Control metabólico y recursos tecnológicos de niños con diabetes durante la pandemia de COVID-19 / Metabolic control and technological resources for children with diabetes during the COVID-19 pandemic

Introducción: La diabetes en pacientes con COVID-19 se asocia a mayor morbilidad y mortalidad. El aislamiento social podría dificultar el acceso a la atención e insumos médicos. Nuestro objetivo fue describir el control glucémico durante la pandemia y los recursos médicos y tecnológicos disponibles. Métodos: Estudio retrospectivo, descriptivo, analítico y transversal. Se analizaron los resultados de una encuesta realizada a pacientes diabéticos del Hospital de Pediatría Juan P. Garrahan. Se indagó infección por coronavirus, proximidad geográfica, control metabólico, cobertura, insumos y conectividad. Resultados: No se informaron casos de COVID-19. El 52,9% vivía a más de dos horas de viaje. El 95,7% realizó 4 o más glucemias diarias, el 12,8% estuvo en el rango glucémico ideal de 70-140 mg%, el 75,2% entre 140-250 mg% y el 12% por encima de 250 mg%. El 6,8% presentó cetosis y el 3,4% hipoglucemia severa. El 17,9% refirió dificultades para conseguir insumos. Todos poseían internet, 12% con limitaciones. El 10% que vivía a 2 o más horas del hospital estuvo en rango ideal vs. 28% de los que vivían más cerca (p=0,02). El 96,4% de los que retiraron insumos de su cobertura social o provincial alcanzaron un control metabólico aceptable (70-250 mg%) vs. 79,5% de los que lo hicieron en el hospital. (p=0,0002). Conclusiones: La mayoría presentó un control metabólico aceptable. La distancia y las dificultades de disponibilidad de insumos, se asociaron a peor control glucémico. La conectividad y recursos tecnológicos son limitados (AU)

Introduction: In patients with diabetes who are infected with COVID-19, the latter is associated with increased morbidity and mortality. Social isolation may complicate access to care and medical supplies. Our aim was to describe glycemic control during the pandemic and the medical and technological resources available. Methods: Retrospective, descriptive, analytical, and cross-sectional study. The results of a survey conducted in patients with diabetes seen at Hospital de Pediatría Juan P. Garrahan were analyzed. Coronavirus infection, geographic proximity to the hospital, metabolic control, healthcare coverage, supplies, and connectivity were investigated. Results: No cases of COVID-19 were reported. Overall, 52.9% lived more than two hours travel from the hospital; 95.7% performed four or more daily capillary blood glucose measurements; in 12.8% blood glucose was within the target range of 70-140 mg%, in 75.2% it was between 140-250 mg%, and in 12% above 250 mg%; 6.8% had ketosis and 3.4% severe hypoglycemia. Overall, 17.9% reported difficulties in obtaining medical supplies. All had internet access, although 12% with limitations. Ten percent of the patients who lived 2 or more hours from the hospital had blood glucose levels within the target range vs. 28% of those who lived closer (p=0.02); 96.4% of those who received diabetes supplies from their social or provincial insurance achieved acceptable metabolic control (70-250 mg%) vs. 79.5% of those who did so from the hospital (p=0,0002). Conclusions: The majority of patients had acceptable metabolic control. Distance and difficulties in the availability of supplies were associated with worse glycemic control. Connectivity and technological resources are limited (AU)

Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes.

BACKGROUND: The possible advantage of hybrid closed-loop therapy (i.e., artificial pancreas) over sensor-augmented pump therapy in very young children with type 1 diabetes is unclear. METHODS: In this multicenter, randomized, crossover trial, we recruited children 1 to 7 years of age with type 1 diabetes who were receiving insulin-pump therapy at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Participants received treatment in two 16-week periods, in random order, in which the closed-loop system was compared with sensor-augmented pump therapy (control). The primary end point was the between-treatment difference in the percentage of time that the sensor glucose measurement was in the target range (70 to 180 mg per deciliter) during each 16-week period. The analysis was conducted according to the intention-to-treat principle. Key secondary end points included the percentage of time spent in a hyperglycemic state (glucose level, >180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level, <70 mg per deciliter). Safety was assessed. RESULTS: A total of 74 participants underwent randomization. The mean (±SD) age of the participants was 5.6±1.6 years, and the baseline glycated hemoglobin level was 7.3±0.7%. The percentage of time with the glucose level in the target range was 8.7 percentage points (95% confidence interval [CI], 7.4 to 9.9) higher during the closed-loop period than during the control period (P<0.001). The mean adjusted difference (closed-loop minus control) in the percentage of time spent in a hyperglycemic state was -8.5 percentage points (95% CI, -9.9 to -7.1), the difference in the glycated hemoglobin level was -0.4 percentage points (95% CI, -0.5 to -0.3), and the difference in the mean sensor glucose level was -12.3 mg per deciliter (95% CI, -14.8 to -9.8) (P<0.001 for all comparisons). The time spent in a hypoglycemic state was similar with the two treatments (P = 0.74). The median time spent in the closed-loop mode was 95% (interquartile range, 92 to 97) over the 16-week closed-loop period. One serious adverse event of severe hypoglycemia occurred during the closed-loop period. One serious adverse event that was deemed to be unrelated to treatment occurred. CONCLUSIONS: A hybrid closed-loop system significantly improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in hypoglycemia. (Funded by the European Commission and others; ClinicalTrials.gov number, NCT03784027.).

Current provision and HCP experiences of remote care delivery and diabetes technology training for people with type 1 diabetes in the UK during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has led to the rapid implementation of remote care delivery in type 1 diabetes. We studied current modes of care delivery, healthcare professional experiences and impact on insulin pump training in type 1 diabetes care in the United Kingdom (UK). METHODS: The UK Diabetes Technology Network designed a 48-question survey aimed at healthcare professionals providing care in type 1 diabetes. RESULTS: One hundred and forty-three healthcare professionals (48% diabetes physicians, 52% diabetes educators and 88% working in adult services) from approximately 75 UK centres (52% university hospitals, 46% general and community hospitals), responded to the survey. Telephone consultations were the main modality of care delivery. There was a higher reported time taken for video consultations versus telephone (p < 0.001). Common barriers to remote consultations were patient familiarity with technology (72%) and access to patient device data (67%). We assessed the impact on insulin pump training. A reduction in total new pump starts (73%) and renewals (61%) was highlighted. Common barriers included patient digital literacy (61%), limited healthcare professional experience (46%) and time required per patient (44%). When grouped according to size of insulin pump service, pump starts and renewals in larger services were less impacted by the pandemic compared to smaller services. CONCLUSION: This survey highlights UK healthcare professional experiences of remote care delivery. While supportive of virtual care models, a number of factors highlighted, especially patient digital literacy, need to be addressed to improve virtual care delivery and device training.

Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance.

AIM: To compare accuracy, efficacy and acceptance of implantable and transcutaneous continuous glucose monitoring (CGM) systems. METHODS: In a randomized crossover trial we compared 12 weeks with Eversense implantable sensor (EVS) and 12 weeks with Dexcom G5 transcutaneous sensor (DG5) in terms of accuracy, evaluated as Mean Absolute Relative Difference (MARD) vs capillary glucose (SMBG), time of CGM use, adverse events, efficacy (as HbA1c, time in range, time above and below range) and psychological outcomes evaluated with Diabetes Treatment Satisfaction Questionnaire (DTSQ), Glucose Monitoring Satisfaction Survey (GMSS), Hypoglycemia Fear Survey (HFS2), Diabetes Distress Scale (DDS). RESULTS: 16 subjects (13 males, 48.8 ± 10.1 years, HbA1c 55.8 ± 7.9 mmol/mol, mean ± SD) completed the study. DG5 was used more than EVS [percentage of use 95.7 ± 3.6% vs 93.5 ± 4.3% (p = 0.02)]. MARD was better with EVS (12.2 ± 11.5% vs. 13.1 ± 14.7%, p< 0.001). No differences were found in HbA1c. While using EVS time spent in range increased and time spent in hyperglycemia decreased, but these data were not confirmed by analysis of retrofitted data based on SMBG values. EVS reduced perceived distress, without significant changes in other psychological outcomes. CONCLUSIONS: CGM features may affect glycemic control and device acceptance.

Desenvolvimento de rota sintética da Rosiglitazona em processo batelada e microrreator capilar / Rosiglitazone synthetic route development in batch process and capillary microreactor

Para que os fármacos possam ser comercializados economicamente, a sua escala de produção deve ser aumentada para atender à demanda do mercado. Atualmente, a maior parte dos fármacos são sintetizados em processos batelada que possuem limitações quanto à eficiência de mistura, temperatura e pressão. O uso de microrreatores surge como alternativa na indústria químico-farmacêutica, aumentando a eficiência dos processos de maneira segura. Ferramentas utilizadas no segmento computacional multidisciplinar teórico, como o DFT (Density Functional Theory), podem prever e compreender o comportamento das reações químicas, podendo ter grande utilidade na síntese de novos fármacos economizando tempo, investimento e reduzindo a geração de resíduos. A diabetes mellitus é uma doença de caráter epidêmico, que a cada ano vem aumentando o número de casos. O emprego de fármacos derivados das glitazonas no tratamento de diabetes mellitus tipo 2 é recomendado devido ao excelente controle glicêmico que esta classe de fármacos oferece. Neste trabalho, foi sintetizada a Rosiglitazona, um fármaco derivado das glitazonas, que auxilia no tratamento da diabetes mellitus tipo 2, sendo estudadas duas rotas de síntese distintas, que foram otimizadas com o intuito de maximizar o rendimento de seus intermediários, obtendo a Rosiglitazona com pureza de cerca de 94%. Foi realizada, para os intermediários, aqui denominados, 1R, 2R2 e 3R2 a síntese one-pot e para os intermediários 1R, 2R1 e 3R2 foi realizada a transposição do processo usual em batelada para fluxo contínuo no microrreator, com rendimentos de até 93%. Com o auxílio da química quântica computacional, a reação de síntese do intermediário 1R, foi elucidada teoricamente e determinadas as grandezas termodinâmicas (ΔH‡, ΔG‡ e ΔS‡) no estado de transição, que foram comparadas com os valores experimentais, sendo constatada uma boa concordância, com desvio máximo de 14%

In order for drugs to be commercialized economically, their production scale must be increased to meet market demand. Currently, most drugs are synthesized in batch processes that have limitations in terms of mixing efficiency, temperature and pressure. The use of microreactors appears as an alternative in the chemical-pharmaceutical industry, increasing the efficiency of the synthesis processes in a safe way. Tools used in the theoretical multidisciplinary computational segment, such as DFT (Density Functional Theory), can predict and understand the behavior of chemical reactions, and can be very useful in the synthesis of new drugs, saving time, investment and reducing waste generation. Diabetes mellitus is an epidemic disease that has been increasing the number of cases every year. The use of drugs derived from glitazones in the treatment of type 2 diabetes mellitus is recommended due to the excellent glycemic control that this class of drugs offers. In this work, Rosiglitazone, a drug derived from glitazones, which helps in the treatment of type 2 diabetes mellitus, was synthesized. Two different synthetic routes were studied and optimized in order to maximize the yield of its intermediates, obtaining Rosiglitazone with purity of about 94%. One-pot synthesis was performed to 1R, 2R2 and 3R2 intermediates, and the transposition from the usual batch process to continuous flow in microreactor was performed to 1R, 2R1 and 3R2 intermediates, with yields of up to 93%. With the aid of computational quantum chemistry, the intermediate 1R synthesis reaction was theoretically elucidated and the thermodynamic properties were determined (ΔH‡, ΔG‡ and ΔS‡) in the transition state, which were compared with the experimental results, obtaining good agreement, with a maximum deviation of 14%

Prevalence of hypertension and obesity in patients with type 2 Diabetes Mellitus

Abstract Faced with the increase of type 2 Diabetes mellitus (DM2) and the failure in treatment, questions have been raised about the clinical situation of these patients. The present study analyzes the prevalence of hypertension and obesity in DM2 patients. Data were collected through interviews and anamnesis of 16 participants. After the meetings, in which capillary glycemia and blood pressure were measured, the participants received guidance about glycemic monitoring, blood pressure control and changes in lifestyle. Approximately 75% of the participants were women with average age of 65 years, 87.5% were sedentary, 18.75% smoked and/or used alcoholic beverages and none performed regular blood glucose monitoring. The initial blood glucose average was 148 mg/ dL and finally decreased to 133 mg/dL. There was no significant difference in blood pressure levels. Regarding the body mass index, 89.4% of the patients were above normal standards and 100% had altered waist circumference values. There is a need for studies like this in order to promote educational practices for health and disease control, highlighting the importance of multidisciplinary teams and the pharmaceutical professional, since non-adherence to blood glucose monitoring, also associated with hypertension and obesity, can interfere with the individual's clinical condition.

Association of cigarette and water-pipe smoking with increased visceral adiposity, glycemic intolerance and hematological derangement in Iraqi healthy smokers

Abstract The present study aims to investigate the impacts of cigarette smoking (CS) and water-pipe smoking (WPS) on the visceral adiposity index (VAI), hematological characteristics, and glycemic tolerance in Iraqi healthy smokers. A total of 528 healthy males from different locations of Baghdad city were allocated to three groups; nonsmokers (176), cigarette smokers (178), and WP smokers (174). Baseline characteristics, anthropometric and hematological markers and were reported. Glycemic control was evaluated using the glucose tolerance test. The evidence of elevated VAI, disrupted hematological markers, and impaired glucose tolerance was significantly (P<0.001) different compared with non-smokers and related to the duration of smoking. The impacts of WPS seem to be significantly greater than CS in certain parameters (hemoglobin, hematocrit, methemoglobin, and 2-hour glucose tolerance values). In conclusion, CS and WPS negatively impacted body fat distribution, glucose tolerance, and hematological markers. There is a positive association between the rate of smoking and obesity, glycemic intolerance in both groups

COVID-19 Pandemic and Pediatric Type 1 Diabetes: No Significant Change in Glycemic Control During The Pandemic Lockdown of 2020.

Importance: There is no consensus on the impact of the 2020 COVID-19 pandemic lockdown on glycemic control in children and adolescents with type 1 diabetes (T1D) in the US. Aim: To determine the impact of the pandemic lockdown of March 15th through July 6th, 2020 on glycemic control after controlling for confounders. Subjects and Methods: An observational study of 110 subjects of mean age 14.8 ± 4.9 years(y), [male 15.4 ± 4.0y, (n=57); female 14.1 ± 3.8y, (n=53), p=0.07] with T1D of 6.31 ± 4.3y (95% CI 1.0-19.7y). Data were collected at 1-4 months before the lockdown and 1-4 months following the lifting of the lockdown at their first post-lockdown clinic visit. Results: There was no significant change in A1c between the pre- and post-pandemic lockdown periods, 0.18 ± 1.2%, (95% CI -0.05 to 0.41), p=0.13. There were equally no significant differences in A1c between the male and female subjects, -0.16 ± 1.2 vs -0.19 ± 1.2%, p=0.8; insulin pump users and non-pump users, -0.25 ± 1.0 vs -0.12 ± 1.4%, p=0.5; and pubertal vs prepubertal subjects, 0.18 ± 1.3 vs -0.11 ± 0.3%, p=0.6. The significant predictors of decrease in A1c were pre-lockdown A1c (p<0.0001) and the use of CGM (p=0.019). The CGM users had significant reductions in point-of-care A1c (0.4 ± 0.6%, p=0.0012), the CGM-estimated A1c (p=0.0076), mean glucose concentration (p=0.022), a significant increase in sensor usage (p=0.012), with no change in total daily dose of insulin (TDDI). The non-CGM users had significantly increased TDDI (p<0.0001) but no change in HbA1c, 0.06 ± 1.8%, p=0.86. Conclusions: There was no change in glycemic control during the pandemic lockdown of 2020 in US children.

Constructing a Smartphone-Controlled Semiautomatic Theranostic System for Glucose Homeostasis in Diabetic Mice.

With the development of mobile communication technology, smartphones have been used in point-of-care technologies (POCTs) as an important part of telemedicine. Using a multidisciplinary design principle coupling electrical engineering, software development, synthetic biology, and optogenetics, the investigators developed a smartphone-controlled semiautomatic theranostic system that regulates blood glucose homeostasis in diabetic mice in an ultraremote-control manner. The present chapter describes how the investigators tailor-designed the implant architecture "HydrogeLED," which is capable of coharboring a designer-cell-carrying alginate hydrogel and wirelessly powered far-red light LEDs. Using diabetes mellitus as a model disease, the in vivo expression of insulin or human glucagon-like peptide 1 (shGLP-1) from HydrogeLED implants could be controlled not only by pre-set ECNU-TeleMed programs, but also by a custom-engineered Bluetooth-active glucometer in a semiautomatic and glycemia-dependent manner. As a result, blood glucose homeostasis was semiautomatically maintained in diabetic mice through the smartphone-controlled semiautomatic theranostic system. By combining digital signals with optogenetically engineered cells, the present study provides a new method for the integrated diagnosis and treatment of diseases.

The cost implications of continuous glucose monitoring in pregnant women with type 1 diabetes in 3 Canadian provinces: a posthoc cost analysis of the CONCEPTT trial.

BACKGROUND: The Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial (CONCEPTT) found improved health outcomes for mothers and their infants among those randomized to self-monitoring of blood glucose (SMBG) with continuous glucose monitoring (CGM) compared with SMBG alone. In this study, we evaluated whether CGM or standard SMBG was more or less costly from the perspective of a third-party payer. METHODS: We conducted a posthoc analysis of data from the CONCEPTT trial (Mar. 25, 2013, to Mar. 22, 2016). Health care resource data from 215 pregnant women, randomized to CGM or SMBG, were collected from 31 hospitals in 7 countries. We determined resource costs posthoc based on prices from hospitals in 3 Canadian provinces (Ontario, British Columbia, Alberta). The primary outcome was the difference between groups in the mean total cost of care for mother and infant dyads, paid by each government (i.e., the third-party payer) from randomization to hospital discharge (time horizon). The secondary outcome included CGM and SMBG costs not paid by governments (e.g., glucose monitoring devices and supplies). RESULTS: The mean total cost of care was lower in the CGM group compared with the SMBG group in each province (Ontario: $13 270.25 v. $18 465.21, difference in mean total cost [DMT] -$5194.96, 95% confidence interval [CI] -$9841 to -$1395; BC: $13 480.57 v. $18 762.17, DMT -$5281.60, 95% CI -$9964 to -$1382; Alberta: $13 294.39 v. $18 674.45, DMT -$5380.06, 95% CI -$10 216 to -$1490). There was no difference in the secondary outcome. INTERPRETATION: Government health care costs are lower when CGM is paid by the patient, driven by lower costs from reduced use of the neonatal intensive care unit in the CGM group; however, when governments pay for CGM equipment, there is no overall cost difference between CGM and SMBG. Governments should consider paying for CGM, as it results in improved maternal and neonatal outcomes with no added overall cost. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01788527.

Efficacy of flash glucose monitoring in pregnant women with poorly controlled pregestational diabetes (FlashMom): A randomized pilot study.

BACKGROUND AND AIMS: Good glycemic control is crucial to reduce the risk of adverse pregnancy outcomes. Our aim was to evaluate the efficacy of Flash Glucose Monitoring (FGM) on glucose control in women with pregestational diabetes. METHODS AND RESULTS: Forty women with inadequately controlled type 1 (T1D, n = 34) and type 2 (T2D, n = 6) diabetes at conception were randomly assigned to two arms: the Flash Glucose group (FG, n = 21) using FGM, and the control group (CG, n = 19) using self-monitoring of blood glucose (SMBG). Glycated hemoglobin (HbA1c, %), time in (TIR), below (TBR) and above (TAR) range, glucose variability as well as the occurrence of maternal and neonatal adverse outcomes, were evaluated. HbA1c decreased significantly (p < 0.01) and similarly (-0.65 ± 0.7 vs. -0.67 ± 0.8 for FG and CG, respectively; p = 0.89) in both groups during pregnancy. HbA1c reduction was positively associated with the number of daily FGM scans (p < 0.01). TBR (12.1 ± 2.0% vs. 19.6 ± 3.9%, p = 0.04) and the mean of the daily serum glucose difference (MODD) index (59.1 ± 5.4 vs. 77.7 ± 4.6, p = 0.02) were significantly lower in FG at second trimester. The rates of perinatal adverse outcomes were not different in the two studied groups. CONCLUSIONS: In women with pregestational diabetes, FGM and SMBG had similar efficacy on glucose control during pregnancy. FGM showed additional advantages in terms of TBR and glucose variability. Achievement of good metabolic results depended on the adequate use of glucose sensor. REGISTRATION: At ClinicalTrials.gov as NCT04666818 on December 14, 2020.

Real-world outcomes with different technology modalities in type 1 diabetes.

BACKGROUND AND AIMS: Several treatment modalities are available for type 1 diabetes (T1D), including continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) with MDI, sensor-augmented pumps with predictive low-glucose suspend function (SAP-PLGS) and hybrid closed-loop systems (HCL). The aim of the study was to evaluate the real-world benefits obtained with these treatment modalities. METHODS AND RESULTS: A cross-sectional study was performed, selecting 4 groups of T1D subjects, regarding their treatment modalities, paired by age, sex and diabetes duration. A comparison was performed, concerning time in different glucose ranges in 2-week sensor downloads. Estimated HbA1c, glycaemic variability measures and sensor use were also compared. 302 T1D people were included (age: 39 ± 12 years, 47% male, diabetes duration: 21 ± 10 years, estimated HbA1c: 7.28 ± 0.84% (56 ± 9 mmol/mol), baseline HbA1c: 7.4 ± 1.0% (57 ± 11 mmol/mol), length of use of the device 8 [3-21] months). Group 1 (CGM + MDI) and 2 (FGM + MDI) showed no differences in time in different glucose ranges. Group 4 (HCL) showed a higher time 70-180 mg/dl and a lower time in hypoglycaemia than group 3 (SAP-PLGS). Group 1 and 2 showed lower time 70-180 mg/dl, higher time in hyperglycaemia and higher glycaemic variability measures than group 3. Group 4 was superior to groups 1 and 2 in all the outcomes. CONCLUSION: Real-life achievements in glycaemic control and glycaemic variability are described. HCL offer the maximum benefit in terms of time in range and hypoglycaemia protection, compared to CGM + MDI, FGM + MDI and SAP-PLGS.

Impact of the FreeStyle Libre flash glucose monitoring system on diabetes- self-management practices and glycemic control among patients with type 2 diabetes in Saudi Arabia: A prospective study.

BACKGROUND AND AIMS: To examine the efficacy of FreeStyle Libre Flash Glucose Monitoring System (FGMS) on Diabetes Self-Management Practices (DSMP) and glycemic control among patients with type 2 diabetes (T2D). METHODS: This prospective study was conducted among 105 patients with T2D (aged 30-70 years), who self-tested their glucose levels by conventional finger-prick method using blood glucose meters (BGM). At baseline visit, FGMS sensors were fixed by a diabetes educator to all patients. At the baseline and at 12 weeks of the study, an interviewer collected the responses of Diabetes Self-Management (DSM) from all the study population using a questionnaire. RESULTS: At 12 weeks, significant improvements in the DSM subscales were observed, which includes glucose management (P = 0.042), dietary control (P = 0.048), physical activity (P = 0.043), health care use (P = 0.001) and self-care (P = 0.001), compared to the values at baseline. At baseline, when the HbA1c level was 8.2%, at 12 weeks, it dropped to 7.9%. Also, at baseline, when the hypoglycemia frequency was 3.1, it declined to 1.2 episodes/month at 12 weeks. While comparing the blood glucose monitoring through BGM at the baseline (1.92/day), a higher degree of frequency of blood glucose monitoring was evident at 12 weeks (6.84/day), after the patients employed the FreeStyle Libre. CONCLUSION: After 12 weeks of using the FreeStyle Libre, the frequency of hypoglycemic episodes and the HbA1c levels were dropped, while the practice of DSM and frequency of blood glucose monitoring were improved.

Continuous glucose monitoring: A review of the evidence in type 1 and 2 diabetes mellitus.

CONTEXT AND AIM: Continuous glucose monitoring (CGM) is becoming widely accepted as an adjunct to diabetes management. Compared to standard care, CGM can provide detailed information about glycaemic variability in an internationally standardised ambulatory glucose profile, enabling more informed user and clinician decision making. We aimed to review the evidence, user experience and cost-effectiveness of CGM. METHODS: A literature search was conducted by combining subject headings 'CGM' and 'flash glucose monitoring', with key words 'type 1 diabetes' and 'type 2 diabetes', limited to '1999 to current'. Further evidence was obtained from relevant references of retrieved articles. RESULTS: There is a strong evidence for CGM use in people with type 1 diabetes, with benefits of reduced glycated haemoglobin and hypoglycaemia, and increased time in range. While the evidence for CGM use in type 2 diabetes is less robust, similar benefits have been demonstrated. CGM can improve diabetes-related satisfaction in people with diabetes (PWD) and parents of children with diabetes, as well as the clinician experience. However, CGM does have limitations including cost, accuracy and perceived inconvenience. Cost-effectiveness analyses have indicated that CGM is a cost-effective adjunct to type 1 diabetes management that is associated with reduced diabetes-related complications and hospitalisation. CONCLUSIONS: Continuous glucose monitoring is revolutionising diabetes management. It is a cost-effective adjunct to diabetes management that has the potential to improve glycaemic outcomes and quality of life in PWD, especially type 1 diabetes.

Effects of real-time continuous glucose monitoring in type 1 diabetes: a meta-analysis of randomized controlled trials.

AIMS: Self-monitoring of blood glucose (SMBG) represented a major breakthrough in the treatment of type 1 diabetes. The aim of the present meta-analysis is to assess the effect of continues glucose monitoring (CGM) and flash glucose monitoring (FGM), on glycemic control in type 1 diabetes. MATERIALS AND METHODS: The present analysis includes randomized clinical trials comparing CGM or FGM with SMBG, with a duration of at least 12 weeks, identified in Medline or clinicaltrials.gov. The principal endpoint was HbA1c at the end of the trial. A secondary endpoint was severe hypoglycemia. Mean and 95% confidence intervals for HbA1c and Mantel-Haenzel odds ratio [MH-OR] for severe hypoglycemia were calculated, using random effect models. A sensitivity analysis was performed using fixed effect models. In addition, the following secondary endpoints were explored, using the same methods: time in range, health-related quality of life, and treatment satisfaction. Separate analyses were performed for trials comparing CGM with SMBG, and those comparing CGM + CSII and SMBG + MDI and CGM-regulated insulin infusion system (CRIS) and CSII + SMBG. RESULTS: CGM was associated with a significantly lower HbA1c at endpoint in comparison with SMBG (- 0.24 [- 0.34, - 0.13]%); CGM was associated with a significantly lower risk of severe hypoglycemia than SMBG. Treatment satisfaction and quality of life were not measured, or not reported, in the majority of studies. FGM showed a significant reduction in the incidence of mild hypoglycemia and an increased treatment satisfaction, but no significant results are shown in HbA1c. CGM + CSII in comparison with SMBG + MDI was associated with a significant reduction in HbA1c. Only two trials with a duration of at least 12 weeks compared a CRIS with SMBG + CSII; HbA1c between the two treatment arms was not statistically significant (difference in means: - 0.23 [- 0.91; 0.46]%; p = 0.52). CONCLUSION: GCM compared to SMBG has showed a reduction in HbA1c and severe hypoglycemia in patient with type 1 diabetes. The comparison between CGM + CSII and SMBG + MDI showed a large reduction in HbA1c; it is conceivable that the effects of CSII + CGM on glycemic control additives. The only comparison available between FGM and SMBG was conducted in patients in good control.

A Comparison of Two Hybrid Closed-Loop Systems in Italian Children and Adults With Type 1 Diabetes.

Tandem Control-IQ and Minimed 780G represent the most Advanced Hybrid Closed Loop (AHCL) systems currently available in pediatric and adult subjects with Type 1 Diabetes (T1D). We retrospectively compared clinical and continuous glucose monitoring data from 51 patients who upgraded to Minimed 780G system and have completed 1-month observation period with data from 39 patients who upgraded to Tandem Control-IQ. Inverse probability weighting was used to minimize the basal characteristics imbalances. Both AHCL systems showed a significant improvement in glycemic parameters. Minimed 780G group achieved higher TIR increase (p= 0.004) and greater reduction of blood glucose average (p= 0.001). Tandem Control-IQ system significantly reduced the occurrence of TBR (p= 0.010) and the Coefficient of Variation of glucose levels (p= 0.005). The use of ACHL systems led to a significant improvement of glycemic control substantially reaching the International recommended glycemic targets. Minimed 780G appears to be more effective in managing hyperglycemia, while Tandem Control-IQ seems to be more effective in reducing time in hypoglycemia.

One-year experience of hybrid closed-loop system in children and adolescents with type 1 diabetes previously treated with multiple daily injections: drivers to successful outcomes.

OBJECTIVE: To evaluate the effect of a 1-year hybrid closed-loop (HCL) system on glycemic control in children and adolescents with type 1 diabetes (T1D) previously treated with multiple daily injections (MDI). METHODS: This was a 1-year observational study, as a continuation of the previous 3 months prospective study of pediatric patients with T1D conducted at Sidra Medicine in Qatar. The study enrolled individuals aged 7-18 years with T1D > 1 year, on MDI with self-monitoring of blood glucose or continuous glucose monitoring, with no prior pump experience, and with an HbA1c level < 12.5% (< 113 mmol/mol). After the first 3 months of HCL use, patients were followed at 6, 9 and 12 months, where HbA1c was obtained and pump data were collected. RESULTS: All 30 participants (age 10.24 ± 2.6 years) who initiated HCL completed 12 months of HCL system use in Auto Mode. The participants used the sensor 88.4 ± 6.5% of the time with Auto Mode usage 85.6 ± 7.4% during 12 months of HCL system use. HbA1c decreased from 8.2 ± 1.4% (66 ± 15.3 mmol/mol) at baseline, to 6.7 ± 0.5% (50 ± 5.5 mmol/mol) at 3 months (p = 0.02) and remained stable to 7.1 ± 0.6 (54 ± 6.6 mmol/mol) at 12 months (p = 0.02). TIR (70-180 mg/dL) increased from 46.9% at baseline to 71.9% at 1 month and remained above 70% during the 12 months of HCL use. CONCLUSION: HCL system (MiniMed 670G) in children and adolescents previously treated with MDI significantly improves glycemic outcomes (HbA1c and Time in Ranges) immediately during the first month. This improved glycemic control was maintained over the 1 year following Auto Mode initiation.

Artificial Pancreas With Carbohydrate Suggestion Performance for Unannounced and Announced Exercise in Type 1 Diabetes.

OBJECTIVE: To evaluate the safety and performance of a new multivariable closed-loop (MCL) glucose controller with automatic carbohydrate recommendation during and after unannounced and announced exercise in adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: A randomized, 3-arm, crossover clinical trial was conducted. Participants completed a heavy aerobic exercise session including three 15-minute sets on a cycle ergometer with 5 minutes rest in between. In a randomly determined order, we compared MCL control with unannounced (CLNA) and announced (CLA) exercise to open-loop therapy (OL). Adults with T1D, insulin pump users, and those with hemoglobin (Hb)A1c between 6.0% and 8.5% were eligible. We investigated glucose control during and 3 hours after exercise. RESULTS: Ten participants (aged 40.8 ± 7.0 years; HbA1c of 7.3 ± 0.8%) participated. The use of the MCL in both closed-loop arms decreased the time spent <70 mg/dL of sensor glucose (0.0%, [0.0-16.8] and 0.0%, [0.0-19.2] vs 16.2%, [0.0-26.0], (%, [percentile 10-90]) CLNA and CLA vs OL respectively; P = 0.047, P = 0.063) and the number of hypoglycemic events when compared with OL (CLNA 4 and CLA 3 vs OL 8; P = 0.218, P = 0.250). The use of the MCL system increased the proportion of time within 70 to 180 mg/dL (87.8%, [51.1-100] and 91.9%, [58.7-100] vs 81.1%, [65.4-87.0], (%, [percentile 10-90]) CLNA and CLA vs OL respectively; P = 0.227, P = 0.039). This was achieved with the administration of similar doses of insulin and a reduced amount of carbohydrates. CONCLUSIONS: The MCL with automatic carbohydrate recommendation performed well and was safe during and after both unannounced and announced exercise, maintaining glucose mostly within the target range and reducing the risk of hypoglycemia despite a reduced amount of carbohydrate intake.Register Clinicaltrials.gov: NCT03577158.