Successful At-Home Use of the Tandem Control-IQ Artificial Pancreas System in Young Children During a Randomized Controlled Trial.
Diabetes Technol Ther
; 21(4): 159-169, 2019 04.
Article
em En
| MEDLINE
| ID: mdl-30888835
ABSTRACT
OBJECTIVE:
Hybrid closed-loop (HCL) artificial pancreas (AP) systems are now moving from research settings to widespread clinical use. In this study, the inControl algorithm developed by TypeZero Technologies was embedded to a commercial Tandem tslim X2 insulin pump, now called Control-IQ, paired with a Dexcom G6 continuous glucose monitor and tested for superiority against sensor augmented pump (SAP) therapy. Both groups were physician-monitored throughout the clinical trial. RESEARCH DESIGN ANDMETHODS:
In a randomized controlled trial, 24 school-aged children (6-12 years) with type 1 diabetes (T1D) participated in a 3-day home-use trial at two sites Stanford University and the Barbara Davis Center (50% girls, 9.6 ± 1.9 years of age, 4.5 ± 1.9 years of T1D, baseline hemoglobin A1c 7.35% ± 0.68%). Study subjects were randomized 11 at each site to either HCL AP therapy with the Control-IQ system or SAP therapy with remote monitoring.RESULTS:
The primary outcome, time in target range 70-180 mg/dL, using Control-IQ significantly improved (71.0% ± 6.6% vs. 52.8% ± 13.5%; P = 0.001) and mean sensor glucose (153.6 ± 13.5 vs. 180.2 ± 23.1 mg/dL; P = 0.003) without increasing hypoglycemia time <70 mg/dL (1.7% [1.3%-2.1%] vs. 0.9% [0.3%-2.7%]; not significant). The HCL system was active for 94.4% of the study period. Subjects reported that use of the system was associated with less time thinking about diabetes, decreased worry about blood sugars, and decreased burden in managing diabetes.CONCLUSIONS:
The use of the Tandem tslim X2 with Control-IQ HCL AP system significantly improved time in range and mean glycemic control without increasing hypoglycemia in school-aged children with T1D during remote monitored home use.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Glicemia
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Automonitorização da Glicemia
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Pâncreas Artificial
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Diabetes Mellitus Tipo 1
Tipo de estudo:
Clinical_trials
Limite:
Child
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Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article