Table 2.
Hybrid closed-loop system studies with simplified meal bolus strategy
| References | Study design and CLS type | Control Arms | Meal bolus description | N and Setting | Duration | Meals | Exercise | Main outcomes and postprandial outcomes |
|---|---|---|---|---|---|---|---|---|
| Body weight dependent bolus | ||||||||
| Haidar et al. 2014 51 | Randomized; dual-hormone | CHO-matched bolus | Based on body weight: 0.047 U/kg | 12 Adults; Inpatient | 2 x 5-h | 75g CHO breakfast | - | Glucose values returned to pre-prandial levels after 5 h with the body weight dependent bolus and after 2 h with the CHO-matched bolus; 5-h incremental area under the curve and percentage of time above 10 mmol/L were lower after the CHO-matched bolus compared with the body weight dependent bolus. |
| Meal category announcement | ||||||||
|
Gingras V et al. 2016
53 Previous study 52 |
Randomized; single and dual-hormone | CHO-matched bolus and CSII | Based on semi-quantitative meal CHO content assessment; 1) snack <30g (bolus for 15g); 2) regular meal 30–60g (bolus for 35g); 3) large meal 60–90g (bolus for 65g); 4) very large meal >90g (bolus for 95g) | 12 Adults; Outpatient | 5 x 15-h | Uncontrolled | Uncontrolled | Similar mean glucose level and percentage of time in target range with the carbohydrate-matched boluses and simplified strategy using both single-hormone and dual-hormone CLS; increased time in hypoglycemia with single and dual-hormone CLS and the simplified strategy compared with CSII. |
|
Russell SJ et al. 2016
36 Previous study 16 |
Randomized cross-over; dual-hormone | CSII | Meal type selection: breakfast, lunch or dinner; then, meal size selection: typical, more than usual, less than typical or small bite (individualized based on usual CHO intakes) | 19 Children; Outpatient | 2 x 5-d | Uncontrolled | Uncontrolled | Lower mean sensor glucose was observed with CLS as compared with CSII; increased proportion of time within target range, including less time in hyperglycemia; lower proportion of time spent in hypoglycaemia in CLS compared with CSII: lower % of time with sensor glucose <3.3 mmol/L and lower number of episodes requiring treatment. |
CSII: Continuous subcutaneous insulin infusion; CHO: Carbohydrate, CLS: Closed-loop system