This document summarizes a randomized controlled trial that studied the effects of intensive versus conventional diabetes therapy in 1441 patients with type 1 diabetes between 1983-1989. The trial had two arms - a primary prevention arm of patients with diabetes for 1-5 years and no complications, and a secondary prevention arm of patients with diabetes for 1-15 years and some retinopathy or nephropathy. The intensive therapy group achieved significantly lower average blood glucose and HbA1c levels. In both prevention arms, intensive therapy reduced the risk of retinopathy, nephropathy, and neuropathy compared to conventional therapy, with risk reductions ranging from 34-76%. However, intensive therapy also led to higher rates of hypoglycemia.

1. Aftab Aziz
19/12/13

2. 1441 pt with T1DM
Secondary
Prevention
Primary Prevention
n=726
Conventional
therapy
n=378
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•
•
•
•
Intensive therapy
n=348
n=715
Conventional
therapy
n=352
Intensive therapy
n=363
Randomised, multicentre trial
1441 pts recruited from 29 centres 1983-89
Av follow-up was 6.5 yrs (mean 3-9)
Inclusion age 13-39 yrs, Type 1 DM
Primary prevention arm
– 1-5 yrs DM, no retinopathy or nephropathy
• Secondary prevention arm
– 1-15yrs DM, M NPRetinopathy, Ur Microalb <200mg/24 hrs

3. Glycemic control
16.6
13.8
11.1
8.3
5.5
• HbA1c improvement in intensive vs. conventional treated
group (p0.001)
• Mean glucose level 8.6mmol/l vs. 12.8mmol/l (p<0.001)

4. Retinopathy
• Primary prevention group (Intensive vs. conventional)
– 23 vs 91 pts developed retinopathy in 6 years followup (Mean risk
reduction 76%)
• Secondary prevention group (Intensive vs. conventional)
– 77 vs 143 pts developed progressive retinopathy (Mean risk reduction
54%)
– 47% reduction of severe retinopathy, 56% reduction in laser
photocoagulation
• Transient worsening of retinopathy (22% vs. 13%) 18 months

5. Nephropathy
• Primary prevention group
– Mean risk reduction for microalbuminuria by 34% (p 0.04) intensive gp
• Secondary prevention group
– Mean risk reduction for microalbuminuria by 43% (p 0.001) intensive gp
• Risk reduction in albuminuria (54%) and microalbunimuria
(39%) in intensive treatment arms

6. Neuropathy
• Primary Prevention group
– 3% vs 10% developed neuropathy (69% reduction of neuropathy by 5
years, p0.006)
• Secondary Prevention group
– 7% vs 16% developed neuropathy (57% reduction of neuropathy by 5
years)

7. Secondary analysis
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Severe hypoglycemic episodes 62 vs. 19/100 pt yrs
Hypoglycemia Coma / seizure episodes 16 vs. 5/100 pt yrs
Hospitalisation 54/40 pts vs. 36/27 pts
Major accidents 20 vs. 22 (2 fatalities, 1 vs. 1)
No difference in neuropsycholgical function
No death, MI or stroke
Wt gain ( overweight 12.7 vs. 9.3 /100 pt yrs)