1. In a follow-up study of over 1400 patients with type 1 diabetes (T1DM), patients who received intensive therapy demonstrated a significant reduction in cardiovascular disease at 30 years follow-up compared to conventional therapy.
Evidence Rating Level: 3 (Average)
Study Rundown: The Diabetes Control and Complications Trial (DCCT) was a landmark trial that randomized patients with T1DM to 6.5 years of intensive diabetic therapy versus conventional diabetes treatment. The DCCT demonstrated that intensive diabetic therapy at the time of diagnosis significant reduced the progression of diabetic retinopathy, nephropathy, and neuropathy compared to conventional therapy. This study is the 30-year follow-up of the participants of the DCCT to evaluate the long-term effects of intensive diabetic therapy.
Health outcomes of over 1200 patients with T1DM 30 years after the original DCCT trial were reviewed. At the conclusion of the study, patients formerly in the intensive treatment group demonstrated significantly reduced incidence of cardiovascular disease, major cardiac events and cardiac death at 30-years follow-up. The study supports the hypothesis that early, intensive diabetic intervention may have positive long-term benefits on CVD in patients with T1DM, even after such treatment regimen has stopped. The study is strengthened by the strong and robust cohort established by the DCCT trial. However, the study does include a small number of total CVD events and excluded individuals with preexisting hypertension, hyperlipidemia, or CVD, which may limit the external generalizability of these results.
In-Depth [retrospective cohort]: The DCCT trial, published in 1993, randomized 1441 patients with T1DM (age 13 to 39) to receive either conventional therapy or intense diabetes therapy over an average of 6.5 years. The intensive therapy consisted of at least three insulin injections, or an infusion pump with at least four glucose measurements per day. Specific glucose goals were set as 70–120 mg/dL before meals and 180 mg/dL after meals. The conventional therapy consisted of 1-2 insulin injections and no consequent goals apart from preventing hypo and hyperglycemia. This trial was the 30 year follow-up trial to determine the outcomes of patients originally recruited in the DCCT trial. In total, 1236 patients from the original trials were included in this analysis. The primary outcome was any of the following events: myocardial infarction or stroke, death, angina, coronary heart failure, and coronary artery revascularization. At the conclusion of the trial, there were 149 cardiovascular outcomes in 82 patients who received intensive therapy, and 217 events in 102 patients who received conventional therapy. There was a 30% reduction in CVD among those who received intensive therapy (95% CI: 7.0 to 48; p = 0.016). Additionally, patients who were randomized to the intensive therapy had a trend towards decreased incidence of non-fatal myocardial infarction (95% CI: -3.0 to 56.0; p = 0.07).
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