Real-life glycemic control in patients with type 2 diabetes treated with insulin therapy: A prospective, longitudinal cohort study (Diabetes Distress and Care Registry at Tenri [DDCRT 9])

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We investigated the association between four insulin regimens, and increase in glycated hemoglobin (HbA1c) and insulin dose in a real-life clinical setting because there are no data about them among insulin regimens.

Materials and Methods:

Participants included 757 patients with type 2 diabetes having been treated with insulin therapy for more than 1 year. The four insulin regimens were regimen 1 (long-acting insulin, once daily), regimen 2 (biphasic insulin, twice daily), regimen 3 (biphasic insulin, three times daily) and regimen 4 (basal–bolus therapy). Main outcomes were increases in HbA1c levels >0.5% and increases in daily insulin units after 1 year. We carried out multivariable analyses to examine differences in glycemic control and insulin dose with adjustment for possible confounders.


Mean HbA1c level and duration of insulin therapy were 7.8% and 11.3 years, respectively. HbA1c levels increased by >0.5% at follow up in 22.8, 24.9, 20.7, and 29.3% of participants using regimen 1, 2, 3 and 4, respectively, with no significant differences between groups. Daily insulin doses increased in 62.3, 68.8, 65.3 and 38.6% of patients, respectively (P < 0.001). Multivariable regression analysis showed that patients who received regimen 4 had significantly lower odds of requiring future insulin dose increases than those who had received regimen 2 (adjusted odds ratio 0.24, 95% confidence interval 0.14–0.41; P < 0.001).


Many patients receiving insulin therapy showed increases in HbA1c levels and insulin doses 1 year later. The smallest increase in insulin dose was observed in the basal–bolus therapy group compared with other regimens.

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