scholarly journals Effect of Afrezza on glucose dynamics during HCL treatment

2020 ◽  
Author(s):  
Alfonso Galderisi ◽  
Nathan Cohen ◽  
Peter Calhoun ◽  
Kristen Kraemer ◽  
Marc Breton ◽  
...  

<b>Objective: </b>A major obstacle in optimizing the performance of closed-loop (CL) automated insulin delivery systems has been the delay in insulin absorption and action that results from the subcutaneous (SC) route of insulin delivery leading to exaggerated post-meal hyperglycemic excursions. We aimed to investigate the effect of Afrezza inhaled insulin with ultrafast-in and out action profile on improving post-prandial blood glucose control during hybrid closed loop (HCL) treatment in young adults with type 1 diabetes. <p><b>Methods: </b>We conducted an inpatient, three-way, randomized crossover standardized meal study to assess the efficacy and safety of Afrezza at a low (A<sub>L</sub>) and a high (<a>A<sub>H</sub></a>) dose as compared to a standard SC rapid-acting insulin (aspart) pre-meal bolus during Diabetes Assistant (DiAs) HCL treatment. Participants received two sequential meals on three study days, and pre-meal insulin bolus was determined based on home insulin to carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for A<sub>H </sub>and down for A<sub>L</sub>). The primary efficacy outcome was the peak postprandial plasma glucose (PPG) level calculated by pooling data for up to four hours after the start of each meal. Secondary outcomes included hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics. </p> <p><b>Results: </b>The mean PPG for the rapid acting insulin control arm and A<sub>H</sub> were similar (185±50mg/dL vs. 195±46mg/dL, respectively; p=0.45), while it was higher for meals using A<sub>L</sub> (208±54mg/dL, p=0.04). The A<sub>H</sub> achieved significantly lower early PPG level than the control arm (30 min; p<0.001), and improvement in PPG waned at later time points (120 and 180 min; p=0.02) coinciding with the end of Afrezza glucodynamic action. </p> <p><b>Conclusions: </b>Afrezza (A<sub>H</sub>) pre-meal bolus reduced the early glycemic excursion and improved PPG during HCL compared to aspart pre-meal bolus. The improvement in PPG was not sustained after the end of Afrezza glucodynamic action at 120min. </p>

2020 ◽  
Author(s):  
Alfonso Galderisi ◽  
Nathan Cohen ◽  
Peter Calhoun ◽  
Kristen Kraemer ◽  
Marc Breton ◽  
...  

<b>Objective: </b>A major obstacle in optimizing the performance of closed-loop (CL) automated insulin delivery systems has been the delay in insulin absorption and action that results from the subcutaneous (SC) route of insulin delivery leading to exaggerated post-meal hyperglycemic excursions. We aimed to investigate the effect of Afrezza inhaled insulin with ultrafast-in and out action profile on improving post-prandial blood glucose control during hybrid closed loop (HCL) treatment in young adults with type 1 diabetes. <p><b>Methods: </b>We conducted an inpatient, three-way, randomized crossover standardized meal study to assess the efficacy and safety of Afrezza at a low (A<sub>L</sub>) and a high (<a>A<sub>H</sub></a>) dose as compared to a standard SC rapid-acting insulin (aspart) pre-meal bolus during Diabetes Assistant (DiAs) HCL treatment. Participants received two sequential meals on three study days, and pre-meal insulin bolus was determined based on home insulin to carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for A<sub>H </sub>and down for A<sub>L</sub>). The primary efficacy outcome was the peak postprandial plasma glucose (PPG) level calculated by pooling data for up to four hours after the start of each meal. Secondary outcomes included hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics. </p> <p><b>Results: </b>The mean PPG for the rapid acting insulin control arm and A<sub>H</sub> were similar (185±50mg/dL vs. 195±46mg/dL, respectively; p=0.45), while it was higher for meals using A<sub>L</sub> (208±54mg/dL, p=0.04). The A<sub>H</sub> achieved significantly lower early PPG level than the control arm (30 min; p<0.001), and improvement in PPG waned at later time points (120 and 180 min; p=0.02) coinciding with the end of Afrezza glucodynamic action. </p> <p><b>Conclusions: </b>Afrezza (A<sub>H</sub>) pre-meal bolus reduced the early glycemic excursion and improved PPG during HCL compared to aspart pre-meal bolus. The improvement in PPG was not sustained after the end of Afrezza glucodynamic action at 120min. </p>


2009 ◽  
Vol 25 (03) ◽  
pp. 359-366 ◽  
Author(s):  
Camila Guimarães ◽  
Carlo A. Marra ◽  
Lindsey Colley ◽  
Sabrina Gill ◽  
Scot H. Simpson ◽  
...  

Objectives:The aim of this study was to determine the insulin-delivery system and the attributes of insulin therapy that best meet patients' preferences, and to estimate patients' willingness-to-pay (WTP) for them.Methods:This was a cross-sectional discrete choice experiment (DCE) study involving 378 Canadian patients with type 1 or type 2 diabetes. Patients were asked to choose between two hypothetical insulin treatment options made up of different combinations of the attribute levels. Regression coefficients derived using conditional logit models were used to calculate patients' WTP. Stratification of the sample was performed to evaluate WTP by predefined subgroups.Results:A total of 274 patients successfully completed the survey. Overall, patients were willing to pay the most for better blood glucose control followed by weight gain. Surprisingly, route of insulin administration was the least important attribute overall. Segmented models indicated that insulin naïve diabetics were willing to pay significantly more for both oral and inhaled short-acting insulin compared with insulin users. Surprisingly, type 1 diabetics were willing to pay $C11.53 for subcutaneous short-acting insulin, while type 2 diabetics were willing to pay $C47.23 to avoid subcutaneous short-acting insulin (p&lt; .05). These findings support the hypothesis of a psychological barrier to initiating insulin therapy, but once that this barrier has been overcome, they accommodate and accept injectable therapy as a treatment option.Conclusions:By understanding and addressing patients' preferences for insulin therapy, diabetes educators can use this information to find an optimal treatment approach for each individual patient, which may ultimately lead to improved control, through improved compliance, and better diabetes outcomes.


Author(s):  
Roman Hovorka

The standard therapy of type 1 diabetes is based on multiple daily injections of short- and long acting-insulin analogues accompanied by blood glucose self-monitoring. However, treatment goals identified by the Diabetes Control and Complications Trial are difficult to achieve due, at least in part, to a high risk of hypoglycaemia associated with many currents forms of intensive insulin therapy. Recent technological developments in real-time subcutaneous continuous glucose monitoring (CGM), combined with the continuous subcutaneous insulin infusion (CSII), could potentially reduce this risk. Since late 1990s at least five continuous or semicontinuous glucose monitors have received regulatory approval (1). CGM has been shown to improve glycaemic control in adults with type 1 diabetes, although apparent barriers to effectiveness in children and adolescents remain to be identified (see Chapter 13.4.9.1) (2). The availability of commercial CGM devices has reinvigorated research towards closed-loop systems (3-6), in which insulin is delivered according to real-time needs, as opposed to open-loop systems, which lack real-time responsiveness to changing glucose concentrations. Closed-loop insulin delivery, in which the insulin delivery is informed by the measured glucose concentrations has the potential gradually to revolutionize the management of type 1 diabetes by reducing or eliminating the risk of hypoglycaemia while achieving near-normal glucose levels. A closed-loop system, also called the ‘artificial pancreas’, comprises three components: a CGM device to measure real-time glucose concentration, a titrating algorithm to compute the amount of insulin needed, and an insulin pump delivering a rapid-acting insulin analogue (see Fig. 13.4.9.2.1). Only a few prototypes have been developed. Progress has been hindered by suboptimal accuracy and reliability of CGM devices, the relatively slow absorption of subcutaneously administered ‘rapid’-acting insulin analogues, and the lack of adequate control algorithms. So far, testing has been confined to the clinical setting. However, a concentrated effort promises an accelerated progress towards home testing of closed-loop systems. The research focus centres on systems utilizing subcutaneous glucose sensing and subcutaneous insulin delivery. This approach has the greatest potential for a near-future commercial exploitation, although other approaches utilizing intraperitoneal or intravenous sensing/delivery are, in principle, also feasible.


Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1065-P ◽  
Author(s):  
ANASTASIOS KOUTSOVASILIS ◽  
ALEXIOS SOTIROPOULOS ◽  
ANASTASIA ANTONIOU ◽  
VASILIOS KORDINAS ◽  
DESPINA PAPADAKI ◽  
...  

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 725-P
Author(s):  
SEMAH TAGOUGUI ◽  
NADINE TALEB ◽  
CORINNE SUPPERE ◽  
INÈS BOUKABOUS ◽  
VIRGINIE MESSIER ◽  
...  

2021 ◽  
Vol 14 (9) ◽  
pp. e243522
Author(s):  
Khulood Bukhari ◽  
Rana Malek

A 40-year-old woman used an open-source automated insulin delivery system to manage her type 1 diabetes (T1D) prior to conception. The code for building the iPhone application called ‘Loop’ that carried the software for the hybrid closed-loop controller was available online. Her glycated hemoglobin before conception was 6.4%. Between 6 and 12 weeks gestation, she spent 66% time-in-range (TIR), 28% time-above-range (TAR) and 6% time-below-range (TBR). Between 18 and 24 weeks gestation, she spent 68% TIR, 27% TAR and 5% TBR. During her third trimester, she spent 72% TIR, 21% TAR and 7% TBR. She delivered a healthy infant with no neonatal complications. Clinicians should be aware of this technology as it gains traction in the T1D community and seeks Food and Drug Administration approval.


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