Study Examines Intensive Therapy and Children
Highlights from The 59th Scientific Sessions of the American Diabetes Association in San Diego
During the 1999 ADA Scientific Sessions, Tim Wysocki, PhD presented information on an ongoing study of Intensive Therapy and Children (Advances in Behavioral Medicine, Thursday June 18, 1999).
The Study is funded by the National Institutes of Health, and is designed to gain insight into some of the safety and efficacy issues of intensive insulin therapy (IT) in children. The Diabetes Control and Complications Trial (DCCT), studied only adults and teenagers. This new study will look at 160 children between the ages of 6 and 15 years, and follow them for 18 months. The study will try to identify information about knowledge, social and behavioral factors, as well as level of diabetes control, frequency of severe hypoglycemia, and weight gain. The study will try to specify what self-management behaviors might identify who would benefit from intensive insulin therapy versus standard diabetes care.
At this time 107 children are participating in the study. The children are receiving their diabetes care at one of two children's diabetes centers (at the Nemours Children's Clinic in Jacksonville, Florida or at Washington University in St. Louis, Missouri). The children are randomized into either the standard or intensive therapy group.
The standard treatment group will continue to receive up-to date diabetes care which involves 4 visits per year to the doctor and nurse, 3-4 blood sugars per day, annual free dietitian and mental health provider visits. They will have as needed phone access to the diabetes team. The hemoglobin A1c target will be less than 8%, and blood sugar goals of 70-150 mg/dl.
The intensive therapy group will have more frequent contact with the diabetes team. These participants will have weekly phone contact with the diabetes team, monthly nurse visits and quarterly physician visits. They will have as needed access to dietian and mental health provider. The intensive therapy group will have goals to keep their blood glucose levels between 70-120 mg/dl before meals, and less than 180 mg/dl after meals. Their hemoglobin A1c goal will be less than 6.5%.
The outcomes measured from this study will be hemoglobin A1c, information on severe hypoglycemia, weight gain, and use of health care services. The participants will be assessed periodically on criteria concerning psychosocial and quality of life issues. They will keep diaries of blood sugars and hypoglycemia factors, and have their blood glucose meters downloaded.
The participants who were randomized to the standard treatment group will be offered the opportunity of intensive therapy at the end of the study.
Comments: The DCCT and other studies have offered invaluable information about the importance of tight control in adolescents and adults. Those of us who care for children with diabetes, and families of children with diabetes, wrestle with the issues of where tight control fits in for children. We know that very young children are at risk from tight control due to the recurring hypoglycemia, but what about the child over the age of 6 or 7 years? We look forward to the information gained from this study to help us in our approach to the care of children with diabetes.
Posted July 3, 1999
Last Updated: Thursday August 29, 2002 20:59:48
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