RESUMEN
AIMS: To compare the efficacy and safety of different hybrid closed loop (HCL) systems in people with diabetes through a network meta-analysis. METHODS: We searched MEDLINE, EMBASE, CENTRAL and PubMed for randomised clinical trials (RCTs) enrolling children, adolescents and/or adults with type 1 or type 2 diabetes, evaluating Minimed 670G, Minimed 780G, Control-IQ, CamAPS Fx, DBLG-1, DBLHU, and Omnipod 5 HCL systems against other types of insulin therapy, and reporting time in target range (TIR) as outcome. RESULTS: A total of 28 RCTs, all enrolling people with type 1 diabetes, were included. HCL systems significantly increased TIR compared with subcutaneous insulin therapy without continuous glucose monitoring (SIT). Minimed 780G achieved the highest TIR ahead of Control IQ (mean difference (MD) 5.1%, 95% confidence interval (95% CI) [0.68; 9.52], low certainty), Minimed 670G (MD 7.48%, 95% CI [4.27; 10.7], moderate certainty), CamAPS Fx (MD 8.94%, 95% CI [4.35; 13.54], low certainty), and DBLG1 (MD 10.69%, 95% CI [5.73; 15.65], low certainty). All HCL systems decreased time below target range, with DBLG1 (MD -3.69%, 95% CI [-5.2; -2.19], high certainty), Minimed 670G (MD -2.9%, 95% CI [-3.77; -2.04], moderate certainty) and Minimed 780G (MD -2.79%, 95% CI [-3.94; -1.64], high certainty) exhibiting the largest reductions compared to SIT. The risk of severe hypoglycaemia and diabetic ketoacidosis was similar to other types of insulin therapy. CONCLUSIONS: We show a hierarchy of efficacy among the different HCL systems in people with type 1 diabetes, thus providing support to clinical decision-making. TRIAL REGISTRATION: PROSPERO CRD42023453717.
Asunto(s)
Diabetes Mellitus Tipo 1 , Hipoglucemiantes , Sistemas de Infusión de Insulina , Insulina , Humanos , Glucemia/análisis , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/uso terapéutico , Insulina/administración & dosificación , Insulina/uso terapéutico , Metaanálisis en Red , Pronóstico , Ensayos Clínicos Controlados Aleatorios como Asunto , Monitoreo Continuo de Glucosa/instrumentación , Monitoreo Continuo de Glucosa/métodosRESUMEN
BACKGROUND: Amidst the escalating prevalence of glucose-related chronic diseases, the advancements, potential uses, and growing accessibility of continuous glucose monitors (CGM) have piqued the interest of healthcare providers, consumers, and health behaviour researchers. Yet, there is a paucity of literature characterising the use of CGM in behavioural intervention research. This scoping review aims to describe targeted populations, health behaviours, health-related outcomes, and CGM protocols in randomised controlled trials (RCTs) that employed CGM to support health behaviour change. METHODS: We searched Ovid MEDLINE, Elsevier Embase, Cochrane Central Register of Controlled Trials, EBSCOhost PsycINFO, and ProQuest Dissertations & Theses Global from inception to January 2024 for RCTs of behavioural interventions conducted in adults that incorporated CGM-based biological feedback. Citation searching was also performed. The review protocol was registered ( https://doi.org/10.17605/OSF.IO/SJREA ). FINDINGS: Collectively, 5389 citations were obtained from databases and citation searching, 3995 articles were screened, and 31 were deemed eligible and included in the review. Most studies (n = 20/31, 65%) included adults with type 2 diabetes and reported HbA1c as an outcome (n = 29/31, 94%). CGM was most commonly used in interventions to target changes in diet (n = 27/31, 87%) and/or physical activity (n = 16/31, 52%). 42% (n = 13/31) of studies provided prospective CGM-based guidance on diet or activity, while 61% (n = 19/31) included retrospective CGM-based guidance. CGM data was typically unblinded (n = 24/31, 77%) and CGM-based biological feedback was most often provided through the CGM and two-way communication (n = 12/31, 39%). Communication typically occurred in-person (n = 13/31, 42%) once per CGM wear (n = 13/31; 42%). CONCLUSIONS: This scoping review reveals a predominant focus on diabetes in CGM-based interventions, pointing out a research gap in its wider application for behaviour change. Future research should expand the evidence base to support the use of CGM as a behaviour change tool and establish best practices for its implementation. TRIAL REGISTRATION: doi.org/10.17605/OSF.IO/SJREA.
Asunto(s)
Glucemia , Monitoreo Continuo de Glucosa , Conductas Relacionadas con la Salud , Humanos , Automonitorización de la Glucosa Sanguínea/métodos , Monitoreo Continuo de Glucosa/métodos , Diabetes Mellitus Tipo 2 , Hemoglobina Glucada/análisis , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVE: The aim of this analysis was to assess glycemic control before and during the coronavirus disease (COVID-19) pandemic. METHODS: Data from 64 (main analysis) and 80 (sensitivity analysis) people with type 1 diabetes (T1D) using intermittently scanned continuous glucose monitoring (isCGM) were investigated retrospectively. The baseline characteristics were collected from electronic medical records. The data were examined over three periods of three months each: from 16th of March 2019 until 16th of June 2019 (pre-pandemic), from 1st of December 2019 until 29th of February 2020 (pre-lockdown) and from 16th of March 2020 until 16th of June 2020 (lockdown 2020), representing the very beginning of the COVID-19 pandemic and the first Austrian-wide lockdown. RESULTS: For the main analysis, 64 individuals with T1D (22 female, 42 male), who had a mean glycated hemoglobin (HbA1c) of 58.5 mmol/mol (51.0 to 69.3 mmol/mol) and a mean diabetes duration 13.5 years (5.5 to 22.0 years) were included in the analysis. The time in range (TIR[70-180mg/dL]) was the highest percentage of measures within all three studied phases, but the lockdown 2020 phase delivered the best data in all these cases. Concerning the time below range (TBR[<70mg/dL]) and the time above range (TAR[>180mg/dL]), the lockdown 2020 phase also had the best values. Regarding the sensitivity analysis, 80 individuals with T1D (26 female, 54 male), who had a mean HbA1c of 57.5 mmol/mol (51.0 to 69.3 mmol/mol) and a mean diabetes duration of 12.5 years (5.5 to 20.7 years), were included. The TIR[70-180mg/dL] was also the highest percentage of measures within all three studied phases, with the lockdown 2020 phase also delivering the best data in all these cases. The TBR[<70mg/dL] and the TAR[>180mg/dL] underscored the data in the main analysis. CONCLUSION: Superior glycemic control, based on all parameters analyzed, was achieved during the first Austrian-wide lockdown compared to prior periods, which might be a result of reduced daily exertion or more time spent focusing on glycemic management.
Asunto(s)
COVID-19 , Monitoreo Continuo de Glucosa , Diabetes Mellitus Tipo 1 , Control Glucémico , Monitoreo Continuo de Glucosa/métodos , Humanos , Masculino , Femenino , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/epidemiología , COVID-19/epidemiología , Austria/epidemiología , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea/métodos , Estudios RetrospectivosRESUMEN
OBJECTIVE: To estimate the budget impact of the potential coverage of FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) for glycemia monitoring in all type 1 diabetes mellitus (T1DM) patients and in those with type 2 diabetes mellitus (T2DM) with multiple daily insulin injections, from the social security and the private third-party payer's perspective in Argentina. METHODS: A budget impact model was developed to estimate the cost difference between the self-monitoring of blood glucose (standard of care) and FSL over 5 years. Input parameters were retrieved from local literature complemented by expert opinion. Health care costs were estimated by a micro-costing approach and reported in USD as of April 2022 (1 USD = 113.34 Argentine pesos). One-way sensitivity and scenario analyses were conducted. RESULTS: From a social security third-party payer perspective, the incorporation of FSL was associated with net savings per member per month (PMPM) of $0.026 (Year 1) to $0.097 (Year 5) and net savings PMPM of $0.002 (Year 1) to $0.008 (Year 5) for T1DM and T2DM patients, respectively. Similar findings are reported from the private third-party payer perspective. The budget impact results were more sensitive to the acquisition costs of the FSL and test strips. CONCLUSION: The potential coverage of FSL in patients with T1DM and T2DM with multiple daily insulin injections could be associated with small financial savings considering current technology acquisition costs (FSL and test strips) for social security and the private sector third-party payers in Argentina.