Discussion
hypoglycemia, nausea
HYPERGLYCEMIA, EVENTS, TYPE 1 DIABETES, HYPOGLYCEMIA
In this 26-h inpatient study, we compared the performance of the DiaCon DH and SH configurations in adolescents with type 1 diabetes. For the entire study period, we found no differences in TBRThe DiaCon AP has previously been tested in adults with type 1 diabetes (Even though our SH configuration managed to ensure good glycemic control comparable to that of the commercially available APs with a TIRIn the overnight period participants were administered higher doses of bolus insulin during DH compared to SH (2.55 [ ± 2.50] vs. 0.5 [ ± 1.13] IE). This was most likely due to a couple of different factors. During the DH arm some participants were administered glucagon right before dinner announcement, resulting in inadequate meal bolus insulin, and subsequent hyperglycemia. Due to restrictions in the DiaCon AP around meals this led to insulin corrections being administered in the night hours (Initially, we hypothesized that the addition of glucagon could have counteracted the increased risk for hypoglycemia during physical activity (The side effects experienced in this study were mild and self-limiting, but the adolescents reported more clinically significant events of nausea during DH than during SH (27% vs. 0%). The other side effects were equally distributed across both study visits, as reported by other study groups (The current study had some limitations. Firstly, a small sample size makes the generalizability of the study results difficult. Furthermore, the current DiaCon AP set-up was too comprehensive for commercial pump use. Simpler set-up versions of the DiaCon AP, should be developed. The use of native glucagon limited the possibility to be used in real-world settings, but the current data show that soluble glucagon has a similar response. Furthermore, we conducted our study on adolescents of 13-17-years-old. This age group is different from all other due to the considerable hormonal and physiological changes over time. Therefore, it is important that studies with DH and SH APs also include adolescents before concluding whether it is beneficial in this age group. We chose a McDonalds meal as dinner, which is not typically classified as a balanced and healthy meal, however, we decided to do so in order to test our configurations maximally during the limited study time. Meals with a high carbohydrate and fat content are usually more difficultly handled for people with type 1 diabetes and testing our system in such a situation was therefore important. Furthermore, McDonalds is known worldwide making the approach universally applicable. Our participants were overall better regulated during the study days than in their everyday lives, though, we did not have a usual care control arm to test whether the superior glycemic control achieved by the DiaCon AP would persist an inpatient setting. This was the first 26-h inpatient study, during which the DH configuration was tested during multiple metabolic challenges.