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Safety of User-Initiated Intensification of Insulin Delivery Using Cambridge Hybrid Closed-Loop Algorithm.

Published version
Peer-reviewed

Type

Article

Change log

Authors

Wilinska, Malgorzata E 
Ruan, Yue 
Allen, Janet M 
Boughton, Charlotte K  ORCID logo  https://orcid.org/0000-0003-3272-9544

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.

Description

Keywords

artificial pancreas, automated insulin delivery, closed-loop, hypoglycemia, personalized medicine, type 1 diabetes, Humans, Diabetes Mellitus, Type 1, Algorithms, Insulin Infusion Systems, Insulin, Adolescent, Child, Retrospective Studies, Male, Female, Adult, Hypoglycemic Agents, Blood Glucose, Middle Aged, Child, Preschool, Hypoglycemia, Infant, Young Adult, Aged

Journal Title

J Diabetes Sci Technol

Conference Name

Journal ISSN

1932-2968
1932-2968

Volume Title

Publisher

SAGE Publications
Sponsorship
Wellcome Trust (100574/Z/12/Z)
National Institute of Diabetes and Digestive and Kidney Diseases (DP3DK112176)
European Commission Horizon 2020 (H2020) Societal Challenges (731560)
NIHR Evaluation Trials and Studies Coordinating Centre (14/23/09)