Clinical Trials Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Jul 15, 2025; 16(7): 106470
Published online Jul 15, 2025. doi: 10.4239/wjd.v16.i7.106470
Factors influencing insulin requirements in using continuous subcutaneous insulin infusion or multiple daily injections in type 2 diabetes
Ruo-Man Sun, De-Xing Dai, Feng Xu, Ya-Li Ling, Zhong-Jian Xie
Ruo-Man Sun, De-Xing Dai, Feng Xu, Ya-Li Ling, Zhong-Jian Xie, National Clinical Research Center for Metabolic Diseases, Hunan Provincial Key Laboratory of Metabolic Bone Disease, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
Author contributions: Sun RM, Xu F, and Xie ZJ contributed to conceptualizing and designing the study; Sun RM, Dai DX, and Ling YL contributed to acquiring the data; Sun RM and Xu F contributed to the data analyses and interpretation; All authors contributed to collecting the data and critically revising the paper, providing final approval of the version to be published, and agreeing to be accountable for all aspects of the work.
Supported by the National Key R and D Program of China, No. 2021YFC2501700 and No. 2021YFC2501705; and the National Natural Science Foundation of China, No. 82171580 and No. 81672646.
Institutional review board statement: The protocol for this research project has been approved by the Ethics Committee of The Second Xiangya Hospital of Central South University and Institutional Review Board (Approval No. 2021K014), and conforms to the provisions of the Declaration of Helsinki
Clinical trial registration statement: As this study is a retrospective cohort investigation, it is exempt from clinical trial registration requirements applicable to observational research. We confirm that all ethical approvals and data access permissions for the use of retrospective clinical data were obtained, and relevant supporting documentation has been uploaded.
Informed consent statement: This retrospective analysis utilized fully anonymized clinical data derived from historical medical records, and written informed consent was waived by the Ethics Committee of the Second Xiangya Hospital of Central South University (approval No. 2021K014) under the following rationale: (1) The study posed minimal risk, involving no interventions and exclusively analyzed de-identified data; (2) Obtaining individual consent was logistically unfeasible due to the archival nature and large temporal scope of the dataset (2014-2022); (3) Strict anonymization protocols were implemented, removing all direct identifiers (e.g., names, IDs) and aggregating indirect identifiers (e.g., rare diagnoses, exact dates) to prevent re-identification; and (4) The study addressed critical gaps in T2DM insulin therapy optimization, with findings directly informing clinical practice.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The datasets generated and analyzed during this study are not publicly available due to institutional ethics committee restrictions and participant privacy protection requirements. However, de-identified data supporting the findings may be made available to qualified researchers upon reasonable request for non-commercial academic purposes. Requests should be directed to Ruo-Man Sun at 208202056@csu.edu.cn.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Zhong-Jian Xie, MD, PhD, National Clinical Research Center for Metabolic Diseases, Hunan Provincial Key Laboratory of Metabolic Bone Disease, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, No. 139 Middle Renmin Road, Changsha 410011, Hunan Province, China. zhongjian.xie@csu.edu.cn
Received: February 27, 2025
Revised: April 20, 2025
Accepted: June 9, 2025
Published online: July 15, 2025
Processing time: 138 Days and 18.6 Hours
Abstract
BACKGROUND

Studies have shown that patients with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) require a lower dose of insulin than those treated with multiple daily injections (MDIs). However, it is unclear whether this is also the case for patients with type 2 diabetes mellitus (T2DM).

AIM

To compare insulin dosage requirements between CSII and MDI in T2DM, identifying influencing factors associated with both therapeutic modalities.

METHODS

A total of 954 patients with T2DM were divided into two groups: CSII and MDI groups. The total daily insulin dose (TDD), TDD per kilogram per day (TDD/kg), and ratio of total basal insulin dose to TDD (%TBa) required to achieve the target blood glucose levels were compared between the two groups. In addition, factors affecting insulin dosage were analyzed in both groups of patients.

RESULTS

Compared to the CSII group, the MDI group required a higher TDD [median (interquartile)]: 30.00 (24.00, 38.00) U/day vs 26.40 (21.60, 32.40) U/day; P < 0.01, TDD/kg and %TBa. In the MDI group and CSII groups, an increase in TDD was independently associated with an increase in body mass index (BMI), waist circumference (WC), fasting plasma glucose (FPG), and glycated hemoglobin (HbA1c).

CONCLUSION

Patients with T2DM receiving CSII treatment require a lower dose of insulin to achieve good glycemic control. BMI, WC, FPG, and HbA1c are the main factors affecting insulin dosage.

Keywords: Continuous subcutaneous insulin infusion; Insulin dose; Multiple daily injections; Type 2 diabetes; Glycemic control

Core Tip: This study demonstrates that patients with type 2 diabetes mellitus (T2DM) on continuous subcutaneous insulin infusion require a lower dose of insulin than those receiving multiple daily injections, while achieving good glycemic control. Fasting plasma glucose, glycated hemoglobin, body mass index, and waist circumference correlated with increased insulin requirements across both therapies. Our data also suggest that the ratio of total basal insulin dose to total daily dose of approximately 40% (lower than the 50% recommended percentage) may optimize glycemic outcomes. These findings highlight the need for careful selection of insulin therapy and revision of basal insulin recommendations in T2DM management.