Diabetologia

, Volume 57, Issue 5, pp 868–877

A randomised, controlled trial of self-monitoring of blood glucose in patients with type 2 diabetes receiving conventional insulin treatment

  • Michael A. Nauck
  • Burkhard Haastert
  • Christoph Trautner
  • Ulrich A. Müller
  • Matthias A. Nauck
  • Lutz Heinemann
  • for the Clinical Trials Study Group of the German Association for the Study of Diabetes (Deutsche Diabetes-Gesellschaft)
Article

DOI: 10.1007/s00125-014-3168-1

Cite this article as:
Nauck, M.A., Haastert, B., Trautner, C. et al. Diabetologia (2014) 57: 868. doi:10.1007/s00125-014-3168-1

Abstract

Aims/hypothesis

We evaluated whether self-monitoring of blood glucose (SMBG) leads to better glycaemic control (HbA1c) in patients with type 2 diabetes on conventional insulin regimens.

Methods

Patients with type 2 diabetes on a conventional insulin regimen (basal or premixed insulin with or without additional oral glucose-lowering agents) were recruited at study centres led by members of the German Diabetes Association. In a randomised, prospective, open 2 × 2 factorial design, the once-weekly performance of four-point glucose profiles (SMBG +; n = 151 patients) was compared with no SMBG (SMBG −; n = 149), and the measuring and transmitting of HbA1c results to the study centres (HbA1c +; n = 158, of these 82 SMBG − and 76 SMBG +) was compared with HbA1c measurement without disclosure of results (HbA1c −; n = 142, of these 67 SMBG − and 75 SMBG +). Randomised allocation was carried out by a central office, using sequentially numbered, sealed envelopes. The primary endpoint was the reduction of HbA1c compared with baseline after 12 months. Secondary analyses were of therapy intensification in response to higher blood or urinary glucose or HbA1c. Participants and caregivers were not blinded as to the allocation of interventions, whereas the laboratory determining HbA1c remained blinded.

Results

Patient characteristics were balanced across groups. A total of 56 patients dropped out. In completers, HbA1c was reduced in the SMBG + group from 7.3% to 7.0%, i.e. by 0.3% (0.1%, 0.5%) vs SMBG − from 7.3% to 7.0% and 0.3% (0.2%, 0.5%), respectively, the difference being 0.0% (−0.2%, 0.2%) (p = 0.93). The disclosure of HbA1c results had no significant influence, with a difference of 0.1% (−0.1%, 0.4%) (p = 0.28). Values above are mean (95% CI). The ORs for therapy intensification significantly rose as the following increased: proportions of urine samples testing positive for glucose, HbA1c concentrations, and fasting or postprandial glucose concentrations. No important adverse events were associated with the interventions.

Conclusions/interpretation

SMBG profiles once weekly or the disclosure of HbA1c results did not improve glycaemic control in patients with type 2 diabetes on conventional insulin treatment, although indicators of hyperglycaemia increased the likelihood of therapy intensification. Greater intensification may be necessary to impact on glycaemic control.

Trial registration:

www.clinicaltrials.gov (registration code NCT00688363)

Funding:

Deutsche Diabetes-Gesellschaft, Deutsche Diabetes-Stiftung, Bayer Vital GmbH

Keywords

Conventional insulin treatment Glycaemic control Glycated haemoglobin Self-monitoring of blood glucose Self-monitoring of urinary glucose Type 2 diabetes 

Abbreviations

LOCF

Last observation carried forward

SMBG

Self-monitoring of blood glucose

SMUG

Self-monitoring of urinary glucose

Supplementary material

125_2014_3168_MOESM1_ESM.pdf (11 kb)
ESM Fig. 1(PDF 10 kb)
125_2014_3168_MOESM2_ESM.pdf (10 kb)
ESM Fig. 2(PDF 10 kb)

Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Michael A. Nauck
    • 1
  • Burkhard Haastert
    • 2
  • Christoph Trautner
    • 3
    • 4
  • Ulrich A. Müller
    • 5
  • Matthias A. Nauck
    • 6
  • Lutz Heinemann
    • 7
  • for the Clinical Trials Study Group of the German Association for the Study of Diabetes (Deutsche Diabetes-Gesellschaft)
  1. 1.Diabeteszentrum Bad LauterbergBad Lauterberg im HarzGermany
  2. 2.mediStatisticaNeuenradeGermany
  3. 3.Ostfalia University of Applied SciencesWolfsburgGermany
  4. 4.Medicine Science ConsultingBerlinGermany
  5. 5.Endocrinology and Metabolic Diseases/Internal Medicine IIIJena University HospitalJenaGermany
  6. 6.Institut für Klinische Chemie und LaboratoriumsmedizinUniversitätsmedizin Greifswald, KöRGreifswaldGermany
  7. 7.Profil Institut für Stoffwechselforschung GmbHNeussGermany