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Article Dans Une Revue Diabetes Care Année : 2014

Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas

B. P. Kovatchev
  • Fonction : Auteur
Eric Renard
C. Cobelli
  • Fonction : Auteur
H. C. Zisser
  • Fonction : Auteur
P. Keith-Hynes
  • Fonction : Auteur
S. M. Anderson
  • Fonction : Auteur
S. A. Brown
  • Fonction : Auteur
D. R. Chernavvsky
  • Fonction : Auteur
M. D. Breton
  • Fonction : Auteur
L. B. Mize
  • Fonction : Auteur
D. Bruttomesso
  • Fonction : Auteur
S. del Favero
  • Fonction : Auteur
F. Boscari
  • Fonction : Auteur
S. Galasso
  • Fonction : Auteur
A. Avogaro
  • Fonction : Auteur
L. Magni
  • Fonction : Auteur
F. Di Palma
  • Fonction : Auteur
C. Toffanin
  • Fonction : Auteur
M. Messori
  • Fonction : Auteur
E. Dassau
  • Fonction : Auteur
F. J. Doyle
  • Fonction : Auteur

Résumé

OBJECTIVE We estimate the effect size of hypoglycemia risk reduction on closed-loop control (CLC) versus open-loop (OL) sensor-augmented insulin pump therapy in supervised outpatient setting. RESEARCH DESIGN AND METHODS Twenty patients with type 1 diabetes initiated the study at the Universities of Virginia, Padova, and Montpellier and Sansum Diabetes Research Institute; 18 completed the entire protocol. Each patient participated in two 40-h outpatient sessions, CLC versus OL, in randomized order. Sensor (Dexcom G4) and insulin pump (Tandem t:slim) were connected to Diabetes Assistant (DiAs)da smart-phone artificial pancreas platform. The patient operated the system through the DiAs user interface during both CLC and OL; study personnel supervised on site and monitored DiAs remotely. There were no dietary restrictions; 45-min walks in town and restaurant dinners were included in both CLC and OL; alcohol was permitted. RESULTS The primary outcomedreduction in risk for hypoglycemia as measured by the low blood glucose (BG) index (LGBI)dresulted in an effect size of 0.64, P = 0.003, with a twofold reduction of hypoglycemia requiring carbohydrate treatment: 1.2 vs. 2.4 episodes/session on CLC versus OL (P = 0.02). This was accompanied by a slight decrease in percentage of time in the target range of 3.9-10 mmol/L (66.1 vs. 70.7%) and increase in mean BG (8.9 vs. 8.4 mmol/L; P = 0.04) on CLC versus OL. CONCLUSIONS CLC running on a smartphone (DiAs) in outpatient conditions reduced hypoglyce-mia and hypoglycemia treatments when compared with sensor-augmented pump therapy. This was accompanied by marginal increase in average glycemia resulting from a possible overemphasis on hypoglycemia safety.

Dates et versions

hal-01944936 , version 1 (24-02-2020)

Identifiants

Citer

B. P. Kovatchev, Eric Renard, C. Cobelli, H. C. Zisser, P. Keith-Hynes, et al.. Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas. Diabetes Care, 2014, 37 (7), pp.1789--96. ⟨10.2337/dc13-2076⟩. ⟨hal-01944936⟩
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