Initiating insulin treatment in insulin-requiring type 2 diabetic patients: comparative efficiency and cost of outpatient and inpatient management. INNOV Study Group.

The main objective of this randomised study was to compare glycaemic control (as determined by HbA1c levels) in two groups of insulin-requiring Type 2 diabetic patients three months after initiation of insulin therapy either on an inpatient (group A, n = 58) or outpatient (group B, n = 56) basis. Evaluation of the safety and cost of both methods was a secondary objective. Although HbA1c level at inclusion was slightly but significantly lower in group A than group B (10.17 +/- 0.19% vs. 10.87 +/- 0.22% respectively, P = 0.019), covariance analysis showed equivalent glycaemic control at 3 months in both groups (adjusted means with respect to inclusion values: 9.00 +/- 1.14% vs. 9.37 +/- 1.14% respectively; equivalence hypothesis: P = 0.01). A low and similar incidence of episodes of hypoglycaemia and hyperglycaemia with ketonuria was observed. Clinical tests, paramedical care and the cost of hospitalisation itself resulted in a direct cost of initiating treatment that was more than four times higher in group A than in group B (mean total cost per patient: FF 15,231 and FF 3,296 respectively). Insulin-requiring Type 2 diabetic patients can be efficiently and safely started on insulin as outpatients, and this approach to initiating insulin therapy is cost-effective.

RCT Entities:   Population Interventions Outcomes