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Recruitment to a clinical trial improves glycemic control in patients with diabetes

¹ Diabetes and Metabolism, University of Bristol
² Eli Lilly and Company, Indianapolis, IN, USA
³ Lilly Research Laboratories, Hamburg, Germany

Edwin.Gale{at}bristol.ac.uk

ABSTRACT

Objective: We assessed the effect of recruitment to a clinical trial upon HbA1c in patients with diabetes who had been screened and interviewed to determine eligibility, but whose therapy was otherwise unchanged.

Research Design and Methods: Eligible trials were selected from the global program of an insulin manufacturer. Included were studies in which patients were seen on a single screening visit, pharmaceutical therapy was not altered before randomization, and HbA1c was measured in a central laboratory at both screening and randomization. Three trials involving patients with type 1 diabetes (n= 429) and three trials with type 2 diabetes (n=611) were identified for analysis. The main outcome measure was change in HbA1c. Separate regression equations on the change in HbA1c were fitted for type 1 and type 2 diabetes, and included effects of baseline HbA1c and interval between the screening and randomization visits.

Results: HbA1c changed by –0.13% (range +0.09 to –0.26 %) in those with type 1 diabetes at a median of 28 days, and by –0.16% (range –0.14 to –0.27 %) for those with type 2 diabetes (median 14 days). The mean change in HbA1c in those with an interval 28 days was –0.24% (type 1 diabetes) and –0.23% (type 2 diabetes). The reduction was proportional to initial HbA1c, with large decreases in those with the poorest initial control, but no overall change in those at or below the 10^th percentile of HbA1c.

Conclusion: Recruitment to a clinical trial, independent of any therapeutic intervention, produces improvements in glucose control.

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