Investigators:
- Tim Wysocki, PhD
Background
The purpose of the study is to test some mathematical methods to analyze blood sugar test results to see if these can be used to predict a patients future risk of severe low blood sugar reactions and future glycosylated hemoglobin (Hemoglobin A-1-C) level. If these methods work, it may be possible to use them in automatic systems that warn patients with diabetes about their risks of these problems and help them to keep these problems from happening.
What We're Doing
Children ages 6 to 11 who have had type 1 diabetes for at least one year are eligible to participate. Each child and parent is in the study for 6 months. This includes one initial visit and two more brief trips to the clinic 3 months and 6 months later. At the initial visit, an intravenous blood sample is taken for a glycosylated hemoglobin test, and participants are given a packet of measures to complete and a blood glucose meter and testing supplies. Children will test their blood with a study meter four times a day for six months. Parents will report on diabetes-related events by automated phone interviews or e-mail messages a total of 12 times during the study. The child will return to the clinic 3 months and 6 months after the initial visit so that an intravenous blood sample for a glycosylated hemoglobin test can be obtained. Investigators will use the blood glucose results from the meters and the hemoglobin A1c results to test the mathematical models they are developing.
Some of What We've Found
This study is being conducted as the second phase of a three-part study. Previously, investigators developed several mathematical models that are used to predict HbA1c and the occurrence of episodes of severe hypoglycemia in adults. In this phase of the study, investigators are testing and validating these models to see if they make accurate predictions for children. There are not sufficient data at this time to draw any conclusions about the effectiveness of these models with children, but investigators expect that this study will allow them to refine the models so that they will be useful in this population.