RANDOMIZED STUDY OF 2 DIFFERENT TARGET LEVELS OF GLYCEMIC CONTROL WITHIN THE ACCEPTABLE RANGE IN TYPE-2 DIABETES - EFFECTS ON WELL-BEING AT1-YEAR

OBJECTIVE - A randomized trial with 1-year follow-up was conducted in 23 general practices to study the relationship between target values f or 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 d ecisions according to a standardized step-up regimen until the target level of glycemic control was reached. The random allocation to a stri ct or a less strict target level of glycemic control (fasting capillar y glucose <6.5 or <8.5 mmol/l), change in HbA(1c) and fasting glucose, and initiating insulin or treatment with oral hypoglycemic agents wer e studied as putative determinants of scores on a type 2 diabetes symp tom checklist, a profile of mood states, an affect balance scale, and general well-being. Adjustments were made for baseline scores on the o utcome 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 stri cter target levels (fasting capillary glucose <6.5 mmol/l). Patients w ho had a decrease in HbA(1c) of 1% or more tended to have comparativel y favorable mood (OR displeasure score 0.35 [0.13-0.94]) and general w ell-being scores at 1 year (ORs of having unfavorable scores ranged fr om 0.4 to 0.5, NS). CONCLUSIONS - Perceived treatment burden and posit ive effect are unfavorably affected by random allocation to a strict t arget level for glycemic control. Improved glycemic control is associa ted with favorable mood and possibly general well-being in type 2 diab etes.