Evidence mapPaperPMID 39395826Full record

ArticleBMJ open2024

Efficacy and safety of henagliflozin combined with continuous subcutaneous insulin infusion in the treatment of Chinese inpatients with type 2 diabetes mellitus based on a continuous glucose monitoring system: protocol of a multicentre, open-label, inpatient, randomised, controlled trial.

Yingling Wu, Zhenxing Huang, Yingfen Qin

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05677334 (Study on the Efficacy and Safety of Henagliflozin Combined with Continuous Subcutaneous Insulin Infusion in the Treatment of Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring System), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05677334 phase4completednot on this map

Study on the Efficacy and Safety of Henagliflozin Combined with Continuous Subcutaneous Insulin Infusion in the Treatment of Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring System

TypeinterventionalSponsorFirst Affiliated Hospital of Guangxi Medical UniversityRan2023 to 2024Enrolled210ConditionsType2diabetesArmsHenagliflozin, Continuous Subcutaneous Insulin Infusion
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Yingling Wu *Department of Endocrinology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.ORCID 0009-0009-0365-0520
Zhenxing Huang *Department of Endocrinology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.ORCID 0000-0002-2764-2674
Yingfen QinDepartment of Endocrinology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China qinyingfen@gxmu.edu.cn.ORCID 0000-0001-7715-7311

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe role of sodium-glucose cotransporter 2 inhibitors (SGLT2is) in diabetes treatment is expanding; however, few studies have investigated the efficacy and safety of combining SGLT2is with insulin pump therapy. Notably, there is a scarcity of high-quality, multicentre, clinical trials. Therefore, we aim to conduct a prospective multicentre, randomised, controlled, study to investigate whether treatment of type 2 diabetes patients with continuous subcutaneous insulin infusion (CSII) combined with henagliflozin can reduce the time required for blood glucose control, decrease total insulin requirements, mitigate blood glucose fluctuations and enhance beta-cell function. METHODS AND ANALYSIS: In this inpatient, open-label, multicentre, randomised, controlled trial, 200 patients with type 2 diabetes who have not received hypoglycaemic drugs will be randomly allocated at a 1:1 ratio to either the henagliflozin combined with CSII group or the CSII group. The efficacy and safety of treatment in both groups will be compared. We will use a real-time continuous glucose monitoring system for blood glucose monitoring. The primary aim of this study is to compare the time (% time in range (TIR)) in the range of 3.9~10.0 mmol/L blood glucose between the two treatment groups. The secondary outcome measures will include comparisons of the two treatment groups with respect to the (a) time at TIR >70%; (b) mean amplitude of glycaemic excursions; (c) time below range; (d) total insulin dosage; and (e) time above range. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of the First Affiliated Hospital of Guangxi Medical University and is to be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. The study will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05677334.

Indexed as

Blood GlucoseDiabetes Mellitus, Type 2Hypoglycemic AgentsInsulinInsulin Infusion SystemsAdultAgedBlood Glucose Self-MonitoringChinaContinuous Glucose MonitoringEast Asian PeopleFemaleGlucosidesHumansInfusions, SubcutaneousMaleBlood GlucoseGlucosidesHypoglycemic AgentsInsulinSodium-Glucose Transporter 2 InhibitorsDIABETES & ENDOCRINOLOGYGeneral diabetesGeneral endocrinology

Identifiers

PMID39395826
PMCPMC11474858

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.