Trial information
A Study of Accu-Chek Advisor Insulin Guidance Software in Adolescents and Young Adults With Type 1 Diabetes Mellitus.
Status: Completed
Protocol number: 2005-09
Sponsor: Roche Diagnostics
Company division: Diagnostic
Brief summary: This study compares the standard of care to standard of care plus the use of Accu-Chek Advisor Insulin Guidance Software for personal data assistants in adolescents and young adults diagnosed with Type 1 diabetes. Clinic visits are scheduled every 3 months. The anticipated duration of the trial is 12 months, and the target sample size is 160 individuals.
Study type: Interventional study
Condition: Diabetes Mellitus, Type 1
Intervention type: Diagnostic Test
Intervention name: Accu-Chek Advisor Insulin Guidance Software
Inclusion criteria:
- male or female subjects, 12–21 years of age;
- Type 1 diabetes for ≥1 year before enrollment;
- HbA1c ≥7.5% and <=12%;
- dual-insulin regimen (≥2 daily injections) supported by Accu-Chek Advisor software;
- weight between 100 and 300 pounds;
- agreement to perform ≥3 pre-meal capillary blood glucose testing per day.
Exclusion criteria:
- continuous subcutaneous insulin infusion therapy (insulin pump);
- insulin regimen not supported by Accu-Chek Advisor software;
- any condition that may cause significant increase of insulin sensitivity factor (eg, need for corticosteroid therapy, diabetic ketosis, or insulin-resistant syndrome);
- pregnancy;
- other chronic disease such as cancer and renal failure;
- major phsychological disturbance.
Gender: Males or Females
Accepts healthy volunteers: No
Anticipated start date: August, 2005
Trial registration date: 08/08/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
United States
