Diabetes technology & therapeutics最新文献

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 However, Exubera was withdrawn from the market in 2007 due to low sales.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.

Objective: CamAPS FX is a customizable hybrid closed-loop app with a default target glucose of 105 mg/dL. The personal glucose target is user-adjustable in 1 mg/dL increments between 80 and 198 mg/dL in 30-min segments over 24 h. We assessed the impact of different personal glucose targets on glycemic control during real-world use of CamAPS FX in different age-groups.

Methods: We retrospectively analyzed data from real-world CamAPS FX users from 11 countries across all age-groups (1 to 90 years), who used the system between December 1, 2022 and November 30, 2023, and had a minimum of 8 weeks of closed-loop use. Every sensor glucose reading was matched to the user-specified glucose target.

Results: In total, 8604 users (mean age 32 ± 19 years, median days of data 89 [IQR 59, 119]) were included. Personal glucose targets were most frequently used by very young children (>50%), followed by school-aged children (>40%). All other age-groups used the default target 65%-68% of the time. Overall, personal glucose targets >120 mg/dL were associated with time in target range <70%. Time <70 mg/dL remained <4% across targets, apart from at the lowest (80-89 mg/dL). Older adults achieved time in range ≥70% across all targets. Very young children and young adults were only able to achieve time in range >70% with targets set below the default, which was associated with time <70 mg/dL of >4% in very young children.

Conclusions: Personal glucose targets are frequently used, with clinical impact differing depending on user-age. Adjusting glucose targets may help to achieve recommended glycemic targets and individual glycemic goals.

Barriers to insulin therapy remain a critical challenge for individuals with insulin-treated diabetes, contributing to suboptimal clinical outcomes. The Afrezza® inhaled insulin system, with Technosphere® insulin (TI), is a promising alternative to subcutaneous insulin injections, offering a rapid pharmacokinetic profile and ease of use. Clinical studies demonstrate comparable HbA1c reductions, fewer hypoglycemic events, and improved treatment satisfaction with TI compared with rapid-acting insulin analogs. By addressing barriers such as needle aversion, injection-related pain, and variable insulin absorption, TI has the potential to enhance diabetes treatment and quality of life. Individual choice, supported by shared decision-making, is essential for individualized diabetes care, empowering people with diabetes and improving outcomes. Broader adoption requires increased clinician awareness and insurance coverage.

Continuous glucose monitoring (CGM) technology is becoming increasingly available to people with diabetes using insulin therapy; however, availability for people with type 2 diabetes (T2D) not on insulin remains limited. For people with T2D, there is strong evidence of glycemic benefit with CGM use for those treated with insulin, and CGM is accepted as standard of care. This review explores the impact of CGM use on glycemic and patient-reported outcomes in noninsulin treated populations with T2D, reporting outcomes from 10 identified randomized controlled trials and 15 nonrandomized studies. We report evidence that supports the use of this technology in people with T2D not using insulin.