Adverse effects of intensified treatment of insulin-dependent diabetes mellitus

Evidence Summaries

Level of Evidence = A
Intensified insulin treatment carries a substantial risk of severe adverse effects. Multiple daily injection schemes may be safer than treatment with insulin pumps.

A systematic review 1 including 14 studies (12 RCTs, 2 cross-over studies) with a total of 2069 subjects was abstracted in DARE. Intensified treatment always included frequent self-monitoring of blood glucose. Intensively treated patients had a median of 7.9 episodes (range 0 - 66.6) of severe hypoglycaemia per 100 person-years, while conventionally treated patients had a median of 4.6 episodes (range 0 - 33.3), OR 2.99. Intensively treated patients had more episodes of ketoacidosis, which was mostly associated with the use of insulin pumps. Fifteen deaths occurred in intensively treated patients compared to 11 deaths with conventional treatment. Of the 7 deaths (5 ketoacidosis, 2 sudden death) definitely or probably associated with acute complications of insulin therapy, all were in the intensively treated group.


1. Egger M, Davey Smith G, Stettler C, Diem P. Risk of adverse effects of intensified treatment in insulin-dependent diabetes mellitus: a meta-analysis. Diabet Med 1997 Nov;14(11):919-28.  [PMID:9400915]

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