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BACKGROUND: Automated insulin delivery (AID) devices have shown to be a promising treatment to improve glycemic control in patients with type 1 diabetes mellitus (T1DM). However, its efficacy in pregnant women with T1DM remains uncertain. METHODS: PubMed, Scopus, Cochrane Central and ClinicalTrials.gov were systematically searched for randomized controlled trials (RCTs) comparing AID to standard care (SC), defined as use of sensor-augmented pump and multiple daily insulin injections. Outcomes included time in range (TIR), nocturnal TIR, time in hypoglycemic and hyperglycemic ranges, among others. Sensitivity and trial sequential analyses (TSA) were performed. PROSPERO ID: CRD42023474398. RESULTS: We included five RCTs with a total of 236 pregnant women, of whom 117 (50.6%) received AID. There was a significant increase in nocturnal TIR (mean difference [MD] 12.69%; 95% CI 8.74-16.64; p < 0.01; I2 = 0%) and a decrease in glucose variability (standard deviation of glucose; MD -2.91; 95% CI -5.13 to -0.69; p = 0.01; I2 = 0%). No significant differences were observed for TIR, HBGI, LGBI, mean glucose and time spent in hyperglycemia and hypoglycemia. Regarding TSA, the statistical significance obtained in nocturnal TIR was conclusive and with minimal risk of a type I error. CONCLUSION: Our findings suggest that AID systems can significantly improve nocturnal glycemic control and potentially reduce glycemic variability in pregnant women with T1DM, with no effect in the risk of hypoglycemia and hyperglycemia compared with current insulin treatments.
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Diabetes Mellitus Tipo 1 , Hipoglicemiantes , Sistemas de Infusão de Insulina , Insulina , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto , Feminino , Humanos , Gravidez , Glicemia/metabolismo , Glicemia/análise , Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/sangue , Controle Glicêmico/métodos , Controle Glicêmico/instrumentação , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Gravidez em Diabéticas/tratamento farmacológico , Gravidez em Diabéticas/sangue , Resultado do TratamentoRESUMO
BACKGROUND: Evidence regarding the implementation of medium-term strategies in advanced hybrid closed-loop (AHCL) system users is limited. Therefore, this study aimed to describe the efficacy and safety of the AHCL system in patients with type 1 diabetes (T1D) on a six-month follow-up in a virtual diabetes clinic (VDC). METHOD: A prospective cohort of adult patients with T1D treated using the AHCL system (Mini Med 780G; Medtronic, Northridge, California) in a VDC follow-up. Standardized training and follow-up were conducted virtually. Clinical data and metabolic control outcomes were reported at baseline, and at three and six months. RESULTS: Sixty-four patients (mean age = 42 ± 14.6 years, 65% men, 54% with graduate education) were included. Percentage time in range (%TIR) increased significantly regardless of prior therapy with intermittently scanned continuous glucose monitoring + multiple daily injections and sensor-augmented pump therapy with predictive low-glucose management after starting AHCL and persisted during the follow-up period with no hypoglycemic events. The %TIR 70 to 180 mg/dL according to socioeconomic strata was 73.4% ± 5.3%, 78.1% ± 8.1%, and 84.2% ± 7.5% for the lower, middle, and upper strata, respectively. The sensor was used more frequently in the population with a higher education level. Adherence to sensor use and SmartGuard retention were higher in patients who underwent the VDC follow-up. CONCLUSIONS: Medium-term follow-up of users of AHCL systems in a VDC contributes to safely achieving %TIR goals. Virtual diabetes clinic follow-up favored adherence to sensor use and continuous SmartGuard use. Socioeconomic strata were associated with a better glycemic profile and education level was associated with better adherence to sensor use.
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BACKGROUND AND AIMS: Evidence supports the efficacy and safety of the Hybrid Close loop (HCL) system in patients with type 1 diabetes (T1D). However, limited data are available on the long-term outcomes of patients on HCL with telemedicine follow-up. METHODS: A prospective observational cohort study including T1D patients, who were upgrading to HCL system. Virtual training and follow-up were done through telemedicine. CGM data were analyzed to compare the baseline time in range (TIR), time below range (TBR), glycemic variability and auto mode (AM), with measurements performed at 3, 6 and 12 months. RESULTS: 134 patients were included with baseline A1c 7.6% ± 1.1. 40.5% had a severe hypoglycemia event in the last year. Baseline TIR, measured two weeks after starting AM was 78.6 ± 9.94%. No changes were evident at three (Mean difference - 0.15;CI-2.47,2.17;p = 0.96), six (MD-1.09;CI-3.42,1.24;p = 0.12) and 12 months (MD-1.30;CI-3.64,1.04;p = 0.08). No significant changes were found in TBR or glycemic variability throughout the follow-up. Use of AM was 85.6 ± 17.5% and percentage of use of sensor was 88.75 ± 9.5% at 12 months. No severe hypoglycemic (SH) events were reported. CONCLUSIONS: HCL systems allow to improve TIR, TBR and glycemic variability safely, early and sustained up to 1 year of follow-up in patients with T1D and high risk of hypoglycemia followed through telemedicine.
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Diabetes Mellitus Tipo 1 , Hipoglicemia , Telemedicina , Humanos , Diabetes Mellitus Tipo 1/etiologia , Insulina/uso terapêutico , Glicemia , Estudos Prospectivos , Sistemas de Infusão de Insulina/efeitos adversos , Hipoglicemiantes/uso terapêutico , Hipoglicemia/etiologia , Hipoglicemia/induzido quimicamente , Automonitorização da GlicemiaRESUMO
The goal of this study was to assess the 6-month effectiveness of hybrid closed loop on glycemic control in type 1 diabetes (T1D) patients in Latin America. An exploratory analysis of data prospectively collected from non-selected consecutive patients with T1D who initiated treatment with the MiniMed™ 670G system in Argentina was conducted. Baseline and follow-up visits at days 7, 28, 90, and 180 were carried out and data were downloaded at each visit. A total of 30 patients (age range 9-57 years, female 63.3%), 73.3% (n = 22) of whom previously used sensor augmented pump-predictive low glucose management (SAP-PLGM), with baseline glycated hemoglobin 7.4% ± 1% were included. Time in range between 70 and 180 mg/dL significantly increased from 65.1% at baseline to 77.3%, 76.2%, 75.7%, and 75.2% at days 7, 28, 90 and 180, respectively. Time above range (>180 mg/dL) significantly decreased from 33% to 22.5% (P < 0.001), while time below range (<70 mg/dL) did not change. Mean glucose levels were reduced from 163.5 mg/dL at baseline to 150.9 mg/dL (P = 0.001) at last visit. The Auto Mode feature was used > 90% of the time. Virtual training was successfully completed with a Net Promoter Score® (NPS®) of 87%. This analysis confirms that MiniMed 670G system use allowed successful achievement of glycemic control within recommended targets in a non-selected Latin American patient population who underwent virtual system training.
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Diabetes Mellitus Tipo 1 , Adolescente , Adulto , Glicemia/análise , Automonitorização da Glicemia , Criança , Diabetes Mellitus Tipo 1/tratamento farmacológico , Feminino , Controle Glicêmico , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , América Latina , Pessoa de Meia-Idade , Adulto JovemRESUMO
BACKGROUND AND AIMS: In Colombia, the government established mandatory isolation after the first case of COVID-19 was reported. As a diabetes care center specialized in technology, we developed a virtual training program for patients with type 1 diabetes (T1D) who were upgrading to hybrid closed loop (HCL) system. The aim of this study is to describe the efficacy and safety outcomes of the virtual training program. METHOD: ology: A prospective observational cohort study was performed, including patients with diagnosis of T1D previously treated with multiple doses of insulin (MDI) or sensor augmented pump therapy (SAP) who were updating to HCL system, from March to July 2020. Virtual training and follow-up were done through the Zoom video conferencing application and Medtronic Carelink System version 3.1 software. CGM data were analyzed to compare the time in range (TIR), time below range (TBR) and glycemic variability, during the first two weeks corresponding to manual mode with the final two weeks of follow-up in automatic mode. RESULTS: 91 patients were included. Mean TIR achieved with manual mode was 77.3 ± 11.3, increasing to 81.6% ± 7.6 (p < 0.001) after two weeks of auto mode use. A significant reduction in TBR <70 mg/dL (2,7% ± 2,28 vs 1,83% ± 1,67, p < 0,001) and in glycemic variability (% coefficient of variation 32.4 vs 29.7, p < 0.001) was evident, independently of baseline therapy. CONCLUSION: HCL systems allows T1D patients to improve TIR, TBR and glycemic variability independently of previous treatment. Virtual training can be used during situations that limit the access of patients to follow-up centers.