Journal Article
Randomized Controlled Trial
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The additional dose of insulin for high-protein mixed meal provides better glycemic control in children with type 1 diabetes on insulin pumps: randomized cross-over study.

Pediatric Diabetes 2017 December
BACKGROUND: Delivery of insulin for high-protein low-fat meals with carbohydrates on the basis of carbohydrates leads to higher late postprandial glycemia. Studies with mixed meals demonstrated lower blood glucose level after dual wave bolus. The objective of our study was to assess the impact of additional dose of insulin in dual wave bolus for high-protein mixed meal on the postprandial glycemia.

MATERIALS AND METHODS: We performed a randomized, double-blind, two-way cross-over study, including 58 children with type 1 diabetes, aged 14.7 ± 2.2 years. Participants were randomly assigned into two treatment orders: NORMAL-DUAL or DUAL-NORMAL BOLUS. They consumed standardized high-protein, low-fat meals with carbohydrates. The primary outcome was postprandial glycemia (PPG) based on capillary blood glucose measurements (CBGM). The secondary outcomes were the frequency of hypoglycemia, area under glucose curve, mean amplitude of glycemic excursion (MAGE) and glycemic rise.

RESULTS: PPG assessed at 180 min was significantly lower when dual wave bolus was delivered (NORMAL 162 mg/dL [9 mmol/L] vs DUAL 130.0 mg/dL [7.22 mmol/L]; P = .004). There were no differences in CBGM between both groups at 60 and 120 min. We found differences between the groups in MAGE at 120 min (NORMAL 82.86 mg/dL [4.6 mmol/L] versus DUAL 54.76 mg/dL [3.04 mmol/L]; P = .0008). We observed no differences in the number of hypoglycemic episodes in both groups.

CONCLUSION: Applying an additional dose of insulin in dual wave bolus for high-protein mixed meal improved PPG. We observed no statistically significant increase in the number of hypoglycemic episodes associated with this intervention.

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