[Effects of insulin caliper for blood glucose control on glucose control in emergent and critical patients]

To observe the effects of insulin caliper for blood glucose control on glycemic central tendency, fluctuation and incidence of hypoglycemia, etc., in emergent and critical patients to evaluate its application value.

A prospective single-blinded randomized parallel controlled intervention study was conducted. One hundred patients with severe hyperglycemia requiring treatment with insulin infusion admitted to emergency department and intensive care unit (ICU) of the First Hospital of Jiaxing from November 2015 to November 2017 were enrolled, and they were divided into the caliper group (used patented product insulin calipers for blood glucose control to adjust insulin dose for blood glucose control) and the conventional group (used paper-based insulin dose modification scheme to adjust insulin dose for blood glucose control) on average by random number table, 50 in each group. The gender, age, acute physiology and chronic health evaluation II (APACHE II), sequential organ failure assessment (SOFA), the principal diseases, main factors affecting blood glucose (hepatic and renal insufficiency, hypoglycemic drugs, glucocorticoids, mechanical ventilation, enteral nutrition, parenteral nutrition, intravenous glucose use, etc.), blood glucose levels at each time node (once every 2 hours after insulin use and once every 4 hours after 16-72 hours), glycemic coefficient of variance (CV), glycemic lability index (GLUGLI) and mean amplitude of glycemic excursion (GLUMAGE), insulin dose, incidence of hypoglycemia, proportion of achieving the glucose control target at each time point, the length of ICU stay and hospitalization cost per patient were recorded and compared between the two groups.

After excluding those with incomplete data and withdraw in the midway, 92 patients were enrolled in the analysis finally, 47 in caliper group and 45 in conventional group. There were no significant differences in the incidence of the gender, age, APACHE II, SOFA, presence of infection at admission, previous diabetes history, glycosylated hemoglobin level, blood glucose at admission, proportion of patients after surgery, major diseases at admission and major factors affecting blood glucose between the two groups. A total of 1 379 blood glucose measurements were obtained in the caliper group and 1 332 blood glucose measurements were obtained in the conventional group. The glycemic measurements in caliper group were significantly lower than that in conventional group at each time point from 6-72 hours. Compared with conventional group, GLUGLI and GLUMAGE were significantly decreased in the caliper group [GLUGLI: 12.96 (8.73, 19.58) vs. 23.27 (13.07, 44.61), GLUMAGE (mmol/L): 0.66±0.22 vs. 0.87±0.28, both P < 0.01]; there was a tendency towards decreasing incidence of hypoglycemia in the caliper group [8.51% (4/47) vs. 15.56% (7/45)], but no statistical difference was found (P > 0.05); the proportion of achieving the glucose control target was significantly increased in the caliper group [41.99% (579/1 379) vs. 27.18% (362/1 332), P < 0.01]. There were no significant differences in glycemic CV, insulin dose, proportion of hypoglycemic measurements in total measurements, and the length of ICU stay, the length of hospital stay, incidence of nosocomial infection, patient prognosis and cost between the two groups.

For emergent and critical patients, insulin caliper for blood glucose control presents favorable application value for achieving glucose control target, reducing glycemic fluctuation, and lowering the incidence of hypoglycemia.

China clinical trial registration center, ChiCTR1800015024.