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Background The advanced hybrid closed loop (AHCL) algorithm combines automated basal rates and corrections yet requires meal announcement for optimal performance, which poses a challenge for some. We aimed to compare glucose control in adults with T1D using the MiniMedTM 780G AHCL system utilizing simplified meal announcement versus precise carbohydrate counting. Methods In a study involving 14 adults with T1D, we evaluated glycemic control during a 13 week "precise phase", followed by two 3-4 week simplified meal announcement phases: "universal" (preset of one personalized fixed carbohydrate amount) and "incremental" (entry of multiples of one, two, or three of these presets depending on meal size estimate). Results Mean age was 45.7±12.4 and ten participants were male (71%). Mean baseline HbA1c was 6.8%±1.2% and TIR 67.5%±16.7%. Comparing the universal to the precise study phase, TIR was similar (75.4±13% vs. 77.7±9%, p=0.12) and GMI was slightly higher (6.8±0.4 vs. 6.6±0, p=0.01). Furthermore, there was less level 1 and 2 hypoglycemia (1.6±1% vs. 2.8±2%, p=0.03 and 0.3±5% vs. 0.65±1%, p=0.08), but slightly more level 1 and 2 hyperglycemia (17.1±8% vs. 15.0±7%, p=0.05 and 5.5±5% vs. 3.6±3%, p=0.04). When comparing the incremental to the precise phase, GMI was identical (6.6%) and TIR superior (80.5±10% vs. 77.7±9%, p=0.02). Additionally, there was less level 1 hypoglycemia (1.9±1% vs. 2.8±2%, p=0.01) and a trend for less level 2 hypoglycemia (0.4±0.7% vs. 0.65±1%, p=0.08). Conclusions A simplified meal announcement strategy in adults using the MiniMedTM780G system, relying on three increments of a universal CHO amount, may offer a way to improve glycemic control and ease self-care. For patients with more limitations, using one universal CHO amount could be a safe alternative meeting most consensus glycemic targets.
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BACKGROUND: Anastomotic leak after tracheal resection may occur while coughing in the early postoperative period. We investigated the varying effects of suturing technique, stretch, and tension on anastomotic leaks during simulated coughs. METHODS: End-to-end anastomoses were performed using continuous or interrupted sutures on excised porcine larynges. Tracheas were secured to a pressurized system simulating cough forces, submerged in a water bath, and stretched to 1, 2, and 3 cm above baseline. Peak pressure, incomplete cough generation, and observed leakages were recorded. Parameters were analyzed using Analysis of Variance (ANOVA), multiple linear regression, and logistic regression modeling. RESULTS: Peak tension (B = -0.660, p < 0.001) and stretch lengths (B = -0.329, p = 0.006) were associated with variance in peak pressure (R2 = 0.77, F(3,294) = 8.182, p < 0.001). Incomplete coughs increased with higher peak tension (odds ratio [OR] = 15.627, p < 0.001) and stretching to 3 cm above baseline (OR = 4.335, p < 0.007). Similarly, leak occurrences, primarily from the posterior tracheal wall, increased with higher peak tension (OR = 1.787, p < 0.001) and stretching to 3 cm (OR = 2.613, p = 0.017). No significance was identified with suturing technique. CONCLUSION: Interrupted and continuous suture techniques do not differ in anastomotic strength during simulated coughs. Increased peak tracheal tension is associated with a weaker anastomosis, and tracheal stretch to 3 cm was associated with a weaker anastomosis. Our study supports the commonly held clinical belief that, to create a stronger anastomosis, tension should be minimized, and particular attention should be placed at the posterior tracheal wall during closure. LEVEL OF EVIDENCE: N/A, Benchtop study Laryngoscope, 2024.
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Intensive therapy with exogenous insulin is the treatment of choice for individuals living with type 1 diabetes (T1D) and some with type 2 diabetes, alongside regular glucose monitoring. The development of systems allowing (semi-)automated insulin delivery (AID), by connecting glucose sensors with insulin pumps and algorithms, has revolutionized insulin therapy. Indeed, AID systems have demonstrated a proven impact on overall glucose control, as indicated by effects on glycated hemoglobin (HbA1c), risk of severe hypoglycemia, and quality of life measures. An alternative endpoint for glucose control that has arisen from the use of sensor-based continuous glucose monitoring is the time in range (TIR) measure, which offers an indication of overall glucose control, while adding information on the quality of control with regard to blood glucose level stability. A review of literature on the health-economic value of AID systems was conducted, with a focus placed on the growing place of TIR as an endpoint in studies involving AID systems. Results showed that the majority of economic evaluations of AID systems focused on individuals with T1D and found AID systems to be cost-effective. Most studies incorporated HbA1c, rather than TIR, as a clinical endpoint to determine treatment effects on glucose control and subsequent quality-adjusted life year (QALY) gains. Likely reasons for the choice of HbA1c as the chosen endpoint is the use of this metric in most validated and established economic models, as well as the limited publicly available evidence on appropriate methodologies for TIR data incorporation within conventional economic evaluations. Future studies could include the novel TIR metric in health-economic evaluations as an additional measure of treatment effects and subsequent QALY gains, to facilitate a holistic representation of the impact of AID systems on glycemic control. This would provide decision makers with robust evidence to inform future recommendations for health care interventions.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes , Hemoglobinas Glicadas , Glicemia/metabolismo , Automonitorização da Glicemia/métodos , Qualidade de Vida , Insulina , Sistemas de Infusão de Insulina , Insulina Regular Humana/uso terapêuticoRESUMO
The MiniMed™ 780G system (780G) received Conformité Européenne mark in June 2020 and was, recently, approved by the U.S. Food and Drug Administration (April 2023). Clinical trials and real-world analyses have demonstrated MiniMed™ 780G system safety and effectiveness and that glycemic outcomes (i.e., time in range) improve with recommended settings use. In this publication, we will explain the iterative development of the 780G algorithm and how this technology has simplified diabetes management.
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Diabetes Mellitus Tipo 1 , Hipoglicemiantes , Humanos , Hipoglicemiantes/uso terapêutico , Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , Automonitorização da Glicemia , AlgoritmosRESUMO
INTRODUCTION: Insulin requirement in women with Type 1 diabetes (T1DM) changes throughout pregnancy. The aim of this study was to determine the total change in insulin requirements and the effect of gestational weight gain (GWG) and pre-gestational BMI on insulin requirements during pregnancy in women with T1DM treated with continuous subcutaneous insulin infusion and continuous glucose monitoring. METHODS: This historical cohort study included all consecutive women with T1DM who were monitored during pregnancy at the high-risk pregnancy clinic at a tertiary medical center during April 2011-April 2019. One Way Repeated Measures ANOVA with Bonferroni adjustment was conducted to compare the effects of gestational age on insulin requirements and a Two Way Repeated Measures ANOVA was employed to test for the interaction between gestational age intervals and maternal BMI and GWG. RESULTS: Data regarding insulin requirements of 185 pregnancies were included in the analyses. There was a significant effect of gestational age on total insulin (Wilks' Lambda = 0.34, F(6,14) = 4.52, p = 0.009), basal insulin (Wilks' Lambda = 0.41, F(6,14) = 3.30, p = 0.031) and bolus insulin (Wilks' Lambda = 0.43, F(6,14) = 3.02, p = 0.041). Total insulin/kg requirements increased by 5.5% from 13-20 weeks to 20-26 weeks, 19% from 20-26 weeks to 26-33 weeks, and 17.4% from 26 to 33 weeks to delivery (p for trend = 0.009). Overall, insulin requirements increased by 42.1% from conception to delivery (p < 0.01). There was no significant main effect of maternal BMI or GWG on insulin requirements. CONCLUSIONS: There is a significant increase in insulin requirements per kg during pregnancy in women with T1DM who were treated with an insulin pump.
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Diabetes Mellitus Tipo 1 , Diabetes Gestacional , Gravidez , Feminino , Humanos , Insulina/uso terapêutico , Diabetes Mellitus Tipo 1/tratamento farmacológico , Estudos de Coortes , Automonitorização da Glicemia , Glicemia , Insulina Regular Humana , Índice de Massa Corporal , Resultado da Gravidez , Estudos RetrospectivosRESUMO
Background: Carbohydrate counting (CC) and meal announcements, before eating, introduce a significant burden for individuals managing type 1 diabetes (T1D). An automated insulin delivery system with automatic bolusing that eliminates the need for CC and premeal bolusing (i.e., a hands-free closed-loop [HFCL] system) was assessed in a feasibility trial of adults with T1D. Methods: The system included the MiniMed™ 780G pump and a smartphone-paired smartwatch with the Klue application (Klue, Inc.) that detects eating and drinking gestures. A smartphone algorithm converted gestures into carb amounts that were transmitted to the pump for automatic bolusing. For 5 days, participants (N = 17, 18-75 years of age) used the system at home with meal announcements based on traditional CC, with the Klue application disabled (Home-stay phase). Thereafter, participants moved to a supervised hotel setting, where the Klue application was enabled for 5 days and meals were not announced (Hotel-stay phase). Participants consumed the same eight test meals (six solid and two liquid) of varying caloric and carb size at the same time and day of the week for both phases, and glycemic metrics were compared. Otherwise, there were no other meal restrictions. Results: The overall time in range (70-180 mg/dL) was 83.4% ± 7.0% and 80.6% ± 6.7% for the Home-stay and Hotel-stay, respectively (P = 0.08). The average time at <70 mg/dL was 3.1% and 3.0% (P = 0.9144), respectively, and the average time at >180 mg/dL was 13.5% and 16.3% (P = 0.1046), respectively. Postprandial glycemia following low-carb test meals was similar between the two phases. The system's ability to accommodate high-carb meals was somewhat limited. There were no episodes of severe hypoglycemia or diabetic ketoacidosis. Conclusion: Preliminary findings show that a HFCL system was safe and maintained overall glycemic control, similar to that observed with traditional CC and manual meal bolusing. By eliminating these daily T1D burdens, a HFCL system may improve quality of life for individuals with T1D. ClinicalTrials.gov number: NCT04964128.
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The concept of maintaining blood glucose levels within the 70-180 mg/dL range, known as time-in-range, has raised questions regarding its representation of true physiological euglycemia. Some have speculated that focusing on the time spent within the 70-140 mg/dL range, introduced as time in tight range (TITR) through the International Consensus statement, could serve as a more precise metric for assessing normoglycemia in individuals with type 1 diabetes. This article delves into the current status of TITR as an emerging marker and explores how advanced hybrid closed-loop systems may offer a promising avenue for achieving this higher level of glycemic control.
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Diabetes Mellitus Tipo 1 , Hipoglicemiantes , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Objetivos , Sistemas de Infusão de Insulina , Diabetes Mellitus Tipo 1/tratamento farmacológico , Glicemia , Automonitorização da GlicemiaRESUMO
Introduction: The present report celebrates the benchmarking of 100,000 MiniMed™ 780G system users in Europe, Middle East, and Africa (EMEA) and summarizes the major insights into the usability and outcomes of this system. Methods: Carelink Personal data (August 2020-August 2023) of users living in EMEA were analyzed. Continuous glucose monitoring-based endpoints were aggregated for (1) the full cohort and (2) a 12-month longitudinal cohort. Subanalyses were done for users on optimal settings (those spending ≥95% of time with glucose target of 100 mg/dL, and ≥95% of time with active insulin time of 2 h), for self-reported age groups (≤15 and ≥56 years) and for various countries/regions. Results: Data from 101,629 users (34 countries) were analyzed. Mean time in range (TIR) was 72.3%, glucose management indicator (GMI) was 7%, time below 70 mg/dL (TBR70) was 2.0% and time below 54 mg/dL (TBR54) was 0.4%. In terms of international targets, 59.6% of users achieved a GMI <7%, 62.5% a TIR >70%, 88.4% a TBR70 < 4%, and 90.0% a TBR54 < 1%. Data improved impressively in optimal setting users (TIR = 78.8%, and users reaching TIR >70% = 86.3%) while safety remained (TBR70 = 2.2% and TBR54 = 0.4%). Data showed consistency across self-reported age groups and geographies. In the longitudinal cohort, TIR reached 75.5% in the first month and remained 73.3% or higher over the 12-month period. Conclusion: Over 100,000 users of the MiniMed™ 780G system have demonstrated consistency in achieving target control of glycemia.
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Automonitorização da Glicemia , Diabetes Mellitus Tipo 1 , Humanos , Pessoa de Meia-Idade , Glicemia , África , Oriente Médio , Europa (Continente) , Glucose , Insulina/uso terapêutico , Hipoglicemiantes , Sistemas de Infusão de InsulinaRESUMO
Dopaminergic neurons are specialized cells in the substantia nigra, tasked with dopamine secretion. This secretion relies on intracellular calcium signaling coupled to neuronal electrical activity. These neurons are known to display spontaneous calcium oscillationsin-vitroandin-vivo, even in synaptic isolation, controlling the basal dopamine levels. Here we outline a kinetic model for the ion exchange across the neuronal plasma membrane. Crucially, we relax the assumption of constant, cytoplasmic sodium and potassium concentration. We show that sodium-potassium dynamics are strongly coupled to calcium dynamics and are essential for the robustness of spontaneous firing frequency. The model predicts several regimes of electrical activity, including tonic and 'burst' oscillations, and predicts the switch between those in response to perturbations. 'Bursting' correlates with increased calcium amplitudes, while maintaining constant average, allowing for a vast change in the calcium signal responsible for dopamine secretion. All the above traits provide the flexibility to create rich action potential dynamics that are crucial for cellular function.
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Cálcio , Neurônios Dopaminérgicos , Potenciais de Ação , Dopamina , Sinalização do Cálcio , Potássio , SódioRESUMO
AIM: To report on the effectiveness and safety of the MiniMed 780G automated insulin delivery system in real-world users during the month of Ramadan. MATERIALS AND METHODS: CareLink Personal data were extracted from MiniMed 780G system users from the Gulf region. Users were included if they had ≥10 days of sensor glucose data during the month of Ramadan 2022 as well as in the month before and after. For the main analysis, continuous glucose monitoring endpoints were aggregated per month and were reported by time of day (daytime: 05.31-18.00 h, and night-time). Additional analyses were performed to study the pace at which the algorithm adapts. RESULTS: Glycaemic control was well kept in the 449 included users (mean sensor glucose = 152.6 ± 18.7 mg/dl, glucose management indicator = 7.0 ± 0.4%, time in range = 70.7 ± 11.0%, time below 70 mg/dl = 2.3 ± 2.3%). Albeit some metrics differed from the month before (p < .0001 for all), absolute differences were very small and considered clinically irrelevant. During Ramadan, there was no increased risk of hypoglycaemia during daytime (time below 70 mg/dl = 2.3 ± 2.4%), time in range was highest during daytime (80.0 ± 10.7%, night: 60.4 ± 15.3%), while time above 180 mg/dl was highest during night-time (37.3 ± 16.3%, day: 17.7 ± 10.7%). The algorithm adapted immediately upon lifestyle change. CONCLUSION: The MiniMed 780G automated insulin delivery system is effective, safe and fast in adapting to the substantial changes that occur in the lifestyle of people with type 1 diabetes during Ramadan.
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Diabetes Mellitus Tipo 1 , Hipoglicemia , Humanos , Insulina/efeitos adversos , Glicemia/análise , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemia/prevenção & controle , Insulina Regular Humana/uso terapêutico , Sistemas de Infusão de Insulina/efeitos adversos , Hipoglicemiantes/efeitos adversosRESUMO
AIMS: To assess the effect of using sensor-augmented pump therapy (SAP) during pregnancy on neonatal birth weight percentile and other neonatal and pregnancy outcomes. METHODS: This retrospective cohort study included consecutive women with pregestational diabetes mellitus (PGDM) treated with an insulin pump and sensor that enabled the SAP feature during pregnancy. SAP use was defined as utilization of either low-glucose suspend (LGS) or predictive LGS technology. Utilization of SAP was according to physician discretion. Differences in neonatal birth weight percentile and in other neonatal and pregnancy outcomes were compared between those who did and not use SAP. OUTCOMES: Of 142 women, 136 had type 1 diabetes, 5 type 2 diabetes and one diabetes due to pancreatectomy. 83 women used SAP and 59 did not. For the neonates of the mothers of the respective groups, the median birth weight percentiles were similar (79 and 80, pV = 0.96), as were the other neonatal outcomes assessed. The rate of cesarean section was higher in the SAP group. However, after adjusting for maternal age, BMI, and a history of severe hypoglycemic events before pregnancy, the relation between mode of delivery and the use of SAP was no longer statistically significant. CONCLUSION: In women with PGDM treated with an insulin pump and sensor, SAP use during pregnancy was not associated with higher neonatal birth weight percentile or the occurrences of other adverse neonatal or pregnancy outcomes.
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Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Recém-Nascido , Humanos , Gravidez , Feminino , Peso ao Nascer , Diabetes Mellitus Tipo 2/induzido quimicamente , Insulina/uso terapêutico , Cesárea , Estudos Retrospectivos , Resultado da GravidezRESUMO
OBJECTIVE: We studied time in tight range (TITR) (70-140 mg/dL) in real-world users of the MiniMed 780G system (MM780G). RESEARCH DESIGN AND METHODS: CareLink Personal data were extracted (August 2020 to December 2022) to examine TITR and its relationship with time in range (TIR; 70-180 mg/dL), factors predicting higher TITR, and which TITR target is a reasonable treatment goal. RESULTS: The 13,461 users (3,762 age ≤15 years and 9,699 age >15 years) showed an average TITR of 48.9% in those age ≤15 years and 48.8% in the older group (vs. TIR 71.2% and 73.9%, respectively). Consistent use of a glucose target (GT) of 100 mg/dL and active insulin time (AIT) of 2 h were the most relevant factors predicting higher TITR (P < 0.0001). In users consistently applying these optimal settings, TITR was 56.7% in those age ≤15 years and 57.0% in the older group, and the relative impact of these settings on TITR was 60% and 86% greater than that on TIR, respectively. TITRs of â¼45% (age ≤15 years 46.3% and older group 45.4%), â¼50% (50.7% and 50.7%) and â¼55% (56.4% and 58.0%) were best associated with glucose management indicators <7.0%, <6.8%, and <6.5%, respectively. TITRs of >45%, >50%, and >55% were achieved in 91%, 74%, and 55% of those age ≤15 years and 93%, 81%, and 57% of older group users, respectively, at optimal settings. CONCLUSIONS: This study demonstrates that 1) mean TIR is high with a high mean TITR in MM780G users (>48%), 2) consistent use of optimal GT/AIT improves TITR (>56%), 3) the impact of these settings on TITR is larger than on TIR, and 4) a TITR target >50% is our suggested treatment goal.
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Diabetes Mellitus Tipo 1 , Humanos , Adolescente , Diabetes Mellitus Tipo 1/tratamento farmacológico , Glucose , Glicemia , Automonitorização da Glicemia , Insulina/uso terapêutico , HipoglicemiantesRESUMO
Background: Advanced hybrid closed-loop (AHCL) automated insulin delivery systems are the most effective therapy in terms of assisting people with type 1 diabetes (T1D) to achieve glycemic targets; however, the cost can represent a barrier to uptake. In this study, a cost-utility analysis of the MiniMed™ 780G AHCL system (MM780G) versus intermittently scanned continuous glucose monitoring (is-CGM) plus multiple daily insulin injections (MDI) in people with T1D not achieving glycemic goals was performed across six European countries. Methods: Clinical input data were sourced from the ADAPT trial. Assuming a baseline HbA1c of 9.04%, HbA1c reductions of 1.54% for AHCL and 0.2% for is-CGM+MDI were modeled. The analyses were performed from a payer perspective over a time horizon of 40 years and an annual discount rate of 3% was applied. Results: Across all countries, the use of AHCL was projected to result in an incremental gain in quality-adjusted life expectancy of >2 quality-adjusted life years (QALYs) versus is-CGM+MDI. Lifetime direct costs were higher with AHCL resulting in incremental cost-utility ratios for AHCL versus is-CGM+MDI ranging from EUR 11,765 per QALY gained in Austria to EUR 43,963 per QALY gained in Italy. Conclusions: For people with T1D managed with is-CGM+MDI not achieving glycemic targets, initiation of the MM780G system was projected to improve long-term clinical outcomes; however, due to differences in health care costs between countries, the health economic outcomes differed. In all included countries, AHCL is likely to be cost-effective relative to is-CGM+MDI for people not achieving glycemic goals with is-CGM+MDI. The ADAPT trial is registered with ClinicalTrials.gov, NCT04235504.
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Diabetes Mellitus Tipo 1 , Humanos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Insulina , Hipoglicemiantes , Análise Custo-Benefício , Glicemia , Hemoglobinas Glicadas , Automonitorização da Glicemia/métodos , Sistemas de Infusão de InsulinaRESUMO
Aim: To evaluate the effect of a one-year use of an advanced hybrid closed-loop (AHCL) system on the quality of life, level of anxiety, and level of self-efficacy in adults with type 1 diabetes (T1D) previously treated with multiple daily injections (MDI) and naïve to advanced diabetes technology. Methods: A total of 18 participants of a previously published 3-month randomized trial (10 men, 8 women; age 40.9 ± 7.6 years) who were switched directly from MDI/BMG to AHCL completed 12 months of MiniMed 780G™system use (a 3-month randomized trial followed by a 9-month follow-up phase). At month 6 of the study, patients were switched from the sensor GS3 (Continuous Glucose Monitoring) system, powered by Guardian™ Sensor 3) to GS4. Quality of life was assessed using the Polish validated version of the 'QoL-Q Diabetes' questionnaire. The level of anxiety was evaluated with the use of the State-Trait Anxiety Inventory (STAI). Self-efficacy was assessed with the General Self-Efficacy Scale (GSES). Results were obtained at baseline and at the end of the study. Results: Significant increase in QoL was reported in the global score (p=0.02, Cohen d=0.61) and in as many as 11 out of 23 analyzed areas of life: being physically active (p=0.02, Cohen d = 0.71); feeling well (p<.01, Cohen d = 0.73); feeling in control of my body (p<.01, Cohen d = 0.72); looking good (p<.01, Cohen d = 1.07); working (p<.01, Cohen d = 1.12); sleeping (p=0.01, Cohen d = 0.66); eating as I would like (p<.01, Cohen d = 0.79); looking after or being useful to others (p= 0.02, Cohen d = 0.65); being active with pets/animals (p<.01, Cohen d = 0.95); being spontaneous (p=0.02, Cohen d = 0.67); and doing "normal" things (p=0.02, Cohen d = 0.67). Both state (p=0.04, Cohen d = 0.56) and trait (p=0.02, Cohen d = 0.60) anxiety decreased while the general self-efficacy increased (p=0.03, Cohen d = 0.76). No participant stopped the use of the pump. Conclusion: Adult patients with T1D previously treated with MDI and naïve to modern technologies experienced significant improvement in their psychological well-being after transitioning to the AHCL system after 12 months of treatment.
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AIMS: To reassess the 6-month efficacy and to assess the 12-month sustained efficacy of the MiniMed™ 780G advanced hybrid closed-loop automated insulin delivery (AID) system compared to multiple daily injections plus intermittently scanned glucose monitoring (MDI+isCGM) in people with type 1 diabetes not meeting glucose targets. METHODS: The ADAPT study was a prospective, multicentre, open-label, randomized control trial in people with type 1 diabetes, with a glycated haemoglobin (HbA1c) concentration of at least 8.0% (64 mmol/mol), on MDI+isCGM therapy. After a 6-month study phase, participants randomized at baseline to MDI+isCGM switched to AID (SWITCH) while the others continued AID therapy (SUSTAIN) for an additional 6 months. The primary endpoint of this continuation phase was the within-group change in mean HbA1c between 6 and 12 months, with superiority in the SWITCH group and noninferiority in the SUSTAIN group (ClinicalTrials.gov: NCT04235504). RESULTS: A total of 39 SWITCH and 36 SUSTAIN participants entered the continuation phase. In the SWITCH group, HbA1c was significantly decreased by -1.4% (95% confidence interval [CI] -1.7% to -1.1%; P < 0.001) from a mean ± SD of 8.9% ± 0.8% (73.9 ± 8.6 mmol/mol) at 6 months to 7.5% ± 0.6% (58.5 ± 6.9 mmol/mol) at 12 months. Mean HbA1c increased by 0.1% (95% CI -0.05% to +0.25%), from 7.3% ± 0.6% (56.5 ± 6.7 mmol/mol) to 7.4% ± 0.8% (57.7 ± 9.1 mmol/mol) in the SUSTAIN group, meeting noninferiority criteria. Three severe hypoglycaemia events occurred in two SWITCH participants during the continuation phase. CONCLUSION: ADAPT study phase glycaemic improvements were reproduced and sustained in the continuation phase, supporting the early adoption of AID therapy in people with type 1 diabetes not meeting glucose targets on MDI therapy.
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Diabetes Mellitus Tipo 1 , Humanos , Adulto , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Hemoglobinas Glicadas , Estudos Prospectivos , Automonitorização da Glicemia , Reprodutibilidade dos Testes , Glicemia , Sistemas de Infusão de InsulinaRESUMO
OBJECTIVE: The use of parathyroid lesion aspiration in preoperative adenoma localisation is controversial. Concerns have been raised regarding both immediate safety (hematoma, infection, alterations on a subsequent histologic preparate) and long-term safety (seeding). We aimed to evaluate the short- and long-term safety, and the efficacy, of parathyroid fine-needle aspiration with parathyroid hormone washout as a localisation modality of parathyroid adenoma in patients with primary hyperparathyroidism. DESIGN: A retrospective study. PATIENTS: The sample comprised 29 patients with primary hyperparathyroidism who underwent minimally invasive parathyroidectomy at a tertiary referral centre, following localisation with parathyroid hormone washout. MEASUREMENTS: We reviewed all parathyroid hormone washout procedures performed during 2011-2021. Clinical, biochemical, and imaging information; and cytology, surgery, and pathology reports were extracted from electronic medical records. RESULTS: Parathyroid hormone levels from the needle wash were 2.1-112.5 times the upper limit of the serum norm. Other than mild neck discomfort, no immediate procedure complications were documented. Fibrotic changes and necrosis were reported in two patients, with no effect on the final pathologic diagnosis or surgery course. No long-term complications (seeding, or parathyromatosis) were found. A total of 26 (90%) patients who were operated following a positive parathyroid hormone washout result were normocalcemic at the end of a mean 38.1-month follow-up period. CONCLUSIONS: Parathyroid fine-needle aspiration with parathyroid hormone washout was accurate. Immediate, surgical, or delayed complications were not demonstrated in our series. This approach might be considered for selected patients.
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Hiperparatireoidismo Primário , Neoplasias das Paratireoides , Humanos , Neoplasias das Paratireoides/complicações , Hormônio Paratireóideo , Estudos Retrospectivos , Hiperparatireoidismo Primário/cirurgia , Biópsia por Agulha Fina , Paratireoidectomia/métodos , Tecnécio Tc 99m SestamibiRESUMO
Background: The advanced hybrid closed-loop (AHCL) algorithm combines automated basal rates and corrections yet requires meal announcement for optimal outcomes. We aimed to compare the performance of the MiniMed™ 780G AHCL algorithm with and without meal announcement. Methods: In a single-arm study involving 14 adults with type 1 diabetes, we evaluated the safety and efficacy of AHCL when meals were not announced. Participants stayed at a supervised environment for 5 days, during which the outcomes of not announcing meals (≤80 g of carbohydrate) were assessed. Next, participants entered a 90-day at-home "unannounced" phase, during which all meals (≤80 g of carbohydrate) were unannounced, followed by a 90-day at-home phase in which all meals were announced. Results: Time in range (TIR 70-180 mg/dL) was lower in the unannounced versus announced periods (67.5% ± 12.5% vs. 77.7% ± 9.5%; P < 0.01, respectively), with more time spent in hyperglycemia range 180-250 mg/dL (22.7% ± 7.7% vs. 15.7% ± 7.2%) and >250 mg/dL (7.9% ± 6.4% vs. 3.6% ± 2.7%), but less time in hypoglycemia range 54-70 mg/dL (1.6% ± 1% vs. 2.8% ± 1.8%) and <54 mg/dL (0.3% ± 0.4% vs. 0.7% ± 0.9%). Not announcing meals containing up to 60 g of carbohydrate did not lead to increase in postprandial extreme dysglycemia >250 mg/dL, and up to 20 g of unannounced carbohydrates did not significantly change the TIR 70-180 mg/dL compared with full announcement. Conclusion: The AHCL system is optimized for use with meal announcement. While not announcing meals of ≤80 g carbohydrates appears to be safe, it results in suboptimal postprandial glycemic control, especially with high-carbohydrate meals. Not announcing small meals (≤20 g carbohydrate) does not deteriorate glycemic control. Clinical Trial Registration number: NCT04479826.
Assuntos
Diabetes Mellitus Tipo 1 , Hipoglicemia , Adulto , Humanos , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemia/prevenção & controle , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , RefeiçõesRESUMO
AIM: Use of the MiniMed 780G system (MM780G) can result in a reduction in mean and standard deviation (SD) of sensor glucose (SG) values. We assessed the significance of the coefficient of variation (CV) as a measure of hypoglycaemia risk and glycaemic control. MATERIALS AND METHODS: Data from 10 404 MM780G users were analysed using multivariable logistic regression to assess the contribution of CV to (a) hypoglycaemia risk, measured as not reaching target <1% for time below range (TBR), and (b) achieving targets of time-in-range (TIR) >70% and glucose management indicator <7%. CV was compared with SD and low blood glucose index. To assess the relevance of CV <36% as a therapeutic threshold, we identified the CV cut-off point that optimally discriminated users at risk of hypoglycaemia. RESULTS: The contribution of CV was the smallest in terms of risk of hypoglycaemia (vs. low blood glucose index and SD) and TIR and glucose management indicator targets (vs. SD). In all cases the models with SD showed the best fit. A CV <43.4% (95% CI: 42.9-43.9) was the optimal cut-off point with a correct classification rate of 87.2% (vs. 72.9% for CV <36%). CONCLUSION: For MM780G users, CV is a poor marker for hypoglycaemia risk and glycaemic control. We recommend using, for the former, TBR and whether the TBR target is met (and not using CV <36% as a therapeutic threshold for hypoglycaemia); for the latter, TIR, time above range, whether targets are met and a discrete description of mean SG and SD of SG values.