The influence of different insulin regimens on quality of life and metabolic control in insulin-dependent diabetics.

Administration of insulin with premeal boluses of short-acting insulin using a new injection device (Novopen) was compared with a conventional three times daily injection regimen regarding aspects of quality of life and metabolic control in insulin-dependent diabetes mellitus (IDDM). Eighteen C-peptide-negative patients with IDDM (16 men, two women, aged 31.0 +/- 7.4 years, duration of diabetes 13.0 +/- 4.6 years; mean +/- SD) participated in the study. All patients had been treated with three daily insulin injections for at least 1 year prior to the study. The patients were randomized into two groups. Group A started a 3-month treatment period with premeal injections of short-acting insulin and intermediate-acting insulin at bedtime. This period was followed by another 3 months using the initial three times daily injection regimen. Group B completed the study in the reverse order. Quality of life was assessed by using questionnaires and personal interviews by the same clinical psychologist. Metabolic control was assessed by measuring the levels of glycosylated hemoglobin. The results show that both treatment groups experienced a general improvement in mood and well-being during the period with multiple insulin injection treatment. Furthermore, during the periods of insulin pen treatment, an increased experience of freedom and less dependence on fixed meal times were noted. Overall metabolic control, insulin dosage, body weight, and number of hypoglycemic episodes did not change during the study. It is concluded that metabolic control, safety, and number of hypoglycemic episodes using premeal doses of short-acting insulin using Novopen were not different from those seen during conventional treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes