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Sample Letter To Participants
Dear ACCORD Participant,
We are writing you to share with you important news about an important outcome in one of the three trials in ACCORD. As a valued study participant, you are receiving this information before an announcement is made to the general public and news media on Wednesday, February 6, 2008.
Due to safety concerns, the ACCORD intensive blood sugar treatment group is being changed to that of the standard group. Please do not change anything without first consulting with your ACCORD study staff. Regardless of treatment group, we will continue to treat your diabetes until the study ends as planned in the spring of 2009. The lipid or blood pressure trials will continue without change.
Why the change? ACCORD has found a higher risk of death in the intensive group than in the standard group. Specifically, for every 1,000 participants treated in each group for one year, about 14 people in the intensive group would die compared to about 11 in the standard group. While our data indicate an increased risk of death in the intensive group, this risk to an individual is very small and still lower than in the general Type 2 diabetes population.
What does this mean for you? If you are in the standard group--there will be no changes in your blood sugar management, visit schedule or A1C goal.
If you are in the intensive group--Your new A1C goal will be 7.0 to 7.9%. The ACCORD team will help you safely adjust your medications to reach this new goal. To do this, a "transition" appointment will be scheduled with you. At this visit, you will be given details about the visit schedule and medication changes. You will also be able to ask questions and discuss your concerns.
At this time, ACCORD investigators are not sure why the risk of death is higher in the intensive group. Experts have carefully and extensively analyzed the data to find a reason, but no specific cause has been found to date. ACCORD will be conducting additional analyses to try and explain this finding.
We thank you for your dedication and commitment to this important study. You, and thousands of other participants, have allowed us to answer the important question of whether tighter glucose control is better than standard control. Your continued participation will help us answer critical questions about blood pressure and lipid treatment for type 2 diabetes patients.
We know you may have questions and we will be glad to answer them. You will receive a call from your ACCORD clinic very soon. At this time, we respectfully request that you keep this information confidential until Wednesday, February 6th. However, if you have questions before then, please contact us at the phone number below. More information will be available on the ACCORD Web site on February 6 at www.accordtrial.org.
[Signed by clinical site investigator]
Last Updated June 2011