Efficacy of dual-hormone artificial pancreas to alleviate the carbohydrate-counting burden of type 1 diabetes: A randomized crossover trial

Abstract

Aim: Carbohydrate-counting is a complex task for many patients with type 1 diabetes. This study examined whether an artificial pancreas, delivering insulin and glucagon based on glucose sensor readings, could alleviate the burden of carbohydrate-counting without degrading glucose control.

Methods: Twelve adults were recruited into a randomized, three-way, crossover trial (ClinicalTrials.gov identifier No. NCT01930097). Participants were admitted on three occasions from 7AM to 9PM and consumed a low-carbohydrate breakfast (women: 30g; men: 50g), a medium-carbohydrate dinner (women: 50g; men: 70g) and a high-carbohydrate lunch (women: 90g; men: 120g). At each visit, glucose levels were randomly regulated by: (1) conventional pump therapy; (2) an artificial pancreas (AP) accompanied by prandial boluses, matching the meal's carbohydrate content based on insulin-to-carbohydrate ratios (AP with carbohydrate-counting); or (3) an AP accompanied by prandial boluses based on qualitative categorization (regular or large) of meal size (AP without carbohydrate-counting).

Results: The AP without carbohydrate-counting achieved similar incremental AUC values compared with carbohydrate-counting after the low- (P=0.54) and medium- (P=0.38) carbohydrate meals, but yielded higher post-meal excursions after the high-carbohydrate meal (P=0.004). The AP with and without carbohydrate-counting yielded similar mean glucose levels (8.2±2.1mmol/L vs. 8.4±1.7mmol/L; P=0.52), and both strategies resulted in lower mean glucose compared with conventional pump therapy (9.6±2.0mmol/L; P=0.02 and P=0.03, respectively).

Conclusion: The AP with qualitative categorization of meal size could alleviate the burden of carbohydrate-counting without compromising glucose control, although more categories of meal sizes are probably needed to effectively control higher-carbohydrate meals.

Keywords: Artificial pancreas; Carbohydrate-counting; Closed-loop hormonal delivery systems; Continuous glucose monitoring; Type 1 diabetes.