An intensive insulin therapy targeting normoglycemia in acute myocardial infarction
a) Background
Large surveys in several countries have shown that approximately two thirds of people admitted to a coronary care unit (CCU) have impaired fasting glucose (IFG), impaired glucose tolerance (IGT), newly detected diabetes or established diabetes. Prospective studies have also consistently reported that these dysglycemic patients have a higher mortality and in-hospital complications than euglycemic patients and that mortality is correlated to the degree of dysglycemia. These epidemiologic relationships suggest that strategies to lower glucose levels in the setting of an acute myocardial infarction (AMI) may reduce mortality.
To conduct a pilot study of intensive insulin therapy in at least 500 AMI patients to determine the feasibility of trial implementation in sites in India, Argentina, and Canada. It was estimated that it will take 12-14 months to enroll at least 500 patients (250 patients in each arm).
c) Methods
A total of 287 participants with an acute ST segment elevation myocardial infarction (STEMI) and a capillary glucose level ?8.0 mmol/L were randomly allocated to glucose management with intravenous glulisine insulin using this algorithm in the coronary care unit (CCU), followed by once-daily subcutaneous insulin glargine for 30 days versus standard glycemic approaches. The primary outcome was a difference in mean glucose levels at 24 h. Participants were followed for clinical outcomes through 90 days.
d) Results
At 24 h, the mean glucose level was 1.41 mmol/L (95% CI 0.69–2.13) lower in the insulin (6.53 vs. 7.94 mmol/L). Differences in glucose levels were maintained at 72 h and 30 days. A total of 22.7% of the insulin group versus 4.4% of the standard group had biochemical hypoglycemia (with neither signs nor symptoms) in the CCU because of lower glycemic goals. However, there were no differences in symptomatic hypoglycemia or clinical outcomes between the groups.
e) Total recruitment & no. of sites
273 patients & 15 sites
f) Conclusion
The RECREATE pilot trial showed that an insulin-based approach comprised of a simple, paper-based insulin algorithm targeting normal glucose levels followed by subcutaneous insulin for one month’s time can effectively and safely lower glucose levels with minimal hypoglycemia in patients with an acute STEMI. It is therefore feasible to test the effect of this approach in a large outcomes trial that could be globally conducted in a wide variety of settings.
g) Publication status (Name & year):
Diabetes Care, 2011
h) Publication link
Updated as on: 18 Jul 2022