Lowering elevated glucose has long been viewed as the primary goal in the treatment of diabetes mellitus. Furthermore, this goal has come into renewed focus after the publication of the Diabetes Control and Complications Trial (DCCT) in the September 1993 issue of The New England Journal of Medicine. The DCCT, a pivotal study in the treatment of diabetes, concluded that improved glycemic control reduces the progression of microvascular complications caused by diabetes, namely retinopathy and neuropathy. However, concerns have been raised that the currently available therapies fall short of achieving tight glycemic control. Furthermore, it has been proposed that these shortcomings are related to an inability to match the dosing and timing of insulin to a patient's rise in glucose following a food load. Carbohydrates, proteins, and fats all affect blood glucose differently. Particularly, the effect of different carbohydrates on glucose can vary depending on the amount of fiber, type of simple sugar (glucose, fructose, etc.) involved, or rapidity of breakdown of starch to simple sugars. This study's purpose is to collect information from two patients with type I diabetes mellitus in order to determine whether it is feasible to develop a novel devise and software which will allow patients to evaluate and predict the degree of metabolic control they can achieve with a specific dose of insulin on a particular diet. If such a program could be developed it would help the diabetic population gain further glycemic control. Per protocol, two patients were evaluated for a 4 day hospitalization, including baseline hemoglobin A1c and fructosamine, and hourly glucose levels. Additionally, patients were fed standard meals based on their caloric needs, and reproduced for the whole admission; additional glucose levels were obtained every 15 minutes for two hours after each meal and bedtime snack (all glucose data obtained from a bedside meter). Both patients continued with their prescribed pre-study intensive insulin regimen (one patient was on a external continuous subcutaneous insulin pump with pre-meal boluses, and one patient was injecting subcutaneous regular insulin before three meals and NPH insulin at bedtime daily). The study has been completed and the data has been forwarded to Array Vision Engineering Inc., for analysis. The NIH funded this pilot program, and, pending the results from this study, there may future studies to further develop this program.

Project Start
1975-10-01
Project End
1998-11-30
Budget Start
1996-10-01
Budget End
1997-09-30
Support Year
36
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Duke University
Department
Type
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705
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