Article ; Online: Subcutaneous fast-acting insulin analogues, alone or in combination with long-acting insulin, versus intravenous regular insulin infusion in patients with diabetic ketoacidosis: protocol for an updated systematic review and meta-analysis of randomised trials.
2023 Volume 13, Issue 2, Page(s) e070131
Abstract: Introduction: Diabetic ketoacidosis (DKA) is traditionally managed using intravenous regular insulin infusion (RII) in intensive care unit (ICU)/high dependency unit (HDU). Subcutaneous fast-acting insulin analogues (FAIAs) may help to manage DKA ... ...
| Abstract | Introduction: Diabetic ketoacidosis (DKA) is traditionally managed using intravenous regular insulin infusion (RII) in intensive care unit (ICU)/high dependency unit (HDU). Subcutaneous fast-acting insulin analogues (FAIAs) may help to manage DKA outside ICU/HDU. Furthermore, combining subcutaneous long-acting insulin (LAI) with subcutaneous FAIAs may accelerate ketoacidosis resolution. The latest (2016) Cochrane review was inconclusive regarding subcutaneous FAIAs versus intravenous RII in DKA. It was limited by small sample sizes, unclear risk of bias (RoB) in primary trials and did not examine subcutaneous FAIAs with subcutaneous LAI versus intravenous RII in DKA. We report the protocol for an updated meta-analysis on the safety and benefits of subcutaneous FAIAs with/without subcutaneous LAI versus intravenous RII in DKA. Methods and analysis: We will search Medline, Embase, CINAHL and Cochrane Library, from inception until December 2022, without language restrictions, for randomised trials on subcutaneous FAIAs with/without subcutaneous LAI versus intravenous RII in DKA. We also search ClinicalTrials.gov, ClinicalTrialsRegister.eu and reference lists of included trials. Primary outcomes include all-cause in-hospital mortality, time to DKA resolution, in-hospital DKA recurrence and hospital readmission for DKA post-discharge. Secondary outcomes include resource utilisation and patient satisfaction. Safety outcomes include important complications of DKA and insulin. Reviewers will extract data, assess overall RoB and quality of evidence using Grading of Recommendations, Assessment, Development and Evaluation. We will assess statistical heterogeneity by visually inspecting forest plots and the I Ethics and dissemination: Ethics board approval is not required. Results will be disseminated through publication in a peer-reviewed journal. Prospero registration number: CRD42022369518. |
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| MeSH term(s) | Humans ; Young Adult ; Adult ; Insulin/therapeutic use ; Insulin, Long-Acting/therapeutic use ; Hypoglycemic Agents/therapeutic use ; Diabetic Ketoacidosis/drug therapy ; Aftercare ; Injections, Subcutaneous ; Patient Discharge ; Diabetes Mellitus ; Meta-Analysis as Topic ; Systematic Reviews as Topic ; Randomized Controlled Trials as Topic |
| Chemical Substances | Insulin ; Insulin, Long-Acting ; Hypoglycemic Agents |
| Language | English |
| Publishing date | 2023-02-10 |
| Publishing country | England |
| Document type | Clinical Trial Protocol ; Journal Article |
| ZDB-ID | 2599832-8 |
| ISSN | 2044-6055 ; 2044-6055 |
| ISSN (online) | 2044-6055 |
| ISSN | 2044-6055 |
| DOI | 10.1136/bmjopen-2022-070131 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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