INITIATE (INITiate Insulin by Aggressive Titration and Education). A randomized study to compare initiation of insulin combination therapy in type 2 diabetic patients individually and in groups

Abstract

Background. Insulin is often postponed for years because initiation is time-consuming.

Objectives. To compare initiation of insulin individually (IND) and in groups (GROUP) with respect to change in HbA_1c and several other parameters in type 2 diabetic patients.

Design: A randomized (1:1), multi-center two-arm parallel design study with a recruiting period of up to 14 weeks and a 24-week treatment period. 121 insulin-naïve type 2 diabetic patients with an HbA_1c of 7.0-12.0 % were randomized to initiate bedtime insulin glargine either in groups of 4-8 or individually using the same personnel and education program. The patients visited the treatment center before, at the time of insulin initiation and at 6, 12 and 24 weeks. Patients self-adjusted the insulin dose to achieve a fasting plasma glucose of 4.0-5.5 mmol/l.

Results. At 24 weeks, HbA_1c had decreased from 8.7±0.2 to 6.9±0.1% in IND and from 8.8±0.2 to 6.8±0.1% in GROUP (NS).Insulin doses averaged 62±5 IU and 56±5 IU at 24 weeks (NS), respectively. The frequency of hypoglycemia was similar. The total time (visits and phone calls) spent in initiating insulin in GROUP (2.2±0.1 hrs) was 48% less than in IND (4.2±0.2 hrs). Diabetes treatment satisfaction improved significantly in both groups.

Conclusions. Similar glycemic control and treatment satisfaction can be achieved by initiating insulin in groups and individually. Starting insulin in groups takes half as much time as individual initiation.