PP439 Data Driven Subgroups Of Patients With Type 1 Diabetes Based On Health Technology For Insulin Delivery

2021 ◽  
Vol 37 (S1) ◽  
pp. 37-37
Author(s):  
Francisco Javier Somolinos Simón ◽  
Gema García Sáez ◽  
Jose Tapia Galisteo ◽  
Maria Elena Hernando Pérez
Keyword(s):  
Hba1c Level ◽  
Insulin Delivery ◽  
Health Technology ◽  
Data Driven ◽  
Controlled Trials ◽  
Delivery Method ◽  
Real World Data ◽  
Men And Women ◽  
Randomized Controlled

IntroductionPatients with type 1 diabetes (T1D) require the administration of insulin to maintain glycemic control. Currently, two modes of subcutaneous insulin delivery have gained wider acceptance: multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII). Randomized controlled trials have shown that CSII is associated with a slightly lower glycated hemoglobin (HbA1c) level when compared with MDI.The case study on diabetes by the H2020 Next Generation Health Technology Assessment project aims to link evidence from randomized controlled trials to real-world data to estimate the impact of health technology on specific subgroups of patients, as a first step in building prediction models to personalize treatment strategies. This work aims to assess whether patients with T1D can be stratified according to the use of health technology for insulin delivery and associated glycemic control from real-world data.MethodsWe used a longitudinal prospective data repository of T1D patients from 83 clinics in the United States (T1D exchange). A data-driven two-step clustering analysis was done on adult individuals (n = 8,034) with more than five years of disease duration. Clusters were based on body mass index (BMI), sex, age at diagnosis, diabetes duration, HbA1c level, and insulin delivery method. The optimal number of clusters was estimated based on silhouette width.ResultsWe identified the following four clusters of T1D patients characterized by differences in gender and insulin delivery method: men and women with insulin injections or pens and men and women with CSII. Individuals that used CSII had lower HbA1c levels, a higher BMI, and longer diabetes duration than those using Injections or pens.ConclusionsThis preliminary work identified subgroups of T1D patients linked to insulin delivery methods. Future research includes the study of complications associated with different clusters and additional data sources. While the data were sourced from the T1D Exchange, the analyses, content, and conclusions presented have not been reviewed or approved by the T1D Exchange.

scholarly journals Incorporating single-arm studies in meta-analysis of randomised controlled trials: a simulation study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Janharpreet Singh ◽  
Keith R. Abrams ◽  
Sylwia Bujkiewicz
Keyword(s):  
Simulation Study ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Health Technology ◽  
Small Error ◽  
Aggregate Data ◽  
Controlled Trials ◽  
Real World Data ◽  
Study Heterogeneity ◽  
Randomised Controlled

Abstract Background Use of real world data (RWD) from non-randomised studies (e.g. single-arm studies) is increasingly being explored to overcome issues associated with data from randomised controlled trials (RCTs). We aimed to compare methods for pairwise meta-analysis of RCTs and single-arm studies using aggregate data, via a simulation study and application to an illustrative example. Methods We considered contrast-based methods proposed by Begg & Pilote (1991) and arm-based methods by Zhang et al (2019). We performed a simulation study with scenarios varying (i) the proportion of RCTs and single-arm studies in the synthesis (ii) the magnitude of bias, and (iii) between-study heterogeneity. We also applied methods to data from a published health technology assessment (HTA), including three RCTs and 11 single-arm studies. Results Our simulation study showed that the hierarchical power and commensurate prior methods by Zhang et al provided a consistent reduction in uncertainty, whilst maintaining over-coverage and small error in scenarios where there was limited RCT data, bias and differences in between-study heterogeneity between the two sets of data. The contrast-based methods provided a reduction in uncertainty, but performed worse in terms of coverage and error, unless there was no marked difference in heterogeneity between the two sets of data. Conclusions The hierarchical power and commensurate prior methods provide the most robust approach to synthesising aggregate data from RCTs and single-arm studies, balancing the need to account for bias and differences in between-study heterogeneity, whilst reducing uncertainty in estimates. This work was restricted to considering a pairwise meta-analysis using aggregate data.

Need for high-quality studies in health technology assessments: The case of a systematic review of treatment for retinoblastoma

2006 ◽  
Vol 22 (4) ◽  
pp. 408-418 ◽  
Author(s):  
Catriona M. Mc Daid ◽  
Suzanne Hartley ◽  
Anne-Marie Bagnall ◽  
Gill Ritchie ◽  
Kate Light ◽  
...  
Keyword(s):  
Systematic Review ◽  
Methodological Quality ◽  
Retrospective Studies ◽  
Treatment Success ◽  
Relative Effectiveness ◽  
Health Technology ◽  
Controlled Trials ◽  
High Quality ◽  
Treatment Groups ◽  
Randomized Controlled

Objectives: The aim of this study was to conduct a systematic review of the evidence for treatments for retinoblastoma in children.Methods: Seventeen electronic databases were searched. Two reviewers independently selected studies. Studies of participants diagnosed with childhood retinoblastoma, any interventions, and all clinical outcomes were eligible. Randomized and nonrandomized controlled trials and cohort studies with clear comparisons between treatment groups were included. Methodological quality was assessed.Results: Thirty-one observational comparative studies were included, of which twenty-seven were retrospective. The methodological quality was generally poor, with a high risk of selection bias in all studies. Although there were high levels of treatment success in many of the studies, due to the limitations of the evidence identified, it was not possible to make meaningful and robust conclusions about the relative effectiveness of different treatment approaches for retinoblastoma in children.Conclusions: Good quality randomized controlled trials are required. Where controlled trials are not feasible, only high quality prospective, nonrandomized studies should be given consideration, due to the generally higher risk of bias in retrospective studies.

scholarly journals The road from intermittently scanned continuous glucose monitoring to hybrid closed-loop systems. Part B: results from randomized controlled trials

2019 ◽  
Vol 10 ◽  
pp. 204201881987190 ◽  
Author(s):  
Francesca De Ridder ◽  
Marieke den Brinker ◽  
Christophe De Block
Keyword(s):  
Randomized Controlled Trials ◽  
Continuous Glucose Monitoring ◽  
Closed Loop ◽  
Glucose Monitoring ◽  
Insulin Delivery ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Closed Loop Systems ◽  
Adults And Children

Background: Advances in diabetes technology have been exponential in the last few decades. With evolution in continuous glucose monitoring (CGM) systems and its progressive automation in control of insulin delivery, these advances have changed type 1 diabetes mellitus (T1DM) management. These novel technologies have the potential to improve glycated haemoglobin (HbA1c), reduce hypoglycaemic events, increase time spent in range and improve quality of life (QoL). Our aim was to evaluate the sustained effects in free-living unsupervised conditions of CGM systems (intermittently scanned and real time) and insulin delivery [from multiple daily injections, via sensor-augmented pump therapy and (predictive) low-glucose insulin suspension to hybrid closed-loop systems] on glucose control and QoL in adults and children with T1DM. Methods: We performed a systematic review of randomized controlled trials (RCTs), using PubMed and the Cochrane library up to 30 May 2019. Inclusion of RCTs was based on type of intervention (comparing glucose-monitoring devices and insulin-delivery devices), population (nonpregnant adults and children with T1DM), follow-up (outpatient setting for at least 8 weeks) and relevant outcomes [HbA1c, time in range (TIR), time in target, time in hypoglycaemia and QoL]. Exclusion of RCTs was based on intervention (exercise, only overnight use). The Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines were used to score the quality of the papers and for the final selection of the articles. Results: Our search resulted in 214 articles, of which 19 were eligible. Studies on advanced use in adults and children with T1DM reported increased TIR (all 9 studies); decreased time in hypoglycaemia (13 out of 15 studies); lowered HbA1c levels (5 out of 15 studies); improved QoL (10 of 16 studies) and treatment satisfaction (7 studies). Conclusions: Recent technologies have dramatically changed the course of T1DM. They are proving useful in controlling glycaemia in patients with T1DM, without increasing the treatment burden.

scholarly journals 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

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)    

scholarly journals A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing the Safety of Dapagliflozin in Type 1 Diabetes Patients

2020 ◽  
Author(s):  
Sumanta Saha ◽  
Sujata Saha
Keyword(s):  
Systematic Review ◽  
Type 1 Diabetes ◽  
Side Effects ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled

Background and Purpose: The dapagliflozin’s safety profile in insulin-treated adult type-1 diabetes mellites (T1DM) patients remains poorly explored. Therefore, this systematic review and meta-analysis compared the risk of all-cause side effects, study discontinuation of participants due to side effects, urinary tract infection (UTI), diabetic ketoacidosis, and hypoglycemia between dapagliflozin 10 mg and dapagliflozin 5 mg, dapagliflozin 10 mg and placebo, and dapagliflozin 5 mg and placebo.Materials and Methods: Parallel-arm randomized controlled trials juxtaposing the above outcomes between the afore-mentioned interventions were eligible for inclusion in this study and were searched in PubMed, Embase, and Scopus. Utilizing the Cochrane tool, the risk of bias was assessed in the recruited trials. Finally, by random-effect meta-analysis, each outcome was compared among the above interventions, and the risk ratio was estimated.Results: Four trials of varying length (1-52 weeks) sourcing data from almost 1760 participants from about 32 nations were reviewed. Overall, the trials had a low or unclear risk of bias, and only one was at a high risk of bias.  Compared to the placebo, the risk of side effects was higher in those treated with dapagliflozin 5 mg (RR=1.10; 95% CI=1.02-1.18; p=0.014; I2=0%). UTI risk was less with the 10mg dapagliflozin than its lower dose (RR=0.50; 95% CI=0.32-0.79; p-value=0.003; I2=0%). All the remaining comparisons were statistically not significantly different between the juxtaposed intervention pairs.Conclusion: In contrast to placebo, dapagliflozin 5mg increased the risk of overall adversities in insulin-treated type-1 diabetes, and dapagliflozin 10 mg had a reduced risk of UTI than its 5mg preparation.

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