Robert Thomann, Philipp Schuetz , Beat Müller, Sabine Thomke, Ronald A. Schoenenberger, Ulrich Keller

Study question

Prospective evaluation of an algorithm which incorporates insulin resistance due to individual features and acute illness with subcutaneous (s.c.) insulin doses for correction of hyperglycaemia and to reach glycaemic targets.

Summary answer

Glycaemic targets were reached more rapidly and patients remained longer in the target range when insulin doses were adjusted using the algorithm.

What is known and what this paper adds

Evidence-based strategies to reach glycaemic targets safely with s.c. injections outside the critical care setting are largely lacking. This was the first randomised controlled trial to evaluate an insulin algorithm including an insulin resistance factor in patients on general medical wards.

Design

This was a two-centre, randomised controlled trial in two Swiss hospitals. Randomisation was 1:1 and allocation was concealed by the use of sealed, numbered envelopes. In both groups all previous known diabetes medication was stopped. In the control group patients were managed with a prefixed glucose-adapted sliding scale, using three preprandial injections of insulin aspart (Novorapid®). In patients who did not reach the target level within 24 hours, 50% of the daily rapid-acting insulin dose was administered before bedtime as the long-acting insulin analogue detemir (Levemir®). All adaptations in the control group after 24 hours were at the discretion of the treating physician. The intervention group was treated according our new algorithm.

Participants and setting

A total of 130 adult patients presenting to the emergency department of either hospital with hyperglycaemia (initial plasma glucose level of >8.0 mmol/l) and with a presumed in-hospital stay of >48 hours were included.

Primary outcome

The primary endpoint was the time in the glycaemic target range (5.5‒7.0 mmol/l) within the first 48 hours.

Main results and the role of chance

The intervention group remained longer in the target glucose range as compared with the control group (mean ± standard deviation 22.5 ± 10.5 vs 13.0 ± 14.7 hours) with a mean difference of 9.5 hours (95% confidence interval [CI] 5.1, 13.9). The median time to reach the target range was significantly shorter in the intervention group than in the control group (9.5 [95% CI 6.6, 11.5] vs 24.0 [95% CI 10.0, 29.0] hours, p log rank <0.0001).

Harms

There were more episodes of mild hypoglycaemia in the intervention group (19.4% vs 6.3%; absolute difference 13.5%; 95% CI 1.8, 24.3), with no difference in rates of severe hypoglycaemia. No other side effects associated with the intervention were found.

Bias, confounding and other reasons for caution

Limitations of our study are the small number of patients included and the open design without blinding of patients and caregivers.

Generalisability to other populations

The results of this trial should be pertinent to other populations in industrialised countries.

This is a summary of a paper that was published on www.smw.ch. Must be cited as: Thomann R, Schuetz P, Müller B, Thomke S, Schoenenberger RA, Keller U. Evaluation of an algorithm for intensive subcutaneous insulin therapy in noncritically ill hospitalised patients with hyperglycaemia in a randomised controlled trial. Swiss Med Wkly. 2013;143:w13808.

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