The challenges of achieving postprandial glucose control using closed‐loop systems in patients with type 1 diabetes

Gingras, Véronique; Taleb, Nadine; Roy‐Fleming, Amélie; Legault, Laurent; Rabasa‐Lhoret, Rémi

doi:10.1111/dom.13052

Cited by 88 publications

(75 citation statements)

References 115 publications

(201 reference statements)

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“…A recent study found a positive correlation between time‐to‐peak insulin action and HbA1c level in studies of closed‐loop insulin delivery and sensor‐augmented pump therapy, indicating the need for insulins with rapid and consistent absorption properties that are more able to reproduce physiological insulin responses . Current rapid‐acting insulin analogues (RAIAs) — insulin aspart (IAsp), insulin lispro and insulin glulisine — have faster absorption kinetics than regular human insulin; however, post‐prandial glucose (PPG) control with pump therapy remains limited by the pharmacokinetics of RAIAs …”

Section: Introductionmentioning

confidence: 99%

“…15 Current rapid-acting insulin analogues (RAIAs)insulin aspart (IAsp), insulin lispro and insulin glulisinehave faster absorption kinetics than regular human insulin; 16 however, post-prandial glucose (PPG) control with pump therapy remains limited by the pharmacokinetics of RAIAs. 17 A new generation of ultra-fast-acting insulins, such as BioChaperone Lispro, 18,19 treprostinil lispro 20 and fast-acting insulin aspart (faster aspart), is under development. Faster aspart is the first of these to be approved for pump use in adults with T1D and type 2 diabetes (T2D) and it is now available in several countries.…”

mentioning

confidence: 99%

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Use of fast‐acting insulin aspart in insulin pump therapy in clinical practice

Evans

Ceriello

Danne

et al. 2019

Diabetes Obesity Metabolism

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Fast‐acting insulin aspart (faster aspart) is a novel formulation of insulin aspart (IAsp) containing the additional excipients niacinamide and L‐arginine. The improved pharmacological profile and greater early glucose‐lowering action of faster aspart compared with IAsp suggests that faster aspart may be advantageous for people with diabetes using continuous subcutaneous insulin infusion (CSII). The recent onset 5 trial was the first to evaluate the efficacy and safety of an ultra‐fast‐acting insulin in CSII therapy in a large number of participants with type 1 diabetes (T1D). Non‐inferiority of faster aspart to IAsp in terms of change from baseline in HbA1c was confirmed, with an estimated treatment difference (ETD) of 0.09% (95% CI, 0.01; 0.17; P < 0.001 for non‐inferiority [0.4% margin]). Faster aspart was superior to IAsp in terms of change from baseline in 1‐hour post‐prandial glucose (PPG) increment after a meal test (ETD [95% CI], −0.91 mmol/L [−1.43; −0.39]; P = 0.001), with statistically significant improvements also at 30 minutes and 2 hours. The overall rate of severe or blood glucose‐confirmed hypoglycaemia was not statistically significantly different between treatments, with an estimated rate ratio of 1.00 (95% CI, 0.85; 1.16). A numerical imbalance in severe hypoglycaemic episodes between faster aspart and IAsp was seen in the treatment (21 vs 7) and the 4‐week run‐in periods (4 vs 0). Experience from clinical practice indicates that all pump settings should be reviewed when initiating faster aspart with CSII, and that the use of continuous glucose monitoring or flash glucose monitoring, along with a good understanding of meal content and bolus type, may also facilitate optimal use. This review summarizes the available clinical evidence for faster aspart administered via CSII and highlights practical considerations based on clinical experience that may help healthcare providers and individuals with T1D successfully initiate and adjust faster aspart with CSII.

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Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

Use of fast‐acting insulin aspart in insulin pump therapy in clinical practice

Evans

Ceriello

Danne

et al. 2019

Diabetes Obesity Metabolism

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“…The potential that these new rapid‐acting insulins could improve the performance of closed‐loop automated insulin delivery systems (e.g. the artificial pancreas) remains of great interest, with ongoing trials evaluating their use in this environment.…”

Section: What Is the Potential Role For The Second‐generation Of Rapimentioning

confidence: 99%

The continuing quest for better subcutaneously administered prandial insulins: a review of recent developments and potential clinical implications

Owens

Bolli

2020

Diabetes Obesity Metabolism

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The class of rapid-acting insulin analogues were introduced more than 20 years ago to control postprandial plasma glucose (PPG) excursions better than unmodified regular human insulin. Insulins, lispro, aspart and glulisine all achieved an earlier onset of action, greater peak effect and shorter duration of action resulting in lower PPG levels and a reduced risk of late postprandial hypoglycaemia. However, the subcutaneous absorption rate of these analogues still fails to match the physiological profile of insulin in the systemic circulation following a meal. Recent reformulations of aspart and lispro have generated a second generation of more rapid-acting insulin analogue candidates, including fast-acting aspart (faster aspart), ultra-rapid lispro and BioChaperone Lispro. These modifications have the potential to mimic physiological prandial insulin secretion better with an even earlier onset of action with improved PPG control, shorter duration of effect and reduced risk of hypoglycaemia. Recent phase 3 trials in type 1 and type 2 diabetes show that faster aspart and ultra-rapid lispro compared with conventional aspart and lispro, achieved fewer PPG excursions with a small increase in post-meal hypoglycaemia but similar or marginally superior glycated haemoglobin levels, and suggest the need for parallel optimization of basal insulin replacement. Phase 1 trials for BioChaperone Lispro are equally encouraging with phase 3 trials yet to be initiated. Comparative analysis of the clinical and pharmacological evidence for these new prandial insulin candidates in the treatment of type 1 and type 2 diabetes is the main focus of this review.

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“…Understandably, several patients with T1D view eating as a stressful task, and eating disorders have a higher prevalence especially among women with T1D than in the general population [70]. Current versions of the AP perpetuate glucocentric T1D management by requiring users to enter their carbohydrate intake at every meal [8]. …”

Section: Domains Of Ethical Issuesmentioning

confidence: 99%

“…A first commercial version of the AP was approved by the FDA in September 2016 [7]. Most of the currently developed AP versions are hybrid closed-loop systems: they still require the patient to announce exercise and meals, with or without exact carbohydrate counting [8, 9]. This is partly due to the pharmacokinetics of the available insulins and equilibration between interstitial glucose measured by the continuous glucose monitoring device and actual blood glucose values.…”

Section: Introductionmentioning

confidence: 99%

A critical review and analysis of ethical issues associated with the artificial pancreas

Quintal

Messier

Rabasa‐Lhoret

et al. 2019

Diabetes & Metabolism

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The artificial pancreas combines a hormone infusion pump with a continuous glucose monitoring device, supported by a dosing algorithm currently installed on the pump. It allows for dynamic infusions of insulin (and possibly other hormones such as glucagon) tailored to patient needs. For patients with type 1 diabetes the artificial pancreas has been shown to prevent more effectively hypoglycaemic events and hyperglycaemia than insulin pump therapy and has the potential to simplify care. However, the potential ethical issues associated with the upcoming integration of the artificial pancreas into clinical practice have not yet been discussed. Our objective was to identify and articulate ethical issues associated with artificial pancreas use for patients, healthcare professionals, industry and policymakers. We performed a literature review to identify clinical, psychosocial and technical issues raised by the artificial pancreas and subsequently analysed them through a common bioethics framework. We identified five sensitive domains of ethical issues. Patient confidentiality and safety can be jeopardized by the artificial pancreas' vulnerability to security breaches or unauthorized data sharing. Public and private coverage of the artificial pancreas could be cost-effective and warranted. Patient selection criteria need to ensure equitable access and sensitivity to patient-reported outcomes. Patient coaching and support by healthcare professionals or industry representatives could help foster realistic expectations in patients. Finally, the artificial pancreas increases the visibility of diabetes and could generate issues related to personal identity and patient agency. The timely consideration of these issues will optimize the technological development and clinical uptake of the artificial pancreas.

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The challenges of achieving postprandial glucose control using closed‐loop systems in patients with type 1 diabetes

Cited by 88 publications

References 115 publications

Use of fast‐acting insulin aspart in insulin pump therapy in clinical practice

Use of fast‐acting insulin aspart in insulin pump therapy in clinical practice

The continuing quest for better subcutaneously administered prandial insulins: a review of recent developments and potential clinical implications

A critical review and analysis of ethical issues associated with the artificial pancreas

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