Oscar Crofford: On the horns of a revolution pg. 5
It was also one of the most difficult. Participants were randomly assigned to a “treatment group” or a “control group,” as is the case in most clinical trials, but those in the treatment group required an unprecedented amount of monitoring by health professionals.
These participants used an insulin pump or gave themselves three or more insulin injections every day, monitored their blood glucose at least four times a day, and adjusted their insulin dose accordingly. They also visited their study center once a month and were in frequent phone contact with the researchers to review and adjust their regimens.
In comparison, participants in the control group gave themselves one or two insulin injections a day, at the time the standard treatment for type 1 diabetes. They did not adjust their insulin dose as frequently, and they were examined once every three months.
Smooth as a United Nations diplomat, Crofford worked to reach consensus and to resolve disputes that could have stopped the study in its tracks.
“I’d say Oscar masterfully allowed, fostered, stimulated, directed and finally concluded those discussions in a way that we had a sound protocol,” says Dr. Saul Genuth, professor of Medicine at Case Western Reserve University in Cleveland, Ohio, who was vice chair of the DCCT and chaired its planning committee. “Oscar pushed us when we needed to be pushed, and he pulled us when we needed to be pulled.”
Just as important to the study’s success were the participants themselves. “They weren’t human guinea pigs,” Crofford says. “They were partners in doing the most important study in diabetes that had ever been done since the discovery of insulin. If they dropped out, they were not only hurting themselves but they might blow the whole study ... So they had to be part of the team.”
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