The Jesse and Sara Lea Shafer Institute for Endocrinology and Diabetes

Petah Tikva, Israel

The Jesse and Sara Lea Shafer Institute for Endocrinology and Diabetes

Petah Tikva, Israel
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Dovc K.,University of Ljubljana | Macedoni M.,University of Milan | Bratina N.,University of Ljubljana | Lepej D.,University of Ljubljana | And 9 more authors.
Diabetologia | Year: 2017

Aims/hypothesis: Hypoglycaemia during and after exercise remains a challenge. The present study evaluated the safety and efficacy of closed-loop insulin delivery during unannounced (to the closed-loop algorithm) afternoon physical activity and during the following night in young people with type 1 diabetes. Methods: A randomised, two-arm, open-label, in-hospital, crossover clinical trial was performed at a single site in Slovenia. The order was randomly determined using an automated web-based programme with randomly permuted blocks of four. Allocation assignment was not masked. Children and adolescents with type 1 diabetes who were experienced insulin pump users were eligible for the trial. During four separate in-hospital visits, the participants performed two unannounced exercise protocols: moderate intensity (55% of (Formula presented.)) and moderate intensity with integrated high-intensity sprints (55/80% of (Formula presented.)), using the same study device either for closed-loop or open-loop insulin delivery. We investigated glycaemic control during the exercise period and the following night. The closed-loop insulin delivery was applied from 15:00 h on the day of the exercise to 13:00 h on the following day. Results: Between 20 January and 16 June 2016, 20 eligible participants (9 female, mean age 14.2 ± 2.0 years, HbA1c 7.7 ± 0.6% [60.0 ± 6.6 mmol/mol]) were included in the trial and performed all trial-mandated activities. The median proportion of time spent in hypoglycaemia below 3.3 mmol/l was 0.00% for both treatment modalities (p = 0.7910). Use of the closed-loop insulin delivery system increased the proportion of time spent within the target glucose range of 3.9–10 mmol/l when compared with open-loop delivery: 84.1% (interquartile range 70.0–85.5) vs 68.7% (59.0–77.7), respectively (p = 0.0057), over the entire study period. This was achieved with significantly less insulin delivered via the closed-loop (p = 0.0123). Conclusions/interpretation: Closed-loop insulin delivery was safe both during and after unannounced exercise protocols in the in-hospital environment, maintaining glucose values mostly within the target range without an increased risk of hypoglycaemia. Trial registration: Clinicaltrials.govNCT02657083 Funding: University Medical Centre Ljubljana, Slovenian National Research Agency, and ISPAD Research Fellowship © 2017 The Author(s)

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