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Medicine Aug 2020To systematically evaluate the efficacy and safety of sotagliflozin (SOTA) adjuvant therapy for type 1 diabetes mellitus (T1DM). (Meta-Analysis)
Meta-Analysis
BACKGROUND
To systematically evaluate the efficacy and safety of sotagliflozin (SOTA) adjuvant therapy for type 1 diabetes mellitus (T1DM).
METHODS
Through April 2019, the Web of Science, PubMed, Cochrane Library, Embase, and China National Knowledge Infrastructure databases were electronically searched to identify randomized controlled trials exploring SOTA adjuvant therapy for T1DM. Strict screening and quality evaluations of the obtained literature were performed independently by 2 researchers. Outcome indexes were extracted, and a meta-analysis of the data was performed using Revman 5.3 software.
RESULTS
A total of 7 randomized controlled trials were included. The meta-analysis results showed that compared with the patients in the placebo group, the patients in the SOTA group had a lower hemoglobin A1c (mean difference [MD] = -0.28, 95% confidence interval [CI] [-0.34, -0.22], P < .01), lower total daily insulin use (MD = -8.89, 95% CI [-11.64, -6.13], P < .01), faster weight loss (MD = -3.03, 95% CI [-3.79, -2.26], P < .01), better fasting blood glucose and 2-hour postprandial blood glucose control (MD = -0.75, 95% CI [-1.04, -0.45], P < .01; MD = -2.42, 95% CI [-3.17, -1.67], P < .01), and a higher rate of well-controlled glucose levels (relative risk = 1.75, 95% CI [1.55, 1.99], P < .01), while no significant difference in the incidence of severe hypoglycemic events was found between the SOTA and placebo groups (risk difference [RD] = -0.01, 95% CI [-0.02, 0.00], P = .13). The incidence of diabetic ketoacidosis was higher in the SOTA group than in the placebo group (RD = 0.03, 95% CI [0.02, 0.04], P < .01). The incidence of genital mycotic infection was higher in the SOTA group than in the placebo group (RD = 0.06, 95% CI [0.05, 0.08], P < .01). No significant difference in the incidence of urinary tract infections was detected between the SOTA group and the placebo group (RD = 0.00, 95% CI [-0.01, 0.01], P = 0.97).
CONCLUSIONS
SOTA is a potential drug for the treatment of T1DM and is effective for controlling blood sugar. The main adverse reactions to SOTA are genital mycotic infections and diabetic ketoacidosis. We must further assess the severity of diabetic ketoacidosis caused by SOTA.
Topics: Chemotherapy, Adjuvant; Diabetes Mellitus, Type 1; Glycosides; Humans; Randomized Controlled Trials as Topic; Sodium-Glucose Transporter 1
PubMed: 32871972
DOI: 10.1097/MD.0000000000020875 -
Turkish Journal of Emergency Medicine 2023The first-line treatment of diabetes ketoacidosis (DKA) involves fluid resuscitation with normal saline infusion to correct hypovolemia. Hyperchloremic metabolic... (Review)
Review
The first-line treatment of diabetes ketoacidosis (DKA) involves fluid resuscitation with normal saline infusion to correct hypovolemia. Hyperchloremic metabolic acidosis from aggressive normal saline administration was associated with worse clinical outcomes in managing DKA. Other choices for normal saline include balanced electrolyte solutions (BESs). This study aimed to compare the clinical effects between BESs and normal saline in managing DKA. This study was a systematic review of probing articles published from inception to October 2021 in Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Google Scholar, and Scopus. Eight randomized controlled trials with a total of 595 individuals were included. The data were analyzed at 95% confidence level using random-effects models. For the primary outcomes, there was no difference in the duration of DKA resolution. (Mean difference [MD] -4.73, 95% confidence interval [CI] -2.72-4.92; = 92%; = 0.180). However, there was a significantly lower postresuscitation chloride concentration in the BES (MD 2.96 95% CI - 4.86 to - 1.06; = 59%; = 0.002). For the secondary outcomes, there was a significant reduction in duration for normalization of bicarbonate in the BES group (MD 3.11 95% CI - 3.98-2.23; = 5%; = 0.0004). There were no significant differences between groups in duration for recovery of pH, intensive unit admission, and adverse events (mortality and acute renal failure). Resuscitation with BES was associated with decreased chloride and increased bicarbonate values in DKA patients. It suggests that BES prevents DKA patients from hyperchloremic metabolic acidosis.
PubMed: 37529790
DOI: 10.4103/tjem.tjem_355_22 -
Diabetes Therapy : Research, Treatment... Apr 2021Sodium-glucose co-transporter 2 inhibitors (SGLT2is) are licensed for the treatment of type 2 diabetes (T2D) and more recently for heart failure with or without... (Review)
Review
INTRODUCTION
Sodium-glucose co-transporter 2 inhibitors (SGLT2is) are licensed for the treatment of type 2 diabetes (T2D) and more recently for heart failure with or without diabetes. They have been shown to be safe (from the cardiovascular (CV) perspective) and effective (in terms of glycaemia, and in some cases, in reducing CV events) in extensive randomised controlled trials (RCTs). However, there remain concerns regarding the generalisability of these findings (to those ineligible for RCT participation) and about non-CV safety. For effectiveness, population-based pharmacoepidemiology studies can confirm and extend the findings of RCTs to broader populations and explore safety, for which RCTs are not usually powered, in more detail.
METHODS
A pre-planned and registered ((International PROSPEctive Register Of Systematic Reviews) PROSPERO registration CRD42019160792) systematic review of population-based studies investigating SGLT2i effectiveness and safety, following Meta-analyses Of Observational Studies in Epidemiology (MOOSE) guidelines was conducted.
RESULTS
A total of 37 studies were identified (total n = 1,300,184 adults; total follow-up 910,577 person-years; exposures: SGLT2i class, canagliflozin, dapagliflozin and empagliflozin) exploring CV disease (CVD) outcomes, acute kidney injury (AKI), lower limb amputation (LLA), diabetic ketoacidosis (DKA), bone fracture, urinary tract infection (UTI), genital mycotic infection (GMI), hypoglycaemia, pancreatitis and venous thromboembolism. For CV and mortality outcomes, studies confirmed the associated safety of these drugs and correlated closely with the findings from RCTs, which may extend to primary CVD prevention (major adverse cardiovascular events point estimate range (PER) hazard ratio (HR) 0.78-0.94; hospitalised heart failure PER HR 0.48-0.79). For safety outcomes, SGLT2i exposure was not associated with an increased risk of AKI (PER HR 0.40-0.96), fractures (PER HR 0.87-1.11), hypoglycaemia (PER HR 0.76-2.49) or UTI (PER HR 0.72-0.98). There was a signal for increased association for GMIs (PER HR 2.08-3.15), and possibly for LLA (PER HR 0.74-2.79) and DKA (PER HR 0.96-2.14), but with considerable uncertainty.
CONCLUSION
In T2D, SGLT2is appear safe from the CV perspective and may have associated benefit in primary as well as secondary CVD prevention. For safety, they may be associated with an increased risk of GMI, LLA and DKA, although longer follow-up studies are needed.
PubMed: 33665777
DOI: 10.1007/s13300-021-01004-2 -
Diabetes Therapy : Research, Treatment... Feb 2024The MiniMed™ 780G is a second-generation automated insulin delivery system that implements a modified proportional-integral-derivative algorithm with some features of... (Review)
Review
The MiniMed™ 780G is a second-generation automated insulin delivery system that implements a modified proportional-integral-derivative algorithm with some features of an MD-Logic artificial pancreas algorithm. The system may deliver automatic correction boluses up to every 5 min, and it allows the user to choose between three glucose target setpoints (100, 110 and 120 mg/dL). We aimed to review the current evidence on this device in children, adolescents, and young adults living with type 1 diabetes. We screened 783 papers, but only 31 manuscripts were included in this review. Data on metabolic outcomes show that this system is safe as regards severe hypoglycaemia and diabetic ketoacidosis. The glycated haemoglobin may drop to levels about 7%, with CGM reports showing a time in range of 75-80%. The time above range and the time below range are within the recommended target in most of the subjects. Few studies evaluated the psychological outcomes. This system seems to be more effective than the first-generation automated insulin delivery systems. The MiniMed™ 780G has been associated with an improvement in sleep quality in subjects living with diabetes and their caregivers, along with an improvement in treatment satisfaction. Psychological distress is as reduced as the glucose control is improved. We also discuss some case reports describing particular situations in clinical practice. Finally, we think that data show that this system is a further step towards the improvement of the treatment of diabetes as concerns both metabolic and psychological outcomes.
PubMed: 38038896
DOI: 10.1007/s13300-023-01501-6 -
Cureus Sep 2021Diabetes mellitus (DM) is associated with dreadful changes in the cardiovascular and renal systems, causing increased morbidity and mortality. Sodium-glucose... (Review)
Review
Diabetes mellitus (DM) is associated with dreadful changes in the cardiovascular and renal systems, causing increased morbidity and mortality. Sodium-glucose cotransport-2 (SGLT2) inhibitors belong to the oral hypoglycemic group of drugs believed to reduce these events by various mechanisms in DM. We performed a systematic review to determine the effectiveness of SGLT2 inhibitors in reducing cardiovascular and renal complications and address safety concerns in participants with type 2 diabetes mellitus (T2DM). We explored PubMed, PubMed Central, Medical Literature Analysis and Retrieval System Online (MEDLINE), Cochrane library, and ResearchGate for randomized controlled trials and observational studies done on the advantages of SGLT2 inhibitors in the prevention or reduction of worsening cardiovascular and renal changes in T2DM. Studies were screened for the quality assessment using the Cochrane risk-of-bias assessment tool and Newcastle-Ottawa scale. We screened 5615 articles, out of which 22 articles with 7,02,977 diabetes mellitus patients treated with SGLT2 inhibitors were used for the systematic review after meticulously filtering articles based on inclusion and exclusion criteria. The trials included one of the following drugs - empagliflozin, dapagliflozin, canagliflozin, and luseogliflozin. SGLT2 inhibitors significantly reduced the risk of heart failure (HF), frequency of hospitalizations due to HF, all-cause mortality, cardiovascular mortality, and nonfatal myocardial infarction. Renal outcomes showed a significant lowering of risk of acute kidney failure, progression of chronic kidney disease, renal mortality, and improvement in urinary albumin creatinine ratio. We noticed an initial worsening of the estimated glomerular filtration rate followed by stabilizing and reaching the baseline on long-term treatment, especially in end-stage renal failure patients. The review showed that SGLT2 inhibitors have adverse reactions similar to that of a placebo, with a slight increase in treatable genital mycotic and urinary tract infections but no evidence of diabetic ketoacidosis, fractures, and amputations. According to the available data, SGLT2 inhibitors can significantly prevent or reduce cardiovascular diseases and kidney abnormalities in patients with type 2 diabetes mellitus with tolerable safety outcomes.
PubMed: 34650848
DOI: 10.7759/cureus.17668 -
Diabetic Medicine : a Journal of the... Sep 2019To conduct a systematic review and meta-analysis to understand the timing and factors associated with anti-programmed cell death protein-1 (PD-1)/anti-programmed cell... (Meta-Analysis)
Meta-Analysis
AIM
To conduct a systematic review and meta-analysis to understand the timing and factors associated with anti-programmed cell death protein-1 (PD-1)/anti-programmed cell death protein-1 ligand (PD-L1) inhibitor-induced Type 1 diabetes.
METHODS
We searched MEDLINE, EMBASE, SCOPUS and Cochrane databases (August 2000-2018) for studies of any design on immune checkpoint inhibitors. A total of 71 cases were reviewed from 56 publications. Comparisons were made using Fisher's exact and Student's t-tests.
RESULTS
The mean ± sd age at Type 1 diabetes presentation was 61.7±12.2 years, 55% of cases were in men, and melanoma (53.5%) was the most frequent cancer. The median time to Type 1 diabetes onset was 49 (5-448) days with ketoacidosis in 76% of cases. The average ± sd HbA concentration was 62 ± 0.3 mmol/mol (7.84±1.0%) at presentation. All cases had insulin deficiency and required permanent exogenous insulin treatment. Half of the cases had Type 1 diabetes-associated antibodies at presentation, and those with antibodies had a more rapid onset (P=0.005) and higher incidence of diabetic ketoacidosis (P=0.02) compared to people without antibodies.
CONCLUSIONS
Many people developed Type 1 diabetes within 3 months of initial PD-1/PD-L1 inhibitor exposure. People presenting with Type 1 diabetes-associated antibodies had a more rapid onset and higher incidence of ketoacidosis than those without antibodies. Healthcare providers caring for people receiving these state-of-the-art therapies need to be aware of this potential severe adverse event.
Topics: Antibodies, Monoclonal; B7-H1 Antigen; Cell Cycle Checkpoints; Diabetes Mellitus, Type 1; Diabetic Ketoacidosis; Humans; Incidence; Programmed Cell Death 1 Receptor; Treatment Outcome
PubMed: 31199005
DOI: 10.1111/dme.14050 -
Pediatric Research Apr 2023Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of type 1 diabetes mellitus (T1DM) that has increased during the COVID-19 pandemic. This study... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of type 1 diabetes mellitus (T1DM) that has increased during the COVID-19 pandemic. This study will not only shed light on such life-threatening complications but also be a step to increase the awareness of healthcare providers about such complications in the upcoming pandemic waves and increased dependence on telemedicine. Thus, we aimed to further investigate the increase of DKA in pediatrics.
METHODS
PubMed, Web of Science, and Scopus were broadly searched for studies assessing the incidence of DKA in pediatrics during the COVID-19 pandemic.
RESULTS
Our study included 24 papers with a total of 124,597 children with diabetes. A statistically significant increase occurred in the risk of DKA among newly diagnosed T1DM patients during the pandemic (RR 1.41; 95% CI 1.19, 1.67; p < 0.01; I = 86%), especially in the severe form of DKA (RR 1.66: 95% CI 1.3, 2.11) when compared to before.
CONCLUSION
DKA in newly diagnosed children with T1DM has increased during the pandemic and presented with a severe form. This may reflect that COVID-19 may have contributed not only to the development but also the severity of DKA.
IMPACT
Diabetic ketoacidosis (DKA) is a life-threatening complication of type 1 diabetes mellitus (T1DM) that has increased during the COVID-19 pandemic. Our study included 25 papers with a total of 124,597 children with diabetes. A statistically significant increase occurred in the risk of DKA among newly diagnosed T1DM patients during the pandemic. Our findings reflect that COVID-19 may have an altered presentation in T1DM and can be related to DKA severity.
Topics: Humans; Child; Diabetic Ketoacidosis; Diabetes Mellitus, Type 1; Pandemics; Incidence; Retrospective Studies; COVID-19; Severity of Illness Index
PubMed: 35953513
DOI: 10.1038/s41390-022-02241-2 -
Trials Dec 2017Achieving consensus from a range of relevant stakeholders about an agreed set of core outcomes to be measured and reported as a minimum in clinical trials has the...
BACKGROUND
Achieving consensus from a range of relevant stakeholders about an agreed set of core outcomes to be measured and reported as a minimum in clinical trials has the potential to enhance evidence synthesis and make findings more relevant and applicable. Intervention research to improve outcomes for young adults with type 1 diabetes (T1DM) is hampered by inconsistent use of outcome measures. This population frequently struggles to manage their condition and reports suboptimal clinical outcomes. Our aim was to conduct an international, e-Delphi consensus study to identify a core outcome set (COS) that key stakeholders (young adults with T1DM, diabetes health professionals, diabetes researchers and diabetes policy makers) consider as essential outcomes for future intervention research.
METHODS
Using a list of 87 outcomes generated from a published systematic review, we administered two online surveys to a sample of international key stakeholders. Participants in the first survey (survey 1; n = 132) and the second survey (survey 2; n = 81) rated the importance of the outcomes. Survey 2 participants received information on total mean rating for each outcome and a reminder of their personal outcome ratings from Survey 1. Survey 2 results were discussed at a consensus meeting and participants (n = 12: three young adults with T1DM, four diabetes health professionals, four diabetes researchers and one diabetes policy maker) voted on outcomes. Final core outcomes were included provided that 70% of consensus group participants voted for their inclusion.
RESULTS
Eight core outcomes were agreed for inclusion in the final COS: measures of diabetes-related stress; diabetes-related quality of life; number of severe hypoglycaemic events; self-management behaviour; number of instances of diabetic ketoacidosis (DKA); objectively measured glycated haemoglobin (HbA); level of clinic engagement; and perceived level of control over diabetes.
CONCLUSIONS
This study is the first to identify a COS for inclusion in future intervention trials to improve outcomes for young adults with T1DM. Use of this COS will improve the quality of future research and increase opportunities for evidence synthesis. Future research is necessary to identify the most robust outcome measure instruments.
Topics: Adolescent; Adult; Age Factors; Biomarkers; Blood Glucose; Clinical Trials as Topic; Consensus; Delphi Technique; Diabetes Mellitus, Type 1; Endpoint Determination; Glycated Hemoglobin; Health Knowledge, Attitudes, Practice; Humans; Hypoglycemic Agents; Quality of Life; Research Design; Self Care; Stakeholder Participation; Time Factors; Treatment Outcome; Young Adult
PubMed: 29258565
DOI: 10.1186/s13063-017-2364-y -
Frontiers in Endocrinology 2022Diabetes mellitus (DM) is a global health problem, and it has become a shocking threat in the contemporary era. The objective of this study was to analyze the safety of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Diabetes mellitus (DM) is a global health problem, and it has become a shocking threat in the contemporary era. The objective of this study was to analyze the safety of sotagliflozin in patients with DM systematically and intuitively.
METHODS
On November 15, 2021, literature retrieval was performed on PubMed, Web of Science, EBSCO, and Cochrane libraries. The meta-analysis results included genital mycotic infection, related-to-acidosis events, and other related adverse events, including diarrhea, severe nocturnal hypoglycemia event, and volume depletion. In addition, a subgroup analysis was also conducted based on different doses of sotagliflozin. Moreover, the patient-treated years analyzed in the study were 12 weeks, 24 weeks, and 52 weeks, respectively, for type 1 diabetes, and were 12 weeks, 22 weeks, and 52 weeks, respectively, for type 2 diabetes.
RESULTS
The results of this meta-analysis illustrated that sotagliflozin could increase the risk of genital mycotic infection for patients with T1D and T2D (RR: 3.49, 95% Cl: 2.54-4.79, < 0.001; RR: 2.83, 95% Cl: 2.04-3.93, < 0.001; respectively). In addition, the subgroup analysis showed that the drug doses that could increase the risk of genital mycotic infection were 400 mg and 200 mg (RR: 3.63, 95% Cl: 2.46-5.36, < 0.001; RR: 3.21, 95% Cl: 1.84-5.62, < 0.001; respectively) in T1D. Moreover, sotagliflozin could increase the risk of events related to acidosis in the patients of T1D, including acidosis-related adverse events, positively adjudicated diabetic ketoacidosis, acidosis-related event, and diabetic ketoacidosis (RR: 7.49, 95% Cl: 3.20-17.52, < 0.001; RR: 6.05, 95% Cl: 2.56-14.30, < 0.001; RR: 4.83, 95% Cl: 3.13-7.45, < 0.001; RR: 8.12, 95% Cl: 3.06-21.52, p < 0.001; respectively). In the patients of T2D, sotagliflozin could not increase the risk of DKA (RR: 1.30, 95% Cl: 0.34-4.99, p = 0.70). About serious of acidosis-related adverse events, positively adjudicated diabetic ketoacidosis (DKA) and acidosis-related event, the included studies were not reported for T2D patients. As for the other related adverse events, sotagliflozin was found to be a risk factor for diarrhea and volume depletion in T1D patients (RR: 1.44, 95% Cl: 1.09-1.90, p = 0.01; RR: 2.50, 95% Cl: 1.33-4.69, p < 0.01; respectively) and T2D patients (RR: 1.44, 95% Cl: 1.26-1.64, p < 0.001; RR: 1.25, 95% Cl: 1.07-1.45, p < 0.01; respectively).
CONCLUSIONS
This meta-analysis showed that the adverse events of sotagliflozin were tolerable to patients with DM, in terms of the incidence of genital mycotic infection, related-to-acidosis events, diarrhea, volume depletion, and severe nocturnal hypoglycemia events. In addition, the subgroup analysis of sotagliflozin dosage is considered to have great clinical significance for future guidance of sotagliflozin application in patients with DM.
Topics: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Ketoacidosis; Diarrhea; Humans; Hypoglycemia; Randomized Controlled Trials as Topic
PubMed: 36225203
DOI: 10.3389/fendo.2022.968478 -
Globalization and Health Jun 2022Apart from infecting a large number of people around the world and causing the death of many people, the COVID-19 pandemic seems to have changed the healthcare processes... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Apart from infecting a large number of people around the world and causing the death of many people, the COVID-19 pandemic seems to have changed the healthcare processes of other diseases by changing the allocation of health resources and changing people's access or intention to healthcare systems.
OBJECTIVE
To compare the incidence of endpoints marking delayed healthcare seeking in medical emergencies, before and during the pandemic.
METHODS
Based on a PICO model, medical emergency conditions that need timely intervention was selected to be evaluated as separate panels. In a systematic literature review, PubMed was quarried for each panel for studies comparing the incidence of various medical emergencies before and during the COVID-19 pandemic. Markers of failure/disruption of treatment due to delayed referral were included in the meta-analysis for each panel.
RESULT
There was a statistically significant increased pooled median time of symptom onset to admission of the acute coronary syndrome (ACS) patients; an increased rate of vasospasm of aneurismal subarachnoid hemorrhage; and perforation rate in acute appendicitis; diabetic ketoacidosis presentation rate among Type 1 Diabetes Mellitus patients; and rate of orchiectomy among testicular torsion patients in comparison of pre-COVID-19 with COVID-19 cohorts; while there were no significant changes in the event rate of ruptured ectopic pregnancy and median time of symptom onset to admission in the cerebrovascular accident (CVA) patients.
CONCLUSIONS
COVID-19 has largely disrupted the referral of patients for emergency medical care and patient-related delayed care should be addressed as a major health threat.
Topics: COVID-19; Delivery of Health Care; Emergencies; Humans; Pandemics; Retrospective Studies; SARS-CoV-2
PubMed: 35676714
DOI: 10.1186/s12992-022-00836-2