Previous DirecNet Studies

The Accuracy of Continuous Glucose Monitors in Children with Type 1 Diabetes

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This study evaluated the accuracy of the CGMS and GWB in 89 children with T1DM between the ages of 3 and 17 yr who were admitted to a Clinical Research Center for 24 hours. Blood sugar values from the CGMS and GWB were compared with “gold standard” blood sugar values that were obtained every 30-60 minutes during the day and night and every 5 min during induced hypo- and hyperglycemia.

A Pilot Study to Assess the Accuracy of Continuous Glucose Monitors in Normal Children

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This study evaluated the accuracy of the CGMS and the GWB in normal children while examining the 24-hour pattern of glucose concentrations. Fifteen healthy children 9-17 years of age (11 boys/4 girls) with no family history of type 1 diabetes and normal BMI were admitted to a Clinical Research Center for 24 hours. Blood sugar values from the CGMS and GWB were compared with “gold standard” blood sugar values that were obtained every 30-60 minutes during the day and night

A Pilot Study to Evaluate the GlucoWatch 2 Biographer in the Management of Type 1 Diabetes in Children

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This 3-month pilot study was conducted to assess the feasibility of using PCs in the home for computer-based data acquisition and transmission in a larger 12-month study. Fifteen subjects with T1DM (age range 7.3-17.9 years) were provided with a GW2B and a OneTouch Ultra® meter along with a personal computer and software for downloading glycemic data for each device. The PC was also used weekly to complete a questionnaire regarding hypoglycemia and problems with using the GW2B. Patients were able to view Ultra and GW2B data at any time on the PC. Each week, the data were uploaded to the study coordinating center and made available to the clinical centers on a secure website. Therapeutic changes were based on the downloads, hypoglycemia questionnaires, and telephone contacts with clinical centers. Quality of life, diabetes self-management behaviors and satisfaction with GW2B use were measured periodically.

A Randomized Trial to Assess the Effectiveness of the GlucoWatch Biographer in the Management of Type 1 Diabetes in Children

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This randomized trial was conducted to assess whether use of the GlucoWatch G2 Biographer (GW2B) with standard glucose monitoring (SGM) lowers HbA1c and the frequency of hypoglycemia in comparison to use of standard blood glucose monitoring alone. Two hundred subjects aged 7 to 18 years were randomized to SGM or SGM plus GW2B use for 6 months. Other than use of the GW2B sensor, both groups were managed as similarly as possible. Subjects in both groups were provided with a PC to download sensor and meter results, to review glucose data as an aid in self-management, and to complete a questionnaire each week.

The Effect of Exercise on the Development of Hypoglycemia in Children with Type 1 Diabetes

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The main purpose of this study was to find out how often low blood sugar (hypoglycemia) happens during the night after exercise in the late afternoon. The study also looked at whether or not there are any factors that can predict if low blood sugar is going to develop. Blood samples were drawn to measure the blood sugar overnight and during exercise. Blood samples were also drawn to measure hormones to see how they are affected by exercise. Fifty subjects age 10 to 18 years were hospitalized in a research unit of a hospital for two days. During one of the two days (ordered through randomization), a structured exercise protocol was completed in the late afternoon. On the other day, the subjects did not exercise. The subjects’ meals and insulin doses were kept as similar as possible on both days.

The Effect of Basal Insulin During Exercise on the Development of Hypoglycemia in Children with Type 1 Diabetes

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This study was done to find out if decreasing the insulin that is received during exercise can make low blood sugar (hypoglycemia) less likely. Fifty-five subjects age 8 to 17 years were seen during two outpatient visits each with a 75-minute exercise session in the late afternoon. The basal insulin rate from the subject’s insulin pump was continued during the exercise on one exercise day. On the other exercise day, the basal rate was discontinued at the start of exercise and not restarted until the end of the 45-minute post-exercise observation period. A CGMS continuous glucose monitor was used on both exercise days. Blood samples were collected and blood sugar measurements were performed throughout both visits to determine changes in blood sugar levels during exercise. Blood samples were also drawn to measure hormones to see how they are affected.

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