Diabetes technology & therapeutics最新文献

The aim was to investigate the association between continuous glucose monitoring (CGM) data coverage and glycemic metrics. This study included over 97,000 clinical study participants and real-world data from type 1 or type 2 diabetes treated with multiple daily insulin injections, closed-loop systems, or basal-only insulin regimens. Over 35 million days of CGM data were analyzed with multilevel modeling. Low coverage was observed in 6.4%-10.1% of days and was significantly associated with lower time in range (TIR) across sources (P < 0.001). Each 1% increase in coverage was associated with a within-person increase of 0.07%-0.13% in mean daily TIR (P < 0.001). Our analysis shows that higher daily sensor coverage is significantly associated with higher daily TIR, suggesting that missing CGM data may be missing not-at-random. Although low-coverage days are included in TIR calculations, they contribute fewer measurements and may underrepresent periods of poor glycemic control, potentially leading to a systematic overestimation and bias of overall TIR.

Background: There is limited evidence regarding the safety and efficacy of advanced hybrid closed-loop (AHCL) systems during the perioperative period. Specific management guidelines for these systems are lacking.

Objective: To describe glycemic control metrics in patients with AHCL system during the intraoperative and postoperative periods.

Methods: Analytical study based on a prospective cohort of adults with type 1 diabetes (T1D) or type 2 diabetes who are treated with AHCL system (MiniMed™780G, Medtronic, USA) and are undergoing surgical procedures. The study compared time in range (%TIR) between 70 and 180 mg/dL, time below range (%TBR) <70 and <54 mg/dL, time above range (%TAR) >180 and >250 mg/dL, and time in normoglycemia range (%TINR) between 70 and 140 mg/dL during the intraoperative, immediate postoperative, and late postoperative periods, with baseline measurements.

Results: The analysis included 15 patients (86% T1D; 55.4 ± 16.3 years) and 17 surgical procedures (70% elective; mean duration 65.3 ± 36.3 min). Baseline data obtained 24 h prior to the admission: %TIR 78.4 ± 17.5%, %TINR 58.6 ± 22.9%, and %TBR <70 mg/dL 3.7 ± 4.2%. During the intraoperative period, %TIR increased to 99.6 ± 1.5% (P < 0.001), and %TBR <70 mg/dL decreased to 0 (P < 0.001). %TAR >180 mg/dL decreased from 17.8 ± 16.8% to 0.1 ± 1.5% (P < 0.001). No hypoglycemic events <70 mg/dL or <54 mg/dL were documented in the intraoperative and immediate postoperative periods. No severe adverse events related to device use were recorded.

Conclusions: During the perioperative period, continuing insulin infusion using AHCL system is feasible, maintaining high levels of %TIR and %TINR, without hypoglycemia or serious adverse events. Randomized clinical trials are needed to compare the use of this technology with usual care.

Achieving optimal glycemic control, preventing acute events, and minimizing the risk of chronic complications while maintaining a high quality of life are the primary goals of effective diabetes management. However, many insulin-treated people with type 1 diabetes and type 2 diabetes are not achieving the recommended glycemic goals. In addition to the known acute and chronic complications of hyperglycemia, hypoglycemia is a common occurrence that imposes significant health risks. Although rapid-acting and ultra-rapid-acting insulins have demonstrated improved glycemic and safety outcomes over human regular insulin, their delayed onset and extended duration of action, as well as the risk for dosing errors, make hypoglycemia a frequent event for people using these therapies. Technosphere inhaled insulin is a viable option for mealtime insulin coverage and post-meal corrections, providing a "fast on, fast off" insulin activity profile that closely aligns with the timing of glucose absorption from meals to achieve desired postprandial glycemic control while likely minimizing the risk of hypoglycemia. This article discusses the advantages of TI over injected rapid-acting insulin analogs in addressing hypoglycemia fear and the other barriers associated with treatment adherence.

In January 2006, Exubera^® (Pfizer, New York, NY) became the first inhaled insulin to be approved by the U.S. Food and Drug Administration (FDA). However, Exubera was withdrawn from the market in 2007 due to low sales. Ongoing innovation in inhaled insulin led to FDA approval of Technosphere^® Insulin (TI), the therapeutic component of the Afrezza^® inhaled insulin delivery system (MannKind Corporation, Westlake Village, CA). Currently, TI is the only rapid-acting inhaled insulin currently available. Recent studies have demonstrated the efficacy of TI with no concerning adverse events other than mild cough, which is generally mild, transient, and diminishes over time. However, many clinicians remain cautious about the potential for adverse events with chronic use beyond the duration of closely monitored clinical trials. In this article, we address the pulmonary safety concerns that are often associated with TI and present evidence demonstrating the safety of TI in type 1 diabetes and type 2 diabetes populations.

Aims: To assess the relationship between time in range (TIR), extrapolated from self-monitoring of blood glucose (SMBG) measures, and adverse perinatal outcomes in pregnant women with type 1 diabetes (T1D).

Methods: A retrospective cohort study was conducted, including singleton pregnancies that began antenatal care before 20 weeks of gestation and delivered live newborns without malformations between 2010 and 2019. Glycemic data from SMBG were categorized into TIR (63-140 mg/dL or 3.5-7.8 mmol/L), based on guidelines for real-time continuous glucose monitoring. Extrapolated TIR (eTIR) was defined as the proportion of time spent within the target range and categorized into three intervals: eTIR <50%, eTIR 50%-70%, and eTIR >70%. Clinical characteristics and obstetric outcomes were compared across these intervals. Multivariate logistic regression was used to evaluate the prediction of adverse outcomes, including preeclampsia, nephropathy, cesarean section, preterm birth, macrosomia, large for gestational age (LGA), small for gestational age (SGA), 5-minute Apgar score <7, shoulder dystocia, neonatal respiratory distress, neonatal hypoglycemia, and neonatal intensive care unit (NICU) admission.

Results: Data from 140 pregnancies were analyzed. Of these, 20% had eTIR <50%, 53.6% had eTIR 50%-70%, and 26.4% had eTIR >70%. Women with eTIR 50%-70% and eTIR >70% were less likely to experience preterm birth (OR: 0.271; 95% CI: 0.094-0.786 and OR: 0.219; 95% CI: 0.058-0.826), neonatal respiratory distress (OR: 0.341; 95% CI: 0.124-0.936 and OR: 0.122; 95% CI: 0.029-0.516), and LGA infants (OR: 0.246; 95% CI: 0.084-0.719 and OR: 0.115; 95% CI: 0.028-0.469) compared with women with eTIR <50%.

Conclusions: Higher eTIR values were associated with a reduced risk of preterm birth, neonatal respiratory distress, and LGA infants. For pregnant women with T1D, achieving an eTIR above 50% was sufficient to decrease the risk of these adverse outcomes, highlighting the importance of glucose control even in challenging circumstances.

Since the discovery of insulin in 1921, we have seen a constant stream of innovative insulin formulations designed to more closely mimic physiological insulin secretion in people with type 1 diabetes and insulin-requiring type 2 diabetes. This article briefly reviews the development of inhaled insulin over the past 30 years.

Continuous glucose monitoring with simplification strategies reduces hypoglycemia in older adults with type 1 diabetes (T1D), however the impact on postmeal glycemia is not known. A post-hoc analysis of older adults with T1D randomized to intervention with mealtime simplification strategies, or control, assessed weekly postmeal hypoglycemia and hyperglycemia. At baseline, 88 older adults with T1D (71 ± 5 years) in intervention (n = 47) and control (n = 41) had similar number of episodes of postmeal hypo- and hyperglycemia. The mean decrease from baseline to 6 months in episodes of postmeal hypoglycemia was: after breakfast (-0.77 vs. -0.32; P = 0.02), lunch (-0.80 vs. -0.32; P = 0.05), and dinner (-0.73 vs. -0.22; P = 0.04); and the mean change in episodes of postmeal hyperglycemia was: after breakfast (-2.05 vs. -1; P = 0.04), lunch (-1.23 vs. -0.87; P = 0.09), and dinner (-1.45 vs. -1.66; P = 0.33), respectively in intervention and control. Simplification strategies in older adults with T1D resulted in fewer episodes of postmeal hypoglycemia without worsening episodes of postmeal hyperglycemia.

The management of diabetes in women with gestational diabetes and in children and adolescents with type 1 diabetes presents challenges that require therapeutic options that address the unique needs of these patients. Technosphere® insulin (TI), the main component of the Afrezza® Inhalation System, has the potential to address these challenges by improving glycemic management, reducing hypoglycemia, and promoting treatment adherence. TI is characterized by a rapid onset of action and a short duration of effect, distinguishing it from traditional injectable rapid-acting insulin analogs. This article discusses greater flexibility in insulin delivery, along with potential applications, benefits, and challenges of treatment with Technosphere inhaled insulin in these two patient populations.