Duration of Hybrid Closed-Loop Insulin Therapy to Achieve Representative Glycemic Outcomes in Adults With Type 1 Diabetes

Leelarathna, Lalantha; Thabit, Hood; Willinska, Malgorzata E; Bally, Lia; Mader, Julia K.; Arnolds, Sabine; Benesch, Carsten; Pieber, Thomas R.; Shah, Viral N.; Carlson, Anders; Bergenstal, Richard M.; Evans, Mark; Hovorka, Roman

doi:10.2337/dc19-2041

Cited by 14 publications

(18 citation statements)

References 4 publications

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“…It is reasonable to postulate that time in target range could improve further with a longer duration of use. It has previously been reported that 26 days of closed-loop use are required for the proportion of time in target glucose range to plateau, although this is likely to be population-dependent 13 , 14 .…”

Section: Discussionmentioning

confidence: 99%

Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial

Boughton

Tripyla

Hartnell

et al. 2021

Nat Med

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We evaluated the safety and efficacy of fully closed-loop insulin therapy compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis. In an open-label, multinational, two-center, randomized crossover trial, 26 adults with type 2 diabetes requiring dialysis (17 men, 9 women, average age 68 ± 11 years (mean ± s.d.), diabetes duration of 20 ± 10 years) underwent two 20-day periods of unrestricted living, comparing the Cambridge fully closed-loop system using faster insulin aspart (‘closed-loop’) with standard insulin therapy and a masked continuous glucose monitor (‘control’) in random order. The primary endpoint was time in target glucose range (5.6–10.0 mmol l−1). Thirteen participants received closed-loop first and thirteen received control therapy first. The proportion of time in target glucose range (5.6–10.0 mmol l−1; primary endpoint) was 52.8 ± 12.5% with closed-loop versus 37.7 ± 20.5% with control; mean difference, 15.1 percentage points (95% CI 8.0–22.2; P < 0.001). Mean glucose was lower with closed-loop than control (10.1 ± 1.3 versus 11.6 ± 2.8 mmol l−1; P = 0.003). Time in hypoglycemia (<3.9 mmol l−1) was reduced with closed-loop versus control (median (IQR) 0.1 (0.0–0.4%) versus 0.2 (0.0–0.9%); P = 0.040). No severe hypoglycemia events occurred during the control period, whereas one severe hypoglycemic event occurred during the closed-loop period, but not during closed-loop operation. Fully closed-loop improved glucose control and reduced hypoglycemia compared with standard insulin therapy in adult outpatients with type 2 diabetes requiring dialysis. The trial registration number is NCT04025775.

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Section: Discussionmentioning

confidence: 99%

Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial

Boughton

Tripyla

Hartnell

et al. 2021

Nat Med

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“…However, showing statistically significant benefits compared with control after 2 weeks does not necessarily mean that the numerical estimates of the outcomes are accurate and representative of longer term use. Correlation analysis indicates that a duration of 4 weeks might be needed to reliably obtain representative numerical estimates of time-in-target range and mean glucose outcomes, 27 although using a correlation analysis to obtain this duration has been recently questioned. 28 Despite the significant improvement in time-in-target range with automated insulin delivery, the numerical reduction in mean glucose level of 0.4 mmol/L did not reach Table 3.…”

Section: Discussionmentioning

confidence: 99%

Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial

Haidar

Legault

Raffray

et al. 2021

Diabetes Technology & Therapeutics

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Objective: Several studies have shown that closed-loop automated insulin delivery (the artificial pancreas) improves glucose control compared with sensor-augmented pump therapy. We aimed to confirm these findings using our automated insulin delivery system based on the iPancreas platform. Research Design and Methods: We conducted a two-center, randomized crossover trial comparing automated insulin delivery with sensor-augmented pump therapy in 36 adults with type 1 diabetes. Each intervention lasted 12 days in outpatient free-living conditions with no remote monitoring. The automated insulin delivery system used a model predictive control algorithm that was a less aggressive version of our earlier dosing algorithm to emphasize safety. The primary outcome was time in the range 3.9-10.0 mmol/L. Results: The automated insulin delivery system was operational 90.2% of the time. Compared with the sensoraugmented pump therapy, automated insulin delivery increased time in range (3.9-10.0 mmol/L) from 61% (interquartile range 53-74) to 69% (60-73; P = 0.006) and increased time in tight target range (3.9-7.8 mmol/L) from 37% (30-49) to 45% (35-51; P = 0.011). Automated insulin delivery also reduced time spent below 3.9 and 3.3 mmol/L from 3.5% (0.8-5.4) to 1.6% (1.1-2.7; P = 0.0021) and from 0.9% (0.2-2.1) to 0.5% (0.2-1.1; P = 0.0122), respectively. Time spent below 2.8 mmol/L was 0.2% (0.0-0.6) with sensor-augmented pump therapy and 0.1% (0.0-0.4; P = 0.155) with automated insulin delivery. Conclusions: Our study confirms findings that automated insulin delivery improves glucose control compared with sensor-augmented pump therapy. ClinicalTrials.gov no. NCT02846831.

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“…99 However, data from RCT of an HCL system suggested a minimum of 3 weeks as an optimal sampling duration to reflect long-term glycemic control. 101 We recommend 2-3 weeks of data for the AP Dashboard. Optimal sampling duration may increase in patients less compliant with HCL systems.…”

Section: Optimal Sampling For the Ap Dashboardmentioning

confidence: 99%

Standardized Hybrid Closed-Loop System Reporting

Shah

Garg

2021

Diabetes Technology & Therapeutics

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Duration of Hybrid Closed-Loop Insulin Therapy to Achieve Representative Glycemic Outcomes in Adults With Type 1 Diabetes

Cited by 14 publications

References 4 publications

Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial

Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial

Comparison Between Closed-Loop Insulin Delivery System (the Artificial Pancreas) and Sensor-Augmented Pump Therapy: A Randomized-Controlled Crossover Trial

Standardized Hybrid Closed-Loop System Reporting

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