Faster Compared with Standard Insulin Aspart during Day-And-Night Fully Closed-Loop Insulin Therapy in Type 1 Diabetes: A Double-Blind Randomized Crossover Trial

Klemen Dovc, Claudia Piona, Gül Yeşiltepe Mutlu, Natasa Bratina, Barbara Jenko Bizjan, Dusanka Lepej, Revital Nimri, Eran Atlas, Ido Muller, Olga Kordonouri, Torben Biester, Thomas Danne, Moshe Phillip, Tadej Battelino

Research output: Contribution to journalArticlepeer-review

63 Scopus citations

Abstract

OBJECTIVE We evaluated the safety and efficacy of day-And-night fully closed-loop insulin therapy using faster (Faster-CL) compared with standard insulin aspart (Standard-CL) in young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS In a double-blind, randomized, crossover trial, 20 participants with type 1 diabetes on insulin pump therapy (11 females, aged 21.3 6 2.3 years, HbA1c 7.5 6 0.5% [58.5 6 5.5 mmol/mol]) underwent two 27-h inpatient periods with unannounced afternoon moderate-vigorous exercise and unannounced/uncovered meals. We compared Faster-CL and Standard-CL in random order. During both interventions, the fuzzy-logic control algorithm DreaMed GlucoSitter was used. Glucose sensor data were analyzed by intention-To-Treat principle with the difference (between Faster-CL and Standard-CL) in proportion of time in range 70 180 mg/dL (TIR) over 27 h as the primary end point. RESULTS The proportion of TIR was similar for both arms: 53.3% (83% overnight) in Faster-CL and 57.9% (88% overnight) in Standard-CL (P 5 0.170). The proportion of time in hypoglycemia <70 mg/dL was 0.0% for both groups. Baseline-Adjusted interstitial prandial glucose increments 1 h after meals were greater in Faster-CL compared with Standard-CL (P 5 0.017). The gaps between measured plasma insulin and estimated insulin-on-board levels at the beginning, at the end, and 2 h after the exercise were smaller in the Standard-CL group (P50.029, P50.003, and P50.004, respectively). No severe adverse events occurred. CONCLUSIONS Fully closed-loop insulin delivery using either faster or standard insulin aspart was safe and efficient in achieving near-normal glucose concentrations outside postprandial periods. The closed-loop algorithm was better adjusted to the standard insulin aspart.

Original languageEnglish
Pages (from-to)29-36
Number of pages8
JournalDiabetes Care
Volume43
Issue number1
DOIs
StatePublished - 1 Jan 2020
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2020 American Diabetes Association Inc.. All rights reserved.

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