A Systematic Review and Meta-Analysis of Randomised Controlled Trials, Contrasting the Safety Profile between Sodium-Glucose Cotransporter-2 Inhibitors and Placebo in Type 1 Diabetes Mellitus Patients

Background: This study aims to contrast the side effects of treatment with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and placebo in insulin-treated adult type 1 diabetes mellitus (T1DM) patients. Methods: Double-blinded randomized controlled trials that compare the above outcome were searched in electronic databases. Next, the risk of bias in eligible studies was assessed, and comparable outcomes were compared by a random-effects meta-analysis. Results: Seven eligible papers comprising about 3,900 participants were studied. All trials suffered from an unclear risk of detection bias and performance bias. In comparison with the placebo group, the risk of genital infection (RR = 3.22, p < 0.001, 95% CI 2.31–4.49, I2 = 0%) and diabetic ketoacidosis (RR = 2.66, p = 0.002, 95% CI 1.45–4.89, I2 = 0%) was higher in the SGLT2i-treated group. Conclusion: SGLT2i treatment increased the risk of genital infection and diabetic ketoacidosis in adult insulin-treated T1DM patients.

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Sodium–glucose cotransporter inhibitors as add‐on therapy in addition to insulin for type 1 diabetes mellitus: A meta‐analysis of randomized controlled trials

Journal of Diabetes Investigation ◽

10.1111/jdi.13387 ◽

2020 ◽

Author(s):

Hailan Zou ◽

Lili Liu ◽

Jia Guo ◽

Hongjuan Wang ◽

Siyun Liu ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 1 Diabetes ◽

Randomized Controlled Trials ◽

Type 1 Diabetes Mellitus ◽

Meta Analysis ◽

Controlled Trials ◽

Randomized Controlled ◽

Sodium Glucose Cotransporter

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A juxtaposition of safety outcomes between various doses of sodium-glucose co-transporter inhibitors, in insulin-treated type-1 diabetes mellitus patients: a protocol for systematic review and meta-analysis of randomized controlled trials

Journal of Ideas in Health ◽

10.47108/jidhealth.vol3.iss2.56 ◽

2020 ◽

Vol 3 (2) ◽

pp. 167-172

Author(s):

Sumanta Saha

Keyword(s):

Diabetes Mellitus ◽

Systematic Review ◽

Type 1 Diabetes ◽

Randomized Controlled Trials ◽

Type 1 Diabetes Mellitus ◽

Safety Profile ◽

Meta Analysis ◽

Controlled Trials ◽

Randomized Controlled

Background: Several clinical trials have tested the safety profile of sodium-glucose co-transport inhibitors’ (SGLTis) in adult type 1 diabetes mellitus (T1DM) patients. However, no systematic review has yet compared its variation between large and low dose SGLTis. Henceforth, a review protocol is proposed here to review it. Methods: Different electronic databases will be searched for randomized-controlled trials (published in the English language) studying the above objective, irrespective of their publication date. After selecting the eligible trials, their data on the study design, population characteristics, compared interventions, and outcomes of interest will be extracted. Then, utilizing the Cochrane tool, each trial's risk of selection bias, detection bias, performance bias, attrition bias, reporting bias, and other bias will be judged. Next, depending on clinical heterogeneity among the trials, a random-effect or fixed-effect model meta-analysis will be used to compare the respective outcomes. Via the Chi2 and I2 statistics, the statistical inconsistency among the trials will be estimated. When this is substantial, subgroup analysis will follow. Publication bias will be evaluated by funnel plots and Egger’s test. A sensitivity analysis will be done to check different assumptions. If a quantitative juxtaposition is not possible, a narrative reporting will ensue. Conclusion: The proposed study will perform a dose-wise juxtaposition of the safety profile of SGLTis in insulin-treated T1DM patients. Registration: Prospective Register of Systematic Reviews (PROSPERO) (Registration no. CRD42019146578)

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Sodium-Glucose Cotransporter 2 Inhibitors for Type 1 Diabetes Mellitus—Systematic Review and Meta-analysis

Diabetes ◽

10.2337/db18-1128-p ◽

2018 ◽

Vol 67 (Supplement 1) ◽

pp. 1128-P

Author(s):

TOMOHIDE YAMADA ◽

JUN HOSOE ◽

NOBUHIRO SHOJIMA ◽

TOSHIMASA YAMAUCHI ◽

TAKASHI KADOWAKI

Keyword(s):

Diabetes Mellitus ◽

Systematic Review ◽

Type 1 Diabetes ◽

Type 1 Diabetes Mellitus ◽

Meta Analysis ◽

Sodium Glucose Cotransporter

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Abstract #216: A Systematic Review and Meta-Analysis of Randomized Controlled Trials in Use of GLP1 Receptor Agonists in Type 1 Diabetes Mellitus

Endocrine Practice ◽

10.1016/s1530-891x(20)44336-8 ◽

2017 ◽

Vol 23 ◽

pp. 37

Author(s):

Raju Panta ◽

Sumit Kunwar ◽

Manav Batra ◽

Dipesh Ghimire ◽

Mayuri Mudgal ◽

...

Keyword(s):

Diabetes Mellitus ◽

Systematic Review ◽

Type 1 Diabetes ◽

Randomized Controlled Trials ◽

Type 1 Diabetes Mellitus ◽

Meta Analysis ◽

Controlled Trials ◽

Receptor Agonists ◽

Randomized Controlled

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Sodium‐glucose co‐transporter‐2 inhibitors as add‐on therapy to insulin for type 1 diabetes mellitus: Systematic review and meta‐analysis of randomized controlled trials

Diabetes Obesity and Metabolism ◽

10.1111/dom.13260 ◽

2018 ◽

Vol 20 (7) ◽

pp. 1755-1761 ◽

Cited By ~ 29

Author(s):

Tomohide Yamada ◽

Nobuhiro Shojima ◽

Hisashi Noma ◽

Toshimasa Yamauchi ◽

Takashi Kadowaki

Keyword(s):

Diabetes Mellitus ◽

Systematic Review ◽

Type 1 Diabetes ◽

Randomized Controlled Trials ◽

Type 1 Diabetes Mellitus ◽

Meta Analysis ◽

Controlled Trials ◽

Randomized Controlled

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A juxtaposition of safety outcomes between various doses of sodium-glucose co-transporter inhibitors, in insulin-treated type-1 diabetes mellitus patients: a protocol for systematic review and meta-analysis of double-blinded randomized controlled trials

10.1101/2020.06.22.20137349 ◽

2020 ◽

Author(s):

Sumanta Saha

Keyword(s):

Diabetes Mellitus ◽

Systematic Review ◽

Type 1 Diabetes ◽

Type 1 Diabetes Mellitus ◽

Safety Profile ◽

Low Dose ◽

Meta Analysis ◽

Controlled Trials ◽

Double Blinded

ABSTRACTAimsSeveral clinical trials have tested the safety profile of sodium-glucose co-transport inhibitors’ (SGLTis) in adult type 1 diabetes mellitus (T1DM) patients. However, no systematic review has compared its variation between large and low dose SGLTis. Henceforth, a review protocol is proposed here to review it. Besides, it will compare the side effects of each of these interventions with the placebo.MethodsDifferent electronic databases will be searched for randomized double-blinded placebo-controlled trials (published in the English language) studying the above objective, irrespective of their publication date. After selecting the eligible trials, their data on the study design, population characteristics, compared interventions, and outcomes of interest will be extracted. Then, utilizing the Cochrane tool, each trial’s risk of selection bias, detection bias, performance bias, attrition bias, reporting bias, and other bias will be judged. Next, depending on clinical heterogeneity among the trials, a random-effect or fixed-effect model meta-analysis will be used to compare the respective outcomes. Via the Chi2 and I2 statistics, the statistical inconsistency among the trials will be estimated. When this is substantial, subgroup analysis will follow. Publication bias will be evaluated by funnel plots and Egger’s test. A sensitivity analysis will be done to check different assumptions. If a quantitative juxtaposition is not possible, a narrative reporting will ensue. Conclusions: The proposed review will compare the safety profile between the mega and low dose SGLTis in insulin-treated T1DM patients. Besides, each of these two types of doses will be compared with placebo for the same.REGISTRATIONPROSPERO (Registration no. CRD42019146578)

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