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Boughton, CK; Hartnell, S; Thabit, H; Poettler, T; Herzig, D; Wilinska, ME; Ashcroft, NL; Sibayan, J; Cohen, N; Calhoun, P; Bally, L; Mader, JK; Evans, M; Leelarathna, L; Hovorka, R.
Hybrid closed-loop glucose control with faster insulin aspart compared with standard insulin aspart in adults with type 1 diabetes: A double-blind, multicentre, multinational, randomized, crossover study.
Diabetes Obes Metab. 2021; 23(6):1389-1396
Doi: 10.1111/dom.14355
[OPEN ACCESS]
Web of Science
PubMed
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- Co-authors Med Uni Graz
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Mader Julia
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Pöttler Tina
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- Abstract:
- AIM: To evaluate the use of hybrid closed-loop glucose control with faster-acting insulin aspart (Fiasp) in adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: In a double-blind, multinational, randomized, crossover study, 25 adults with T1D using insulin pump therapy (mean ± SD, age 38 ± 9 years, HbA1c 7.4% ± 0.8% [57 ± 8 mmol/mol]) underwent two 8-week periods of unrestricted living comparing hybrid closed-loop with Fiasp and hybrid closed-loop with standard insulin aspart in random order. During both interventions the CamAPS FX closed-loop system incorporating the Cambridge model predictive control algorithm was used. RESULTS: In an intention-to-treat analysis, the proportion of time sensor glucose was in the target range (3.9-10.0 mmol/L; primary endpoint) was not different between interventions (75% ± 8% vs. 75% ± 8% for hybrid closed-loop with Fiasp vs. hybrid closed-loop with standard insulin aspart; mean-adjusted difference -0.6% [95% CI -1.8% to 0.7%]; p < .001 for non-inferiority [non-inferiority margin 5%]). The proportion of time with sensor glucose less than 3.9 mmol/L (median [IQR] 2.4% [1.2%-3.2%] vs. 2.9% [1.7%-4.0%]; p = .01) and less than 3.0 mmol/L (median [IQR] 0.4% [0.2%-0.7%] vs. 0.7% [0.2%-0.9%]; p = .03) was reduced with Fiasp versus standard insulin aspart. There was no difference in mean glucose (8.1 ± 0.8 vs. 8.0 ± 0.8 mmol/L; p = .13) or glucose variability (SD of sensor glucose 2.9 ± 0.5 vs. 2.9 ± 0.5 mmol/L; p = .90). Total daily insulin requirements did not differ (49 ± 15 vs. 49 ± 15 units/day; p = .45). No severe hypoglycaemia or ketoacidosis occurred. CONCLUSIONS: The use of Fiasp in the CamAPS FX closed-loop system may reduce hypoglycaemia without compromising glucose control compared with standard insulin aspart in adults with T1D.
- Find related publications in this database (using NLM MeSH Indexing)
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Adult - administration & dosage
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Blood Glucose - administration & dosage
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Cross-Over Studies - administration & dosage
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Diabetes Mellitus, Type 1 - drug therapy
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Humans - administration & dosage
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Hypoglycemic Agents - therapeutic use
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Insulin - therapeutic use
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Insulin Aspart - therapeutic use
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Insulin Infusion Systems - administration & dosage
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Middle Aged - administration & dosage
- Find related publications in this database (Keywords)
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artificial pancreas
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aspart
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closed-loop insulin delivery
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continuous glucose monitoring
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faster insulin aspart
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insulin pump therapy
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type 1 diabetes