCT:

Randomized-controlled trials

RR:

Risk ratios

SAP:

Sensor-augmented pump

SD:

Standard deviation

T1D:

Type 1 diabetes

TIR:

Time in range

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Funding

This study was supported by National Natural Science Foundation of China (NSFC, Grant number: 81560345) and Natural Science Foundation of Jiangxi Province (Grant number: 20181BAB215027). Role of the Funding: the funding had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

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WZ had full access to all of the data in the manuscript and takes responsibility for the integrity of the data and the accuracy of the data analysis. All authors read and approved the final manuscript. Concept and design: all authors. Acquisition, analysis, or interpretation of data: all authors. Drafting of the manuscript: ZF, ML, JT, and CL. Critical revision of the manuscript for important intellectual content: ZF and WZ. Statistical analysis: ZF and WZ. Supervision: ZF and WZ.

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Correspondence to W. Zhang.

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Fang, Z., Liu, M., Tao, J. et al. Efficacy and safety of closed-loop insulin delivery versus sensor-augmented pump in the treatment of adults with type 1 diabetes: a systematic review and meta-analysis of randomized-controlled trials. J Endocrinol Invest 45, 471–481 (2022). https://doi.org/10.1007/s40618-021-01674-6

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