My daughter has been in a research study using Lispro insulin. She had two reactions this week, one very serious -- . She had two reactions this week, one very serious -- comatose for over an hour in hospital, the second not so serious, but hospital visit required. We will probably step out of the study tomorrow, but feel badly as we had hoped this would work for us and perhaps others. Have you had many people withdraw from studies that you have conducted, and if so, does it really mess up the study? I wanted to keep our daughter in the study, but feel that she has tried and now because of the low blood sugar reactions, she is basically not a great candidate for the study.
Please let me know how many people, on average, start a study and have to quit the study.
Also, have you heard if Lispro is causing more low blood sugar reactions than the usual R insulin?
I am sorry that you have had so much trouble with Lispro. This substituted insulin starts to work in about ten minutes and its action is for the most part gone in four hours. Ordinary Regular insulin takes significantly longer to become effective, and may have some action for as long as eight hours.
One of the main advantages of Lispro is that you can give it right after a meal and in this way take account of the pre-meal blood sugar as well as appetite. By the same token, when using Lispro you do need to give it either right before or right after a meal and to be prepared to reduce the dose if the before meal blood sugar is unusually low.
Our experience has been that with this new insulin there has been some increase both in mild lows soon after the meal and some increase in high readings just before the next meal or at bedtime and because of this sometimes a doctor will advise mixing Lispro with Regular or giving Lispro at some injection times and Regular at others (e.g., Regular in the morning and Lispro at supper time).
In most clinical studies the investigator tries to compare a group that is getting a new treatment with one that is being looked after in a standard way, a 'test' and a 'control' group and of course you always hope that everyone will continue until the study ends. If someone drops out that counts as a 'failure of treatment'; but when you come to evaluate the results you have to try to disentangle those who leave a study inadvertently because they move to another part of the country for example from those that leave because of adverse effects. The researchers are still able to effect a statistical comparison both beneficial and otherwise of treatment on those that have stayed the course.
Original posting 3 May 97
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