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Archives of Endocrinology and Metabolism May 2023Insulin Icodec is a novel basal insulin analogue designed for once-weekly administration, therefore might propitiate reduction in the frequency of injections and... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Insulin Icodec is a novel basal insulin analogue designed for once-weekly administration, therefore might propitiate reduction in the frequency of injections and facilitate treatment adherence. This study aimed to determine the glycemic control and safety profile of Insulin Icodec, compared with Glargine U100 in patients with diabetes mellitus type 2.
MATERIALS AND METHODS
We performed a systematic review and meta-analysis of randomized controlled trials (RCT) data comparing OnceWeekly Insulin Icodec and Once-Daily Insulin Glargine U100 in patients with type 2 diabetes mellitus. PubMed, Embase, and Cochrane databases were searched for trials published up to May 14, 2022. Data were extracted from published reports and quality assessment was performed per Cochrane recommendations.
RESULTS
Three studies were included comprising 453 patients, 230 (50.77%) using Once-Weekly Insulin Icodec and 223 (49.22%) using Once-Daily Insulin Glargine U100. In the pooled data, Glycated Hemoglobin (MD -0.20% CI -0.33 to -0.07%; P=0.002) change from baseline demonstrated a significantly higher reduction in the Icodec group. Time with Glucose in Range (MD 6.60% CI 3.63 to 9.57%; P < 0.0001) and Insulin Dose Difference (MD 0.97UI CI 0.76 to 1.18UI; P < 0.0001) were higher in the Icodec group. There was no significant difference in fasting plasma glucose, body weight change, hypoglycemia or any adverse event evaluated.
CONCLUSION
OnceWeekly Insulin Icodec was associated with a small reduction in Glycated Hemoglobin, as well as higher Time with Glucose in Range, with similar hypoglycemic adverse events, when compared with Once-Daily Insulin Glargine U100.
Topics: Humans; Insulin Glargine; Glycated Hemoglobin; Blood Glucose; Randomized Controlled Trials as Topic; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Insulin; Glucose; Clinical Trials, Phase II as Topic
PubMed: 37249450
DOI: 10.20945/2359-3997000000614 -
Diabetes Care Dec 2023The glycemic control of automated insulin delivery (AID) systems in outpatient children and adolescents with type 1 diabetes (T1D) has not been systematically evaluated. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The glycemic control of automated insulin delivery (AID) systems in outpatient children and adolescents with type 1 diabetes (T1D) has not been systematically evaluated.
PURPOSE
To evaluate the efficacy and safety of AID systems in children and adolescents in outpatient settings.
DATA SOURCES
PubMed, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched until 4 May 2023. This study was registered with PROSPERO (2023, CRD42023395252).
STUDY SELECTION
Randomized controlled trials that compared AID systems with conventional insulin therapy in outpatient children and adolescents with T1D and reported continuous glucose monitoring outcomes were selected.
DATA EXTRACTION
Percent time in range (TIR) (3.9-10 mmol/L), time below range (TBR) (<3.9 mmol/L), and time above range (TAR) (>10 mmol/L) were extracted. Data were summarized as mean differences (MDs) with 95% CIs.
DATA SYNTHESIS
Twenty-five trials (1,345 participants) were included in the meta-analysis. AID systems were associated with an increased percentage of TIR (MD, 11.38% [95% CI 9.01-13.76], P < 0.001; high certainty). The favorable effect was consistent whether AID was used over 3 months (10.46% [8.71-12.20]) or 6 months (10.87% [7.11-14.63]). AID systems had a favorable effect on the proportion of TBR (-0.59% [-1.02 to -0.15], P = 0.008; low certainty) or TAR (-12.19% [-14.65 to -9.73], P < 0.001; high certainty) compared with control treatment.
LIMITATIONS
Substantial heterogeneity was observed in most analyses.
CONCLUSIONS
AID systems are more effective than conventional insulin therapy for children and adolescents with T1D in outpatient settings. The favorable effect is consistent both in the short term and long term.
Topics: Child; Adolescent; Humans; Diabetes Mellitus, Type 1; Blood Glucose Self-Monitoring; Outpatients; Blood Glucose; Randomized Controlled Trials as Topic; Insulin
PubMed: 38011519
DOI: 10.2337/dc23-0504 -
Diabetes, Obesity & Metabolism Jun 2023To compare the clinical efficacy and safety of glargine-U100 (Lantus/Gla-100) with glargine-U300 (Toujeo/Gla-300) in adult patients with type 2 diabetes (T2D) and type 1... (Comparative Study)
Comparative Study Meta-Analysis
Comparative clinical efficacy and safety of insulin glargine 300 U/ml (Toujeo) versus insulin glargine 100 U/ml in type 2 diabetes and type 1 diabetes: A systematic literature review and meta-analysis.
AIM
To compare the clinical efficacy and safety of glargine-U100 (Lantus/Gla-100) with glargine-U300 (Toujeo/Gla-300) in adult patients with type 2 diabetes (T2D) and type 1 diabetes (T1D).
MATERIALS AND METHODS
A literature search on Gla-300/Gla-100 in diabetes management was conducted using the MEDLINE/Embase/Cochrane databases from inception to 10 January 2021. Eligible studies considered for inclusion were parallel-design, randomized controlled trials (RCTs). The Cochrane risk-of-bias tool was used to evaluate the quality of the included studies. The random-effects model was applied for interpretation of the results.
RESULTS
Of 5348 records screened, 592 were assessed for eligibility and 15 RCTs were considered for data extraction and meta-analysis (T2D [N = 10; n = 7082]; T1D [N = 5; n = 2222]). In patients with T1D, all safety parameters were comparable between Gla-100 and Gla-300. In T2D, statistically significant differences were observed in favour of Gla-300 over Gla-100 for nocturnal and total hypoglycaemia. For efficacy parameters, a statistically and clinically significant difference favouring Gla-100 in basal insulin dose requirement was observed for both T2D and T1D. Change in HbA1c showed a statistically but not clinically significant reduction with Gla-100 compared with Gla-300 in T1D. Statistically significant but clinically less relevant differences favoured Gla-300 for control of body weight in T1D and T2D and Gla-100 for fasting blood glucose in T2D.
CONCLUSIONS
Gla-100 and Gla-300 had comparable efficacy and safety profiles in both T1D and T2D populations. Gla-300 showed a lower risk of nocturnal and total hypoglycaemia, significant in insulin-experienced/exposed patients with T2D. Patients on Gla-300 required significantly more units of insulin daily than the Gla-100 group to achieve equivalent efficacy.
Topics: Adult; Humans; Blood Glucose; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Hypoglycemia; Hypoglycemic Agents; Insulin Glargine; Insulin, Regular, Human; Treatment Outcome
PubMed: 36748186
DOI: 10.1111/dom.15007 -
Systematic Reviews May 2022Stem cell transplantation (SCT) has paved the way for treatment of autoimmune diseases. SCT has been investigated in type 1 diabetes mellitus (T1DM) as an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Stem cell transplantation (SCT) has paved the way for treatment of autoimmune diseases. SCT has been investigated in type 1 diabetes mellitus (T1DM) as an autoimmune-based disorder, but previous studies have not presented a comprehensive view of its effect on treatment of T1DM.
METHODOLOGY
After registration of the present systematic review and meta-analysis in the PROSPERO, a search was done according to the Cochrane guidelines for evaluation of clinical trials to find eligible clinical trials that investigated the effect of SCT on T1DM (based on ADA® diagnostic criteria) from PubMed, Web of science, Scopus, etc, as well as registries of clinical trials from January 1, 2000, to September 31, 2019. A search strategy was designed using MeSH and EM-tree terms. Primary outcome included the changes in the insulin total daily dose (TDD) (U/kg) level, and secondary outcomes included the changes in the HbA1c, c-peptide, and adjusted HbA1c levels. The Q Cochrane test and I statistic were performed to assess the heterogeneity and its severity in primary clinical trials. The Cochrane ROB was used to determine risk of bias, and Cochrane Handbook for Systematic Reviews of Interventions was used in the full text papers. The meta-analysis was accomplished in the STATA software, and the results were shown on their forest plots. Confounders were evaluated by the meta-regression test.
RESULTS
A total of 9452 studies were electronically screened, and 35 papers were included for data extraction. The results of this review study showed that 173 (26.5%) diabetic patients experienced insulin-free period (from 1 to 80 months), and 445 (68%) showed reduction in TDD of insulin after the SCT. Combination of hematopoietic stem cell (HSC) with mesenchymal stem cell (MSC) transplantation were significantly associated with improvement of the TDD (SMD: - 0.586, 95% CI: - 1.204/- 0.509, I: 0%), HbA1c (SMD: - 0.736, 95% CI: - 1.107/- 0.365, I: 0%), adjusted HbA1c (SMD: - 2.041, 95% CI: - 2.648/- 1.434, I: 38.4%), and c-peptide (SMD: 1.917, 95% CI: 0.192/3.641, I: 92.5%) on month 3 of follow-up, while its association had a growing trend from 3 to 12 months after the transplantation. Considering severe adverse events, HSC transplantation accompanied with conditioning could not be suggested as a safe treatment.
CONCLUSION
Most of the clinical trials of SCT in T1DM were single arm. Although meta-analysis illustrated the SCT is associated with T1DM improvement, well-designed randomized clinical trials are needed to clarify its efficacy.
RECOMMENDATION
Based on the results of this meta-analysis, the MSC and its combination with HSC could be considered as "Safe Cell" for SCT in T1DM. Furthermore, to evaluate the SCT efficacy, calculation of insulin TDD (U/kg/day), AUC of c-peptide, and adjusted HbA1c are highly recommended.
Topics: C-Peptide; Diabetes Mellitus, Type 1; Glycated Hemoglobin; Hematopoietic Stem Cell Transplantation; Humans; Insulin; Mesenchymal Stem Cell Transplantation
PubMed: 35501872
DOI: 10.1186/s13643-022-01950-3 -
Complementary Therapies in Medicine Nov 2022Prediabetes and type 2 Diabetes Mellitus (T2DM) are characterized by increased blood sugar concentration and insulin resistance. Although there are only a few reports of... (Meta-Analysis)
Meta-Analysis Review
Effect of flaxseed (Linum usitatissimum) supplementation on glycemic control and insulin resistance in prediabetes and type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
Prediabetes and type 2 Diabetes Mellitus (T2DM) are characterized by increased blood sugar concentration and insulin resistance. Although there are only a few reports of potential benefits of flaxseed's consumption on different metabolic parameters, there is no evidence of its effect among people with these conditions.
OBJECTIVES
The present systematic review and meta-analysis aimed to assess the effect of flaxseed supplementation on glycemic control variables and insulin resistance in prediabetes and T2DM.
METHODS
A literature search was conducted through PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science, to identify Randomized Control Trials (RCTs) that evaluated the effect of milled or ground flaxseed supplementation on fasting blood glucose, HbA1c, insulin concentrations, or HOMA-IR. The data were analyzed using Comprehensive Meta-Analysis (CMA) software version 3.3 in a fixed-effect model.
RESULTS
Seven studies were included in the systematic review and the meta-analysis, the results showed a significant reduction on fasting blood sugar (SMD: -0.392, 95% CI: -0.596, -0.187, p = <0.001, I = 64.81%) insulin concentrations, (SMD: -0.287, 95% CI: -0.534, -0.041, p = 0.022, I = 32.53%), HbA1c (SMD: -0.442, 95% CI: -0.770, -0.114, p = 0.008, I = 11.058%), and HOMA-IR (SMD: -0.284, 95% CI: -0.530, -0.038, p = 0.024, I = 0.00%) after flaxseed supplementation.
CONCLUSIONS
Flaxseed supplementation seems to improve glycemic control variables and insulin resistance in prediabetes and T2DM; however, more RCTs are needed to have more decisive evidence about doses, method of supplementation, and the possible effect of synergy with the dietetic treatment.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Dietary Supplements; Flax; Glycated Hemoglobin; Glycemic Control; Humans; Insulin; Insulin Resistance; Prediabetic State; Randomized Controlled Trials as Topic
PubMed: 35843472
DOI: 10.1016/j.ctim.2022.102852 -
Diabetes Research and Clinical Practice Apr 2022We performed a systematic review and meta-analysis to investigate the effects of high-intensity interval training (HIIT) on postprandial glucose (PPG) and insulin (PPI)... (Meta-Analysis)
Meta-Analysis Review
AIMS
We performed a systematic review and meta-analysis to investigate the effects of high-intensity interval training (HIIT) on postprandial glucose (PPG) and insulin (PPI) versus non-exercise control and moderate-intensity continuous training (MICT) in participants with both normal and impaired glucose.
METHODS
The PubMed, Scopus, and Web of Science electronic databases were searched up to October 2021 for randomized trials evaluating HIIT versus control and/or versus MICT on glucose and insulin AUC using oral glucose tolerance testing. Subgroup analyses based on intervention duration (short-duration < 8 weeks, moderate-duration ≥ 8 weeks), baseline glucose levels (normal glucose and impaired glucose) and type of HIIT (L-HIIT and SIT) were also conducted across included studies.
RESULTS
A total of 25 studies involving 870 participants were included in the current meta-analysis. HIIT effectively reduced glucose [-0.37 (95% CI -0.60 to -0.13), p = 0.002] and insulin [-0.36 (95% CI -0.68 to -0.04), p = 0.02] AUC when compared with a CON group. Reductions in glucose AUC were significant for those with impaired glucose at baseline (p = 0.03), but not for those with normal glucose levels (p = 0.11) and following moderate-duration (p = 0.01), but not short-duration interventions (p = 0.18). However, there were no differences in glucose (p = 0.76) or insulin (p = 0.43) AUC between HIIT and MICT intervention arms.
CONCLUSIONS
Our results demonstrated that both HIIT and MICT are effective for reducing postprandial glycemia and insulinemia, particularly by moderate-duration interventions, and in those with impaired glucose.
Topics: Blood Glucose; Glucose; High-Intensity Interval Training; Humans; Insulin; Insulin, Regular, Human
PubMed: 35271876
DOI: 10.1016/j.diabres.2022.109815 -
Neonatology 2022Glucagon is often used in neonatal hypoglycaemia, but its effects have not been systematically assessed. We undertook a systematic review to determine the efficacy and... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Glucagon is often used in neonatal hypoglycaemia, but its effects have not been systematically assessed. We undertook a systematic review to determine the efficacy and safety of glucagon treatment for neonatal hypoglycaemia.
METHODS
We searched MEDLINE, CINAHL, EMBASE, and CENTRAL from inception until May 2021. We included studies that reported one or more prespecified outcomes and compared glucagon with placebo or no glucagon. Studies were excluded if the majority (>70%) of participants were >1 month of age. Two authors independently extracted data. We used ROB-2/modified ROBINS-I to assess risk of bias, GRADE for certainty of evidence, and RevMan for meta-analysis.
RESULTS
100 studies were screened, 37 reviewed in full, and seven single-arm non-randomised intervention studies, involving 348 infants, were included (no trials). Data were insufficient to undertake meta-analysis of the critical outcomes (time to blood glucose normalization, recurrent hypoglycaemia, neurocognitive impairment). In 3 studies, ≥80% of neonates achieved normoglycaemia within 4 h of glucagon administration. However, recurrent hypoglycaemia was common (up to 55%). Glucagon increased blood glucose concentration at 1-2 h by 2.3 mmol/L (95% CI 2.1, 2.5) (low certainty evidence, 6 studies, N = 323). There were few data for other important clinical outcomes.
CONCLUSION
There is a paucity of evidence about the efficacy and safety of glucagon for treatment of neonatal hypoglycaemia. Low certainty evidence suggests that glucagon may increase blood glucose by ∼2.3 mmol/L but recurrent hypoglycaemia appears common. High-quality, randomized controlled trials are required to determine the role of glucagon in managing neonatal hypoglycaemia.
Topics: Blood Glucose; Glucagon; Humans; Hypoglycemia; Infant; Infant, Newborn
PubMed: 35263748
DOI: 10.1159/000522415 -
Current Drug Safety Nov 2013Patients suffering from diabetes mellitus (DM) may experience an increased risk of cancer; however, it is not certain whether this effect is due to diabetes per se. (Meta-Analysis)
Meta-Analysis Review
CARING (CAncer Risk and INsulin analoGues): the association of diabetes mellitus and cancer risk with focus on possible determinants - a systematic review and a meta-analysis.
BACKGROUND
Patients suffering from diabetes mellitus (DM) may experience an increased risk of cancer; however, it is not certain whether this effect is due to diabetes per se.
OBJECTIVE
To examine the association between DM and cancers by a systematic review and meta-analysis according to the PRISMA guidelines.
DATA SOURCES
The systematic literature search includes Medline at PubMed, Embase, Cinahl, Bibliotek.dk, Cochrane library, Web of Science and SveMed+ with the search terms: "Diabetes mellitus", "Neoplasms", and "Risk of cancer".
STUDY ELIGIBILITY CRITERIA
The included studies compared the risk of cancer in diabetic patients versus non-diabetic patients. All types of observational study designs were included.
RESULTS
Diabetes patients were at a substantially increased risk of liver (RR=2.1), and pancreas (RR=2.2) cancer. Modestly elevated significant risks were also found for ovary (RR=1.2), breast (RR=1.1), cervix (RR=1.3), endometrial (RR=1.4), several digestive tract (RR=1.1-1.5), kidney (RR=1.4), and bladder cancer (RR=1.1). The findings were similar for men and women, and unrelated to study design. Meta-regression analyses showed limited effect modification of body mass index, and possible effect modification of age, gender, with some influence of study characteristics (population source, cancer- and diabetes ascertainment).
LIMITATIONS
Publication bias seemed to be present. Only published data were used in the analyses.
CONCLUSIONS
The systematic review and meta-analysis confirm the previous results of increased cancer risk in diabetes and extend this to additional cancer sites. Physicians in contact with patients with diabetes should be aware that diabetes patients are at an increased risk of cancer.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Diabetes Complications; Diabetes Mellitus; Humans; Hypoglycemic Agents; Infant; Insulin; Middle Aged; Neoplasms; Publication Bias; Regression Analysis; Risk; Young Adult
PubMed: 24215312
DOI: 10.2174/15748863113086660071 -
Endocrine Practice : Official Journal... Apr 2021The transition of diabetes care from home to hospital, within the hospital, and upon discharge is fraught with gaps that can adversely affect patient safety and length... (Review)
Review
OBJECTIVE
The transition of diabetes care from home to hospital, within the hospital, and upon discharge is fraught with gaps that can adversely affect patient safety and length of stay. We aimed to highlight the variability in care during these transitions and point out areas where research is needed.
METHODS
A PubMed search was performed with a combination of search terms that pertained to diabetes, hyperglycemia, hospitalization, locations in the hospital, discharge to home or a nursing facility, and diabetes medications. Studies with at least 50 patients that were written in the English language were included.
RESULTS
With the exception of transitioning from intravenous insulin infusion to subcutaneous insulin and perhaps admission to the regular floors, few studies pointedly focused on transitions of care, leading us to extrapolate recommendations based on data from disparate areas of care in the hospital. There is evidence at every stage of care, starting from the entry into the hospital and ending with discharge home or to a facility, that patients benefit from having protocols in place guiding overall care.
CONCLUSION
Pockets of care exist in hospitals where methods of effective diabetes management have been studied and implemented. However, there is no sustained continuum of care. Protocols and care teams that follow patients from one physical location to the other may result in improved clinical outcomes during and following a hospital stay.
Topics: Hospitalization; Humans; Hyperglycemia; Inpatients; Insulin; Patient Discharge
PubMed: 33529732
DOI: 10.1016/j.eprac.2021.01.016 -
Journal of Affective Disorders Aug 2023Although insulin resistance (IR) and cardiometabolic syndrome are prevalent in patients with bipolar disorder (BD), only a few studies have attempted to precisely assess... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Although insulin resistance (IR) and cardiometabolic syndrome are prevalent in patients with bipolar disorder (BD), only a few studies have attempted to precisely assess the degree and clinical impact of IR in BD.
METHODS
A comprehensive search was conducted from multiple research databases through May 2022, following a pre-defined protocol (PROSPERO: CRD42022359259). We extracted neuroimaging, cognition, illness course, and treatment response findings from individuals with BD with evidence of IR compared with euglycemic BD individuals.
RESULTS
Of 1436 identified articles, 10 reports fulfilling inclusion criteria were included (n = 1183). BD patients with IR displayed worse composite verbal memory scores and worse executive function and exhibited smaller hippocampal volumes along with prefrontal neurochemical alterations compared to euglycemic BD patients. Fixed-effect meta-analysis revealed that BD patients with impaired glucose metabolism (IGM) were more likely to develop a chronic and rapid cycling course when compared with euglycemic BD patients (k = 2, OR = 2.96, 95 % CI 1.69-5.17, OR = 2.88, 95 % CI 1.59-5.21, p < 0.001, respectively), with a trend for significantly lower Global Assessment of Functioning scores (k = 5, MD = -4, 95 % CI -8.23-0.23, p = 0.06). BD patients with IGM displayed a higher rate of poor response to mood stabilizers when compared with euglycemic BD patients (k = 2, OR = 6.74, 95 % CI 1.04-43.54, p = 0.04).
LIMITATIONS
Cross-sectional design and small sample sizes of studies included limit the generalizability of results.
CONCLUSION
IR is associated with worse clinical outcomes of BD and inadequate treatment response. Implementing strategies to prevent and treat IR in BD is crucial to improve the prognosis of such a difficult-to-treat population.
Topics: Humans; Bipolar Disorder; Cross-Sectional Studies; Executive Function; Immunoglobulin M; Insulin Resistance; Insulin
PubMed: 37086806
DOI: 10.1016/j.jad.2023.04.068