Sunday, May 11, 2008

Remembering landmark trials of the past - DCCT(1993)

Type 1 Diabetes or Insulin dependent Diabetes accounts for a small proportion of total diabetic population, but has younger age of onset. The younger the age the more are they affected by glycemic control. The Diabetes Control and Complications trial was done in Type 1 Diabetics to assess the effect of glycemic control not only on preventing complications but also on the progression of complications.

Key points:
  • 1,441 subjects with type 1 diabetes were enrolled
  • 726 subjects within 5 yrs of DM and no complications(primary cohort) - randomised to Intensive and conventional arms(1:1)
  • 715 subjects within 15 yrs and had mild retinopathy and microalbuminuria(Secondary cohort) - randomised to Intensive and conventional arms(1:1)
  • Intensive Rx arm used CSII(insulin pump) or by MDI injections (three or more injections per day); self monitoring of glucose 3-4 times daily, meticulous attention to diet; and monthly visits to the treating clinic.
  • Conventional Rx arm used no more than two daily insulin injections; urine glucose monitoring or SMBG no more than twice-daily; periodic diet review; and clinic visits every 2-3 months.
  • Intensive arm had median HbA1C throughout the study of 7.2% vs. 9.1% in the Conventional arm
  • Macrovascular events, either cardiac or peripheral vascular, were not significantly reduced. There was a 41% nonsignificant risk reduction in Intensive arm when episodes of cardiac and peripheral vascular events were combined.


  • The most important adverse event associated with Intensive Rx was a three-fold increase in 'severe' hypoglycaemia (episodes requiring assistance of another person to recover), including a three-fold increased risk of coma or seizures.

Intensive therapy, with the goal of achieving glucose levels as close to the nondiabetic range as possible, should be employed in most patients with type 1 diabetes. - DCCT


DCCT - Original Article In NEJM

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