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

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 HbA_lc 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 HbA_1c 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.