THE EFFECT OF INTENSIVE DIABETES TREATMENT ON THE PROGRESSION OF DIABETIC-RETINOPATHY IN INSULIN-DEPENDENT DIABETES-MELLITUS - THE DIABETESCONTROL AND COMPLICATIONS TRIAL
H. Shamoon et al., THE EFFECT OF INTENSIVE DIABETES TREATMENT ON THE PROGRESSION OF DIABETIC-RETINOPATHY IN INSULIN-DEPENDENT DIABETES-MELLITUS - THE DIABETESCONTROL AND COMPLICATIONS TRIAL, Archives of ophthalmology, 113(1), 1995, pp. 36-51
Objective: To determine the magnitude of the decrease in the risk of r
etinopathy progression observed with intensive treatment and its relat
ionship to baseline retinopathy severity and duration of follow-up. De
sign: Randomized clinical trial, with 3 to 9 years of follow-up. Setti
ng and Patients: Between 1983 and 1989, 29 centers enrolled 1441 patie
nts with insulin-dependent diabetes mellitus aged 13 to 39 years, incl
uding 726 patients with no retinopathy and a duration of diabetes of 1
to 5 years (primary prevention cohort) and 715 patients with very mil
d to moderate nonproliferative diabetic retinopathy and a duration of
diabetes of 1 to 15 years (secondary intervention cohort). Ninety-five
percent of all scheduled examinations were completed. Interventions:
Intensive treatment consisted of the administration of insulin at leas
t three times a day by injection or pump, with doses adjusted based on
self-blood glucose monitoring and with the goal of normoglycemia. Con
ventional treatment consisted of one or two daily insulin injections.
Outcome Measures: Change between baseline and follow-up visits on the
Early Treatment Diabetic Retinopathy Study retinopathy severity scale,
assessed with masked gradings of stereoscopic color fundus photograph
s obtained every 6 months. Results: Cumulative 8.5-year rates of retin
opathy progression by three or more steps at two consecutive visits we
re 54.1% with conventional treatment and 11.5% with intensive treatmen
t in the primary prevention cohort and 49.2% and 17.1% in the secondar
y intervention cohort. At the 6- and 12-month visits, a small adverse
effect of intensive treatment was noted (''early worsening''), followe
d by a beneficial effect that increased in magnitude with time. Beyond
3.5 years of follow-up, the risk of progression was five or more time
s lower with intensive treatment than With conventional treatment. Onc
e progression occurred, subsequent recovery was at lease two times mor
e likely with intensive treatment than with conventional treatment. Tr
eatment effects were similar in all baseline retinopathy severity subg
roups. Conclusion: The results of the Diabetes Control and Complicatio
ns Trial strongly support the recommendation that most patients with i
nsulin-dependent diabetes mellitus use intensive treatment, aiming for
levels of glycemia as close to the nondiabetic range as is safely pos
sible.