Metabolic control and complications in Italian people with diabetes treated with continuous subcutaneous insulin infusion

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Highlights

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    The study marks the largest Italian study on glucose control in CSII-treated people.

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    The median HbA1c level among all participants was 60.0 mmol/mol (7.6%).

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    Patient skills on sensor use are associated with lower HbA1c levels.

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    The frequency of severe hypoglycaemia and ketoacidosis episodes was very low.

Abstract

Background and aim

The objective of this cross-sectional study was to evaluate the degree of glycaemic control and the frequency of diabetic complications in Italian people with diabetes who were treated with continuous subcutaneous insulin infusion (CSII).

Methods and results

Questionnaires investigating the organisation of diabetes care centres, individuals' clinical and metabolic features and pump technology and its management were sent to adult and paediatric diabetes centres that use CSII for treatment in Italy. Information on standard clinical variables, demographic data and acute and chronic diabetic complications was derived from local clinical management systems. The sample consisted of 6623 people with diabetes, which was obtained from 93 centres. Of them, 98.8% had type 1 diabetes mellitus, 57.2% were female, 64% used a conventional insulin pump and 36% used a sensor-augmented insulin pump. The median glycated haemoglobin (HbA1c) level was 60 mmol/mol (7.6%). The HbA1c target (i.e. <58 mmol/mol for age <18 years and <53 mmol/mol for age >18 years) was achieved in 43.4% of paediatric and 23% of adult participants. Factors such as advanced pump functions, higher rate of sensor use, pregnancy in the year before the study and longer duration of diabetes were associated with lower HbA1c levels.

The most common chronic complications occurring in diabetes were retinopathy, microalbuminuria and hypertension. In the year before the study, 5% of participants reported ≥1 episode of severe hypoglycaemic (SH) episodes (SH) and 2.6% reported ≥1 episode of ketoacidosis.

Conclusions

Advanced personal skills and use of sensor-based pump are associated with better metabolic control outcomes in Italian people with diabetes who were treated with CSII. The reduction in SH episodes confirms the positive effect of CSII on hypoglycaemia.

Clinical trial registration number

NCT 02620917 (ClinicalTrials.gov).

Introduction

In the past 25 years, continuous subcutaneous insulin infusion (CSII) has become a viable alternative to multiple daily insulin injections (MDIs) in people with type 1 diabetes mellitus (T1DM). Meta-analyses of both randomised controlled trials (RCTs) and observational studies have found lower glycated haemoglobin (HbA1c) level, less severe hypoglycaemic (SH) episodes and a better quality of life in people on CSII than those on MDI [1], [2], [3]. The limitations of these reviews, however, are the inclusion of MDI-treated individuals who do not use basal insulin analogue and CSII-treated individuals who use regular insulin. Recent studies comparing treatments with CSII and MDI along with insulin analogue showed less evident benefits for CSII [4], [5].

A sensor-augmented insulin pump (SAP) is an insulin pump that has the feature of continuous glucose monitoring (CGM). RCTs have shown that SAPs improve metabolic control without increasing SH episodes in individuals with T1DM with elevated HbA1c levels, and SAPs reduce the frequency and duration of hypoglycaemic events in individuals with satisfactory glucose control [6], [7], [8]. Recent studies have also suggested the protective role of CSII against chronic diabetic complications and cardiovascular mortality [9], [10], [11], [12], [13].

In 2013, we performed a survey on CSII in Italy and addressed the organisation of diabetes centres and care recipients and device characteristics [14]. Factors such as quality of glycaemic control and acute and chronic metabolic complications were not considered in that survey. In this study, we report a new survey to investigate metabolic control and diabetic complications in CSII-treated individuals in Italy.

Section snippets

Study design

In this multicentre cross-sectional study, data were collected using questionnaires sent by e-mail to adult and paediatric diabetes care centres that use CSII for treatment. Centres were identified from previous surveys and through information from companies selling CSII devices. Incomplete data were obtained by phone or e-mail and integrated.

Participants

Subjects treated with CSII for at least 1 year were consecutively enrolled among people who attended diabetes outpatient clinics between September 2015

Study participants and centres

Italy has 272 diabetes care centres that use CSII for treatment. Of them, 93 were included in the study – 21 offering paediatric care and 72 offering adult care – caring for 6623 patients.

In 41% of the adult care centres, the caring team composed of physician, dietician and nurse, whereas 71% of the paediatric centres had a team composed of physician, nurse, dietician and psychologist. Among the centres, 71% offering adult care and 86% offering paediatric care were available around the clock.

Discussion

We analysed metabolic control and acute and chronic diabetic complications in a cohort of Italian paediatric and adult individuals with diabetes mellitus who were treated with CSII. Participants belonged to 16 of the 19 regions of Italy.

We found that 43% of paediatric and 23% of adult individuals achieved age-specific HbA1c targets. Concerning adults, our data agree with the US T1D Exchange clinic registry, but considering the paediatric population, the fraction on target in Italy is almost

Conclusions

We provide an overview of the metabolic control and frequency of acute complications of diabetes in Italian individuals treated with CSII. Mean HbA1c levels were satisfactory, but only 43% of children and 23% of adults achieved their age-specific HbA1c target levels. Better metabolic control was associated with CHO counting, use of advanced pump functions, compliance with sensor use, pregnancy in the year before the study and longer duration of diabetes. The low frequency of SH episodes

Contributor statement

All authors contributed substantially to the study design; data collection, analysis and interpretation; and manuscript writing and revision. All authors approved the publication of the final version of the manuscript. No author received any specific grant from funding agencies in the public, commercial or non-profit sectors for the research.

Conflict of interest

GL acted as advisory board member for Eli Lilly, Boheringer Ingelheim and Merck Sharp & Dohme and received speaker honorary from Novo Nordisk, Sanofi Aventis and Astrazeneca.

RB acted as advisory board member for Lifescan, Novo Nordisk, Roche and Eli Lilly and received speaker honoraria from Eli Lilly, Abbott, Sanofi Aventis, Theras, Medtronic and Ypsomed.

LB none.

VDB none.

AG none.

GG acted as advisory board member for Johnson & Johnson and Novo Nordisk and received speaker honoraria from Novo

Acknowledgements

The authors thank the statistician Francesco Cavallin, MSc, for his critical, comprehensive review of our statistical analysis.

References (25)

  • V. Cherubini et al.

    Severe hypoglycemia and ketoacidosis over one year in Italian pediatric population with type 1 diabetes mellitus: a multicenter retrospective observational study

    Nutr Metab Cardiovasc Dis

    (2014 May)
  • M.L. Misso et al.

    Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus

    Cochrane Database Syst Rev

    (2010 Jan 20)
  • H.C. Yeh et al.

    Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis

    Ann Intern Med

    (2012 Sep 4)
  • J.C. Pickup et al.

    Severe hypoglycaemia and glycaemic control in Type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion

    Diabet Med

    (2008 Jul)
  • G.B. Bolli et al.

    Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study

    Diabetes Care

    (2009 Jul)
  • D. Bruttomesso et al.

    In Type 1 diabetic patients with good glycaemic control, blood glucose variability is lower during continuous subcutaneous insulin infusion than during multiple daily injections with insulin glargine

    Diabet Med

    (2008 Mar)
  • J1 Hermanides et al.

    Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial

    Diabet Med

    (2011 Oct)
  • R.M. Bergenstal et al.

    Threshold-based insulin-pump interruption for reduction of hypoglycemia

    N Engl J Med

    (2013 Jul 18)
  • T.T. Ly et al.

    Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: a randomized clinical trial

    J Am Med Assoc

    (2013 Sep 25)
  • G. Lepore et al.

    Continuous subcutaneous insulin infusion is more effective than multiple daily insulin injections in preventing albumin excretion rate increase in Type 1 diabetic patients

    Diabet Med

    (2009 Jun)
  • S. Rosenlund et al.

    Effect of sensor-augmented pump treatment versus multiple daily injections on albuminuria: a 1-year randomized study

    J Clin Endocrinol Metab

    (2015 Nov)
  • S. Rosenlund et al.

    Effect of 4 years subcutaneous insulin infusion treatment on albuminuria, kidney function and HbA1c compared with multiple daily injections: a longitudinal follow-up study

    Diabet Med

    (2015 Nov)

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    A complete list of members of the Italian Study Group on Diffusion of CSII can be found in the Appendix.

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    © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.