Long-term Improvement of Metabolic Control Without Increased Risk of Hypoglycaemia by Intensive Insulin Regimens in Type 1 Diabetes Patients Treated in a Regular Clinical Setting

Abstract

Aim: To evaluate if intensive insulin regimen with multiple daily injections (MDI) is successful for treating type 1 diabetes patients over a long period of time in a regular clinical setting.

Method: This is a prospective, observational seven-year study. Fifty-nine (35male) type 1 diabetic patients with bad metabolic control (HbA1c≥9%), aged 31.9 years, range 18-47 were included in the present study. All of them had had at least 5 years of diabetes duration after diagnosis and showed negative responses of serum C-peptide to a standard breakfast. The main control variables are: Metabolic control measured by serum HbA1c values (values < 6.2 % was the treatment objective) and the frequency of hypoglycaemic episodes (episodes/patient-month).

Results: Significant decreases in mean±SD HbA1c values in this group of patients were observed from the first year of follow-up, with the mean values being: 7.5±1.5%, 7.2±1.8%, 7.6±1.6%, 7.1±1.7%, 7±1.4, 6.6±1.6% and 6.8±1.4% for the first, second, third, fourth, fifth, sixth and seventh years of follow-up respectively. Sixteen %, 27.5%, 15.7%, 33.3%, 28.6%, 42% and 33% of the patients reached the treatment objective (HbA1c values<6.2%) for each year of follow-up. Throughout the study period the rate of severe hypoglycaemia (episodes/patient-year) was 0.32±0.2 which was not significantly different compared with the value of 0.28±0.1 observed the year before the study began. Similarly frequencies of mild/moderate hypoglycaemia episodes (episodes/patient-month) varies between 16.5±4 and 21.7±5, which are not significantly different from the value of 17.7±6 observed the year before the study began.

Conclusion: Long-term improvement in metabolic control was observed in this group of type 1 diabetes patients with previous bad control, during treatment in a regular clinical setting. A considerable percentage of type 1 diabetic patients with MDI reached the treatment objective in every year of follow-up. Furthermore improvement in metabolic control is not associated with significantly increased frequency of hypoglycaemia episodes.

Key words

type 1 diabetes - intensive insulin regimen - HbA1c - hypoglycaemia

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