Multicenter closed-loop/hybrid meal bolus insulin delivery with type 1 diabetes

Abstract

Background: This study evaluated meal bolus insulin delivery strategies and associated postprandial glucose control while using an artificial pancreas (AP) system.

Subjects and methods: This study was a multicenter trial in 53 patients, 12-65 years of age, with type 1 diabetes for at least 1 year and use of continuous subcutaneous insulin infusion for at least 6 months. Four different insulin bolus strategies were assessed: standard bolus delivered with meal (n=51), standard bolus delivered 15 min prior to meal (n=40), over-bolus of 30% delivered with meal (n=40), and bolus purposely omitted (n=46). Meal carbohydrate (CHO) intake was 1 g of CHO/kg of body weight up to a maximum of 100 g for the first three strategies or up to a maximum of 50 g for strategy 4.

Results: Only three of 177 meals (two with over-bolus and one with standard bolus 15 min prior to meal) had postprandial blood glucose values of <60 mg/dL. Postprandial hyperglycemia (blood glucose level >180 mg/dL) was prolonged for all four bolus strategies but was shorter for the over-bolus (41% of the 4-h period) than the two standard bolus strategies (73% for each). Mean postprandial blood glucose level was 15.9 mg/dL higher for the standard bolus with meal compared with the prebolus (baseline-adjusted, P=0.07 for treatment effect over the 4-h period).

Conclusions: The AP handled the four bolus situations safely, but at the expense of having elevated postprandial glucose levels in most subjects. This was most likely secondary to suboptimal performance of the algorithm.

Trial registration: ClinicalTrials.gov NCT01271023.

FIG. 1.

Glycemic control following standard bolus delivered with and before breakfast: (top panel) glucose levels and (bottom panel) insulin delivery following breakfast. Lines with dots denote the median glucose, lines without dots denote the 25^th and 75^th percentiles for glucose, and bars denote mean insulin delivery.

FIG. 2.

Glycemic control following over-bolus and no bolus delivered with breakfast: (top panel) glucose levels and (bottom panel) insulin delivery following breakfast. Lines with dots denote the median glucose, lines without dots denote the 25^th and 75^th percentiles for glucose, and bars denote mean insulin delivery.