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Ware, J; Wilinska, ME; Ruan, Y; Allen, JM; Boughton, CK; Hartnell, S; Bally, L; de, Beaufort, C; Besser, REJ; Campbell, FM; Draxlbauer, K; Elleri, D; Evans, ML; Fröhlich-Reiterer, E; Ghatak, A; Hofer, SE; Kapellen, TM; Leelarathna, L; Mader, JK; Mubita, WM; Narendran, P; Poettler, T; Rami-Merhar, B; Tauschmann, M; Randell, T; Thabit, H; Thankamony, A; Trevelyan, N; Hovorka, R.
Safety of User-Initiated Intensification of Insulin Delivery Using Cambridge Hybrid Closed-Loop Algorithm.
J Diabetes Sci Technol. 2024; 18(4):882-888
Doi: 10.1177/19322968221141924
[OPEN ACCESS]
Web of Science
PubMed
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- Co-Autor*innen der Med Uni Graz
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Fröhlich-Reiterer Elke
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Mader Julia
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Pöttler Tina
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Tauschmann Martin
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- Abstract:
- OBJECTIVE: Many hybrid closed-loop (HCL) systems struggle to manage unusually high glucose levels as experienced with intercurrent illness or pre-menstrually. Manual correction boluses may be needed, increasing hypoglycemia risk with overcorrection. The Cambridge HCL system includes a user-initiated algorithm intensification mode ("Boost"), activation of which increases automated insulin delivery by approximately 35%, while remaining glucose-responsive. In this analysis, we assessed the safety of "Boost" mode. METHODS: We retrospectively analyzed data from closed-loop studies involving young children (1-7 years, n = 24), children and adolescents (10-17 years, n = 19), adults (≥24 years, n = 13), and older adults (≥60 years, n = 20) with type 1 diabetes. Outcomes were calculated per participant for days with ≥30 minutes of "Boost" use versus days with no "Boost" use. Participants with <10 "Boost" days were excluded. The main outcome was time spent in hypoglycemia <70 and <54 mg/dL. RESULTS: Eight weeks of data for 76 participants were analyzed. There was no difference in time spent <70 and <54 mg/dL between "Boost" days and "non-Boost" days; mean difference: -0.10% (95% confidence interval [CI] -0.28 to 0.07; P = .249) time <70 mg/dL, and 0.03 (-0.04 to 0.09; P = .416) time < 54 mg/dL. Time in significant hyperglycemia >300 mg/dL was 1.39 percentage points (1.01 to 1.77; P < .001) higher on "Boost" days, with higher mean glucose and lower time in target range (P < .001). CONCLUSIONS: Use of an algorithm intensification mode in HCL therapy is safe across all age groups with type 1 diabetes. The higher time in hyperglycemia observed on "Boost" days suggests that users are more likely to use algorithm intensification on days with extreme hyperglycemic excursions.
- Find related publications in this database (using NLM MeSH Indexing)
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Humans - administration & dosage
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Diabetes Mellitus, Type 1 - drug therapy, blood
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Algorithms - administration & dosage
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Insulin Infusion Systems - adverse effects
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Insulin - administration & dosage, adverse effects
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Adolescent - administration & dosage
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Child - administration & dosage
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Retrospective Studies - administration & dosage
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Male - administration & dosage
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Female - administration & dosage
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Adult - administration & dosage
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Hypoglycemic Agents - administration & dosage, adverse effects
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Blood Glucose - analysis, drug effects
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Middle Aged - administration & dosage
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Child, Preschool - administration & dosage
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Hypoglycemia - chemically induced, epidemiology
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Infant - administration & dosage
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Young Adult - administration & dosage
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Aged - administration & dosage
- Find related publications in this database (Keywords)
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artificial pancreas
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automated insulin delivery
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closed-loop
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hypoglycemia
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personalized medicine
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type 1 diabetes