Diabetes technology & therapeutics最新文献

Afrezza inhaled insulin offers a unique alternative to subcutaneous insulin delivery, providing a rapid onset to effectively manage postprandial glucose spikes with a short duration of action that minimizes delayed postprandial hypoglycemia. Although Afrezza has been commercially available for more than a decade, its adoption has been limited by lack of clinician awareness, confusion about dosing, and skepticism about its efficacy and safety. This article presents our perspectives on Afrezza regarding dosing and titration strategies, patient selection and education, and other practical considerations.

Innovations in diabetes medications and technologies have revolutionized our approach to the management of diabetes. Automated insulin delivery (AID) systems have substantially improved overall glycemia and time-in-range; however, AID systems do not eliminate postprandial hyperglycemia or correct hyperglycemia quickly, given the glucose-lowering action lag of insulins that are used in AID systems. Inhaled insulin offers a novel approach to prandial insulin delivery, characterized by rapid absorption kinetics and a "rapid on, rapid off" pharmacokinetic profile that closely mimics endogenous insulin secretion and can compensate for the glucose-lowering action delay of subcutaneous insulin delivery. While the integration of inhaled insulin with AID systems presents an opportunity to address the limitations of subcutaneous insulin formulations, challenges remain in harmonizing the pharmacokinetics of inhaled insulin with AID systems. This article reviews the current evidence supporting the potential role of concomitant use of TI with AID and gaps in our current knowledge that need to be filled with future studies.

Reliance on endogenous insulin remains a significant challenge for individuals with type 1 diabetes (T1D). Although current rapid-acting insulin analogs (RAA) and ultra-rapid-acting insulin analogs (URAA) can provide effective postprandial glycemic control, inaccurate calculation of carbohydrates and mistiming of insulin injections can result in postprandial glucose spikes or early hypoglycemia. Their long duration of action also raises concerns about insulin stacking, which may result in late postprandial hypoglycemia. Unlike injected or infused rapid-acting insulins, Technosphere® insulin (TI) may bypass the slower absorption and hepatic degradation associated with subcutaneous delivery, ensuring faster systemic availability, however definitive studies have not been conducted. This characteristic of TI aligns closely with the timing of ketone body production, enabling timely intervention to prevent progression to full-blown ketoacidosis. The RAA and URAA profile characteristics are also problematic for individuals who engage in regular physical activity, often resulting in hypoglycemia, hyperglycemia, or both. This article reviews the challenges and potential dangers associated with managing T1D and discusses how TI, the only commercially available inhaled insulin, may overcome the inherent limitations of current RAA and URAA therapies.

Despite the known acute and chronic complications associated with suboptimal glycemic control, only approximately 25% of people with type 1 diabetes and type 2 diabetes who are treated with prandial insulin are achieving the American Diabetes Association-recommended glycated hemoglobin target of <7%. A significant driver of poor diabetes management is therapeutic inertia, which is the failure to intensify therapy when glycemic goals are not achieved. suboptimal adherence to insulin therapy. While patient reluctance to initiate or intensify insulin therapy can be attributed to many factors, the most common reasons for nonadherence include fear of hypoglycemia, aversion to needles, and concerns about weight gain. Whereas clinicians often delay therapy intensification due to lack education/training in insulin therapy, concerns about hypoglycemia, and restrictions on time and resources. Inhaled insulin therapy with Technosphere® insulin has the potential to overcome these obstacles. This article reviews the impact of therapeutic inertia in individuals with diabetes who are treated with insulin or require insulin therapy and discusses how the use of inhaled insulin may overcome many of the barriers to insulin treatment intensification.

Introduction: The present study assessed the impact of the disposable Simplera Sync™ sensor with the MiniMed™ 780G (MM780G) advanced hybrid closed-loop (AHCL) system on type 1 diabetes (T1D) glycemic metrics, insulin delivery, and safety.

Materials and methods: Youths (aged 7-17 years) and adults (aged 18-80 years) with T1D were enrolled in this single-arm, nonrandomized study at 24 sites in the United States. Participants began with an ∼2-week run-in period where hybrid closed-loop (HCL; auto basal only) or open-loop insulin delivery was used, followed by an ∼3-month study period with AHCL activated. Glycemic outcomes and insulin delivery during the last 6-7 weeks of the study, when settings were optimized at investigator's discretion, were compared with the run-in. Glycemic outcomes with the use of recommended optimal settings (ROS, 100 mg/dL glucose target with a 2-h active insulin time) were explored.

Results: Time in automation was high (>93%) and mean time in range (TIR) increased from 54.4% ± 15.7% to 71.4% ± 9.9% (P < 0.001) in youths and from 66.5% ± 12.6% to 80.2% ± 8.1% (P < 0.001) in adults, primarily due to reduced time above range. Youths had a slight increase in time below range (TBR <70 mg/dL) from 1.6% ± 1.7% to 1.9% ± 1.4% (P < 0.001), while adults had no significant difference in TBR. For ROS users, TIR was 74.7% ± 9.3% in youths and 83.8% ± 7.4% in adults. Throughout the study ∼60% of total daily insulin dose was automated (auto basal and auto correction) in both cohorts. There were two cases of severe hypoglycemia and one episode of diabetic ketoacidosis (not related to the device).

Conclusions: MM780G use with the Simplera Sync sensor is safe and demonstrated improved glycemic outcomes in both pediatric and adult participants with T1D, compared with the run-in period.

Background and aims: Continuous glucose monitors (CGMs) can comprehensively assess glycemic patterns in patients treated with dialysis, in whom conventional biomarkers such as glycated hemoglobin are inaccurate. Nonetheless, adoption of recent versions of CGMs in this population has been complicated by concerns about interstitial volume expansion, interfering substances, and effects of dialysis treatment. This study aimed to examine the accuracy of the G6 Pro and G7 CGM systems (Dexcom, Inc.) compared with self-monitored blood glucose (SMBG) in a dialysis population.

Methods: Twelve participants treated with maintenance dialysis (11 hemodialysis, 1 peritoneal dialysis [PD]) with diabetes wore concurrent G6 Pro and G7 CGMs for a period of 10 days, during which they measured SMBG using a Contour Next glucometer. We summarized CGM-glucometer Pearson correlations, calculated the mean absolute relative difference (MARD) of G6 Pro/G7 and SMBG, created Diabetes Technology Society (DTS) error grids, and investigated the CGM lag time that most closely corresponded with SMBG.

Results: Mean (standard deviation [SD]) age of participants was 50 (12) years, 50% were female, mean (SD) diabetes duration was 24 (9) years, and 92% used insulin. Participants collected 245 SMBG measurements over a total of 178 days of CGM. The Pearson correlations of G6 Pro and SMBG, G7 and SMBG, and G6 Pro and G7 were 0.87, 0.88, and 0.95, respectively. The MARDs of G6 Pro versus SMBG and G7 versus SMBG were 21.2% and 16.7%, respectively; excluding one PD participant with highly variable glucose, MARDs were 18.3% and 13.5%. The DTS error grids showed that 96.7% of G6 Pro and 98.0% of G7 measurements were clinically acceptable (Zones A/B) when compared with SMBG. We observed evidence of greater lag times than previously seen in nondialysis populations and substantial between- and within-person variability in CGM performance.

Conclusions: Among patients with diabetes treated with maintenance dialysis, CGM measurements of glucose had high correlation with SMBG, with better performance of the G7 compared with G6 Pro. MARD was higher than previously reported in nondialysis populations, but most values fell within clinically acceptable ranges. While issues around lag time, sensor placement, and interfering substances that may impact CGM performance warrant further investigation, our study findings support the use of CGM to evaluate glycemia in the dialysis population.

Limitations in current insulin formulations contribute to suboptimal glycemic control and increased risks of hypoglycemia and hyperglycemia. Afrezza® with Technosphere® inhaled insulin (TI) offers a novel therapeutic option with a rapid pharmacokinetic and pharmacodynamic profile, addressing challenges associated with injectable insulin therapies. This article presents case reports that illustrate the clinical applications of TI across diverse patient populations, including type 1 diabetes, type 2 diabetes (T2D), pregnancy complicated by T2D, and exercise-related glycemic management.

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.