Outpatient overnight glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or conventional insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, randomised controlled trial

Haidar, Ahmad; Legault, Laurent; Matteau-Pelletier, Laurence; Messier, Virginie; Dallaire, M.; Ladouceur, Martin; Rabasa‐Lhoret, Rémi

doi:10.1016/s2213-8587(15)00141-2

Cited by 102 publications

(108 citation statements)

References 22 publications

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“…The algorithm for the artificial pancreas was initiated using the participant's weight, the time and carbohydrate amount of the last meal, and the basal and total insulin daily doses [18][19][20]. Insulin delivery was based on a proprietary dosing algorithm using a model predictive control.…”

Section: Methodsmentioning

confidence: 99%

“…Two configurations of the artificial pancreas, single hormone (insulin only) and dual hormone (insulin and glucagon), have been shown to offer tighter glucose control compared with conventional pump therapy [14][15][16][17]. However, although the addition of glucagon has the potential to further lower hypoglycaemia, this comes at the expense of increased cost and device complexity [18][19][20].…”

Section: Introductionmentioning

confidence: 99%

“…Several approaches have been investigated for the management of exercise during the operation of the single-hormone artificial pancreas [18][19][20][21][22]. A fully reactive system that is driven by glucose sensor data alone fails to prevent exerciseinduced hypoglycaemia, particularly because the delay in insulin absorption reduces the effectiveness of its suspension after the start of exercise [21].…”

Section: Introductionmentioning

confidence: 99%

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Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial

et al. 2016

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Aims/hypothesis The aim of this study was to assess whether the dual-hormone (insulin and glucagon) artificial pancreas reduces hypoglycaemia compared with the single-hormone (insulin alone) artificial pancreas during two types of exercise. Methods An open-label randomised crossover study comparing both systems in 17 adults with type 1 diabetes (age, 37.2 ± 13.6 years; HbA 1c, 8.0 ± 1.0% [63.9 ± 10.2 mmol/mol]) during two exercise types on an ergocycle and matched for energy expenditure: continuous (60% V : O 2peak for 60 min) and interval (2 min alternating periods at 85% and 50% V : O 2peak for 40 min, with two 10 min periods at 45% V : O 2peak at the start and end of the session). Blocked randomisation (size of four) with a 1:1:1:1 allocation ratio was computer generated. The artificial pancreas was applied from 15:30 hours until 19:30 hours; exercise was started at 18:00 hours and announced 20 min earlier to the systems. The study was conducted at the Institut de recherches cliniques de Montréal. Results During single-hormone control compared with dualhormone control, exercise-induced hypoglycaemia (plasma glucose <3.3 mmol/l with symptoms or <3.0 mmol/l regardless of symptoms) was observed in four (23.5%) vs two (11.8%) interventions (p = 0.5) for continuous exercise and in six (40%) vs one (6.25%) intervention (p = 0.07) for interval exercise. For the pooled analysis (single vs dual hormone), the median (interquartile range) percentage time spent at glucose levels below 4.0 mmol/l was 11% (0.0-46.7%) vs 0% (0-0%; p = 0.0001) and at glucose levels between 4.0 and 10.0 mmol/l was 71.4% (53.2-100%) vs 100% (100-100%; p = 0.003). Higher doses of glucagon were needed during continuous (0.126 ± 0.057 mg) than during interval exercise (0.093 ± 0.068 mg) (p = 0.03), with no reported side-effects in all interventions.A. Haidar and R. Rabasa-Lhoret are joint senior authors.Electronic supplementary material The online version of this article (doi:10.1007/s00125-016-4107-0) contains peer-reviewed but unedited supplementary material, which is available to authorised users.* Rémi Rabasa-Lhoret

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial

et al. 2016

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“…A different dual-hormone system applying insulin delivery in a fashion similar to that of a single-hormone closed-loop system and adding glucagon as a safety mitigation to reduce the risk of hypoglycemia was evaluated in children and adolescents in a diabetes camp over three consecutive nights [42]. Insulin-alone closed-loop and conventional pump therapy were comparators.…”

Section: Glucose Responsive Suspension Of Insulin Deliverymentioning

confidence: 99%

Insulin delivery and nocturnal glucose control in children and adolescents with type 1 diabetes

Tauschmann

Hovorka

2017

Expert Opinion on Drug Delivery

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Introduction: Nocturnal glucose control remains challenging in children and adolescents with type 1 diabetes due to highly variable overnight insulin requirements. The issue may be addressed by glucose responsive insulin delivery based on real-time continuous glucose measurements.Areas covered: This review outlines recent developments of glucose responsive insulin delivery systems from a paediatric perspective. We cover threshold-based suspend application, predictive low glucose suspend, and more advanced single hormone and dual-hormone closed-loop systems. Approaches are evaluated in relation to nocturnal glucose control particularly during outpatient randomised controlled trials.Expert opinion: Significant progress translating research from controlled clinical centre settings to free-living unsupervised home studies have been achieved over the past decade. Nocturnal glycaemic control can be improved whilst reducing the risk of hypoglycaemia with closed-loop systems. Following the US regulatory approval of the first hybrid closed-loop system in non-paediatric population, large multinational closed-loop clinical trials and pivotal studies including paediatric populations are underway or in preparation to facilitate the use of closed-loop systems in clinical practice.

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“…Two recent studies investigated single-versus dual-hormone closed-loop control: the first was performed in adults and adolescents for 24 h in a clinical research center and the second one in children and adolescents for 3 nights in a diabetes camp. Both studies suggested a possible reduction of hypoglycemia thanks to glucagon availability (16,17).…”

mentioning

confidence: 99%

Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home

et al. 2016

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OBJECTIVEAfter testing of a wearable artificial pancreas (AP) during evening and night (E/N-AP) under free-living conditions in patients with type 1 diabetes (T1D), we investigated AP during day and night (D/N-AP) for 1 month. RESEARCH DESIGN AND METHODSTwenty adult patients with T1D who completed a previous randomized crossover study comparing 2-month E/N-AP versus 2-month sensor augmented pump (SAP) volunteered for 1-month D/N-AP nonrandomized extension. AP was executed by a model predictive control algorithm run by a modified smartphone wirelessly connected to a continuous glucose monitor (CGM) and insulin pump. CGM data were analyzed by intention-to-treat with percentage time-in-target (3.9-10 mmol/L) over 24 h as the primary end point. RESULTSTime-in-target (mean 6 SD, %) was similar over 24 h with D/N-AP versus E/N-AP: 64.7 6 7.6 vs. 63.6 6 9.9 (P = 0.79), and both were higher than with SAP: 59.7 6 9.6 (P = 0.01 and P = 0.06, respectively). Time below 3.9 mmol/L was similarly and significantly reduced by D/N-AP and E/N-AP versus SAP (both P < 0.001). SD of blood glucose concentration (mmol/L) was lower with D/N-AP versus E/N-AP during whole daytime: 3.2 6 0.6 vs. 3.4 6 0.7 (P = 0.003), morning: 2.7 6 0.5 vs. 3.1 6 0.5 (P = 0.02), and afternoon: 3.3 6 0.6 vs. 3.5 6 0.8 (P = 0.07), and was lower with D/N-AP versus SAP over 24 h: 3.1 6 0.5 vs. 3.3 6 0.6 (P = 0.049). Insulin delivery (IU) over 24 h was higher with D/N-AP and SAP than with E/N-AP: 40.6 6 15.5 and 42.3 6 15.5 vs. 36.6 6 11.6 (P = 0.03 and P = 0.0004, respectively).

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Outpatient overnight glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or conventional insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, randomised controlled trial

Cited by 102 publications

References 22 publications

Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial

Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial

Insulin delivery and nocturnal glucose control in children and adolescents with type 1 diabetes

Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home

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