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Randomized Study of Two Different Target Levels of Glycemic Control Within the Acceptable Range in Type 2 Diabetes: Effects on well-being at 1 year

  1. Ferdinand E E Van Der Does, MD, PHD,
  2. J Nico D De Neeling, PHD,
  3. Frank J Snoek, PHD,
  4. Peter A Grootenhuis, MD, PHD,
  5. Pieter J Kostense, PHD,
  6. Lex M Bouter, PHD and
  7. Robert J Heine, MD, PHD
  1. Institute for Research in Extramural Medicine, Vrije Universiteit Amsterdam, the Netherlands
  1. Address correspondence and reprint requests to Robert J. Heine, MD, PhD, Department of Endocrinology, Vrije Universiteit Hospital, P.O. Box 7057, NL-1007 MB Amsterdam, the Netherlands. E-mail: rj.heine{at}azvu.nl

Abstract

OBJECTIVE A randomized trial with 1-year follow-up was conducted in 23 general practices to study the relationship between target values for glycemic control and well-being in type 2 diabetes

RESEARCH DESIGN AND METHODS A total of 176 patients with type 2 diabetes, aged 40–75 years, were included. General practitioners were encouraged to make decisions according to a standardized step-up regimen until the target levelof glycemic control was reached. The random allocation to a strict or a less strict target level of glycemic control (fasting capillary glucose <6.5 or <8.5 mmol/;1), change in HbAlc and fasting glucose, and initiating insulin or treatment with oral hypoglycemic agents were studied as putative determinants of scores on a type 2 diabetes symptom checklist, a profile ofmood states, an affect balance scale, and general well-being. Adjustments were made for baseline scores on the outcome at issue.

RESULTS Positive affect (an odds ratio [OR] [95% CI] of 0.39 [0.19–0.83]) and perceived treatment burden (OR 0.48[0.23–0.98]) were unfavorably altered in the group randomly allocated to stricter target levels (fasting capillary glucose <6.5 mmol/l). Patients who had a decrease in HbA1c of 1% or more tended to have comparatively favorable mood (OR displeasure score 0.35 [0.13–0.94]) and general well-being scores at 1 year (ORs of having unfavorable scores ranged from 0.4 to 0.5, NS).

CONCLUSIONS Perceived treatment burden and positive effect are unfavorably affected by random allocation to a strict target level for glycemic control. Improved glycemic control is associated with favorable mood and possibly general well-being in type 2 diabetes.

  • Received January 28, 1998.
  • Revision received August 28, 1998.
  • Accepted August 28, 1998.
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