Assessment of the effectiveness of long-term insulin pump therapy using a combined goal of HbA decrease and absence of severe hypoglycemia.

OBJECTIVE

Less than one third of patients with type 1 diabetes mellitus (T1DM) achieve the cut-off value proposed as good metabolic control by most guidelines, HbA<7%. However, HbA reductions and prevention of severe hypoglycemia (SH) have shown clinically relevant benefits. The study objective therefore was to assess the effectiveness of continuous subcutaneous insulin infusion (CSII) therapy at 5 years of follow-up in a cohort of patients attending a specialized unit using HbA reduction and abscence of SH as combined goals.

METHODS

A retrospective, observational study on 178 patients with T1DM who started CSII treatment at Hospital Clinic of Barcelona between 2003 and 2008. HbA levels at baseline and after 5 years of treatment with CSII and presence or absence of SH were recorded. The combined variables calculated included: a) HbA reduction by≥0.5 points and absence of SH in the last 2 years; b) HbA at 5 years<7.5% and no SH in the last 2 years; c) HbA<8.5% and no HG in the last 2 years, and d) HbA reduction by≥0.5 points and/or HbA<7.5% at 5 years with no SH in the last 2 years of follow-up.

RESULTS

Twenty-seven of the 178 patients were excluded due to loss to follow-up or CSII discontinuation. A total of 151 patients (aged 37.4±10.5 years, 64% women, diabetes duration of 19.2±10.7 years) were therefore analyzed. The 2 main reasons for starting CSII were suboptimal metabolic control (60.9%) and severe hypoglycemia/hypoglycemia unawareness (28.5%). HbA levels in the total cohort and in patients with suboptimal metabolic control were 8.0±1.2 and 8.4±1.1% at CSII start and 7.8±1.2 and 8.0±1.3% at 5 years of treatment (P=.104 and P=.016) respectively. In the overall cohort, 55.5% of patients achieved at 5 years the combined goal of HbA<7.5% and/or HbA reductions≥0.5% without SH.

CONCLUSIONS

After 5 years of CSII therapy, more than half of the patients achieved the combined goal of significant HbA reduction and absence of SH. The use of combined goals offers the opportunity to assess the effectiveness of T1DM treatment from a clinically more meaningful point of view.

Copyright © 2019 SEEN y SED. Publicado por Elsevier España, S.L.U. All rights reserved.