Alleviating Carbohydrate Counting With a FiASP-plus-Pramlintide Closed-Loop Delivery System (Artificial Pancreas): Feasibility and Pilot Studies

Tsoukas, Michael A.; Cohen, Elisa; Legault, Laurent; Oettingen, Julia von; Yale, Jean‐François; Vallis, Michael; Odabassian, Madison; Fathi, Anas El; Rutkowski, Joanna; Jafar, Adnan; Ghanbari, Milad; Gouchie‐Provencher, Nikita; René, Jennifer; Palisaitis, Emilie; Haidar, Ahmad

doi:10.1016/j.jcjd.2021.09.087

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“…The study by Grosman et al [15] was excluded as it was done using a virtual patient simulation and not in real patients. The study by Tsoukas et al [16] was excluded as it used pramlintide along with FIAsp insulin in the insulin pump closed loop system. The details of the studies included in this meta-analysis have been elaborated in Table 1.…”

Section: Resultsmentioning

confidence: 99%

Performance of Fast-Acting Aspart Insulin as Compared to Aspart Insulin in Insulin Pump for Managing Type 1 Diabetes Mellitus: A Meta-Analysis

Dutta¹,

Mohindra

Mahajan

et al. 2023

Diabetes Metab J

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Background:No meta-analysis has analysed efficacy and safety of fast-acting aspart insulin (FIAsp) with insulin pump in type 1 diabetes mellitus (T1DM). Methods: Electronic databases were searched for randomised controlled trials (RCTs) involving T1DM patients on insulin pump receiving FIAsp in intervention arm, and placebo/active comparator insulin in control arm. Primary outcome was to evaluate changes in 1-and 2-hour post-prandial glucose (1hPPG and 2hPPG). Secondary outcomes were to evaluate alterations in percentage time with blood glucose <3.9 mmol/L (hypoglycaemia), time in range (TIR) blood glucose 3.9 to 10 mmol/L, insulin requirements and adverse events. Results: Data from four RCTs involving 640 patients was analysed. FIAsp use in insulin pump was associated with significantly greater lowering of 1hPPG (mean difference [MD], -1.35 mmol/L; 95% confidence interval [CI], -1.72 to -0.98; P<0.01; I 2 =63%) and 2hPPG (MD, -1.19 mmol/L; 95% CI, -1.38 to -1.00; P<0.01; I 2 =0%) as compared to controls. TIR was comparable among groups (MD, 1.06%; 95% CI, -3.84 to 5.96; P=0.67; I 2 =70%). Duration of blood glucose <3.9 mmol/L was lower in FIAsp group, approaching significance (MD, -0.91%; 95% CI, -1.84 to 0.03; P=0.06; I 2 =0%). Total hypoglycaemic episodes (risk ratio [RR], 1.35; 95% CI, 0.55 to 3.31; P=0.51; I 2 =0%), severe hypoglycaemia (RR, 2.26; 95% CI, 0.77 to 6.66; P=0.14), infusion site reactions (RR, 1.35; 95% CI, 0.63 to 2.93; P=0.77; I 2 =0%), and treatment-emergent adverse events (RR, 1.13; 95% CI, 0.80 to 1.60; P=0.50; I 2 =0%) were comparable. Conclusion: FIAsp use in insulin pump is associated with better post-prandial glycaemic control with no increased hypoglycaemia or glycaemic variability.

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Section: Resultsmentioning

confidence: 99%